Active Ingredient: Nicotine
Treatment of tobacco dependence by providing relief of nicotine withdrawal symptoms including cravings, thereby facilitating smoking cessation or temporary smoking reduction in smokers motivated to quit smoking. Permanent cessation of tobacco use is the eventual objective. Patient counselling and support normally improve the success rate.
For this indication, competent medicine agencies globally authorize below treatments:
Oral, 1 milligrams nicotine, 8 to 12 times daily, over the duration of 180 days.
The initial dosage should be individualised on the basis of the patients nicotine dependence. 1 mg nicotine to suck when the user feels the urge to smoke. Initially, 1 mg nicotine should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. For smoking cessation and smoking reduction, the maximum daily dose is 30 lozenges.
Users should stop smoking completely during treatment with nicotine. The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months, the user should gradually reduce the dose nicotine. Treatment should be discontinued when the dose has been reduced to 1-2mg nicotine per day. Use of nicotine medicinal products like 1 mg lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking. Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals. Counselling may help smokers to quit.
Nicotine should be used between periods of smoking in order to prolong smoke-free intervals and with the intention of reducing smoking as much as possible. The number of cigarettes should be gradually replaced nicotine lozenge. If a reduction of at least 50% in the number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. A quit attempt should be made as soon as the smoker feels ready, but not later than 4 months after start of treatment. After that the number of lozenges should be gradually reduced, for example by quitting one lozenge every 2-5 days. If a quit attempt cannot be made within 6 months after starting treatment, professional advice should be sought. Regular use of 1 mg nicotine lozenge beyond 6 months is generally not recommended.
Some ex-smokers may need treatment with the lozenges for longer to avoid returning to smoking. Counselling may improve the chance for smokers to quit.
Transdermal, between 7 milligrams nicotine and 21 milligrams nicotine, once daily, over the duration of 180 days.
Treatment should begin with one patch 21 mg/24 hours in combination with 1mg lozenge. At least 4 pieces of lozenge (1 mg) per day should be used. In most cases, 5-6 lozenges are enough. Not more than 15 pieces of lozenge a day should be used. In normal cases, the treatment may last for 6-12 weeks. Thereafter, the nicotine dose is reduced gradually.
Reduction of nicotine dose: This can be done in two ways.
Alternative 1: Use of the patches of a lower strength, i.e. 14 mg/24 hours patches for 3-6 weeks followed by 7 mg/24 hours for another 3-6 weeks together with the initial dose of 1 mg lozenge. Thereafter, the number of lozenges is reduced gradually. It is generally not recommended to use lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than 9 months.
Alternative 2: Discontinuation of the use of the patches and gradual reduction of the number of 1 mg lozenges. It is generally not recommended to use lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than 9 months.
The patch is applied on a clean, dry, hairless, intact area of skin on the trunk, arms or hips. The patch is pressed against the skin for 10-20 seconds.
To minimize the risk of local irritation the placement of nicotine patches should be alternated between different application sites.
Hands should be washed thoroughly after application of transdermal patches to avoid irritation of the eyes with nicotine from the fingers.
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