SOMA (WATSON BRAND) Soma Indications This medicine is used with rest and physical therapy to treat acute, painful muscle conditions Contraindications Do not take this medication if - you are allergic to any ingredient of this medicine ... more Soma Tablets (carisoprodol) Tablets, USP DESCRIPTION `SOMA' (carisoprodol) Tablets, USP is available as 350 mg round, white tablets. Chemically, carisoprodol is N-isopropyl-2- methyl-2-propyl-1,3-propanediol dicarbamate. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. The molecular formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33. The structural formula is: Other ingredients: alginic acid, magnesium stearate, potassium sorbate, starch, tribasic calcium phosphate. ACTIONS Carisoprodol produces muscle relaxation in animals by blocking interneuronal activity in the descending reticular formation and spinal cord. The onset of action is rapid and effects last four to six hours. INDICATIONS Carisoprodol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Carisoprodol does not directly relax tense skeletal muscles in man. CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncratic reactions to carisoprodol or related compounds. WARNINGS Idiosyncratic Reactions --On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic symptoms appearing within minutes or hours. Symptoms reported include: extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Symptoms usually subside over the course of the next several hours. Supportive and symptomatic therapy, including hospitalization, may be necessary. Usage in Pregnancy and Lactation --Safe usage of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients. Usage in Children --Because of limited clinical experience, `SOMA' is not recommended for use in patients under 12 years of age. Potentially Hazardous Tasks --Patients should be warned that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. Additive Effects --Since the effects of carisoprodol and alcohol or carisoprodol and other CNS depressants or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. Drug Dependence --In dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol from dosages as high as 1 gm/kg/day. In a study in man, abrupt cessation of 100 mg/kg/day (about five times the recommended daily adult dosage) was followed in some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia, chilliness, headache, and nausea. Delirium and convulsions did not occur. In clinical use, psychological dependence and abuse have been rare, and there have been no reports of significant abstinence signs. Nevertheless, the drug should be used with caution in addiction-prone individuals. PRECAUTIONS Carisoprodol is metabolized in the liver and excreted by the kidney; to avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function. ADVERSE REACTIONS Central Nervous System --Drowsiness and other CNS effects may require dosage reduction. Also observed: dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia. (See also Idiosyncratic Reactions under "Warnings." ) Allergic or Idiosyncratic --Allergic or idiosyncratic reactions occasionally develop. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruption with cross reaction to meprobamate have been reported with carisoprodol. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. (See also Idiosyncratic Reactions under "Warnings." ) In case of allergic or idiosyncratic reactions to carisoprodol, discontinue the drug and initiate appropriate symptomatic therapy, which may include epinephrine, antihistamines, and in severe cases corticosteroids. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request). Cardiovascular --Tachycardia, postural hypotension, and facial flushing. Gastrointestinal --Nausea, vomiting, hiccup, and epigastric distress. Hematologic --Leukopenia, in which other drugs or viral infection may have been responsible, and pancytopenia, attributed to phenylbutazone, have been reported. No serious blood dyscrasias have been attributed to carisoprodol. DOSAGE AND ADMINISTRATION The usual adult dosage of `SOMA' (carisoprodol) Tablets, USP is one 350 mg tablet, three times daily and at bedtime. Usage in patients under age 12 is not recommended. OVERDOSAGE Overdosage of carisoprodol has produced stupor, coma, shock, respiratory depression, and, very rarely, death. The effects of an overdosage of carisoprodol and alcohol or other CNS depressants or psychotropic agents can be additive even when one of the drugs has been taken in the usual recommended dosage. Any drug remaining in the stomach should be removed and symptomatic therapy given. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously as indicated. Carisoprodol is metabolized in the liver and excreted by the kidney. Although carisoprodol overdosage experience is limited, the following types of treatment have been used successfully with the related drug meprobamate: diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is dialyzable). Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. Carisoprodol can be measured in biological fluids by gas chromatography (Douglas, J. F. et al.: J Pharm Sci 58: 145, 1969). HOW SUPPLIED `SOMA' (carisoprodol) Tablets, USP 350 mg: Round, convex, white tablets, inscribed with `SOMA' on one side and 37-WALLACE 2001 on the other side, are available in bottles of 100 (NDC 0037-2001-01) and 500 (NDC 0037-2001-03), and unit-dose packages of 100 (NDC 0037-2001-85). PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Are your Dyslexic? Great info on Dyslexia diagnosis, symptoms & treatments. infoscouts.com Lorazepam-Reviewed Is Lorazepam the right prescription medicine for you? Find out. ConsumerHealthDigest.com "Are you dizzy ?" You may have Labyrinthitis Find treatment and remedy options InfoForYourHealth.com Soma (Carisoprodol) on Sale Now 90 tabs $84, 180 tabs just $159. Free FedEx. Order online now. ApexOnlinePharmacy.com. www.apexonlinepharmacy.com (sponsored listing) Soma Premium tickets - lower prices. 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La aspirin actъa reduciendo las substancias en el cuerpo que causan dolor e inflamaciуn. S... Soma Compound La aspirin estб en la clase de drogas llamada salicilatos. Aspirin actъa reduciendo sustancias en el cuerpo que causan inflamaciуn y dolor. Se usa pa... aspirin y carisoprodol La aspirin estб en la clase de drogas llamada salicilatos. Aspirin actъa reduciendo sustancias en el cuerpo que causan inflamaciуn y dolor. Se usa pa... Vanadom Carisoprodol es un relajante para los mъsculos. Йste actъa bloqueando los impulsos de los nervios (o sensaciones de dolor) que se mandan al cerebro. aspirin/carisoprodol/codeine La aspirin estб en la clase de drogas llamada salicilatos. La aspirin actъa reduciendo las substancias en el cuerpo que causan dolor e inflamaciуn. S... carisoprodol Carisoprodol es un relajante para los mъsculos. Йste actъa bloqueando los impulsos de los nervios (o sensaciones de dolor) que se mandan al cerebro. PDR Drug information for Soma Compound w/Codeine Tablets (carisoprodol, aspirin and codeine phosphate tablets, USP) carisoprodol 200 mg + aspirin 325 mg + codeine phosphate 16 mg--Warning: May be habit-forming TABLETS DESCRIPTION `Soma' Compound with Codeine is a combination product containing carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic and anti-inflammatory properties and codeine phosphate, a centrally-acting narcotic analgesic. It is available as a two-layered, white and yellow, oval-shaped tablet for oral administration. Each tablet contains carisoprodol 200 mg, aspirin 325 mg, and codeine phosphate 16 mg. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate. Its empirical formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33. The structural formula is: Other ingredients: croscarmellose sodium, D&C Yellow #10, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, sodium metabisulfite, starch, stearic acid. CLINICAL PHARMACOLOGY Carisoprodol: Carisoprodol is a centrally-acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours. Carisoprodol is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis. Aspirin: Aspirin is a non-narcotic analgesic with anti-inflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its anti-inflammatory and for at least part of its analgesic and antipyretic properties. Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolites. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions ) and is reduced by renal dysfunction. Codeine Phosphate: Codeine phosphate is a centrally-acting narcotic-analgesic. Its actions are qualitatively similar to morphine, but its potency is substantially less. Clinical studies have shown that combining aspirin and codeine produces a significant additive effect in analgesic efficacy. INDICATIONS AND USAGE `Soma' Compound with Codeine is indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions when the additional action of codeine is desired. CONTRAINDICATIONS Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, codeine, or related compounds. WARNINGS On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic reactions, with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue `Soma' Compound with Codeine and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. The effects of carisoprodol with agents such as alcohol, other CNS depressants, or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who take one or more of these agents simultaneously with Soma Compound with Codeine. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. PRECAUTIONS General: To avoid excessive accumulation of carisoprodol, aspirin, or their metabolites, use `Soma' Compound with Codeine with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients (see CLINICAL PHARMACOLOGY ). Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy, and in addiction-prone individuals. Information for Patients: Caution patients that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard. Caution patients that dosage of medications used for gout, arthritis, or diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions ). Each enteric, film-coated, controlled-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg-yellow, 25 mg-pink, 37.5 mg-blue. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30, D&C Yellow No. 6, D&C Yellow No. 10, FD&C Blue No. 2. CLINICAL PHARMACOLOGY Pharmacodynamics: The efficacy of paroxetine in the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder (PMDD) is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT). Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha 1 -, alpha 2 -, beta-adrenergic-, dopamine (D 2 )-, 5-HT 1 -, 5-HT 2 -, and histamine (H 1 )-receptors; antagonism of muscarinic, histaminergic, and alpha 1 -adrenergic receptors has been associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. Because the relative potencies of paroxetine's major metabolites are at most 1/50 of the parent compound, they are essentially inactive. Pharmacokinetics: Tablets of PAXIL CR contain a degradable polymeric matrix (GEOMATRIX™) designed to control the dissolution rate of paroxetine over a period of approximately 4 to 5 hours. In addition to controlling the rate of drug release in vivo, an enteric coat delays the start of drug release until tablets of PAXIL CR have left the stomach. Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. In a study in which normal male and female subjects (n = 23) received single oral doses of PAXIL CR at 4 dosage strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg), paroxetine C max and AUC 0-inf increased disproportionately with dose (as seen also with immediate-release formulations). Mean C max and AUC 0-inf values at these doses were 2.0, 5.5, 9.0, and 12.5 ng/mL, and 121, 261, 338, and 540 ng·hr./mL, respectively. T max was observed typically between 6 and 10 hours post-dose, reflecting a reduction in absorption rate compared with immediate-release formulations. The mean elimination half-life of paroxetine was 15 to 20 hours throughout this range of single doses of PAXIL CR. The bioavailability of 25 mg PAXIL CR is not affected by food. During repeated administration of PAXIL CR (25 mg once daily), steady state was reached within 2 weeks (i.e., comparable to immediate-release formulations). In a repeat-dose study in which normal male and female subjects (n = 23) received PAXIL CR (25 mg daily), mean steady state C max , C min , and AUC 0-24 values were 30 ng/mL, 20 ng/mL, and 550 ng·hr./mL, respectively. Based on studies using immediate-release formulations, steady-state drug exposure based on AUC 0-24 was several-fold greater than would have been predicted from single-dose data. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable. In steady-state dose proportionality studies involving elderly and nonelderly patients, at doses of the immediate-release formulation of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway. In comparison to C min values after 20 mg daily, values after 40 mg daily were only about 2 to 3 times greater than doubled. Social Anxiety Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 12.5 mg/day. Patients were dosed in a range of 12.5 mg to 37.5 mg/day in the clinical trial demonstrating the effectiveness of PAXIL CR in the treatment of social anxiety disorder. If the dose is increased, this should occur at intervals of at least 1 week, in increments of 12.5 mg/day, up to a maximum of 37.5 mg/day. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with PAXIL CR should remain on it. Although the efficacy of PAXIL CR beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. nsure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for paroxetine are known. A specific caution involves patients taking or recently having taken paroxetine who might ingest excessive quantities of a tricyclic antidepressant. In such a case, accumulation of the parent tricyclic and an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation (see PRECAUTIONS -- Drugs Metabolized by Cytochrome P 450 IID 6 ). In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR). DOSAGE AND ADMINISTRATION Major Depressive Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of PAXIL CR in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5-mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with PAXIL CR should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose of an antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown. Systematic evaluation of the efficacy of immediate-release paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg, which corresponds to a 37.5-mg dose of PAXIL CR, based on relative bioavailability considerations (see CLINICAL PHARMACOLOGY -- Pharmacokinetics ). Panic Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning. Patients should be started on 12.5 mg/day. Dose changes should occur in 12.5-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 12.5 to 75 mg/day in the clinical trials demonstrating the effectiveness of PAXIL CR. The maximum dosage should not exceed 75 mg/day. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance Therapy: Long-term maintenance of efficacy with the immediate-release formulation of paroxetine was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release paroxetine demonstrated a lower relapse rate compared to patients on placebo. Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with PAXIL CR. Similarly, at least 14 days should be allowed after stopping PAXIL CR before starting an MAOI. Discontinuation of Treatment With PAXIL CR: Symptoms associated with discontinuation of immediate-release paroxetine hydrochloride or PAXIL CR have been reported (see PRECAUTIONS ). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which PAXIL CR is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. Premenstrual Dysphoric Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning, with or without food. PAXIL CR may be administered either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. The recommended initial dose is 12.5 mg/day. In clinical trials, both 12.5 mg/day and 25 mg/day were shown to be effective. Dose changes should occur at intervals of at least 1 week. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance/Continuation Therapy: The effectiveness of PAXIL CR for a period exceeding 3 menstrual cycles has not been systematically evaluated in controlled trials. However, women commonly report that symptoms worsen with age until relieved by the onset of menopause. Therefore, it is reasonable to consider continuation of a responding patient. Patients should be periodically reassessed to determine the need for continued treatment. Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms. There are Benefits and Risks When Using Antidepressants Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Other side effects can occur with antidepressants (see section below). Of all the antidepressants, only fluoxetine (Prozac®) * has been FDA approved to treat pediatric depression. For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®) * , ser-traline (Zoloft®) * , fluvoxamine, and clomipramine (Anafranil®) * . Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members. Is this all I need to know if my child is being prescribed an antidepressant? No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information. *The following are registered trademarks of their respective manufacturers: Prozac®/Eli Lilly and Company; Zoloft®/Pfizer Pharmaceuticals; Anafranil®/Mallinckrodt Inc. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Bipolar Disorder Special Populations: Treatment of Pregnant Women During the Third Trimester: Neonates exposed to PAXIL CR and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS ). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester. Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment: The recommended initial dose of PAXIL CR is 12.5 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 50 mg/day. Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by cytochrome P 450 IID 6 . Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment. The role of this enzyme in paroxetine metabolism also suggests potential drug-drug interactions (see PRECAUTIONS ). Approximately 64% of a 30-mg oral solution dose of paroxetine was excreted in the urine with 2% as the parent compound and 62% as metabolites over a 10-day post-dosing period. About 36% was excreted in the feces (probably via the bile), mostly as metabolites and less than 1% as the parent compound over the 10-day post-dosing period. Drug Interactions: Clinically important interactions may occur when certain drugs are administered concomitantly with aspirin or aspirin-containing drugs. Oral Anticoagulants -- By interfering with platelet function or decreasing plasma prothrombin concentration, aspirin enhances the potential for bleeding in patients on anticoagulants. Methotrexate -- aspirin enhances the toxic effects of this drug. Probenecid and Sulfinpyrazone -- large doses of aspirin reduce the uricosuric effect of both drugs. Renal excretion of salicylate may also be reduced. Oral Antidiabetic Drugs -- enhancement of hypoglycemia may occur. Antacids -- to the extent that they raise urinary pH, antacids may substantially decrease plasma salicylate concentrations; conversely, their withdrawal can result in a substantial increase. Ammonium Chloride -- this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations. Ethyl Alcohol -- enhanced aspirin-induced fecal blood loss has been reported. Corticosteroids -- salicylate plasma levels may be decreased when adrenal corticosteroids are given, and may be increased substantially when they are discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been done with `Soma' Compound with Codeine. Pregnancy--Teratogenic Effects: Pregnancy Category C. Adequate animal reproduction studies have not been conducted with `Soma' Compound with Codeine. It is also not known whether `Soma' Compound with Codeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. `Soma' Compound with Codeine should be given to a pregnant woman only if clearly needed. Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation in doses considerably greater than usual therapeutic doses in humans. Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring. Labor and Delivery: Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus, or neonate. Nursing Mothers: Carisoprodol is excreted in human milk in concentrations two-to-four times that in maternal plasma. Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in children below the age of twelve have not been established. ADVERSE REACTIONS If severe reactions occur, discontinue `Soma' Compound with Codeine and initiate appropriate symptomatic and supportive therapy. The following side effects which have occurred with the administration of the individual ingredients alone may also occur with the combination. Carisoprodol: Central Nervous System --Drowsiness is the most frequent complaint and along with other CNS effects may require dosage reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia have been infrequent or rare. Idiosyncratic --Idiosyncratic reactions are very rare. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug (see WARNINGS ). Allergic --Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruptions with cross-reaction to meprobamate have been reported. If allergic reactions occur, discontinue `Soma' Compound with Codeine and treat symptomatically. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request). Cardiovascular --Tachycardia, postural hypotension, and facial flushing. Gastrointestinal --Nausea, vomiting, epigastric distress and hiccup. Hematologic --No serious blood dyscrasias have been attributed to carisoprodol alone. Leukopenia and pancytopenia have been reported, very rarely, in situations in which other drugs or viral infections may have been responsible. Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels (see OVERDOSAGE ). Aspirin Intolerance --Allergic type reactions in aspirin-sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former range from rhinorrhea and shortness of breath to severe asthma, and the latter may consist of urticaria, edema, rash, or angioedema (giant hives). These may occur independently or in combination. Codeine Phosphate: Nausea, vomiting, constipation, miosis, sedation, and dizziness have been reported. DRUG ABUSE AND DEPENDENCE Controlled Substance: Schedule C-III (see PRECAUTIONS ).

