nicotine gum (OTC)

Brand and Other Names:Nicorette Gum
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

gum

  • 2mg
  • 4mg

Smoking Cessation

Weeks 1-6: 1 piece of gum q1-2hr; ches at least 9 pieces per day during the first 6 weeks to increase chances of quiting

Weeks 7-9: 1 piece of gum q2-4hr

Weeks 10-12: 1 piece of gum q4-8hr

<25 cigarettes/day: Initiate with 2 mg

≥25 cigarettes/day: Initiate with 4 mg

For strong/frequent cravings, may use second piece within 1 hour

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

Nausea

Vomiting

Cough

Dental

  • May loosen inlays/fillings
  • Stick to dentures
  • Damage to oral mucosa & teeth
  • Temporal mandibular joint dysfunction and pain with excessive chewing
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Warnings

Contraindications

Hypersensitivity drug or excipients, including soya

Cautions

Weigh benefits versus risk in patients with cardiovascular or peripheral vascular disease, including angina pectoris, vasospastic disease, or serious cardiac arrhythmias, hypertension; discontinue use if irregular heartbeat or palpitations occur

Monitor for adverse effects and consider dose reduction in hepatic or renal impairment as clearance may be reduced

Patient should discontinue use and contact healthcare professional if symptoms of nicotine overdose occur, including dizziness, nausea, vomiting, diarrhea, or rapid heartbeat

Poisoning/fatality may occur in children if inhaled, ingested, or buccally absorbed

Continuously chewing gum increases nicotine release leading to increased adverse effects (see administration instructions)

Stop use if oral blistering occurs

If teeth, mouth, or jaw problems occur, discontinue use and talk to healthcare provider

May delay healing of esophagitis or active gastric or peptic ulcer disease

Use caution in patients with insulin-dependent diabetes

Use caution in patients on sodium restricted diet or with history of seizures

Use caution in hyperthyroidism or pheochromocytoma

Stop use and ask a doctor if symptoms of an allergic reaction occur, such as, difficulty breathing or rash

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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

Transdermal nicotine systemically absorbed; binds to nicotine receptors; reduces withdrawal symptoms, including nicotine craving, associated with smoking cessation

Pharmacokinetics

Peak Plasma Level: Dependent on chewing vigor and duration

Trough Plasma Level: trough serum level 1 hr after smoking 1 cigarette/hr about 2x that of 2 mg gum

Elimination Half-Life: 30-120 min

Metabolism: Liver via oxidation

Excretion: (renal; pH dependent, increased with acidic urine) 10-20%

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Administration

Administration

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

Nicotine is bound to an ion exchange resin (polacrilex) and released only during chewing

Delay use until at least 15 minutes after consuming food or liquids

Concurrent consumption of acidic beverages (eg, coffee, cola) significantly decreases nicotine absorption

Instruct patient to not chew nicotine gum as regular gum; begin chewing slowly until feels tingling or peppery taste in mouth; THEN

Move gum between to inside cheek (ie, between patient’s teeth & cheek) until tingling subsides

Repeat chewing until tingling appears & subsides until tingling doesn’t come back (then that piece of gum is finished)

Before using this product, instruct the patient to read the enclosed user's guide for complete directions and other important information

To improve the chances of quitting, chew at least 9 pieces/day for the first 6 weeks

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.