"As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency's tobacco authority to cover addi"...
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NICOTROL (nicotine inhalation system) Inhaler is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL (nicotine inhalation system) Inhaler therapy is recommended for use as part of a comprehensive behavioral smoking cessation program.
DOSAGE AND ADMINISTRATION
Patients must desire to stop smoking and should be instructed to stop smoking completely as they begin using NICOTROL (nicotine inhalation system) Inhaler. It is important that patients understand the instructions, and have their questions answered. They should clearly understand the directions for using the NICOTROL (nicotine inhalation system) Inhaler and safely disposing of the used cartridges.
The initial dosage of NICOTROL (nicotine inhalation system) Inhaler is individualized. Patients may selftitrate to the level of nicotine they require. Most successful patients in the clinical trials used between 6 and 16 cartridges a day. Best effect was achieved by frequent continuous puffing (20 minutes). The recommended duration of treatment is 3 months, after which patients may be weaned from the NICOTROL (nicotine inhalation system) Inhaler by gradual reduction of the daily dose over the following 6 to 12 weeks. The safety and efficacy of the continued use of NICOTROL (nicotine inhalation system) Inhaler for periods longer than 6 months have not been studied and such use is not recommended.
Dosing recommendations are summarized in the table below.
|INITIAL TREATMENT||Up to 12 Weeks||6 – 16|
|Gradual Reduction (if needed)||6–12 Weeks||No tapering strategy has been shown to be superior to any other in clinical studies.|
Initial Treatment (Up to 12 Weeks)
For best results, patients should be encouraged to use at least 6 cartridges per day at least for the first 3 to 6 weeks of treatment. In clinical trials, the average daily dose was > 6 (range 3 to 18) cartridges for patients who successfully quit smoking. Additional doses may be needed to control the urge to smoke with a maximum of 16 cartridges daily for up to 12 weeks. Regular use of NICOTROL (nicotine inhalation system) Inhaler during the first week of treatment may help patients adapt to the irritant effects of the product. Some patients may exhibit signs or symptoms of nicotine withdrawal or excess which will require an adjustment of the dosage (see Individualization of Dosage).
Gradual Reduction of Dose (Up to 12 Weeks)
Most patients will need to gradually discontinue the use of NICOTROL (nicotine inhalation system) Inhaler after the initial treatment period. Gradual reduction of dose may begin after twelve weeks of initial treatment and may last for up to twelve weeks. Recommended strategies for discontinuing use include suggesting to patients that they use the product less frequently, keep a tally of daily usage, try to meet a steadily reducing target or set a planned quit date for stopping use of the product.
Individualization of Dosage
The NICOTROL Inhaler provides the smoker with adequate amounts of nicotine to reduce the urge to smoke, and may provide some degree of comfort by providing a hand-to-mouth ritual similar to smoking, although the importance of such an effect in smoking cessation is, as yet, unknown.
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 (nicotine inhalation system) Inhaler 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 therapeutic 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). Dosage can then be adjusted in those patients with signs or symptoms of nicotine withdrawal or excess. Patients who are successfully abstinent on NICOTROL (nicotine inhalation system) Inhaler should be treated at the selected dosage for up to 12 weeks, after which use of the Inhaler should be gradually reduced over the next 6 to 12 weeks. Some patients may not require gradual reduction of dosage and may abruptly stop treatment successfully. The safe use of this product for 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 (nicotine inhalation system) Inhaler may also smoke intermittently, it is sometimes difficult to determine if they 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
See PATIENT INFORMATION sheet for instructions on handling and disposal. After using the NICOTROL (nicotine inhalation system) Inhaler, carefully separate the mouthpiece, remove the used cartridge and throw it away, out of the reach of children and pets. Store the mouthpiece in the plastic storage case for further use. The mouthpiece is reusable and should be cleaned regularly with soap and water. The NICOTROL (nicotine inhalation system) Inhaler cartridges can be detected on a radiogram.
NICOTROL INHALER (nicotine inhalation system) is supplied as 168 cartridges each containing 10 mg (4 mg is delivered) nicotine. Each unit consists of 5 mouthpieces, 28 storage trays each containing 6 cartridges and 1 plastic storage case. A patient information leaflet is enclosed with the package.
Store at room temperature not to exceed 77°F (25°C). Protect cartridges from light.
Distributed by : Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Dec 2008.
Last reviewed on RxList: 3/18/2009
This monograph has been modified to include the generic and brand name in many instances.
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