What is the appropriate dosing for a nicotine (nicotinic acid) patch for smoking cessation?

From the Guidelines

Nicotine patches should be dosed based on current smoking habits, with the most effective approach being a combination of a nicotine patch with a rapid-delivery form of nicotine replacement therapy (NRT) 1. For those who smoke more than 10 cigarettes daily, start with a 21mg patch daily for 6 weeks, then 14mg daily for 2 weeks, and finally 7mg daily for 2 weeks. For lighter smokers (less than 10 cigarettes daily), begin with 14mg daily for 6 weeks, followed by 7mg daily for 2-4 weeks. Some key points to consider when using nicotine patches include:

• Apply one patch daily to clean, dry, hairless skin upon waking, and remove after 16-24 hours 1.
• Rotate application sites to prevent skin irritation.
• Common side effects include skin irritation, insomnia, and vivid dreams.
• If experiencing sleep disturbances, remove the patch before bedtime.
• Do not smoke while using patches as this can lead to nicotine overdose with symptoms like nausea, vomiting, and rapid heartbeat. The use of nicotine patches, particularly in combination with other forms of NRT, has been shown to increase smoking cessation rates, with varenicline appearing to be more effective than NRT or bupropion SR in some studies 1. Key considerations for the use of nicotine patches include:
• The importance of combining behavioral and pharmacotherapy interventions to increase cessation rates 1.
• The need to provide patients with information on dosing regimens and potential side effects 1.
• The potential benefits of using a combination of NRT products, including short-acting and long-acting forms, to increase the effectiveness of smoking cessation efforts 1.

From the FDA Drug Label

Directions if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed self-help guide for complete directions and other information begin using the patch on your quit day if yousmoke more than 10 cigarettes per day,use the following schedule below: Weeks 1 thru 2Weeks 5 and 6Weeks 7 and 8 Step 1Step 2Step 3 Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/day if you smoke 10 or less cigarettes per day,start with Step 2for 6 weeks, then Step 3for 2 weeks apply one new patch every 24 hours on skin that is dry, clean and hairless remove backing from patch and immediately press onto skin. Hold for 10 seconds. wash hands after applying or removing patch. Save pouch to use for patch disposal Dispose of the used patches by folding sticky ends together and putting in pouch the used patch should be removed and a new one applied to a different skin site at the same time each day if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

The recommended nicotine patch dosing is as follows:

• If you smoke more than 10 cigarettes per day:
  • Step 1: Use one 21 mg patch/day for weeks 1-2
  • Step 2: Use one 14 mg patch/day for weeks 3-4
  • Step 3: Use one 7 mg patch/day for weeks 5-8
• If you smoke 10 or less cigarettes per day:
  • Start with Step 2 for 6 weeks, then Step 3 for 2 weeks Apply one new patch every 24 hours on dry, clean, and hairless skin 2.

From the Research

Nicotine Patch Dosing

• The study 3 examined the responses to progressive nicotine patch dosing prior to quitting smoking, with doses titrated up to 84 mg/day over 4 weeks prior to the target quit date and down again over 4 weeks afterwards.
• The results showed that 72.0% of participants progressed to the 84-mg nicotine dose, and 94.0% completed the trial, with minimal side effects.
• Adverse effects consisted primarily of nausea and were mild and well tolerated.
• Cigarette consumption, smoke intake, and enjoyment of smoking declined significantly during the pre-quit period.

Safety and Efficacy

• The study 3 found that most smokers seeking help with stopping appear to be able to tolerate doses of transdermal nicotine patch up to 84 mg/day during a 4-week pre-quit up-titration period with minimal side effects.
• Another study 4 discussed the safety profile of varenicline, a novel alpha4beta2 nicotinic receptor partial agonist, which is effective for tobacco dependence, with the most commonly occurring adverse events being nausea, typically mild and well tolerated.

Considerations for Special Populations

• A review 5 discussed the risks of nicotine dependence in individuals with chronic kidney disease (CKD) and the potential benefits of smoking cessation, including consideration of dosing of nicotine replacement therapy for this population.
• Another study 6 reviewed the pharmacokinetics and dosing literature for patients with CKD, including nicotine replacement therapy, bupropion, and varenicline.