AdultPediatricDosage Forms & Strengths lozenge 2mg 4mg Smoking Cessation 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 mgSafety and efficacy not established Frequency Not Defined Increased blood pressure Tachycardia Dizziness Insomnia Irritability Anorexia Dyspepsia Hiccups Increased salivation Indigestion Headache Nausea Vomiting Cough Contraindications Hypersensitivity Cautions Ask healthcare professional if on sodium restricted diet, history of heart disease, recent heart attack, or irregular heartbeat; nicotine can increase heart rate Use caution in patients with history of esophagitis, peptic ulcer disease, or oropharyngeal inflammation; if history of stomach ulcer or diabetes, ask a healthcare professional Use caution in patients with insulin dependent diabetes Use caution in patients with history of seizures; ask a healthcare professional Use caution in 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) Ask healthcare professional if using non-nicotine stop smoking drug Smoking can seriously harm a child; try to stop smoking without using any nicotine replacement medicine; this medicine is believed to be safer than smoking; however, the risks to a child from this medicine are not fully known Ask healthcare professional if mouth problems occur, persistent indigestion or severe sore throat occur, irregular heartbeat or palpitation occur, experiencing symptoms of nicotine overdose, including nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat, experiencing symptoms of an allergic reaction such as difficulty breathing or rash Nicotine lozenges may have enough nicotine to make children and pets sick; if you need to remove lozenge, wrap it in paper and throw away in the trash; in case of overdose, get medical help or contact a Poison Control Center right away Pregnancy Ask healthcare professional Lactation Ask healthcare professionalPregnancy Categories 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 Pharmacokinetics Excretion: Urine Instructions 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 BRAND FORM. UNIT PRICE PILL IMAGE Nicorette buccal- 4 mg gumNicorette buccal- 2 mg gumNicorette buccal- 4 mg lozengeNicorette buccal- 2 mg lozengeNicorette buccal- 4 mg gumNicorette buccal- 2 mg gumNicorette buccal- 4 mg gumNicorette buccal- 4 mg lozengeNicorette buccal- 4 mg gumNicorette buccal- 2 mg gumNicorette buccal- 4 mg gumNicorette buccal- 4 mg lozengeNicorette buccal- 4 mg gumNicorette buccal- 2 mg gumNicorette buccal- 4 mg gumNicorette buccal- 2 mg gumNicorette buccal- 4 mg lozengeNicorette buccal- 2 mg lozengeNicorette buccal- 4 mg lozengeNicorette buccal- 2 mg lozengeNicorette buccal- 2 mg lozengeNicorette buccal- 2 mg lozengeNicorette buccal- 2 mg gumNicorette buccal- 4 mg gumNicorette buccal- 2 mg gumnicotine (polacrilex) buccal- 2 mg lozengenicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg lozengenicotine (polacrilex) buccal- 2 mg lozengenicotine (polacrilex) buccal- 4 mg lozengenicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg lozengenicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 4 mg lozengenicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg lozengenicotine (polacrilex) buccal- 2 mg lozengenicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg lozengenicotine (polacrilex) buccal- 2 mg lozengenicotine (polacrilex) buccal- 4 mg lozengenicotine (polacrilex) buccal- 2 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 4 mg gumnicotine (polacrilex) buccal- 2 mg gumCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print