nicotine lozenge (OTC)

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 professional

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.

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