Nicotine Indications and Dosage
- nicotine withdrawal
- Tourette’s syndrome †
- ulcerative colitis †
†non-FDA-approved indication
Nicotine Indications and Dosage
For use as an aid in the treatment of nicotine withdrawal following cessation of smoking:
- for use as a single agent for smoking cessation:
Oral dosage (chewing gum):
Adults: Chew 1 piece of gum (equivalent to 2 mg of nicotine) whenever the urge to smoke occurs. The appropriate daily dose will vary between patients, however, most patients need 20 mg/day during the first month. Maximum dosage 60 mg/day (30 pieces). In a study of 90 highly-motivated smokers, the 2 mg strength was found no better than placebo. Only the 4 mg strength produced statistically significantly higher abstinence rates over a period of 6 weeks. Continuous use for longer than 3 months is not recommended. If gum consumption is not spontaneously reduced within 6 months, a gradual withdrawal should be initiated.
Children: Safety and efficacy have not been established.
Oral dosage (Commit® lozenge):
Adults: The dosage is dependent on ‘Time to First Cigarette’. Persons who smoke their first cigarette of the day within 30 minutes of waking should use 4 mg and those who smoke their first cigarette after 30 minutes of waking require 2 mg. Take one lozenge PO every 1- 2 hours during the first 6 weeks of treatment. Then, reduce to one lozenge PO every 2- 4 hours in weeks 7- 9 and finally, one lozenge PO every 4- 8 hours in weeks 10- 12. The recommended duration of therapy is 12 weeks.
Children: Safety and efficacy have not been established.
Transdermal dosage (Habitrol® patch):
Adults weighing more than 100 pounds, smoking at least 10 cigarettes/day and/or without cardiovascular disease: Initially, one 21 mg patch on intact skin once daily for 4- 8 weeks. Remove and replace every 24 hours. Following initial regimen, reduce to 14 mg patch/day for 2- 4 weeks and then 7 mg patch/day for 2- 4 weeks.
Adults weighing less than 100 pounds, smoking less than 10 cigarettes/day and/or with cardiovascular disease: Initially, one 14 mg patch on intact skin once daily for 4- 8 weeks. Remove and replace every 24 hours. Following initial regimen, reduce to one 7 mg patch/day for 2- 4 weeks.
Transdermal dosage (Nicoderm CQ® patch):
Adults weighing more than 100 pounds, smoking at least 10 cigarettes/day and/or without cardiovascular disease: Initially, one 21 mg patch on intact skin once daily for 6 weeks. Remove and replace every 24 hours. Following initial regimen, reduce to 14 mg patch/day for the next 2 weeks and then one 7 mg patch/day for 2 weeks.
Adults weighing less than 100 pounds, smoking less than 10 cigarettes/day and/or with cardiovascular disease: Initially, one 14 mg patch on intact skin once daily for 6 weeks. Remove and replace every 24 hours. Following initial regimen, reduce to one 7 mg patch/day for 2- 4 weeks.
Transdermal dosage (Nicotrol® patch):
Adults weighing more than 100 pounds, smoking at least 10 cigarettes/day and/or without cardiovascular disease: Initially, one 15 mg patch on intact skin for 16 hrs/day (i.e., apply upon waking and remove at bedtime) for 4- 12 weeks. Following initial regimen, reduce to one 10 mg patch for 16 hrs/day for the next 2- 4 weeks and then one 5 mg patch for 16 hrs/day for 2- 4 weeks.
Transdermal dosage (Nicotrol® TD patch):
Adults weighing more than 100 pounds, smoking at least 10 cigarettes/day and/or without cardiovascular disease: Initially, one 15 mg patch on intact skin for 16 hrs/day (i.e., apply upon waking and remove at bedtime) for 6 weeks. Then, switch to one 10 mg patch for 16 hrs/day for the next 2 weeks. Finally, one 5 mg patch for 16 hrs/day for 2 weeks.
Transdermal dosage (ProStep® patch):
Adults weighing more than 100 pounds, smoking at least 10 cigarettes/day and/or without cardiovascular disease: Initially, one 22 mg patch on intact skin once daily for 4- 8 weeks. Remove and replace every 24 hours. Following initial regimen, reduce to one 11 mg patch/day for the next 2- 4 weeks.
