NICOTROL® Inhaler (nicotine inhalation system) 10 mg per cartridge (4 mg
delivered)
NICOTROL Inhaler (nicotine inhalation system) is indicated as an aid to smoking
cessation for the relief of nicotine withdrawal symptoms. NICOTROL Inhaler therapy is
recommended for use as part of a comprehensive behavioral smoking cessation
program.
Important Safety Information
NICOTROL Inhaler therapy is contraindicated in patients with known hypersensitivity or
allergy to nicotine, menthol or to any component of the product.
The safety and efficacy of the continued use of NICOTROL Inhaler for periods longer
than 6 months have not been adequately studied and such use is not recommended.
The patient must stop smoking completely before using the NICOTROL Inhaler.
Because nicotine is addictive, patient dependency upon the NICOTROL Inhaler is
possible. It is important the patient use it only for as long as needed to overcome a
smoking habit.
Prior to starting NICOTROL Inhaler, the patient must inform the healthcare professional
of all medications he or she is taking. Certain concomitant medications may require a
dosage adjustment.
A special note about children and pets. The NICOTROL Inhaler can cause serious
illness in children and pets—even in very small amounts. If a child chews on or swallows
NICOTROL Inhaler cartridges, immediately call a doctor or call your regional poison
center.
Adverse events. In clinical trials NICOTROL Inhaler was associated with local irritant
side effects of the mouth and throat. The most common nicotine-related adverse event
reported by patients on active drug was dyspepsia. Other nicotine-related events present
in greater than 3% of patients on active drug included nausea, diarrhea, and hiccup.
Smoking-related adverse events present in greater than 3% of patients on active drug
included chest discomfort, bronchitis, and hypertension.
Adverse events of unknown relationship to nicotine occurring in greater than 3% of
patients on active drug included headache, influenza-like symptoms, pain, back-pain,
allergy, paresthesias, flatulence, and fever.
Pregnancy and nursing. The specific effects of NICOTROL Inhaler treatment on fetal
development and nursing infants are unknown. Therefore, pregnant and nursing smokers
should be encouraged to attempt cessation using educational and behavioral
interventions before using pharmacological approaches.
Bronchospastic disease. The NICOTROL Inhaler has not been specifically studied in
asthma or chronic pulmonary disease. Therefore, the NICOTROL Inhaler should be used
with caution in patients with bronchospastic disease because nicotine is an airway irritant
and might cause bronchospasm.
Cardiovascular and peripheral vascular diseases. The NICOTROL Inhaler should be
used with caution in patients with cardiovascular and peripheral vascular diseases,
specifically coronary heart disease, serious cardiac arrhythmias, or vasospastic
diseases. In these situations, the potential risks of using NICOTROL Inhaler should be
discussed with the patient.