Soma (Sanskrit), or Haoma (Avestan), from Proto-Indo-Iranian *sauma-, was a ritual drink of importance among the early Indo-Iranians, and the later Vedic and greater Persian cultures. It is frequently mentioned in the Rigveda, which contains many hymns praising its energizing or intoxicating qualities. In the Avesta, Haoma has an entire Yasht dedicated to it. It is described as prepared by pressing juice from the stalks of a certain mountain plant, which has been variously hypothesized to be a psychedelic mushroom, cannabis, peganum harmala, or ephedra. In both Vedic and Zoroastrian tradition, the drink is identified with the plant, and also personified as a divinity, the three forming a religious or mythological unity. Contents [hide] 1 Etymology 2 Vedic Soma 2.1 In the Rigveda 2.2 In Hinduism 3 Avestan Haoma 4 Candidates for the Soma plant 5 References 6 External links [edit] Etymology Both Soma and the Avestan Haoma are derived from Proto-Indo-Iranian *sauma-. The name of the Scythian tribe Hauma-varga is related to the word, and probably connected with the ritual. The word is derived from an Indo-Iranian root *sav- (Sanskrit sav-) "to press", i.e. *sav-ma- is the drink prepared by pressing the stalks of a plant (cf. es-presso). The root is probably Proto-Indo-European (*sewh-), and also appears in son (from *suhnu-, "pressed out" i.e. "newly born"). [edit] Vedic Soma In the Vedas, Soma is portrayed as sacred and as a god (deva). The god, the drink and the plant probably referred to the same entity, or at least the differentiation was ambiguous. In this aspect, Soma is similar to the Greek ambrosia (cognate to amrita); it is what the gods drink, and what made them deities. Indra and Agni are portrayed as consuming Soma in copious quantities. The consumption of Soma by human beings, was probably under the belief that it bestowed them divine qualities. [edit] In the Rigveda The Rigveda (8.48.3, tr. Griffith) states, a apama somam amrta abhumaganma jyotir avidama devan c ki? nunam asman k??avad arati? kim u dhurtir am?ta martyasya We have drunk Soma and become immortal; we have attained the light, the Gods discovered. Now what may foeman's malice do to harm us? What, O Immortal, mortal man's deception? The Ninth Mandala of the Rigveda is known as the Soma Mandala. It consists entirely of hymns addressed to Soma Pavamana ("purified Soma"). The drink Soma was kept and distributed by the Gandharvas. The Rigveda associates the Sushoma, Arjikiya and other regions with Soma (e.g. 8.7.29; 8.64.10-11). Sharyanavat was possibly the name of a pond or lake on the banks of which Soma could be found. The plant is described as growing in the mountains (giristha, cf. Orestes), with long stalks, and of yellow or tawny (hari) colour. The drink is prepared by priests pounding the stalks with stones, an occupation that creates tapas (literally "heat", later referring to "spiritual excitement" in particular). The juice so gathered is mixed with other ingredients (including milk and honey) before it is drunk. Growing far away, in the mountains, Soma had to be purchased from travelling traders. This is connected with the Indo-Aryan migration model, i.e. the plant supposedly grew in the homeland of the Indo-Iranians, probably the Hindukush, but later migration to the Punjab removed them from the area of its occurrence, and it had to be imported. Later, knowledge of the plant was lost altogether, and Indian ritual reflects this, in expiatory prayers apologizing to the gods for the use of a substitute plant (e.g. rhubarb) because Soma had become unavailable. [edit] In Hinduism In Hindu art, the god Soma was depicted as a bull or bird, and sometimes as an embryo, but rarely as an adult human. In Hinduism, the god Soma evolved into a lunar deity, and became associated with the underworld. The moon is the cup from which the gods drink Soma, and so Soma became identified with the moon god Chandra. A waxing moon meant Soma was recreating himself, ready to be drunk again. Alternatively, Soma's twenty-seven wives were daughters of Daksha, who felt he paid too much attention to just one of his wives, Rohini. He cursed him to wither and die, but the wives intervened and the death became periodic and temporary, and is symbolized by the waxing and waning of the moon. The famous ayurvedic scholar Susruta wrote that the best Soma is found in the upper Indus and Kashmir region (Susruta Samhita: 537-538, SS.CS. 29.28-31). [edit] Avestan Haoma Main article: Haoma The continuing importance of Haoma in Zoroastrianism may be glimpsed from the Avesta (particularly in the Hom Yast, Yasna 9.11), and Avestan language *hauma also survived as middle Persian hom. The plant Haoma yielded the essential ingredient for the ritual drink, parahaoma. In the Hom yast of the Avesta, the Yazata (divine) Haoma appears to Zoroaster "at the time of pressing" (havani ratu) in the form of a beautiful man. Yasna 9.1 and 9.2 exhort him to gather and press Haoma plants. Haoma's epitheta include "the Golden-Green One" (zairi-, Sanskrit hari-), "righteous" (asavan-), "furthering righteousness" (asa-vazah-), and "of good wisdom" (hu.xratu-, Sanskrit sukratu-). In Yasna 9.22, Haoma grants "speed and strength to warriors, excellent and righteous sons to those giving birth, spiritual power and knowledge to those who apply themselves to the study of the nasks". As the religion's chief cult divinity he came to be perceived as its divine priest. In Yasna 9.26, Ahura Mazda is said to have invested him with the sacred girdle, and in Yasna 10.89, to have installed Haoma as the "swiftly sacrificing zaotar" (Sanskrit hotar) for himself and the Amesha Spenta. Haoma services were celebrated until the 1960s in a strongly conservative village near Yazd. [edit] Candidates for the Soma plant Main article: botanic identity of Soma-Haoma There has been much speculation as to the original Proto-Indo-Iranian Sauma plant. It was generally assumed to be hallucinogenic, based on RV 8.48 cited above. But note that this is the only evidence of hallucinogenic properties, in a book full of hymns to Soma. The typical description of Soma is associated with excitation and tapas. Soma is associated with the warrior-god Indra, and appears to have been drunk before battle. For these reasons, there are energizing plants as well as hallucinogenic plants among the candidates that have been suggested. In fact, several texts like the Atharva Veda extol the medicinal properties of Soma and he is regarded as the king of medicinal herbs (and also of the Brahmana class). Since the late 1700s, when Anquetil-Duperron and others made portions of the Avesta available to western scholarship, several scholars have sought a representative botanical equivalent of the haoma as described in the texts and as used in living Zoroastrian practice. Most of the proposals concentrated on either linguistic evidence or comparative pharmacology or reflected ritual use. Rarely were all three considered together, which usually resulted in such proposals being quickly rejected. In the late 19th century, the highly conservative Zoroastrians of Yazd (Iran) were found to use Ephedra (genus Ephedra), which was locally known as hum or homa and which they exported to the Indian Zoroastrians. (Aitchison, 1888) The plant, as Falk also established, requires a cool and dry climate, i.e. it does not grow in India (which is either too hot or too humid or both) but thrives in central Asia. Later, it was discovered that a number of Iranian languages and Persian dialects have hom or similar terms as the local name for some variant of Ephedra. Considered together, the linguistic and ritual evidence appeared to conclusively establish that haoma was some variant of Ephedra. [edit] References Jay, Mike: Blue Tide: The Search for Soma (Autonomedia 1999) Frawley David: The Rig Veda and the History of India, 2001.(Aditya Prakashan), ISBN 81-7742-039-9 Parpola, Asko, The problem of the Aryans and the Soma: Textual-linguistic and archaeological evidence, in: The Indo-Aryans of Ancient South Asia ed. G. Erdosy, de Gruyter (1995), 353–381. Nyberg, Harri, The problem of the Aryans and the Soma: The botanical evidence, in: The Indo-Aryans of Ancient South Asia ed. G. Erdosy, de Gruyter (1995), 382–406. Soma article from The Encyclopedia of Psychoactive Substances by Richard Rudgley Little, Brown and Company (1998) (huxley.net) PBS Secrets of the Dead. Day of the Zulu (pbs.org). Retrieved Feb. 5, 2005. Susruta Samhita. Transl. Kunjalal Bhishagratna, Varanasi: Chowkhama Sanksrit Series. 1981. Bakels, C.C. 2003. “The contents of ceramic vessels in the Bactria-Margiana Archaeological Complex, Turkmenistan.” Electronic Journal of Vedic Studies. Vol. 9. Issue 1c (May 5) http://users.primushost.com/~india/ejvs/ejvs0901/ejvs0901c.txt Swami Rama. Living with the Himalayan Masters. The Himalayan Institute Press. 1978. McDonald, A. A botanical perspective on the identity of soma (Nelumbo nucifera Gaertn.) based on scriptural and iconographic records. Econmic Botany 2004;58:S147-S173 Soma This page contains drug information on Soma. The information provided includes the following: what is Soma the possible side effects of Soma what happens if you miss a dose of Soma what happens if you overdose with Soma the most important information about Soma how to use Soma other drugs that may affect Soma what to avoid while using Soma Generic Name: carisoprodol (kar eye soe PROE dole) Brand Names: Soma, Vanadom What is the most important information I should know about carisoprodol? • Use caution when driving, operating machinery, or performing other hazardous activities. Carisoprodol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. • Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking carisoprodol. What is carisoprodol? • Carisoprodol is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain. • Carisoprodol is used, along with rest and physical therapy, to treat injuries and other painful muscular conditions. • Carisoprodol may also be used for purposes other than those listed in this medication guide. Who should not take carisoprodol? • Do not take carisoprodol if you have acute intermittent porphyria. • Before taking carisoprodol, tell your doctor if you have kidney or liver disease. You may need a lower dose or special monitoring during your therapy. • It is not known whether carisoprodol will harm an unborn baby. Do not take carisoprodol without first talking to your doctor if you are pregnant. • It is also not known whether carisoprodol passes into breast milk. Do not take carisoprodol without first talking to your doctor if you are breast-feeding a baby. • Carisoprodol is not approved for use in children younger than 12 years of age. How should I take carisoprodol? • Take carisoprodol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • The maximum amount of carisoprodol you should take in one day is 1,400 mg (4 tablets). • Store carisoprodol at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication. Try to keep your doses at least 4 hours apart. What happens if I overdose? • Seek emergency medical attention. • Symptoms of a carisoprodol overdose include low blood pressure (weakness, fainting, confusion), decreased breathing, and unconsciousness. What should I avoid while taking carisoprodol? • Use caution when driving, operating machinery, or performing other hazardous activities. Carisoprodol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. • Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking carisoprodol. What are the possible side effects of carisoprodol? • If you experience any of the following serious side effects, stop taking carisoprodol and seek emergency medical attention: · an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); · paralysis (loss of feeling) or extreme weakness; · vision loss; or · agitation or tremor. • Other, less serious side effects may be more likely to occur. Continue to take carisoprodol and talk to your doctor if you experience · drowsiness or dizziness; · headache; · depression; · blurred vision; · insomnia; or · hiccups. • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. Soma Compound w/Codeine Tablets (carisoprodol, aspirin and codeine phosphate tablets, USP) carisoprodol 200 mg + aspirin 325 mg + codeine phosphate 16 mg--Warning: May be habit-forming TABLETS DESCRIPTION `Soma' Compound with Codeine is a combination product containing carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic and anti-inflammatory properties and codeine phosphate, a centrally-acting narcotic analgesic. It is available as a two-layered, white and yellow, oval-shaped tablet for oral administration. Each tablet contains carisoprodol 200 mg, aspirin 325 mg, and codeine phosphate 16 mg. