nicotine lozenge (OTC)

Brand and Other Names:Nicorette Lozenge, Nicorette Mini Lozenge
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lozenge

  • 2mg
  • 4mg
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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 mg

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Increased blood pressure

Tachycardia

Dizziness

Insomnia

Irritability

Anorexia

Dyspepsia

Hiccups

Increased salivation

Indigestion

Headache

Nausea

Vomiting

Cough

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Warnings

Contraindications

Hypersensitivity

Smokers in postmyocardial infarction period

Life-threatening arrhythmias

Severe or worsening angina pectoris

Nonsmokers

Cautions

Caution in coronary artery disease (eg, history of myocardial infarction or angina pectoris)

Serious cardiac arrhythmias

Hypertension

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)

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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

Pregnancy 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.

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Pharmacology

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

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Administration

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

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Images

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