Dosing & Uses
Dosage Forms & Strengths
Weeks 1-6: 1 lozenge q1-2hr
Weeks 7-9: 1 lozenge q2-4hr
Weeks 10-12: 1 lozenge q4-8hr
Do not exceed >5 lozenges/6hr
Do not exceed >20 lozenges/day
First cigarette smoked >30 minutes after awakening: Initiate with 2 mg
First cigarette smoked within 30 minutes of awakening: Initiate with 4 mg
Safety and efficacy not established
Frequency Not Defined
Increased blood pressure
Smokers in postmyocardial infarction period
Severe or worsening angina pectoris
Caution in coronary artery disease (eg, history of myocardial infarction or angina pectoris)
Serious cardiac arrhythmias
Use caution in patients with history of esophagitis, peptic ulcer disease, oropharyngeal inflammation
Use caution in patients with with insulin dependent diabetes
Use caution in patients with history of seizures
Vasospastic disease (eg, Prinzmetal angina, Raynauds phenomena)
Extensively metabolized in liver; hepatic impairment may decrease clearance
Poisoning/fatality may occur in children if inhaled, ingested, or buccally absorbed
Do not bite, chew, or swallow lozenge/troche
Use caution in hepatic impairment, pheochromocytoma, hyperthyroidism, and hepatic or renal impairment
Not for use in patients allergic to soya (mint flavor only)
Pregnancy & Lactation
Pregnancy category: D; tobacco smoke known to cause low birth weight, spontaneous abortion, increased perinatal mortality, decreased placental perfusion; however, nicotine replacement is believed to be safer during pregnancy than smoking
Lactation: Nicotine and metabolite (cotinine) pass into breast milk up to hr after maternal smoking; risk of exposure of infant to 2nd hand smoke may be more detrimental than nicotine replacement; nicotine may increase infant heart rate
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Nicotine is a poatent ganglionic and central nervous stimulant; transdermal nicotine systemically absorbed; binds to nicotine receptors; reduces withdrawal symptoms, including nicotine craving, associated with smoking cessation
Delay use until at least 15 minutes after consuming food or liquids
Concurrent consumption of acidic beverages (eg, coffee, cola) significantly decreases nicotine absorption
Do not bite, chew, or swallow lozenge
Suck on lozenge and allow it to melt slowly in mouth (melts completely in 20-30 minutes)
There are no significant safety concerns associated with using more than 1 nonprescription nicotine replacement therapies (OTC NRT) at the same time or at the same time as another nicotine-containing product—including a cigarette
Patients using an OTC NRT while trying to quit smoking but slip up and have a cigarette, should not stop using the NRT, but keep using the OTC NRT and keep trying to quit
NRT users should still pick a day to quit smoking, and begin using the OTC NRT product on their "quit" day, even if they aren't immediately able to stop smoking
It is important for patients to complete the full program, but some patients may need to use the NRT for a longer period of time to keep from smoking