In 2000, governmental and nonprofit organizations issued the clinical practice guideline "Treating Tobacco Use and Dependence." TTUD lists five products as first-line agents: sustained-release bupropion and four nicotine-replacement products (gum, patch, nasal spray, and inhaler). A nicotine lozenge is also available now.
Patient preference is the biggest determinant of product choice. Within each product category, experts see no difference between the prescription and over-the-counter formulations. Sustained-release bupropion (Zyban) is the only nonnicotine product currently approved as a first-line agent. It can be used as monotherapy or combined with nicotine replacement.
Clonidine and nortriptyline are considered secondline agents. They are not approved by the Food and Drug Administration for this indication, but there is evidence that they make smoking cessation easier.
Patients should start bupropion 1-2 weeks before they stop smoking, to achieve a therapeutic level by the time they quit. Nicotine replacement agents should be started after a patient stops smoking. Information on the activity of nicotine replacement therapy in elderly people is scarce. It's believed that no special dosage adjustments are necessary.
Pregnant women who smoke are urged to use nonpharmacologic means to help them quit. The TTUD states that pharmacologic interventions should be used only if the increased likelihood of abstinence, with its potential benefits, outweighs the risks of drug treatment. If a woman uses nicotine replacement during lactation, the nicotine is excreted into milk, making it safest not to breast-feed. However, both the patch and gum are preferable to smoking if there is no other alternative. There is some evidence that first-trimester bupropion exposure may be related to cardiovascular defects, but additional data are required to confirm this association. Bupropion is also excreted into milk. Although no adverse effects have been noted in nursing infants, the American Academy of Pediatrics has expressed concern that long-term exposure could harm the central nervous system function of these infants. Pregnant women should not start using clonidine because it might cause maternal hypotension and thus decrease placental perfusion. This does not appear to be a risk if the drug is started before pregnancy. Nortriptyline use has not been associated with structural anomalies in developing fetuses, but there have been reports of urinary retention in neonates who had drug exposure in utero. Both clonidine and nortriptyline are excreted into breast milk. There have been no reports of adverse effects in exposed infants.
NICOTINE REPLACEMENT Drug Cost/Day* Dosage gum $7.20 (2 mg, 20/day) as needed [Nicorette] [$8.80] inhaler no generic available 6-16 [Nicotrol inhaler] [$9.70 (10 cartridges/day cartridges)] lozenge no generic available every 1-2 [Commit] [$5.28 (2 mg, hours, then 12/day)] taper nasal spray no generic available 1 spray into [Nicotrol NS] [$8.20 (20 mg)] each nostril, as needed transdermal patch $2.13 (OTC. 14 mg) 1 patch/day $6.29 (prescription) [Habitrol] [$4.73] [Nicoderm] [$3.39] [Nicotrol] [$3.53] OTHER AGENTS bupropion $2.88 150 mg [Zyban] [$4.14] b.i.d. clonidine patch no generic available [Catapres-TTS] [$2.08 (0.1 mg)] 0.1-0.3 mg/day nortriptyline $0.14 [Aventyl] [$1.05] 25 mg/day [Pamelor] [$4.26] Drug What the Experts Say** gum All products are over the counter (OTC). Patients [Nicorette] chew one piece when they have an urge to smoke. The 2-mg formulation should not be used more than 30 times/day if under a doctor's supervision, or more than 24/day by patients quitting on their own. Use of the 4-mg strength should not exceed 24 pieces/day. Should not be used for more than 12 weeks. Some experts suggest patients cut use by one piece every 4-7 days, substituting sugarless gum it necessary. Patients should also try to drop mouth time from 30 minutes per piece to 10-15 minutes. Should not be swallowed. Acidic beverages should be avoided 15 minutes before and after use. inhaler Available in trade formulation only. Prescription [Nicotrol inhaler] product. Satisfies the hand-to-mouth motion associated with smoking. No evidence that any tapering