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate. Its empirical formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33. The structural formula is: Other ingredients: croscarmellose sodium, D&C Yellow #10, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, sodium metabisulfite, starch, stearic acid. CLINICAL PHARMACOLOGY Carisoprodol: Carisoprodol is a centrally-acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours. Carisoprodol is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis. Aspirin: Aspirin is a non-narcotic analgesic with anti-inflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its anti-inflammatory and for at least part of its analgesic and antipyretic properties. Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolites. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions ) and is reduced by renal dysfunction. Codeine Phosphate: Codeine phosphate is a centrally-acting narcotic-analgesic. Its actions are qualitatively similar to morphine, but its potency is substantially less. Clinical studies have shown that combining aspirin and codeine produces a significant additive effect in analgesic efficacy. INDICATIONS AND USAGE `Soma' Compound with Codeine is indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions when the additional action of codeine is desired. CONTRAINDICATIONS Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, codeine, or related compounds. WARNINGS On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic reactions, with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue `Soma' Compound with Codeine and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. The effects of carisoprodol with agents such as alcohol, other CNS depressants, or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who take one or more of these agents simultaneously with Soma Compound with Codeine. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. PRECAUTIONS General: To avoid excessive accumulation of carisoprodol, aspirin, or their metabolites, use `Soma' Compound with Codeine with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients (see CLINICAL PHARMACOLOGY ). Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy, and in addiction-prone individuals. Information for Patients: Caution patients that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard. Caution patients that dosage of medications used for gout, arthritis, or diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions ). Drug Interactions: Clinically important interactions may occur when certain drugs are administered concomitantly with aspirin or aspirin-containing drugs. Oral Anticoagulants -- By interfering with platelet function or decreasing plasma prothrombin concentration, aspirin enhances the potential for bleeding in patients on anticoagulants. Methotrexate -- aspirin enhances the toxic effects of this drug. Probenecid and Sulfinpyrazone -- large doses of aspirin reduce the uricosuric effect of both drugs. Renal excretion of salicylate may also be reduced. Oral Antidiabetic Drugs -- enhancement of hypoglycemia may occur. Antacids -- to the extent that they raise urinary pH, antacids may substantially decrease plasma salicylate concentrations; conversely, their withdrawal can result in a substantial increase. Ammonium Chloride -- this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations. Ethyl Alcohol -- enhanced aspirin-induced fecal blood loss has been reported. Corticosteroids -- salicylate plasma levels may be decreased when adrenal corticosteroids are given, and may be increased substantially when they are discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been done with `Soma' Compound with Codeine. Pregnancy--Teratogenic Effects: Pregnancy Category C. Adequate animal reproduction studies have not been conducted with `Soma' Compound with Codeine. It is also not known whether `Soma' Compound with Codeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. `Soma' Compound with Codeine should be given to a pregnant woman only if clearly needed. Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation in doses considerably greater than usual therapeutic doses in humans. Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring. Labor and Delivery: Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus, or neonate. Nursing Mothers: Carisoprodol is excreted in human milk in concentrations two-to-four times that in maternal plasma. Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in children below the age of twelve have not been established. ADVERSE REACTIONS If severe reactions occur, discontinue `Soma' Compound with Codeine and initiate appropriate symptomatic and supportive therapy. The following side effects which have occurred with the administration of the individual ingredients alone may also occur with the combination. Carisoprodol: Central Nervous System --Drowsiness is the most frequent complaint and along with other CNS effects may require dosage reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia have been infrequent or rare. Idiosyncratic --Idiosyncratic reactions are very rare. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug (see WARNINGS ). Allergic --Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruptions with cross-reaction to meprobamate have been reported. If allergic reactions occur, discontinue `Soma' Compound with Codeine and treat symptomatically. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request). Cardiovascular --Tachycardia, postural hypotension, and facial flushing. Gastrointestinal --Nausea, vomiting, epigastric distress and hiccup. Hematologic --No serious blood dyscrasias have been attributed to carisoprodol alone. Leukopenia and pancytopenia have been reported, very rarely, in situations in which other drugs or viral infections may have been responsible. Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels (see OVERDOSAGE ). Aspirin Intolerance --Allergic type reactions in aspirin-sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former range from rhinorrhea and shortness of breath to severe asthma, and the latter may consist of urticaria, edema, rash, or angioedema (giant hives). These may occur independently or in combination. Codeine Phosphate: Nausea, vomiting, constipation, miosis, sedation, and dizziness have been reported. DRUG ABUSE AND DEPENDENCE Controlled Substance: Schedule C-III (see PRECAUTIONS ). Abuse: In clinical use, abuse has been rare. Dependence: In clinical use, dependence with `Soma' Compound with Codeine has been rare and there have been no reports of significant abstinence signs. Nevertheless, the following information on the individual ingredients should be kept in mind. Carisoprodol --In dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol from dosages as high as 1 gm/kg/day. In a study in man, abrupt cessation of 100 mg/kg/day (about five times the recommended daily adult dosage) was followed in some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia, chills, headache, and nausea. Delirium and convulsions did not occur (see PRECAUTIONS ). Codeine Phosphate-- Drug dependence of the morphine type may result. OVERDOSAGE Signs and Symptoms: Any of the following which have been reported with the individual ingredients may occur and may be modified to a varying degree by the effects of the other ingredients present in `Soma' Compound with Codeine. Carisoprodol --Stupor, coma, shock, respiratory depression and, very rarely, death. Overdosage with carisoprodol in combination with alcohol, other CNS depressants, or psychotropic agents can have additive effects, even when one of the agents has been taken in the usually recommended dosage. Aspirin --Headache, tinnitus, hearing difficulty, dim vision, dizziness, lassitude, hyperpnea, rapid breathing, thirst, nausea, vomiting, sweating and occasionally diarrhea are characteristic of mild to moderate salicylate poisoning. Salicylate poisoning should be considered in children with symptoms of vomiting, hyperpnea, and hyperthermia. Hyperpnea is an early sign of salicylate poisoning, but dyspnea supervenes at plasma levels above 50 mg/dl. These respiratory changes eventually lead to serious acid-base disturbances. Metabolic acidosis is a constant finding in infants but occurs in older children only with severe poisoning; adults usually exhibit respiratory alkalosis initially and acidosis terminally. Other symptoms of severe salicylate poisoning include hyperthermia, dehydration, delirium, and mental disturbances. Skin eruptions, GI hemorrhage, or pulmonary edema are less common. Early CNS stimulation is replaced by increasing depression, stupor, and coma. Death is usually due to respiratory failure or cardiovascular collapse. Codeine Phosphate-- pinpoint pupils, CNS depression, coma, respiratory depression, and shock. Treatment: General --Provide symptomatic and supportive treatment, as indicated. Any drug remaining in the stomach should be removed using appropriate procedures and caution to protect the airway and prevent aspiration, especially in the stuporous or comatose patient. Incomplete gastric emptying with delayed absorption of carisoprodol has been reported as a cause for relapse. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously, as indicated. Carisoprodol --The following have been used successfully in overdosage with the related drug meprobamate: diuretics, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis (see CLINICAL PHARMACOLOGY ). Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Carisoprodol can be measured in biological fluid by gas chromatography (Douglas, J. F., et al: J Pharm Sci 58: 145, 1969). Aspirin --Since there are no specific antidotes for salicylate poisoning, the aim of treatment is to enhance elimination of salicylate and prevent or reduce further absorption; to correct any fluid, electrolyte or metabolic imbalance; and to provide general and cardiorespiratory support. If acidosis is present, intravenous sodium bicarbonate must be given, along with adequate hydration, until salicylate levels decrease to within the therapeutic range. To enhance elimination, forced diuresis and alkalinization of the urine may be beneficial. The need for hemoperfusion or hemodialysis is rare and should be used only when other measures have failed. Codeine Phosphate-- Narcotic antagonists, such as nalorphine and levallorphan, may be indicated. DOSAGE AND ADMINISTRATION Usual Adult Dosage: 1 or 2 tablets, four times daily. Not recommended for use in children under age twelve. HOW SUPPLIED `Soma' Compound with Codeine Tablets (carisoprodol, USP 200 mg, aspirin 325 mg, and codeine phosphate, USP 16 mg) are oval, convex, two-layered and inscribed on the white layer with SOMA CC and on the yellow layer with WALLACE 2403. The tablets are available in bottles of 100 (NDC 0037-2403-01). Storage: Store at controlled room temperature 15°-30°C (59°-86°F). Protect from moisture. Dispense in a tight container. Wallace Pharmaceuticals MedPointe Healthcare Inc. Somerset, NJ 08873 IN-095E2-12 Rev. 9/93 Patent No. 4534974 PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. 