Mayo Clinic NDC Tobacco Dependence Treatment Medication Summary*

Nicotine Replacement Therapy (NRT) Description & Examples Pros & Cons Comments Dosing Recommendations Nicotine patch Pros Comments and limitations Dosing (24-hour patch)  Achieve desired levels of replacement Patches vary in strengths and the length of time (OTC) over which nicotine is delivered. Depending on >40 cpd = 42 mg per day  Easy to use  Only needs to be applied once a day the brand of patch used, may be left on for 21-39 cpd = 28-35 mg per day 24-hour delivery systems: anywhere from 16 to 24 hours. Patches may be 10-20 cpd = 14-21 mg per day 21, 14, 7 mg/24 hour  Few side effects placed anywhere on the upper body, including <10 cpd = 14 mg per day Cons  Less flexible dosing arms and back. Rotate the patch site each time a 16-hour delivery systems: new patch is applied. If a dose > 42mg per day may be indicated, 15, 10, 5 mg/16 hour  Slower onset of delivery contact the patient’s prescriber. Adjust based on  Mild skin rashes and irritation May purchase without a prescription. withdrawal symptoms, urges, and comfort. (Generic available)

After 4-6 weeks of smoking abstinence, taper every 2-4 weeks in 7-14 mg steps as tolerated.

Nicotine lozenge Pros Comments or limitations Dosing as monotherapy  Easy to use Use at least 8-9 lozenges per day initially. Based on time to first cigarette of the day: Regular or “mini” size  Delivers doses of nicotine approximately 25% Efficacy and frequency of side effects related to <30 minutes = 4 mg (OTC) higher than nicotine gum amount used. >30 minutes = 2 mg Cons The mini-lozenge dissolves more rapidly and is Delivers nicotine through the lining of the  Should not eat or drink 15 minutes before use or smaller in size than the standard lozenge. Based on cigarettes per day (cpd): mouth as the lozenge dissolves: during use (especially avoid acidic fluids such as colas and coffee) May purchase without a prescription. >20 cpd = 4 mg 2 mg, 4 mg standard lozenge  Should not be chewed or swallowed <20 cpd = 2 mg 2 mg, 4 mg mini-lozenge  Nausea most common side effect (12-15%) Initial dosing is 1-2 lozenges every 1-2 hours (Generic available for regular size) (minimum of 9 per day).

Taper as tolerated.

Nicotine gum Pros Comments and limitations Dosing as monotherapy  Convenient and flexible dosing Many people use this medication incorrectly. Based on time to first cigarette of the day: (OTC) Review package directions carefully to <30 minutes = 4 mg  Faster delivery of nicotine than patches maximize benefit of product. >30 minutes = 2 mg 2mg, 4mg Cons

 May be inappropriate for people with dental May purchase without a prescription. Based on cigarettes per day (cpd) Flavors: Orange, Mint, Regular problems and those with temporomandibular >20 cpd: 4 mg gum Various Flavors: Cinnamon, Fruit, joint (TMJ) syndrome <20 cpd: 2 mg gum Extreme Chill, Mint, Original  Should not eat or drink 15 minutes before use or

during use (especially avoid acidic fluids such Initial dosing is 1-2 pieces every 1-2 hours Delivers nicotine through the lining of the as colas and coffee) (10-12 pieces per day). mouth while the gum is “parked.”  Frequent use during the day required to obtain

However, the term “gum” is misleading, as adequate nicotine levels Taper as tolerated. it is not chewed like regular gum but rather is chewed briefly and then “parked” between cheek and gum.

(Generic available) Page 1 Description & Examples Pros & Cons Comments Dosing Recommendations Nicotine nasal spray Pros Comments and limitations Dosing as monotherapy  Flexible dosing Unlike decongestant nasal sprays, the nicotine 1 spray in each nostril:

 Can be used in response to stress or urges to spray should not be sniffled. Rather, it is Delivers nicotine through the lining of the smoke sprayed against the lining of each nostril once 1-2 times per hour (up to 5 times per hour, nose when sprayed directly into each  Fastest delivery of nicotine of currently or twice an hour (maximum of five times in one or 40 times per day) nostril. available NRT products hour). Cons: Most users average 14-15 doses per day initially.  Nose and throat irritation is common, but Prescription required for purchase. usually disappears within one week Taper as tolerated.  Frequent use during the day required to obtain adequate nicotine levels  Infrequent nose bleed

Nicotine inhaler Pros Comments and limitations Dosing as monotherapy  Flexible dosing Puffing must be done frequently and far more Minimum of 6 cartridges per day, up to 16 per

 Mimics the hand-to-mouth behavior of smoking often than with a cigarette. Each cartridge is day. Delivers nicotine vapor when puffed  Few side effects designed for 80 puffs and over 20 minutes of through a plastic cylinder containing a Cons use. Patient does not need to inhale deeply to Taper as tolerated. cartridge. The inhaler delivers nicotine achieve an effect. through the lining of the mouth, not to the  Frequent use during the day required to obtain adequate nicotine levels lung, and enters the body in much the same Prescription required for purchase. way as the NRT lozenge or gum.  May cause mouth or throat irritation

