Classes
DEA Class; Rx,OTC
Common Brand Names; Nicorette Lozenge, Nicorette Mini Lozenge, Nicorette Inhaler, Nicotrol Inhaler, Nicotrol NS, Nicoderm CQ, Nicotrol, Nicorette Gum
- Smoking Cessation Aids
Description
Natural alkaloid of complex pharmacology inherent to the autonomic nervous system
Used primarily for non-prescription (OTC) therapy to aide smoking cessation (patches, gum, lozenges); vaping solutions and electronic cigarretes are not FDA-monitored
Prescription-only products (nasal spray, inhalation) are also available
Indications
Indicated for use as an adjunct to psychosocial interventions for tobacco cessation (smoking cessation), including the treatment of nicotine withdrawal.
Contraindications
Hypersensitivity
Smokers in postmyocardial infarction period
Life-threatening arrhythmias
Severe or worsening angina pectoris
Nonsmokers
Adverse Effects
- Increased blood pressure
- Tachycardia
- Dizziness
- Insomnia
- Irritability
- Anorexia
- Dyspepsia
- Hiccups
- Increased salivation
- Indigestion
- Headache
- Nausea
- Vomiting
- Cough
Warnings
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)
Pregnancy and Lactation
Pregnancy Category: C
Lactation: Excretion in milk unknown; use with caution
Maximum Dosage
21 mg/day transdermally; 24 pieces/day chewing gum; 20 lozenges/day; 40 sprays/day of nostril nasal spray; 64 mg/day for oral inhalation.
21 mg/day transdermally; 24 pieces/day chewing gum; 20 lozenges/day; 40 sprays/day of nostril nasal spray; 64 mg/day for oral inhalation.
Safety and efficacy have not been established; off-label studies suggest 24 pieces chewing gum/day; 21 mg/day transdermal patch if weight 45 kg or more and 14 mg/day transdermal patch if weight less than 45 kg.
Safety and efficacy have not been established.
Not indicated.
How supplied
Nicotine
lozenge
2mg
4mg
oral inhaler
10mg/cartridge (4 mg delivered)
intranasal spray
0.5mg/actuation
transdermal patch
7mg/day
14mg/day
21mg/day
gum
2mg
4mg