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Smoking-related diseases claim an estimated 430,700 American lives each year. Smoking costs the United States approximately $97.2 billion each year in health-care costs and lost productivity. It is directly responsible for 87 percent of lung cancer cases and causes most cases of emphysema and chronic bronchitis. Find out more about how smoking has affected you community, see American Lung Association State of Tobacco Control: 2005 Report. The US Surgeon General has stated, "Smoking cessation (stopping smoking) represents the single most important step that smokers can take to enhance the length and quality of their lives." Quitting smoking is not easy, but it can be done. To have the best chance of quitting successfully, you need to know what you’re up against, what your options are, and where to go for help. This document is intended to provide you with this information. Why Is It So Hard to Quit Smoking? Mark Twain said, "Quitting smoking is easy. I've done it a thousand times." Maybe you've tried to quit too. Why is quitting and staying quit hard for so many people? The answer is nicotine. Nicotine Nicotine is a drug found naturally in tobacco. It is highly addictive – as addictive as heroin or cocaine. Over time, the body becomes physically and psychologically dependent on nicotine. Studies have shown that smokers must overcome both of these to be successful at quitting and staying quit. When smoke is inhaled, nicotine is carried deep into the lungs, where it is absorbed quickly into the bloodstream and carried throughout the body. Nicotine affects many parts of the body, including your heart and blood vessels, your hormonal system, your metabolism, and your brain. Nicotine can be found in breast milk and in cervix mucous secretions of smokers. During pregnancy, nicotine freely crosses the placenta and has been found in amniotic fluid and the umbilical cord blood of newborn infants. Several different factors can affect the rate of metabolism and excretion of nicotine. In general, a regular smoker will have nicotine or its by-products present in the body for about 3 to 4 days after stopping. Nicotine produces pleasurable feelings that make the smoker want to smoke more. It also acts as a kind of depressant by interfering with the flow of information between nerve cells. As the nervous system adapts to nicotine, smokers tend to increase the number of cigarettes they smoke, and hence the amount of nicotine in their blood. After a while, the smoker develops a tolerance to the drug, which leads to an increase in smoking over time. Eventually, the smoker reaches a certain nicotine level and then smokes to maintain this level of nicotine. Nicotine Withdrawal When smokers try to cut back or quit, the absence of nicotine leads to withdrawal symptoms. Withdrawal is both physical and mental. Physically, the body is reacting to the absence of nicotine. Psychologically, the smoker is faced with giving up a habit, which is a major change in behavior. Both must be dealt with if quitting is to be successful. W (US Surgeon General's Report, 1988, p. 202) 2 weeks to 3 months after quitting: Your circulation improves and your lung function increases. (US Surgeon General's Report, 1990, pp.193,194,196,285,323) 1 to 9 months after quitting: Coughing and shortness of breath decrease; cilia (tiny hair like structures that move mucus out of the lungs) regain normal function in the lungs, increasing the ability to handle mucus, clean the lungs, and reduce the risk of infection. (US Surgeon General's Report, 1990, pp. 285-287, 304) 1 year after quitting: The excess risk of coronary heart disease is half that of a smoker's. (US Surgeon General's Report, 1990, p. vi) 5 years after quitting: Your stroke risk is reduced to that of a nonsmoker 5-15 years after quitting. (US Surgeon General's Report, 1990, p. vi) 10 years after quitting: The lung cancer death rate is about half that of a continuing smoker's. The risk of cancer of the mouth, throat, esophagus, bladder, cervix, and pancreas decrease. (US Surgeon General's Report, 1990, pp. vi, 131, 148, 152, 155, 164,166) 15 years after quitting: The risk of coronary heart disease is that of a nonsmoker's. (US Surgeon General's Report, 1990, p. vi) Visible and Immediate Rewards of Quitting Smoking is less socially acceptable now than it was in the past. Most workplaces have some type of smoking restrictions. Some employers even prefer to hire nonsmokers. Studies show smoking employees cost businesses more to employ because they are "out sick" more frequently. Employees who are ill more often than others can raise an employer’s need for expensive temporary replacement workers. They can increase insurance costs both for other employees and for the employer, who typically pays part of the workers’ insurance premiums. Smokers in a building also typically increase the maintenance costs of keeping odors at an acceptable level, since residue from cigarette smoke clings to carpets, drapes, and other fabrics. Landlords, also, may choose not to rent to smokers since maintenance costs and insurance rates may rise when smokers occupy buildings. Friends may ask you not to smoke in their houses or cars. Public buildings, concerts, and even sporting events are largely smoke-free. And more and more communities are restricting smoking in all public places, including restaurants and bars. Like it or not, finding a place to smoke can be a hassle. Smokers may find their opportunities for dating or romantic involvement, including marriage, are largely limited to other smokers, who make up only about 1/4th of the population. Health of Others Smoking not only harms your health but the health of those around you. Exposure to secondhand smoke (also called environmental tobacco smoke or passive smoking) includes exhaled smoke as well as smoke from burning cigarettes. Studies have shown that secondhand smoke causes thousands of deaths each year from lung cancer and heart disease in healthy nonsmokers. Smoking by mothers is linked to a higher risk of their babies developing asthma in childhood, especially if the mother smokes while pregnant. It is also associated with sudden infant death syndrome (SIDS) and low-birth weight infants. Babies and children raised in a household where there is smoking have more ear infections, colds, bronchitis, and other respiratory problems than children from nonsmoking families. Secondhand smoke can also cause eye irritation, headaches, nausea, and dizziness. Setting an Example If you have children, you probably want to set a good example for them. When asked, nearly all smokers say they don't want their children to smoke, but children whose parents smoke are more likely to start smoking themselves. You can become a good role model for them by quitting now. Help Is Available With the wide array of counseling services, self-help materials, and medicines available today, smokers have more tools than ever before to help them quit successfully. Remember, tobacco addiction has both a psychological and a physical component. For most people, the best way to quit will be some combination of medicine, a method to change personal habits, and emotional support. The following sections describe these tools and how they may be helpful for you. In This Section: What About Nicotine Replacement Therapy? Types of Nicotine Substitutes Which Is Right for You? Other Methods of Quitting Telephone-based Help to Stop Smoking Support A Word About Success Rates Special Concerns Where Can I Go for Help Help With Psychological Addiction Some people are able to quit on their own, without the help of others or the use of medicines. But for many smokers, it can be hard to break the social and emotional ties to smoking while getting over nicotine withdrawal symptoms at the same time. Fortunately, there are many sources of support out there – both formal and informal. Telephone-based Help to Stop Smoking Most states run some type of free telephone-based program that links callers with trained counselors, such as the American Cancer Society’s Quitline program. These specialists help plan a quit method that fits each person's unique smoking pattern. People who use telephone counseling stop smoking at twice the rate of those who don't get this type of help. With guidance from a counselor, quitters can avoid common mistakes that may hurt a quit attempt. Telephone counseling is also more convenient for many people than some other support programs. It doesn't require transportation or childcare, and it's available nights and weekends. Counselors may recommend a combination of methods including medicines, local classes, self-help brochures, and/or a network of family and friends. Smokers can get help finding a Quitline program in their area by calling ACS at 1-800-ACS-2345 (1-800-227-2345). Support of Family, Friends, and Quit Programs Many former smokers say a support network of family and friends was very important during their quit attempt. Other people who may offer support and encouragement are coworkers, your family doctor, and members of support groups for quitters. You can check with your employer, health insurance company, or local hospital to find support groups; or call the ACS at 1-800-ACS-2345. What to Look for in a Stop-Smoking Program Stop smoking programs are designed to help smokers recognize and cope with problems that come up during quitting and to provide support and encouragement in staying quit. Studies have shown that the best programs will include either individual or group counseling. There is a strong association between the intensity of counseling and the success rate. In general, the more intense the program, the greater the likelihood of success. Intensity may be increased by having more or longer sessions or by increasing the number of weeks over which the sessions are given. So, when considering a program, look for one that has the following: session length – at least 20 to 30 minutes per session number of sessions – at least 4 to 7 sessions number of weeks – at least 2 weeks Be certain the leader of the group has training in smoking cessation. Some communities have a Nicotine Anonymous group that holds regular meetings. This group applies the principles of Alcoholics Anonymous to the addiction of smoking. There is no fee to attend. Often your local American Cancer Society, American Lung Association, or local health department will sponsor quit smoking classes. Call 1-800-ACS-2345 for more information. There are some programs to watch out for as well. Not all programs are ethical. Be very careful of programs that do the following: Promise instant, easy success with no effort on your part. Use injections or pills, especially "secret" ingredients (nicotine