Table 3.6Clinical use of the nicotine lozenge (See FDA package insert for more complete information.)

Clinical use of nicotine lozenge (FDA approved)
Patient selectionAppropriate as a first-line medication for treating tobacco use
Precautions, warnings, contraindications, and side effects (see FDA package insert for complete list)Pregnancy - Pregnant smokers should be encouraged to quit without medication. The nicotine lozenge has not been shown to be effective for treating tobacco dependence for pregnant smokers. The nicotine lozenge has not been evaluated in breastfeeding patients. Because the lozenge was approved as an OTC agent, it was not evaluated by the FDA for teratogenicity.

Cardiovascular diseases - NRT is not an independent risk factor for acute myocardial events. NRT should be used with caution among particular cardiovascular patient groups: those in the immediate (within 2 weeks) postmyocardial infarction period, those with serious arrhythmias, and those with unstable angina pectoris.

Side effects - The most common side effects of the nicotine lozenge are nausea, hiccups, and heartburn. Individuals on the 4-mg lozenge also had increased rates of headache and coughing (less than 10% of participants).
DosageNicotine lozenges are available in 2-mg and 4-mg (per piece) doses. The 2-mg lozenge is recommended for patients who smoke their first cigarette more than 30 minutes after waking, and the 4-mg lozenge is recommended for patients who smoke their first cigarette within 30 minutes of waking. Generally, smokers should use at least nine lozenges per day in the first 6 weeks; the lozenge should be used for up to 12 weeks, with no more than 20 lozenges to be used per day.
AvailabilityOTC only
Prescribing instructionsLozenge use - The lozenge should be allowed to dissolve in the mouth rather than chewing or swallowing it.

Absorption - Acidic beverages (e.g., coffee, juices, soft drinks) interfere with the buccal absorption of nicotine, so eating and drinking anything except water should be avoided for 15 minutes before or during use of the nicotine lozenge.

Dosing information - Patients often do not use enough prn NRT medicines to obtain optimal clinical effects. Generally, patients should use 1 lozenge every 1–2 hours during the first 6 weeks of treatment, using a minimum of 9 lozenges/day, then decrease lozenge use to 1 lozenge every 2–4 hours during weeks 7–9, and then decrease to 1 lozenge every 4–8 hours during weeks 10–12.
Costa2 mg, 72 lozenges per box = $34 (quantity used determines how long supply lasts)
4 mg, 72 lozenges per box = $39 (quantity used determines how long supply lasts)
a

Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI, Sunnyside, NY, and listed online during January 2008 and may not reflect discounts available to health plans and others.

From: 6, Evidence and Recommendations

Cover of Treating Tobacco Use and Dependence: 2008 Update
Treating Tobacco Use and Dependence: 2008 Update.
Tobacco Use and Dependence Guideline Panel.

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