FDA label 4cc74727-e4ab-4b51-8ed2-4a9c488bcfd1

WARNINGS Nicotine from any source can be toxic and addictive. Smoking causes lung disease, cancer and heart disease, and may adversely affect pregnant women or the fetus. For any smoker, with or without concomitant disease or pregnancy, the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement. Pregnancy, Warning Tobacco smoke, which has been shown to be harmful to the fetus, contains nicotine, hydrogen cyanide, and carbon monoxide. The NICOTROL Inhaler does not deliver hydrogen cyanide and carbon monoxide. However, nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that NICOTROL Inhaler can cause fetal harm when administered to a pregnant woman. The effect of nicotine delivery by NICOTROL Inhaler has not been examined in pregnancy (See PRECAUTIONS ). Therefore, pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches. If NICOTROL Inhaler is used during pregnancy, or if the patient becomes pregnant while using it, the patient should be apprised of the potential hazard to the fetus. Safety Note Concerning Children This product contains nicotine and should be kept out of the reach of children and pets. The amounts of nicotine that are tolerated by adult smokers can produce symptoms of poisoning and could prove fatal if the nicotine from the NICOTROL Inhaler is inhaled, ingested, or buccally absorbed by children or pets. A cartridge contains about 60% of its initial drug content when it is discarded, which is about 6 mg. Patients should be cautioned to keep both the used and unused cartridges of NICOTROL Inhaler out of the reach of children and pets. All components of the NICOTROL Inhaler system should also be kept out of the reach of children and pets to avoid accidental swallowing and choking.

ADVERSE REACTIONS Assessment of adverse events in the 1,439 patients (730 on active drug) who participated in controlled clinical trials (including three dose finding studies) is complicated by the occurrence of signs and symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by: (1) the many minor complaints that smokers commonly have, (2) continued smoking by many patients and (3) the local irritation from both the active drug and the placebo. Local Irritation NICOTROL Inhaler and the placebo were both associated with local irritant side effects. Local irritation in mouth and throat was reported by 40% of patients on active drug as compared to 18% of patients on placebo. Irritant effects were higher in the two pivotal trials with higher doses being 66% on active drug and 42% on placebo. Coughing (32% active versus 12% placebo) and rhinitis (23% active versus 16% placebo) were also higher on active drug. The majority of patients rated these symptoms as mild. The frequency of cough, and mouth and throat irritation declined with continued use of NICOTROL Inhaler. Other adverse events that occurred in over 3% of patients on active drug in placebo controlled pivotal trials considered possibly related to the local irritant effects of the NICOTROL Inhaler are taste comments, pain in jaw and neck, tooth disorders and sinusitis. Withdrawal Symptoms of withdrawal were common in both active and placebo groups. Common withdrawal symptoms seen in over 3% of patients on active drug included: dizziness, anxiety, sleep disorder, depression, withdrawal syndrome, drug dependence, fatigue and myalgia. Nicotine-Related Adverse Events The most common nicotine-related adverse event was dyspepsia. This was present in 18% of patients in the active group compared to 9% of patients in the placebo group. Other nicotine related events present in greater than 3% of patients on active drug include nausea, diarrhea, and hiccup. Smoking Related Adverse Events Smoking related adverse events present in greater than 3% of patients on active drug include chest discomfort, bronchitis, and hypertension. Other Adverse Events Adverse events of unknown relationship to nicotine occurring in greater than 3% of patients on active drug include headache (26% of patients on active and 15% of patients on placebo), influenza-like symptoms, pain, back-pain, allergy, paresthesias, flatulence and fever.