replacement is covered elsewhere). Charge a very high fee. Check with the Better Business Bureau if you have doubts. Are not willing to provide references from people who have taken the class. Help With Physical Addiction: Nicotine Replacement Therapy and Other Medicines Nicotine Replacement Therapy As mentioned earlier, the nicotine in cigarettes leads to actual physical dependence, which can cause unpleasant symptoms when a person tries to quit. Nicotine replacement therapy (NRT) provides nicotine – in the form of gums, patches, sprays, inhalers or lozenges – without the other harmful components of tobacco. It can help relieve some of these symptoms so that a person can concentrate more on the psychological aspects of quitting. How Nicotine Replacement Works Nicotine substitutes treat the very difficult withdrawal symptoms and cravings that 70% to 90% of smokers say is their only reason for not giving up cigarettes. By using a nicotine substitute, a smoker's withdrawal symptoms are reduced. While a large number of smokers are able to quit smoking without nicotine replacement, most of those who attempt quitting are not successful on the first try. In fact, smokers usually need several attempts – sometimes as many as 8 to 10 – before they are able to quit for good. Lack of success is often related to the onset of withdrawal symptoms. By reducing these symptoms with the use of nicotine replacement therapy, smokers who want to quit have a better chance of being successful. Getting the Most From Nicotine Replacement Nicotine replacement therapy only deals with the physical aspects of addiction. It is not intended to be the only method used to help you quit smoking. It should be combined with other smoking cessation methods that address the psychological component of smoking, such as a stop smoking program. Studies have shown that approach - pairing NRT with a program that helps to change behavior – can double your chances of successfully quitting. The US Agency for Healthcare Research and Quality (AHRQ) Clinical Practice Guideline on Smoking Cessation recommends NRT for all smokers except pregnant women and people with heart or circulatory diseases. If a health care provider suggests nicotine replacement for people in these groups, the benefits of smoking cessation must outweigh the potential health risk. Smokers who are pregnant or have heart disease should consult with their doctor before using over-the-counter nicotine replacement. The most effective time to start NRT is at the beginning of an attempt to quit. But often smokers first try to quit on their own, then decide to try NRT. Nicotine replacement therapy should not be used if you plan to continue to smoke or use another tobacco product. The combined dose of nicotine could be dangerous to your health. Types of Nicotine Substitutes Five types of nicotine replacement therapy have been approved for use by the US Food and Drug Administration (FDA). Nicotine patches (transdermal nicotine systems): Patches provide a measured dose of nicotine through the skin. As the nicotine doses are lowered by switching patches over a course of weeks, the tobacco user is weaned off nicotine. Patches can be purchased without a prescription. Several types and different strengths are available. Package inserts describe how to use the product as well as special considerations and possible side effects. The 16-hour patch works well for light-to-average tobacco users. It is less likely to cause side effects like skin irritation, racing heartbeat, sleep problems, and headache. But it does not deliver nicotine during the night, so it is not helpful for early morning withdrawal symptoms. The 24-hour patch provides a steady dose of nicotine, avoiding peaks and troughs. It helps with early morning withdrawal. However, there may be more side effects such as disrupted sleep patterns and skin irritation. Depending on body size, most tobacco users should start using a full-strength patch (15-22 mg of nicotine) daily for 4 weeks, and then use a weaker patch (5-14 mg of nicotine) for another 4 weeks. The patch should be applied in the morning to a clean, dry area of the skin without much hair. It should be placed below the neck and above the waist - for example, on the arm. The FDA recommends using the patch for a total of 3 to 5 months. However, some studies have shown that using it for 8 weeks or less is just as effective as using it for longer. Side effects are related to: the dose of nicotine the brand of patch your individual skin characteristics (such as the person’s tendency to have a skin reaction to the patch) how long you use the patch how it is applied Some possible side effects of the nicotine patch include: skin irritation – redness and itching dizziness racing heartbeat sleep problems or unusual dreams headache nausea vomiting muscle aches and stiffness What to do about side effects: Try a different brand of patch if skin irritation occurs. Reduce the amount of nicotine by using a lower dose patch. Sleep problems may be temporary and pass within 3 or 4 days. If not (and you're using a 24-hour patch), try switching to a 16-hour patch. Stop using the patch and try a different form of nicotine replacement. Nicotine gum (nicotine polacrilex): Nicotine gum is a fast-acting form of replacement that acts through the mucous membrane of the mouth. It can be bought over-the-counter without a prescription. It comes in 2 mg and 4 mg strengths. For best results, follow the instructions of the package insert. Chew the gum slowly until you note a peppery taste. Then, "park" it against the cheek, chewing it and parking it off and on for about 20 to 30 minutes. Food and drink can affect how well the nicotine is absorbed. You should avoid acidic foods and drinks such as coffee, juices, and soft drinks for at least 15 minutes before and during gum use. If you smoke a pack or more per day, smoke within 30 minutes of rising, or have trouble not smoking in restricted areas, you may need to start with the higher dose (4 mg). No more than 20 pieces should be used in one day. Nicotine gum is usually recommended for 1 to 3 months, with the maximum being 6 months. Tapering the amount of gum chewed may help you stop using it. If you have sensitive skin, you may prefer the gum to the patch. Another advantage of nicotine gum is that it allows you to control the nicotine doses. The gum can be chewed as needed or on a fixed schedule during the day. The most recent data have shown that scheduled dosing is more effective. A schedule of 1 to 2 pieces per hour is common. On the other hand, with an as-needed schedule, you can chew more gum during a craving. Some possible side effects of the gum: bad taste throat irritation mouth sores hiccups nausea jaw discomfort racing heartbeat Symptoms related to the stomach and jaw are usually caused by improper use of the gum, such as swallowing nicotine or chewing too rapidly. The gum can also cause damage to dentures and dental prostheses. Long-term dependence is one possible disadvantage of nicotine gum. In fact, research has shown that 15% to 20% of gum users who successfully quit smoking continue using the gum for a year or longer. Although the maximum recommended length of use is 6 months, continuing to use the gum is likely to be safer than going back to smoking. But since there is little research on the health effects of long-term nicotine gum use, most health care providers still recommend limiting its use to 6 months. Nicotine nasal spray: The nasal spray delivers nicotine quickly to the bloodstream as it is absorbed through the nose. It is available only by prescription. The nasal spray immediately relieves withdrawal symptoms and offers you a sense of control over nicotine cravings. Because it is easy to use, smokers report great satisfaction. However, the FDA cautions that since this product contains nicotine, it can be addictive. It recommends the spray be prescribed for 3-month periods and should not be used for longer than 6 months. The most common side effects last about 1 to 2 weeks and can include the following: nasal irritation runny nose watery eyes sneezing throat irritation coughing There is also the danger of using more than is needed. If you have asthma, allergies, nasal polyps, or sinus problems, your doctor may suggest another form of nicotine replacement. Nicotine inhalers: Introduced in 1998, inhalers are available only by prescription. The nicotine inhaler is a plastic tube with a nicotine cartridge inside. When you puff on the inhaler, the cartridge provides a nicotine vapor. Unlike other inhalers, which deliver most of the medication to the lungs, the nicotine inhaler delivers most of the nicotine vapor to the mouth. In terms of similar behavior, nicotine inhalers are the closest thing to smoking a cigarette, which some smokers find helpful. The recommended dose is between 6 and 16 cartridges a day, for up to 6 months. The most common side effects, especially when first using the inhaler, include: coughing throat irritation upset stomach At this time, inhalers are the most expensive of the forms of NRT available. Nicotine lozenges: These are the newest form of NRT on the market. The FDA recently approved the first nicotine-containing lozenge as an over-the-counter aid in smoking cessation. As with nicotine gum, the Commit lozenge is available in 2 strengths: 2 mg and 4 mg. Smokers determine which dose is appropriate based on how long after waking up they normally have their first cigarette. The lozenge manufacturer recommends using it as part of a 12-week program. The recommended dose is one lozenge every 1-2 hours for 6 weeks, then one lozenge every 2-4 hours for weeks 7 to 9, and finally, one lozenge every 4-8 hours for weeks 10 to 12. In addition, the manufacturer recommends the following: Stop all tobacco use when beginning therapy with the lozenge. Do not eat or drink for 15 minutes before using the lozenge. (Some beverages can reduce the effectiveness of the lozenge). Suck on the lozenge until it dissolves. Do not bite or chew it like a hard candy, and do not swallow it. Do not use more than 5 lozenges in 6 hours, or more than 20 lozenges total per day. Stop using the lozenge after 12 weeks. If you still feel you need to use the lozenge, talk to your doctor. Do not use the lozenge if you continue to smoke, chew tobacco, use snuff or any other product containing nicotine (e.g., nicotine patch or gum). Possible side effects of the nicotine lozenge include: trouble sleeping nausea hiccups coughing heartburn headache flatulence (gas) Which Type of Nicotine Replacement May Be Right for You? There’s no evidence that any type of nicotine replacement therapy is significantly better than any other. When choosing which type of nicotine replacement you will use, think about which method will best fit your lifestyle and pattern of smoking. Do you want/need something to chew or occupy your hands? Or are you looking for once-a-day convenience? Some important points to consider: Nicotine gums, lozenges, and inhalers are oral substitutes that allow you to control your dosage to help keep cravings under better control. Nicotine nasal spray works very quickly when you need it. Nicotine inhalers allow you to mimic the use of cigarettes by puffing and holding the inhaler. Nicotine patches are convenient and only have to be applied once a day. Both inhalers and nasal sprays require a doctor’s prescription. Some