Adults weighing less than 100 pounds, smoking less than 10 cigarettes/day and/or with cardiovascular disease: One 11 mg patch on intact skin once daily for 4- 8 weeks. Remove and replace every 24 hours.
Children: Safety and efficacy have not been established.
Nasal inhalation dosage (Nicotrol® NS nasal spray):
Adults: The recommended dosage is 1 spray (containing 0.5 mg nicotine/spray) into each nostril 1- 2 times each hour as needed whenever the patient feels the need to smoke. Two sprays (one into each nostril) is considered one dose. The maximum recommended usage is 5 doses (total of 10 sprays)/hour or 40 doses (total of 80 sprays)/day. Initially, encourage use of at least 8 doses (16 sprays)/day, the minimum effective dose. The recommended duration of treatment is 3 months. Treatment for longer periods has not been shown to improve outcome. The safety of use for periods longer than 6 months has not been established.
Oral inhalation dosage (Nicotrol® Inhaler):
Adults: The recommended initial dose is 24 to 64 mg (6 to 16 cartridges) per day for up to 12 weeks followed by a gradual reduction in dosage over a period of up to 12 weeks. Use for more than 6 months is not recommended.
- for use as an aid in the treatment of nicotine withdrawal following cessation of smoking in combination with Zyban ® (see Bupropion monograph):
Transdermal dosage (Habitrol® patch):
Adults: See normal Habitrol® dose for smoking cessation as above. According to the manufacturer of Habitrol®, the combination of Habitrol® (starting dose of 21 mg/day of nicotine topically) with Zyban ® (300 mg/day of bupropion PO) was associated with significantly higher 4-week abstinence rates than Habitrol® alone. However, quit rates for the combination were not significantly higher. (Habitrol® package insert)
For the treatment of Tourette’s syndrome † as an adjunct to haloperidol:
Transdermal dosage (Nicoderm® patch):
Children 9- 15 years: Limited data are available, in one study, a 7 mg patch on intact skin once daily, removed and replaced every 24 hours, has been used to reduce tic severity. Sixteen children with Tourette’s syndrome were given a single Nicoderm® 7 mg patch applied to the deltoid area. Patients were seen within 24 hours and then at variable times thereafter. Fifteen received a second patch; no patient received more than 2 days of treatment in this pilot study. The mean Yale Global Tic Severity Scale was significantly reduced (36%) from the mean baseline score with 6 patients having between 50% and 80% improvement. Other medications such as haloperidol and pimozide were continued concomitantly while nicotine patches were applied.
For ulcerative colitis †:
- for the treatment of active ulcerative colitis †:
Transdermal dosage:
Adults: Dosages of 5- 22 mg/24 hours have been used; patches have been noted to improve clinical symptoms but some studies do not note improvements in disease histology. Several randomized, double-blind studies have been conducted. In one study, 35 patients received nicotine patch of 5- 15 mg/day and 37 received placebo administered daily at bedtime. If no clinical benefit was seen after 2 weeks, the dose was increased to 25 mg/day. Study duration was 6 weeks. Patients receiving nicotine patches had significant improvements in both symptoms and histology. This study was critized because no endoscopic evaluation was conducted. In another study published in 1997, 31 patients received nicotine patches and 33 received placebo for 4 weeks. Treatment with nicotine patches (11 mg/day for the first 7 days, then 22 mg/day for the following 21 days) was associated with a rate of clinical improvement that was significantly higher than the rate associated with placebo. In this study, sigmoidoscopy scores improved but histologic disease activity did not. Five of 31 patients could not tolerate the 22 mg patch due to nondermatologic reactions.
- for secondary prophylaxis of ulcerative colitis (i.e., ulcerative colitis prophylaxis †):
Transdermal dosage:
Adults: A randomized trial of transdermal nicotine 15 mg/day did not find a significant benefit of nicotine compared to placebo for maintaining remission in patients with ulcerative colitis.
Patients with hepatic impairment:
Specific guidelines are not available; because nicotine clearance is dependent on liver blood flow and metabolism, significant hepatic impairment may affect drug clearance.
Patients with renal impairment:
It appears that no dosage adjustments are needed in mild-moderate renal insufficiency; only severe renal impairment is expected to have an effect on nicotine clearance.
†non-FDA-approved indication
[ Last revised: 11/14/2002 10:06:00 AM ]
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