Dosing and uses of Nicorette Inhaler, Nicotrol Inhaler (nicotine inhaled)
Adult dosage forms and strengths
oral inhaler
- 10mg/cartridge (4 mg delivered)
Smoking Cessation
Indicated to reduce withdrawal symptoms during smoking cessation
Best effect observed with frequent, continuous puffing over 20 minute periods throughout the day
6 or more cartridges/day PRN [4 mg/cartridge]; do not exceed 16 cartridges/day
Use at least 6 cartridges/day for the first 3-6 weeks for improved success at quiting
Administration
Before initiating nicotine replacement reatment, patient must have desire to stop smoking
Most effective as part of comprehensive smoking cessation plan
See product user's guides for details
Pediatric dosage forms and strengths
Not recommended
Nicorette Inhaler, Nicotrol Inhaler (nicotine inhaled) adverse (side) effects
>10%
Mouth/throat irritation (66%)
Cough (32%)
Headache (18-26%)
Rhinitis (23%)
Dyspepsia (18%)
1-10%
Back pain (6%)
Arthralgia (5%)
Flatulence (4%)
Gum problems (4%)
Acne (3%)
Dysmenorrhea (3%)
<1%
Nicotine withdrawal (irritability, dizziness, headache, insomnia)
Hiccups
N/V
Anorexia
Diarrhea
Increased salivation
Cardiac dysrhythmia (rare)
Hypertension (rare)
Tachyarrhythmia (rare)
Immune hypersensitivity reaction (rare)
Warnings
Contraindications
Hypersensitivity to nicotine or components
Active smokers following the postmyocardial period
Patients with life-threatening arrhythmias or worsening of angina pectoris if severe
Nonsmokers
Cautions
Not studied in reactive airway disease; may cause bronchospasm
Caution with hypertension, cardiovascular, or peripheral vascular disease
Caution with hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes, since nicotine causes the release of catecholamines by the adrenal medulla
Delays healing of peptic ulcer disease
Use caution in patients with oropharyngeal inflammation, peptic ulcer, or history of esophagitis
Caution in severe renal impairment
Pregnancy and lactation
Pregnancy category: d
Lactation: Unknown whether excreted in breast milk; use caution
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.
Pharmacology of Nicorette Inhaler, Nicotrol Inhaler (nicotine inhaled)
Mechanism of action
Agonist at nicotinic receptors; potent ganglionic and central nervous stimulant
Absorption
Peak plasma time: 15 minutes
Distribution
Protein binding: <5%
Vd: 2-3 L/kg
Metabolism
Metabolism: liver (some renal, lung)
Metabolites: over 20, less active
Elimination
Clearance: 1.2 L/min
Excretion: urine (30%)