people may not be able to use patches, inhalers, or nasal sprays due to allergies or other conditions. Combination of the patch and other nicotine replacement products: Using the nicotine patch along with shorter-acting products such as the gum, lozenge, nasal spray, or inhaler is another method of nicotine replacement therapy. The idea is to provide a steady dose of nicotine with the patch and to use one of the shorter-acting products when strong cravings arise. The few studies that have been done on combination NRT have found that it may be slightly better than a single product, but more research is needed to prove this and to find safe and effective doses. The combined use of nicotine replacement products has not yet been approved by the FDA. If you are considering using more than one nicotine replacement product, be sure to discuss this with your doctor first. Bupropion (Zyban) Bupropion (Zyban) is a prescription antidepressant in an extended-release form that reduces symptoms of nicotine withdrawal. It does not contain nicotine. This drug affects chemicals in the brain that are related to nicotine craving. It can be used alone or together with nicotine replacement. The usual dosage is one or two 150 mg tablets per day. This medication should not be taken if you have a history of seizures, anorexia, heavy alcohol use, or head trauma. Some doctors may recommend combination drug therapy for heavily addicted smokers, such as using bupropion along with a nicotine replacement patch and/or a short acting from of nicotine replacement (such as gum or lozenges). Varenicline (Chantix) Varenicline (Chantix) is a newer medicine developed specifically to help people stop smoking. It works by interfering with nicotine receptors in the brain, which has two effects. It lessens the pleasurable physical effects a person gets from smoking, as well as reducing the symptoms of nicotine withdrawal. Several studies have shown varenicline can more than double the chances of quitting smoking. Some studies have also found it may be more effective than bupropion, at least in the short term. Reported side effects of varenicline have included headaches, nausea, vomiting, trouble sleeping, unusual dreams, flatulence (gas), and changes in taste. Other Methods of Quitting Other tools may also help some people, although there is no strong evidence they can improve your chances of quitting. Atropine and scopolamine combination therapy: Some smoking cessation clinics offer a program using shots of the anticholinergic drugs atropine and scopolamine to help reduce nicotine withdrawal symptoms. These drugs are more commonly prescribed for other reasons, such as digestive system problems, motion sickness, or Parkinson’s disease. The treatment usually involves shots given in the clinic on one day, followed by a few weeks of pills and wearing patches behind the ear. It may include other drugs to help with side effects as well. Possible side effects of this treatment can include dizziness, constipation, dry mouth, an altered sense of taste and smell, problems urinating, and blurry vision. People who are pregnant or have a history of heart problems, glaucoma, or uncontrolled high blood pressure are not allowed to participate in these programs. Some clinics claim high success rates, but there is no published scientific research to back up these claims. Both atropine and scopolamine are FDA approved for other uses, but they have not been formally studied or approved for help in quitting smoking. Before considering such a program, you may want to ask the clinic about long-term success rates (up to a year). Because these medicines are directed only at the physical aspect of quitting, you may also want to ask if the program includes counseling or other methods aimed at the psychological aspects of quitting. Hypnosis might be useful for some people. Ask your doctor if he or she can recommend a good hypnotist if you are interested in this. Acupuncture has been used for quitting smoking, but there is little evidence to support its effectiveness. Acupuncture, when it is done, is typically done on the ears on particular ear sites. Although there is a very weak suggestion that acupuncture might lower the desire for smoking, there still is no solid evidence that it is truly effective as a smoking cessation tool (see ACS document on Acupuncture.) For a list of local physician acupuncturists, contact the American Academy of Medical Acupuncture at 1-800-521-2262. Low level laser therapy, also called cold laser therapy, is a related technique. Cold lasers are sometimes used for acupuncture, with laser beams to stimulate the body's acupoints rather than needles. The treatment is supposed to relax the smoker and release endorphins (naturally-occurring pain relief substances) in the body to simulate the effects of nicotine in the brain, or balance the body’s energy to relieve the addiction. Despite claims of success by some cold laser therapy providers, there is no scientific evidence that shows this is an effective method of helping people stop smoking (see ACS document on Cold Laser Therapy.) Filters that reduce tar and nicotine in cigarettes are generally not effective since studies show that smokers who use filters actually tend to smoke more. Smoking deterrents such as over-the-counter products that change the taste of tobacco, "stop smoking diets" that curb nicotine cravings, and combinations of vitamins have little scientific evidence to support their claims. The same is true of “homeopathic” aids and herbal supplements. Because they are marketed as dietary supplements (as opposed to drugs), they don’t need FDA approval to be sold. The manufacturers don’t have to prove they’re effective, or even safe. Be sure to look closely at the product label of any product claiming it can help you stop smoking. No dietary supplement has been proven effective in helping people quit smoking. Some of these supplements have no nicotine in them, but have multiple combinations of herbal preparations. They too have no proven track record of helping people to stop smoking. Other Nicotine/Tobacco Products, Not Reviewed or Approved by the FDA Tobacco lozenges and pouches: Lozenges containing tobacco, (Arival, Interval) and small, tobacco-containing pouches (Revel, Exalt) are being marketed as alternative ways for smokers to get nicotine in places where smoking is not permitted, rather than as quit smoking aids. The FDA has ruled that these are types of smokeless tobacco, not smoking cessation aids; therefore, the FDA does not have authority over them. There is no evidence that these products can help a person quit smoking. Nicotine lollipops and lip balms: In the past, some pharmacies made a product called a "nicotine lollipop". These lollipops often contained a product called nicotine salicylate with a sugar sweetener. Nicotine salicylate is not approved for pharmacy use by the FDA. The FDA has warned several pharmacies to stop selling nicotine lollipops and lip balm on the Internet, calling the products "illegal." The FDA also said "the candy-like products present a risk of accidental use by children." Other similar smoking cessation products may not use nicotine salicylate, and therefore may be legal. However, they still pose a risk for children if they are not sufficiently labeled and stored safely. Nicotine water and nicotine wafers: These products have been sold in recent years as ways to get nicotine in places where smoking is not permitted. They are not marketed as aids to quitting smoking, but questions about their safety and legality have been raised. A Word About Quitting Success Rates Before you start using nicotine replacement or sign up for a stop smoking class or program, you may wonder what its success rate is. That's a hard question to answer for several reasons. First, not all programs define success in the same way. Does success mean that a person is not smoking at the end of the program? After 3 months, 6 months, or 1 year? If a program you're considering claims a certain success rate, ask for more details on how success is defined and what kind of follow-up is done to verify the rate. The truth is, quit smoking programs, like other programs that treat addictions, often have a fairly low success rate. But that does not mean they are not worthwhile or that you should be discouraged. Your own success in quitting is what really counts, and that is under your control. About 5% to 16% of people are able to quit smoking for at least 6 months without any medicine to help with withdrawal. Several articles in medical journals have reported that between about 25% and about 33% of smokers who use medicines can remain smoke-free for over 6 months. There is early evidence that combining some medicines may be more effective than using them alone. Behavioral and supportive therapies may increase success rates even further. Check the package insert of any product you are using to see if the manufacturer provides free telephone-based counseling. How to Quit Smokers often say, "Don't tell me why to quit, tell me how." There is no one right way to quit, but there are some key elements in quitting smoking successfully. These 4 factors are crucial: making the decision to quit setting a quit date and choosing a quit plan dealing with withdrawal staying quit (maintenance) Making the Decision to Quit The decision to quit tobacco use is one that only you can make. Others may want you to quit, but the real commitment must come from you. Researchers have looked into how and why people stop tobacco use. They have some ideas, or models, of how this happens. The Health Belief Model says that you will be more likely to stop tobacco use if you: believe that you could get a tobacco-related disease and this worries you believe that you can make an honest attempt at quitting believe that the benefits of quitting outweigh the benefits of continuing tobacco use know of someone who has had health problems as a result of their tobacco use Does any of these apply to you? The Stages of Change Model identifies the stages that you go through when you make a change in behavior. Here are the stages as they apply to quitting tobacco use: Pre-contemplation: At this stage, the tobacco user is not thinking seriously about quitting right now. Contemplation: The tobacco user is actively thinking about quitting but is not quite ready to make a serious attempt yet. This person may say, "Yes, I'm ready to quit, but the stress at work is too much, or I don't want to gain weight, or I'm not sure if I can do it." Preparation: Tobacco users in the preparation stage seriously intend to quit in the next month and often have tried to quit in the past 12 months. They usually have a plan. Action: This is the first 6 months when the user is actively quitting. Maintenance: This is the period of 6 months to 5 years after quitting when the ex-user is aware of the danger of relapse and take steps to avoid it. Where do you fit in this model? If you are thinking about quitting, setting a date and deciding on a plan will move you into the preparation stage, the best place to start. Setting a Quit Date and Deciding on a Plan Once you've made a decision to quit, you're ready to pick a quit date. This is a very important step. Pick a specific day within the next month as your "Quit Day." Picking a date too far in the future allows you time to rationalize and change your mind. But do