Non-Nicotine Medication Description & Examples Pros & Cons Comments Dosing Recommendations Bupropion SR Pros Comments and limitations Dosing: Take doses at least 8 hours apart  Easy to use A slight risk of seizure (1:1000) is associated Start medication one week prior to the target quit

 Pill form with use of this medication. Seizure risk should date (TQD): (Generic Available)  Few side effects (most common are dry mouth be assessed. Risk of seizure is increased if there and insomnia) is: 150 mg once daily for 3 days, then  May be used in combination with NRT 150 mg twice daily for 4 days, then (nicotine patches, spray, gum and inhaler)  Personal history of seizures Cons  Significant head trauma or brain injury On TQD stop smoking  Contraindicated with certain medical conditions  Anorexia nervosa or bulimia and may interact adversely with MAO  Concurrent use of medications that lower Continue at 150 mg BID 12 weeks. Treatment inhibitors the seizure threshold can be used for as long as 12 months and may be  Label contains boxed warning about mood effective for reducing relapse. changes, suicidal ideation and attempts, and aggressive behavior May stop abruptly; no need to taper.  Avoid in patients with hepatic failure

Prescription required for purchase.

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Description & Examples Pros & Cons Comments Dosing Recommendations Varenicline Pros Comments and limitations Dosing: Take with food  Easy to use  Nausea is common; taking the medication Start medication one week prior to the target quit  Pill form with food and titrating the dose as directed date (TQD):  Generally well tolerated will help  No known drug interactions  Preliminary studies suggest that 0.5 mg once daily X 3 days, then Cons varenicline can be safely used in 0.5 mg twice daily X 4 days, then  Nausea, abnormal dreams and sleep combination with bupropion and/or NRT; disturbances are common adverse effects however, efficacy of these combinations On TQD stop smoking, and has not been shown  Dose must be lowered if kidney function is Take 1.0 mg twice daily for 11 weeks. If not impaired smoking at the end of twelve weeks, may  Label contains boxed warning about mood continue at 1.0 mg twice daily for an additional changes, suicidal ideation and attempts, 12 weeks. and aggressive behavior May stop abruptly; no need to taper. Prescription required for purchase. Combination Therapy Description & Examples Pros & Cons Comments Dosing Recommendations Long acting + short Pros Comments and limitations Dosing: Dose the patch as described according  Permits sustained levels of nicotine with rapid  Providing two types of delivery systems, to cigarettes used per day acting NRT adjustment for acute needs one or two long-acting medications and one  More efficacious than monotherapy or more short-acting NRTs appears to be Prescribe: Cons more efficacious and should be considered Bupropion + NRT  Cost for those who have failed monotherapy in 2 mg gum, 2 mg lozenge, nicotine inhaler the past and those considered highly tobacco or nicotine nasal spray for ad lib dependent Varenicline + bupropion  This strategy is endorsed by the Treating Use every 1-2 hours and as needed when Tobacco Use and Dependence: 2008 withdrawal symptoms and urges to use tobacco Update, a Public Health Service-sponsored occur. Adjust dose of patch upward if unusually Varenicline + short acting Clinical Practice Guideline, but is frequent use of immediate-release NRT is considered “off-label” prescribing according needed. The goal is to minimize need for short- NRT to the FDA-approved product labels acting NRT dosing.  Short acting NRT and/or bupropion may be used in combination with varenicline if the Some patients will benefit from using nicotine patient has no contraindications for the use patch therapy and bupropion and one or more of each medication above short acting NRT.

Smokeless Tobacco (ST) Description & Examples Pros & Cons Comments Dosing Recommendations 24-hour nicotine patch Other NRT Non-nicotine pharmacotherapy

Treatment >3 cans or pouches per week = 42 mg per day Nicotine lozenge: Empiric evidence suggests that bupropion and 2-3 cans or pouches per week = 21 mg per day varenicline may be of benefit in this population recommendations <2 cans or pouches per week = 14 mg per day 4mg if > 3 times per week of tobacco users through using the dosing 2mg if < 3 times per week guidelines recommended for cigarette smokers. Adjust based on withdrawal symptoms, urges and Page 3 comfort. After 4-6 weeks of abstinence, taper every Nicotine gum or nicotine lozenge may be 2-4 weeks in 7-14 mg steps as tolerated. combined with nicotine patch as described for cigarette smokers. Nicotine inhaler and nicotine nasal spray are not recommended for ST users.

*The table is a summary of recommendations for use of medication in the treatment of tobacco dependence. The most effective regimen and doses vary by individual. Costs will vary depending on retailer. Some of the dosing recommendations are “off-label,” (that is, not contained in the current FDA-approved product labeling information). Adapted from Hurt, R.D., et al. CA Cancer J Clin.2009;59:314-326; Fiore, et.al. Treating Tobacco Use and Dependence: 2008 Update, a Public Health Service-sponsored Clinical Practice Guideline, 2008 Revised January 2015

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