strategy is superior. One common scheme is 6-16 cartridges per day for 12 weeks, reducing gradually over the next 6-12 weeks. Each cartridge provides 4 mg nicotine. lozenge Available in trade formulation only. OTC product. [Commit] Good choice for people with dentures. Not yet considered a first-line therapy because the results from only one study meet the level of evidence required by TTUD for first-line drugs. Lozenges come in two strengths: 4 mg, for people who smoked their first cigarette of the day within 30 minutes of awakening, and 2 mg for everyone else. Recommended dosage is one lozenge of either strength every 1-2 hours for weeks 1-6, one every 2-4 hours during weeks 7-9, and one every 4-8 hours in weeks 10-12. Maximal dosage is 20/day. nasal spray Available in trade formulation only. Prescription [Nicotrol NS] product. Adverse effects include a hot feeling in the mouth or back of the throat or nose, coughing, watery eyes, and sneezing. Should not be used for more than 12 weeks. One dose is one 0.5-mg spray into each nostril. To start, 1-2 doses per hour should be used, increasing as needed to a maximum of 5 doses per hour or 40 doses (40 mg) per day. Recommended minimum is 8 doses per day. transdermal patch Available in prescription and OTC products, but [Habitrol] experts see little difference among these. Strength [Nicoderm] of patch is matched to number of cigarettes smoked [Nicotrol] (1 mg per cigarette per day); each formulation comes in a series of strengths. Strength used is tapered over time, usually every 2 weeks. Patients may experience itching or burning at patch site for the first few minutes after applying. Should be applied to a different site each day. OTHER AGENTS bupropion Start 1-2 weeks before quitting. Dose-related risk [Zyban] of seizures; contraindicated for people with seizure disorders. No need to adjust dose for elderly patients. Also marketed as Wellbutrin, which is prescribed for depression, usually at same dosage of 300 mg/day; do not prescribe both simultaneously. Starting dosage is 150 mg/day for the first 3 days, then 150 mg b.i.d., with doses at least 8 hours apart, for 3 months. clonidine patch Available in trade formulation only. Second-line [Catapres-TTS] treatment; not labeled for smoking cessation but can double abstinence rate. Patches come in three strengths: 0.1, 0.2, and 0.3 mg/day. Patch is changed weekly. Provides sustained drug release, which tends to minimize drug-related fluctuations in blood pressure, compared with tablet form. Despite this, clonidine treatment using a tablet formulation is a possible alternative. Use limited by adverse effects. Abrupt discontinuation should be avoided; tapering recommended. nortriptyline Second-line treatment; not labeled for smoking [Aventyl] cessation. Use limited by fears that overdoses may [Pamelor] be fatal. Also, increases risk of arrhythmias; questionable value in a population with a high risk of heart disease. Listed dosage is starting dosage; if needed, can be increased to 75-100 mg/day; treatment is for 12 weeks. *Cost/day is based on the average wholesale price for the generic or trade formulations listed in the 2004 Red Book, except for generic nortriptyline, which is based on the federal upper limit price listed in the 2004 Red Book, and for Commit, which is based on price information supplied by the manufacturer. **Comments are based on the opinions and expertise of the following sources: Gerald G. Briggs, B.Pharm., pharmacist clinical specialist, Women's Hospital, Long Beach (Calif.) Memorial Medical Center. Source on drug safety in pregnant and nursing women. Stephen Brunton, M.D., director, faculty development. Cabarrus Family Medicine Residency, Charlotte, N.C. Douglas Jorenby, Ph.D., director, clinical services, Center for Tobacco Research and Intervention. University of Wisconsin, Madison. Bernard Karnath, M.D., assistant professor of medicine, University of Texas, Galveston.
Mitchel L. Zoler, Editor
Norra MacReady, Writer
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|Title Annotation:||DRUG UPDATE|
|Author:||Zoler, Mitchel L.; MacReady, Norra|
|Publication:||OB GYN News|
|Date:||Nov 1, 2004|
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