give yourself enough time to prepare and come up with a plan. You might choose a date that has a special meaning like a birthday or anniversary, or the date of the Great American Smokeout (third Thursday in November each year). Or you may want to simply pick a random date. Circle the date on your calendar. Make a strong, personal commitment to quit on that day. There is no one right way to quit. Most tobacco users prefer to quit "cold turkey" – that is, abruptly and totally. They use tobacco until their Quit Day and then stop all at once, or they may cut down on tobacco for a week or 2 before their Quit Day. Another way involves cutting down on the number of times tobacco is used each day. With this method, you gradually reduce the amount of nicotine in your body. While it sounds logical to cut down in order to quit gradually, in practice this method is difficult. Quitting tobacco is a lot like losing weight; it takes a strong commitment over a long period of time. Users may wish there was a magic bullet – a pill or method that would make quitting painless and easy. But that is not the case. Nicotine substitutes can help reduce withdrawal symptoms, but they are most effective when used as part of a stop tobacco use plan that addresses both the physical and psychological components of quitting. Here are some steps to help you prepare for your Quit Day: Pick the date and mark it on your calendar. Tell friends and family about your Quit Day. Stock up on oral substitutes – sugarless gum, carrot sticks, and/or hard candy. Decide on a plan. Will you use NRT or other medications? Will you attend a class? If so, sign up now. Practice saying, "No thank you, I don't smoke." Set up a support system. This could be a group class, Nicotine Anonymous, or a friend or family member who has successfully quit and is willing to help you. Successful quitting is a matter of planning and commitment, not luck. Decide now on your own plan. Some possibilities include using the nicotine patch or gum, joining a tobacco cessation class, going to Nicotine Anonymous meetings, or using self-help materials such as books and pamphlets. For the best chance at success, your plan should include one or more of these options. On your Quit Day, follow these suggestions: Do not smoke. Get rid of all cigarettes, lighters, ashtrays, and any other items related to smoking. Keep active – try walking, exercising, or doing other activities or hobbies. Drink lots of water and juices. Begin using nicotine replacement if that is your choice. Attend stop smoking class or start following a self-help plan. Avoid situations where the urge to smoke is strong. Reduce or avoid alcohol. Dealing With Withdrawal Withdrawal from nicotine has 2 parts – the physical and the psychological. The physical symptoms, while annoying, are not life threatening. Nicotine replacement can help reduce many of these physical symptoms. But most users find that the bigger challenge is the mental part of quitting. If you have been smoking for any length of time, smoking has become linked with nearly everything you do – waking up in the morning, eating, reading, watching TV, drinking coffee, etc. It will take time to "un-link" smoking from these activities. That is why, even if you are using a nicotine replacement, you may still have strong urges to smoke. One way to overcome these urges or cravings is to recognize rationalizations as they come up. A rationalization is a mistaken belief that seems to make sense at the time but is not based on facts. If you have tried to quit before, you will probably recognize many of these common rationalizations. I’ll just use it to get through this rough spot. Today is not a good day; I’ll quit tomorrow. It's my only vice. How bad is tobacco, really? Uncle Harry chewed all his life and he lived to be over 90. You've got to die of something. Life is no fun without smoking. You probably can add more to the list. As you go through the first few days without tobacco, write down any rationalizations as they come up and recognize them for what they are: messages that can trap you into going back to using tobacco. Use the ideas below to help you keep your commitment to quitting. Avoid people and places where you are tempted to smoke. Later on you will be able to handle these with more confidence. Alter your habits. Switch to juices or water instead of alcohol or coffee. Take a different route to work. Take a brisk walk instead of a coffee break. Alternatives. Use oral substitutes such as sugarless gum or hard candy, raw vegetables such as carrot sticks, or sunflower seeds. Activities. Exercise or do hobbies that keep your hands busy, such as needlework or woodworking, that can help distract you from the urge to smoke. Deep breathing. When you were smoking, you breathed deeply as you inhaled the smoke. When the urge strikes now, breathe deeply and picture your lungs filling with fresh, clean air. Remind yourself of your reasons for quitting and the benefits you'll gain as an ex-smoker. Delay. If you feel that you are about to light up, delay. Tell yourself you must wait at least 10 minutes. Often this simple trick will allow you to move beyond the strong urge to smoke. What you're doing is not easy, so you deserve a reward. Put the money you would have spent on tobacco in a jar every day and then buy yourself a weekly treat. Buy a magazine, go out to eat, call a friend long-distance. Or save the money for a major purchase. You can also reward yourself in ways that don't cost money: take time out to read, work on a hobby, or take a relaxing bath. Staying Quit (Maintenance) Remember the quotation by Mark Twain? Maybe you, too, have quit many times before. So you know that staying quit is the final, and most important, stage of the process. You can use the same methods to stay quit as you did to help you through withdrawal. Think ahead to those times when you may be tempted to smoke, and plan on how you will use alternatives and activities to cope with these situations. More dangerous, perhaps, are the unexpected strong desires to smoke that occur sometimes months (or even years) after you've quit. To get through these without relapse, try the following: Review your reasons for quitting and think of all the benefits to your health, your finances and your family. Remind yourself that there is no such thing as just one cigarette – or even one puff. Ride out the desire. It will go away, but do not fool yourself into thinking you can have just one. What if you do smoke? The difference between a slip and a relapse is within your control. You can use the slip as an excuse to go back to smoking, or you can look at what went wrong and renew your commitment to staying off smoking for good. Even if you do relapse, try not to get too discouraged. Very few people are able to quit for good on the first attempt. In fact, it takes most people several attempts before quitting for good. What’s important is figuring out what helped you in your attempt to quit and what worked against you. You can then use this information to make a stronger attempt at quitting the next time. Special Concerns Weight Gain Many smokers do gain some weight when they quit. Even without special attempts at diet and exercise, however, the gain is usually less than 10 pounds. Women tend to gain slightly more weight than men. There is some evidence that smokers will gain weight after they quit even if they do not eat more. For some, a concern about weight gain can lead to a decision not to quit. But the weight gain that follows quitting smoking is generally very small. It is much more dangerous to continue smoking than it is to gain a small amount of weight. You are more likely to be successful with quitting smoking if you deal with the smoking first, and then later take steps to reduce your weight. While you are quitting, try to focus on ways to help you stay healthy, rather than on your weight. Stressing about your weight may make it harder to quit. Eat plenty of fruits and vegetables and limit the fat. Be sure to drink plenty of water, and get enough sleep and regular physical activity. Walking is a great way to be physically active and increase your chances of staying quit. Walking can help you by: reducing stress burning calories and toning muscles giving you something to do instead of thinking about smoking No special equipment or clothing is needed for walking, other than a pair of comfortable shoes. And you can do it pretty much anytime or anywhere. Try the following: walking around a shopping mall getting off the bus one stop before you usually do finding a buddy to walk with during lunch time at work taking the stairs instead of the elevator walking with a friend, family member, or neighbor after dinner pushing your baby in a stroller Set a goal of 30 minutes of physical activity 5 or more times a week. If you don’t already exercise regularly, please check with your doctor before starting an exercise program. Stress Smokers often mention stress as one of the reasons for going back to smoking. Stress is a part of all of our lives, smokers and nonsmokers alike. The difference is that smokers have come to use nicotine to help cope with stress. When quitting, you have to learn new ways of handling stress. Nicotine replacement can help to some extent, but for long-term success other strategies are needed. As mentioned above, physical activity is a good stress-reducer. It can also help with the temporary sense of depression that some smokers experience when they quit. There are also stress-management classes and self-help books. Check your community newspaper, library, or bookstore. Spiritual practices such as prayer and meditation have been used very successfully with other addictions and are an integral part of 12-step recovery programs. These same principles can be applied to quitting smoking and can help with stress reduction. Where Can I Go for Help? It is hard to stop smoking. But if you are a tobacco user you can quit! More than 46 million Americans have quit smoking for good. Many organizations offer information, counseling, and other services on how to quit as well as information on where to go for help. Other good resources where help can be found include your doctor, dentist, local hospital, or employer. If you want to quit smoking and need help, contact one of the following organizations. American Cancer Society Telephone: 1-800-ACS-2345 (1-800-227-2345) Internet address: www.cancer.org American Heart Association & American Stroke Association Telephone: 1-800-AHA-USA-1 (1-800-242-8721) Internet address: www.amhrt.org Internet address: www.strokeassociation.org American Lung Association Telephone: 1-800-LUNG-USA (1-800-586-4872) Internet address: www.lungusa.org Centers for Disease Control and Prevention Office on Smoking & Health Internet address: www.cdc.gov/tobacco National Cancer Institute Cancer Information Service Telephone: 1-800-4-CANCER (1-800-422-6237) Internet address: www.cancer.gov Nicotine Anonymous Telephone: 1-877-TRY-NICA (1-877-879-6422) Internet address: www.nicotine-anonymous.org Smokefree.gov (Online materials, including info on state telephone-based programs) Telephone: 1-800-QUITNOW (1-800-784-8669) Internet address: www.smokefree.gov Smoking Cessation Leadership Center Internet address: http://smokingcessationleadership.ucsf.edu/ References American Cancer Society. 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