General
To increase smoking cessation rate,     use as part of a comprehensive program of multiple treatment strategies, including behavioral modification.                    
Individualize duration of therapy based on patient response and degree of nicotine dependence.     
Stop smoking prior to initiating nicotine replacement therapy;    self-medication not recommended in patients who continue to smoke, chew tobacco, or use snuff or other nicotine-containing preparations.  
Discontinue therapy in patients who continue to smoke 4 weeks after initiating treatment;    may use nicotine replacement therapy again in subsequent attempts to quit smoking.    
Administration
Administer nicotine percutaneously by topical application of a transdermal system. 
Administer nicotine transmucosally by oral inhalation using a special nicotine oral inhaler or intranasally using a metered-dose spray pump.   
Administer nicotine polacrilex intrabuccally (transmucosally) as a lozenge or chewing gum. 
May be administered as a single nicotine preparation (i.e., intrabuccally, intranasally, percutaneously, or by oral inhalation); however, if single therapy does not enable patients to quit smoking, use of transdermal nicotine may be combined with another form of nicotine replacement (i.e., either buccal nicotine polacrilex or nicotine nasal spray).
Buccal Administration
Chewing Gum
Self-administer one piece of gum in response to the urge to smoke.
Chew gum very slowly until a distinctive peppery taste of nicotine, minty, cinnamon, or orange taste of the gum, or a slight tingling in the mouth is perceived (typically about 15 chews); stop chewing gum and park between cheek and gum; once tingling is almost gone (about 1 minute), repeat chewing procedure. Continue for about 30 minutes or until taste dissipates. Do not swallow gum.
Do not eat or drink anything other than water for 15 minutes before and during chewing of gum. 
Do not chew multiple pieces of gum simultaneously; do not chew too rapidly or chew pieces in succession. May cause excessive release of nicotine and result in adverse effects (e.g., lightheadedness, nausea, vomiting, irritation of the throat and mouth, hiccups, indigestion).
Chew at least 9 pieces of gum daily to improve chances of quitting.
Do not attempt to discontinue nicotine polacrilex gum therapy until craving is satisfied by 1 or 2 pieces of the gum daily, but do not continue therapy for >6 months, unless otherwise instructed by clinician.  
4-mg strength gum recommended in highly dependent smokers because of evidence of increased efficacy.
Lozenges
Suck on lozenge until dissolved; do not swallow, bite, or chew.   Allow to slowly dissolve in the mouth over 20–30 minutes, periodically moving the lozenge (e.g., with the tongue) from one side of the mouth to the other; minimize swallowing.  A warm or tingling sensation may be perceived.
Do not eat or drink anything other than water for 15 minutes before and during sucking on the lozenge.  
Use at least 9 lozenges daily for the first 6 weeks to improve chances of quitting.
Using >1 lozenge simultaneously or using one lozenge after another in uninterrupted sequence may result in adverse effects (e.g., hiccups, heartburn, nausea).
Self-administer lozenge in response to nicotine craving; decrease frequency of administration over time. 
Topical Administration
Administer percutaneously by topical application of a transdermal system once daily. 
Apply at the same time each day, usually after awakening.       
Expose the adhesive surface of the system by peeling and discarding the protective liner just prior to application and apply system immediately to avoid loss of nicotine through volatilization.    
Apply transdermal system to a clean, dry, hairless area of intact skin   on the trunk or upper outer arm        by firmly pressing the system with the adhesive side touching the skin.   Press system firmly in place with heel of hand for about 10 seconds, ensuring good contact, particularly around the edges.    Do not apply to sites that are oily, damaged, or irritated;   if necessary, hair may be clipped, but do not shave area.
System may be worn for 16 or 24 hours.  If cravings begin upon awakening, wear patch for 24 hours.  If vivid dreams or sleep disruptions occur, wear patch for 16 hours; remove at bedtime and apply new patch upon awakening.   
If system inadvertently comes off during the period of use, apply a new system;       continue current application schedule or change so that the next system is applied 24 hours later.
Rotate application sites to minimize potential skin irritation; allow ≥1 week before reusing a given site.    (See Dermatologic Effects under Cautions.)
