Nicotine inhaler

FDA label

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Titration Self-titrate to required nicotine level; adjust for signs of withdrawal vs excess; if not abstinent by week 4, probably discontinue

Renal No dose guidance; PK not studied in renal impairment — only severe renal impairment expected to affect clearance

Hepatic No dose guidance; PK not studied in hepatic impairment — anticipate reduced clearance (depends on liver blood flow).

In clinical trials, successful quitters averaged >6 cartridges/day (range 3–18)

Instructions

• Stop smoking completely when starting; use as part of a behavioral cessation program
• Insert cartridge into mouthpiece; inhale deeply into back of throat or puff in short breaths — nicotine vapor is absorbed in mouth and throat
• Cartridge nicotine depleted after ~20 min active puffing; 5 min at a time allows 4 uses; try different schedules.
• Use at room temperature (above 60°F); cold reduces nicotine delivered
• Regular use in week 1 helps adaptation to irritant effects (mouth/throat irritation, cough)
• Gradual reduction may begin after 12 wks and last up to 12 wks: use less often, keep a daily tally, set a reducing target, or set a planned stop date; some may stop abruptly
• Used cartridge retains ~6 mg (about 60%) nicotine — discard and store all components away from children and pets; keep mouthpiece locked; clean mouthpiece with soap and water
• Store cartridges ≤77°F (25°C), protect from light

Available strengths

• inhaler 10 mg/cartridge (4 mg delivered)

Contraindications

• Known hypersensitivity or allergy to nicotine or to menthol

Cautions

• Nicotine from any source is toxic and addictive; weigh NRT risk vs hazard of continued smoking
• Continued smoking during use → peak nicotine levels higher than smoking alone; discontinue if clinically significant cardiovascular effects
• Bronchospastic disease: caution (nicotine is an airway irritant, may cause bronchospasm); not studied in asthma/chronic pulmonary disease; other NRT forms may be preferable in severe bronchospastic airway disease
• Cardiovascular/peripheral vascular disease (CHD, serious arrhythmias, vasospastic disease): evaluate carefully; generally avoid in immediate post-MI period, serious arrhythmias, severe or worsening angina; tachycardia and palpitations reported
• Renal or hepatic impairment: not studied; anticipate reduced clearance with hepatic impairment
• Hyperthyroidism, pheochromocytoma, insulin-dependent diabetes: caution (catecholamine release)
• Active peptic ulcer: caution (delays ulcer healing)
• Accelerated hypertension: caution (risk factor for malignant hypertension)
• Smoking cessation may alter PK of concomitant drugs (e.g., tricyclic antidepressants, theophylline) — dose adjustment may be needed
• Sustained use >6 months not studied and not recommended
• Keep used and unused cartridges and all components away from children and pets (poisoning can be fatal; choking hazard)
• Elderly: start at low end of dosage range

Adverse reactions

• Local mouth/throat irritation 40% vs 18% placebo (66% vs 42% in higher-dose pivotal trials); mostly mild, declines with continued use
• Cough 32% vs 12%; rhinitis 23% vs 16%
• >3% possibly irritant-related: taste comments, jaw and neck pain, tooth disorders, sinusitis
• Dyspepsia 18% vs 9% (most common nicotine-related event); nausea, diarrhea, hiccup >3%
• Headache 26% vs 15%; influenza-like symptoms, pain, back pain, allergy, paresthesias, flatulence, fever >3%
• Withdrawal symptoms >3%: dizziness, anxiety, sleep disorder, depression, withdrawal syndrome, drug dependence, fatigue, myalgia
• Smoking-related >3%: chest discomfort, bronchitis, hypertension

Pregnancy Pregnancy Category D; presumed to cause fetal harm (animal data); not studied in pregnant women; attempt behavioral cessation first; use only if likelihood of cessation justifies risk; spontaneous abortion reported with NRT; not recommended during labor and delivery

Lactation Caution; nicotine passes freely into breast milk (milk:plasma ratio 2.9); milk nicotine expected lower than with smoking; weigh infant exposure vs continued maternal smoking