Patient should stop smoking completely when initiating therapy.

Each use of the device delivers a spray containing 0.5 mg of nicotine. One dose is 1 mg of nicotine (2 sprays, one in each nostril).

Patients should be started with 1 or 2 doses per hour, which may be increased up to a maximum of 40 doses per day (maximum 5 doses per hour.)

No particular tapering strategy is recommended.

Patients should administer the spray with the head titled slightly backward.

Patients should be instructed not to sniff, swallow, or inhale through the nose as the spray is being administered.

Patient should spray once in each nostril per dose.

Maximum recommended duration of therapy is 3 months.

Patients who are successfully abstinent on Nicotrol® NS should be treated at the selected individualized dose for up to 8 weeks, following which use of the spray should be discontinued over the next 4 to 6 weeks. Some patients may not require gradual reduction of dosage and may abruptly stop treatment successfully.

If the patient is unable to stop smoking by the fourth week of therapy, treatment should probably be discontinued.

The most common type of adverse reaction involves irritant effects of the nasophrayngeal and ocular tissues. During the first 2 days of treatment, nearly all patients report nasal irritation. Although the frequency and severity of nasal irritation declines with continued use, most patients continue to experience this effect to some degree.

Other common local side effects: runny nose, throat irritation, watering eyes, sneezing, and cough.

Systemic side effects: headaches and dizziness

Hypersensitivity or allergy to nicotine or other product component.

Not recommended in patients with severe reactive airways disease because of potential to exacerbate bronchospasm.

Do not use during immediate post-myocardial infarction period, in patients with serious arrhythmias, or with severe or worsening angina.

Discontinue if tachycardia occurs.

Use with caution in patients with coronary heart disease, vasospastic diseases, hyperthyroidism, pheochromocytoma, insulin-dependent diabetes, active peptic ulcer disease, and accelerated hypertension.

Nicotrol® NS has a dependence potential intermediate between other nicotine-based therapies and cigarettes.

Pregnancy: Encourage pregnant smokers to attempt cessation without pharmocologic treatment. Use during pregnancy only if the likelihood of smoking cessation justifies the potential risk of using it by the pregnant patient, who might continue to smoke.

Nursing mothers: Nicotine passes freely into breast milk. The risk of exposure of the infant to nicotine from Nicotrol® NS should be weighed against the risks associated with the infant's exposure to nicotine from continued smoking by the mother and from Nicotrol® NS alone, or in combination with continued smoking.

Drug interaction: Smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of certain concomitant medications.

Safety note concerning children: Keep both used and unused containers of Nicotrol® NS out of reach of children and pets.