INDICATIONS AND USAGE NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms.

NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program.

The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.

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.

Nicotine has been shown in animal studies to cause fetal harm.

It is therefore presumed that NICOTROL NS can cause fetal harm when administered to a pregnant woman.

The effect of nicotine delivery by NICOTROL NS has not been examined in pregnancy (See PRECAUTIONS, Pregnancy ).

Therefore, pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

If NICOTROL NS 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 The amounts of nicotine that are tolerated by adult smokers can produce signs and symptoms of poisoning and could prove fatal if NICOTROL NS is used or ingested by children or pets.

Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.

A full bottle of NICOTROL NS contains 100 mg of nicotine, some of which will still be in the bottle when it is discarded.

Therefore, patients should be cautioned to keep both used and unused containers of NICOTROL NS out of the reach of children and pets.

ADVERSE REACTIONS Assessment of adverse events in the 730 patients who participated in controlled clinical trials 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 the many minor complaints that smokers commonly have, by continued smoking by many patients and the local irritation from both active drug and the pepper placebo.

No serious adverse events were reported during the trials.

Common Smoker's Complaints Common complaints experienced by the smokers in the study (users of both active and placebo spray) include: chest tightness, dyspepsia, paresthesia (tingling) in limbs, constipation, and stomatitis.

Tobacco Withdrawal Symptoms Symptoms of tobacco withdrawal were frequent in users of both active and placebo sprays.

Common withdrawal symptoms seen in over 5% of patients included: anxiety, irritability, restlessness, cravings, dizziness, impaired concentration, weight increase, emotional lability, somnolence and fatigue, increased sweating, and insomnia.

Less frequently seen probable withdrawal symptoms (under 5%) included: confusion, depression, apathy, tremor, increased appetite, incoordination, and increased dreaming.

Anxiety, irritability, restlessness, and tobacco cravings occurred about equally in both groups, while other symptoms tended to be slightly more common on placebo spray.

Effects of the Spray NICOTROL NS and the pepper-containing placebo were both associated with irritant side effects on the nasopharyngeal and ocular tissues.

During the first 2 days of treatment, nasal irritation was reported by nearly all (94%) of the patients, the majority of whom rated it as either moderate or severe.

Both the frequency and severity of nasal irritation declined with continued use of NICOTROL NS but was still experienced by most (81%) of the patients after 3 weeks of treatment, with most patients rating it as moderate or mild.

Other common side effects for both active and placebo groups were: runny nose, throat irritation, watering eyes, sneezing, and coughing.

The following local events were reported somewhat more commonly for active than for placebo spray: nasal congestion, subjective comments related to the taste or use of the dosage form, sinus irritation, transient epistaxis, eye irritation, transient changes in sense of smell, pharyngitis, paresthesia of the nose, mouth or head, numbness of the nose, or mouth, burning of the nose or eyes, earache, facial flushing, transient changes in sense of taste, hoarseness, nasal ulcer or blister.

Effects of Nicotine Feelings of dependence on the spray were reported by more patients on active spray than placebo.

Drug-like effects such as calming were also more frequent on active spray (See DRUG ABUSE AND DEPENDENCE ).

Other Adverse Effects Adverse events which could not be classified and listed above and which were reported by >1% of patients on active spray are listed in the following table: Adverse Events Not Attributable to Intercurrent Illness Adverse Event Active Placebo HEADACHE 18% 15% BACK PAIN 6% 4% DYSPNEA 5% 6% NAUSEA 5% 5% ARTHRALGIA 5% 1% MENSTRUAL DISORDER 4% 4% PALPITATION 4% 4% FLATULENCE 4% 3% TOOTH DISORDER 4% 1% GUM PROBLEMS 4% 1% MYALGIA 3% 4% ABDOMINAL PAIN 3% 3% CONFUSION 3% 3% ACNE 3% 1% DYSMENORRHEA 3% 0% PRURITUS 2% 3% Adverse events reported with a frequency of <1% among active spray users are listed below: Body as a Whole: edema peripheral, pain, numbness, allergy Gastrointestinal: dry mouth, hiccup, diarrhea Hematologic: purpura Neurological: aphasia, amnesia, migraine, numbness Respiratory: bronchitis, bronchospasm, sputum increased Skin and appendages: rash, purpura Special Senses: vision abnormal Adverse reactions not listed above that have been identified during post-marketing experience with the nicotine nasal spray formulation are listed below: Gastrointestinal disorders: dysphagia General disorders and administration site conditions: chest pain Immune system disorders: anaphylactic reaction Nervous system disorders: seizure