Overview
DESCRIPTION NICOTROL ® NS (nicotine nasal spray) is an aqueous solution of nicotine intended for administration as a metered spray to the nasal mucosa. Nicotine is a tertiary amine composed of pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacologic Action Nicotine, the chief alkaloid in tobacco products, binds stereo-selectively to nicotinic-cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. Two types of central nervous system effects are believed to be the basis of nicotine's positively reinforcing properties. A stimulating effect is exerted mainly in the cortex via the locus ceruleus and a reward effect is exerted in the limbic system. At low doses, the stimulant effects predominate while at high doses the reward effects predominate.
Indications
- 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.
Common Doses
- 0.5 mg
- 1 mg
- 40 mg
Dosage
DOSAGE AND ADMINISTRATION It is important that patients understand the instructions for use of NICOTROL NS, and have their questions answered. They should clearly understand the directions for using NICOTROL NS and safely disposing of the used container. They should be instructed to stop smoking completely when they begin using the product. Patients should be instructed not to sniff, swallow or inhale through the nose as the spray is being administered. They should also be advised to administer the spray with the head tilted back slightly.
Contraindications
- CONTRAINDICATIONS Use of NICOTROL NS therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to any component of the product.
Side Effects
- 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.
Interactions
- Drug Interactions The extent of absorption and peak plasma concentration is slightly reduced in patients with the common cold/rhinitis. In addition, the time to peak concentration is prolonged. The use of a nasal vasoconstrictor such as xylometazoline in patients with rhinitis will further prolong the time to peak (See PHARMACOKINETICS ). Smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of certain concomitant medications.