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Nicotrol NS

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Nicotrol NS

Nicotrol NS

INDICATIONS

NICOTROL NS (nicotine nasal spray) is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS (nicotine nasal spray) 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 (nicotine nasal spray) for periods longer than 6 months have not been adequately studied and such use is not recommended.

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 (nicotine nasal spray) 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.

The dose of NICOTROL NS, should be individualized on the basis of each patient's nicotine dependence and the occurrence of symptoms of nicotine excess (See Individualization of Dosage).

Each actuation of NICOTROL NS (nicotine nasal spray) delivers a metered 50 microliter 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 recommended dose of 40 mg (80 sprays, somewhat less than 1/2 bottle) per day. For best results, patients should be encouraged to use at least the recommended minimum of 8 doses per day, as less is unlikely to be effective. In clinical trials, the patients who successfully quit smoking used the product heavily when nicotine withdrawal was at its peak, sometimes up to the recommended maximum of 40 doses per day ( in heavier smokers). Dosing recommendations are summarized in Table 4.

Table 4

Maximum Recommended
Duration of Treatment
Recommended
Doses per Hour
Maximum
Doses per Hour
Maximum
Doses per Day
3 months 1–2* 5 40
*One dose=2 sprays (one in each nostril). One dose delivers 1 mg of nicotine to the nasal mucosa.

No tapering strategy has been shown to be optimal in clinical studies. Many patients simply stopped using the spray at their last clinic visit.

Recommended strategies for discontinuation of use include suggesting that patients: use only 1/2 a dose (1 spray) at a time, use the spray less frequently, keep a tally of daily usage, try to meet a steadily reducing usage target, skip a dose by not medicating every hour, or set a planned “quit date” for stopping use of the spray.

Individualization of Dosage

The success or failure of smoking cessation is influenced by the quality, intensity and frequency of supportive care. Patients are more likely to quit smoking if they are seen frequently and participate in formal smoking cessation programs.

The goal of NICOTROL NS (nicotine nasal spray) therapy is complete abstinence. If a patient is unable to stop smoking by the fourth week of therapy, treatment should probably be discontinued.

Patients who fail to quit on any attempt may benefit from interventions to improve their chances for success on subsequent attempts. Patients who were unsuccessful should be counseled and should then probably be given a “therapy holiday” before the next attempt. A new quit attempt should be encouraged when conditions are more favorable.

Based on the clinical trials, a reasonable approach to assisting patients in their attempt to quit smoking is to begin initial treatment, using the recommended dosage (See DOSAGE AND ADMINISTRATION). Regular use of the spray during the first week of treatment may help patients adapt to the irritant effects of the spray. Dosage can then be adjusted in those subjects with signs or symptoms of nicotine withdrawal or excess. Patients who are successfully abstinent on NICOTROL NS (nicotine nasal spray) should be treated at the selected dosage 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. Treatment with NICOTROL NS (nicotine nasal spray) for longer periods has not been shown to improve outcome, and the safety of use for periods longer than 6 months has not been established.

The symptoms of nicotine withdrawal overlap those of nicotine excess (See Pharmacodynamics and ADVERSE REACTIONS sections). Since patients using NICOTROL NS (nicotine nasal spray) may also smoke intermittently, it is sometimes difficult to determine if patients are experiencing nicotine withdrawal or nicotine excess. Controlled clinical trials of nicotine products suggest that palpitations, nausea and sweating are more often symptoms of nicotine excess, whereas anxiety, nervousness and irritability are more often symptoms of nicotine withdrawal.

Safety And Handling

As with all medicines, especially ones in liquid form, care should be taken in handling NICOTROL NS (nicotine nasal spray) during periods of opening and closing the container (See WARNINGS and Safety Note Concerning Children). If it is dropped it may break. If this occurs, the spill should be cleaned up immediately with an absorbent cloth/paper towel. Care should be taken to avoid contact of the solution with the skin. Broken glass should be picked up carefully, using a broom. The area of the spill should be washed several times. Absorbent material may be disposed of as any other household waste. Should even a small amount of NICOTROL NS (nicotine nasal spray) come in contact with the skin, lips, mouth, eyes or ears, the affected area(s) should be immediately rinsed with water only.

Disposal

Used bottles of NICOTROL NS (nicotine nasal spray) should be disposed of with their child-resistant caps in place. Used bottles should be disposed of in such a way as to prevent access by children or pets. See PATIENT INFORMATION for further information on handling and disposal.

HOW SUPPLIED

Nicotrol® NS (nicotine nasal spray) 10 mg/mL, is supplied as four 10 mL bottles (NDC 0009-5401-01). Each unit consists of a glass container, mounted with a metered spray pump. A PATIENT INFORMATION leaflet is enclosed with the package.

Store at room temperature not to exceed 86°F (30°C).

Pharmacia & Upjohn Company LLC. Dist: Pfizer Inc, New York, New York 10017, USA. Revised December 2006.

Last reviewed on RxList: 3/10/2009
This monograph has been modified to include the generic and brand name in many instances.

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