Avoid unnecessary contact with transdermal systems.    Avoid touching eyes after handling; wash hands with water alone as soap may enhance percutaneous absorption.    
Intranasal Administration
Administer intranasally using a metered-dose spray pump.
Prime spray pump prior to initial use by spraying into a tissue until a fine spray is seen (6–8 times); discard tissue.
If spray pump is not used for 24 hours, reprime pump by spraying into a tissue 1–2 times.
Clear nasal passages prior to administration.
Tilt the head back slightly;  insert tip of bottle into one nostril as far as is comfortable. Breathe through the mouth and spray once into nostril; do not sniff, swallow, or inhale through the nose while administering. Repeat this procedure for the other nostril.
If nose runs, sniff gently to keep nasal spray in nose; wait 2–3 minutes before blowing nose.
Avoid contact with skin, eyes, and mouth; if contact occurs, rinse with plain water immediately. If intranasal bottle breaks, wear protective gloves, wipe with paper towels, and wash surfaces thoroughly.
Oral Inhalation
Administer transmucosally as an inhaled vapor by oral inhalation using a special nicotine oral inhaler that mimics smoking cigarettes.    
Hold the oral inhaler with two hands; separate the top and bottom pieces by pushing and turning the pieces until markings line up. Insert one nicotine cartridge and push the cartridge until it pops into place. Line up markings on the top and bottom pieces of the inhaler and push pieces together tightly; lock inhaler by turning pieces until markings do not line up.
Place the mouthpiece of the inhaler between lips and puff on the inhaler using rapid shallow sucking (“buccal mode”);  alternatively, inhale slowly and deeply into back of throat (“pulmonary mode”).  Nicotine is vaporized and absorbed in mouth and throat. (See Absorption under Pharmacokinetics.) Shallow puffing method generally is preferred.   Deep inhalation technique requires considerable effort and does not result in substantially increased drug delivery or other benefits.
Individualize orally inhaled dosage to the level of nicotine replacement required; optimum results generally achieved by frequent continuous puffing of the inhaler over 20 minutes.
Nicotine is used up from cartridge after about four 5-minute sessions or one 20-minute session of active puffing.
When cartridge is empty, remove top of mouthpiece; discard empty cartridge away from children and pets. Store with mouthpiece in locked position and cartridges in plastic case. Clean reusable mouthpiece regularly with soap and water.
Use inhaler at temperatures >60°F; cold temperatures decrease the amount of nicotine inhaled.
Also administered transmucosally as an inhaled vapor by oral inhalation via electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape pens; however, safety and efficacy in smoking cessation not evaluated by FDA.  
Dosage
Chewing gum and lozenges available as nicotine polacrilex; dosage expressed in terms of nicotine. 
Nicotine oral inhaler cartridges labeled as containing 10 mg of nicotine deliver ≤4 mg total with repeated inhalation.   The amount of nicotine released depends on the volume and temperature of the air passing through the inhaler.     An intensive inhalation regimen (80 deep inhalations over 20 minutes) releases approximately 4 mg of nicotine.
Metered nasal spray delivers 0.5 mg of the nicotine per metered spray and about 200 sprays (i.e., 100 doses) per 100-mg container.
Adults
Smoking Cessation
Buccal (Chewing Gum)
Patients who smoke <25 cigarettes daily: Chew a 2-mg piece of gum every 2 hours during weeks 1–6; chew a 2-mg piece every 2–4 hours during weeks 7–9; and chew a 2-mg piece every 4–8 hours during weeks 10–12 of therapy. Alternatively, chew a 2-mg piece of gum whenever the urge to smoke occurs; do not exceed 2 pieces (4 mg) per hour.
Patients who smoke ≥25 cigarettes daily: Chew a 4-mg piece of gum every 2 hours during weeks 1–6; chew a 4-mg piece every 2–4 hours during weeks 7–9; and chew a 4-mg piece every 4–8 hours during weeks 10–12 of therapy. Alternatively, chew a 4-mg piece whenever the urge to smoke occurs; do not exceed 2 pieces (8 mg) per hour.
Taper dosage by chewing each piece for only 10–15 minutes and gradually reducing the number of pieces chewed, or chew each piece for longer than 30 minutes but reduce the total pieces per day, or substitute regular chewing gum for some pieces.
