What is the recommended dose and frequency of nicotine (Nicotinic acid) patch therapy?

From the Guidelines

Nicotine patches should be used for a longer course of treatment, potentially more than 14 weeks, to prevent relapse to smoking. According to the 2009 study published in the Mayo Clinic Proceedings 1, prolonged treatment with a nicotine patch is superior to standard duration of treatment. The study suggests that occasional patients may benefit from treatment for longer periods, and in some cases, indefinite NRT treatment may be necessary to prevent relapse.

When using nicotine patches, it is essential to consider the individual's smoking habits and tailor the treatment approach accordingly. For heavy smokers, a step-down approach can be used, starting with a higher dose patch and gradually reducing the dosage over time. However, the key takeaway from the study is that a longer course of treatment with nicotine patches, potentially more than 14 weeks, is recommended to prevent relapse to smoking. This approach can be combined with behavioral support strategies to manage cravings and gradually wean the body off nicotine dependence.

Some important considerations when using nicotine patches include:

• Applying one fresh patch each morning to clean, dry, hairless skin on the upper body or outer arm
• Rotating sites to prevent skin irritation
• Wearing the patch for 16-24 hours and removing before bedtime if sleep disturbances occur
• Avoiding cutting patches and washing hands after application
• Combining patch use with behavioral support strategies to enhance treatment effectiveness.

From the FDA Drug Label

Directions if you are under 18 years old, 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 you smoke 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 dose and frequency is as follows:

• Step 1: 21 mg patch/day for weeks 1-2
• Step 2: 14 mg patch/day for weeks 3-6 (or starting dose for those who smoke 10 or less cigarettes per day)
• Step 3: 7 mg patch/day for weeks 7-8
• Apply one new patch every 24 hours on dry, clean, and hairless skin.
• Remove the used patch and apply a new one to a different skin site at the same time each day 2.

From the Research

Nicotine Patch Dose and Frequency

• The effectiveness of different nicotine patch doses was studied in several trials 3, 4, 5, 6.
• A study found that 21 mg patches resulted in higher quit rates than 14 mg (24-hour) patches, and using 25 mg patches resulted in higher quit rates than using 15 mg (16-hour) patches, although in the latter case the CI included one 3.
• There was no clear evidence of superiority for 42/44 mg over 21/22 mg (24-hour) patches 3.
• Another study examined the responses to, and 4-week abstinence rates observed, when titrating the dose of transdermal nicotine patch up to 84 mg/day over 4 weeks prior to a target quit date and titrating down again over 4 weeks afterwards, and 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 4.
• A randomized clinical trial compared the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates, and found that all medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion 5.

Comparison of Nicotine Replacement Therapies

• A review of nicotine replacement therapies found that all of the commercially available forms of NRT (nicotine gum, transdermal patch, the nicotine nasal spray, nicotine inhaler and nicotine sublingual tablets/lozenges) are effective as part of a strategy to promote smoking cessation, and increase quit rates approximately 1.5 to 2 fold regardless of setting 6.
• The review also found that the effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the smoker, and that provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT 6.
• A study found that combination NRT (fast-acting form + patch) results in higher long-term quit rates than single form NRT 3.
• Another study found that using NRT prior to quitting may improve quit rates versus using it from quit date only, although further research is needed to ensure the robustness of this finding 3.