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NICOTROL® Inhaler (nicotine inhalation system) is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. It is available only by prescription and 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.
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. 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 should stop smoking completely before using the NICOTROL Inhaler.
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 or be fatal in children and pets—even in very small amounts. If a child chews on or swallows new or used NICOTROL Inhaler cartridges, immediately call a doctor or call your regional poison center.
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.
Adverse events: The patient may experience 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 >3% of patients on active drug included nausea, diarrhea, and hiccup. Smoking-related adverse events present in >3% of patients on active drug included chest discomfort, bronchitis, and hypertension.
Adverse events of unknown relationship to nicotine occurring in >3% of patients on active drug included headache, influenza-like symptoms, pain, back pain, allergy, paresthesias, flatulence, and fever.