Buccal (Lozenges)
Patients who smoke first cigarette >30 minutes after waking: One 2-mg lozenge every 1–2 hours during weeks 1–6; then one 2-mg lozenge every 2–4 hours during weeks 7–9; and one 2-mg lozenge every 4–8 hours during weeks 10–12.  
Patients who smoke first cigarette ≤30 minutes after waking: One 4-mg lozenge every 1–2 hours during weeks 1–6; then one 4-mg lozenge every 2–4 hours during weeks 7–9; and one 4-mg lozenge every 4–8 hours during weeks 10–12.  
Do not exceed 5 lozenges in 6 hours or 20 lozenges daily. 
Discontinue therapy if mouth problems, persistent indigestion, severe sore throat, irregular heartbeat, palpitations, or symptoms suggestive of overdosage (nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat) develop.
Transdermal
Patients who smoke ≤10 cigarettes daily: Initially, 14 mg daily for 6 weeks, then 7 mg daily for 2 weeks, then discontinue.  
Patients who smoke >10 cigarettes daily: Initially, 21 mg daily for 4–6 weeks; then 14 mg daily for 2 weeks; then 7 mg daily for 2 weeks; then discontinue therapy.  
Intranasal
Initially, 1–2 sprays (0.5–1 mg) in each nostril per hour (1–2 mg per hour total); may increase up to a maximum of 5 sprays (5 mg) in each nostril per hour (10 mg total) or a maximum total of 80 sprays (40 mg) daily. 
Initially, use at least 16 sprays (8 mg total) daily to increase chance of efficacy. Then, individualize dosage based on nicotine dependence and occurrence of symptoms of nicotine excess.
Continue treatment in successfully abstinent patients for up to 8 weeks then discontinue over 4–6 weeks.
Taper dosage by using only 1 spray at a time, using the spray less frequently, keeping a tally of daily usage, trying to meet a steadily reducing usage target, skipping a dose by not medicating every hour, or setting a planned “quit date” for stopping use of the spray. Some patients may not require tapering.
Oral Inhalation
Initially, 6–16 cartridges daily for up to 12 weeks, then gradually decrease daily dosage over 6–12 weeks.  
Use ≥6 cartridges daily for the first 3–6 weeks to increase chance of efficacy. Individualize dosage based on nicotine dependence and occurrence of symptoms of nicotine excess.
Taper dosage by using less frequently, keeping a tally of daily usage, trying to meet a steadily reducing usage target, or setting a planned “quit date” for stopping use of the inhaler. Some patients may not require tapering.
Prescribing Limits
Adults
Smoking Cessation
Buccal (Chewing Gum)
Maximum 2 pieces of 2-mg gum per hour (i.e., maximum 24 pieces [48 mg nicotine] daily). Maximum 12 weeks of therapy.
Maximum 2 pieces of 4-mg gum per hour (i.e., maximum 24 pieces [96 mg nicotine] daily). Maximum 12 weeks of therapy.
Clinician supervised: Maximum 30 pieces of 2-mg gum daily (i.e., 60 mg nicotine) or 24 pieces of 4-mg gum daily (i.e., 96 mg nicotine).  
Buccal (Lozenges)
Maximum 5 lozenges in 6 hours or 20 lozenges daily. Maximum 12 weeks of therapy.
Transdermal
Patients who smoke ≤10 cigarettes daily: Maximum 8 weeks of therapy.
Patients who smoke >10 cigarettes daily: Maximum 10 weeks of therapy.
Continued therapy for periods longer than usually recommended may be appropriate for certain patients to promote extended abstinence. Continuation of therapy >12 weeks not recommended by manufacturer.   
Intranasal
Maximum 5 sprays (5 mg) in each nostril per hour (maximum 10 mg total) or a maximum total of 80 sprays (40 mg) daily.  
Manufacturer states that continuing therapy >12 weeks does not improve outcome. Safety of continuing therapy >6 months not established.
Oral Inhalation
Maximum 16 cartridges daily for up to 12 weeks.
Manufacturer states that safety of continuing therapy >6 months not established.
Special Populations
No special population dosage recommendations at this time. 
 Detailed Nicotine dosage information
