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FDA-Approved Medications for Smoking Cessation

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FDA-Approved Medications for Smoking Cessation PHARMACOLOGIC PRODUCT GUIDE: FDA-Approved Medications for Smoking Cessation NICOTINE REPLACEMENT THERAPY (NRT) FORMULATIONS BUPROPION SR VARENICLINE GUM LOZENGE TRANSDERMAL PATCH NASAL SPRAY ORAL INHALER Nicorette1, Generic Nicorette1, Generic NicoDerm CQ1, Generic Nicotrol NS2 Nicotrol Inhaler2 Zyban1, Generic Chantix2 OTC Nicorette1 Mini OTC (NicoDerm CQ, generic) Rx Rx Rx Rx PRODUCT 2 mg, 4 mg OTC 7 mg, 14 mg, 21 mg (24-hr release) Metered spray 10 mg cartridge 150 mg sustained-release tablet 0.5 mg, 1 mg tablet original, cinnamon, fruit, mint 2 mg, 4 mg; cherry, mint 10 mg/mL nicotine solution delivers 4 mg inhaled vapor • Recent (≤ 2 weeks) myocardial • Recent (≤ 2 weeks) myocardial • Recent (≤ 2 weeks) myocardial • Recent (≤ 2 weeks) myocardial • Recent (≤ 2 weeks) myocardial • Concomitant therapy with medications/ • Severe renal impairment (dosage infarction infarction infarction infarction infarction conditions known to lower the seizure adjustment is necessary) • Serious underlying arrhythmias • Serious underlying arrhythmias • Serious underlying arrhythmias • Serious underlying arrhythmias • Serious underlying arrhythmias threshold • Pregnancy3 • Serious or worsening angina • Serious or worsening angina • Serious or worsening angina • Serious or worsening angina • Serious or worsening angina • Hepatic impairment and breastfeeding pectoris pectoris pectoris pectoris pectoris • Pregnancy3 and breastfeeding • Adolescents (<18 years) • Temporomandibular joint disease • Pregnancy3 and breastfeeding • Pregnancy3 and breastfeeding • Underlying chronic nasal • Bronchospastic disease • Adolescents (<18 years) • Treatment-emergent • Pregnancy3 and breastfeeding • Adolescents (<18 years) • Adolescents (<18 years) disorders (rhinitis, nasal polyps, • Pregnancy3 and breastfeeding • Treatment-emergent neuropsychiatric neuropsychiatric symptoms4 • Adolescents (<18 years) sinusitis) • Adolescents (<18 years) symptoms4 BOXED WARNING REMOVED 12/2016 • Severe reactive airway disease BOXED WARNING REMOVED 12/2016 • Pregnancy3 and breastfeeding • Adolescents (<18 years) CONTRAINDICATIONS: • Seizure disorder • Concomitant bupropion PRECAUTIONS (e.g., Wellbutrin) therapy • Current or prior diagnosis of bulimia or anorexia nervosa • Simultaneous abrupt discontinuation of alcohol or sedatives/benzodiazepines • MAO inhibitors in preceding 14 days; concurrent use of reversible MAO inhibitors 1st cigarette ≤30 minutes after 1st cigarette ≤30 minutes after >10 cigarettes/day: 1–2 doses/hour 6–16 cartridges/day 150 mg po q AM x 3 days, then 150 mg Days 1–3: waking: 4 mg waking: 4 mg 21 mg/day x 4–6 weeks (8–40 doses/day) po bid 0.5 mg po q AM Individualize dosing; initially use 1st cigarette >30 minutes after 1st cigarette >30 minutes after 14 mg/day x 2 weeks One dose = 2 sprays (one in Days 4–7: 1 cartridge q 1–2 hours • Do not exceed 300 mg/day waking: 2 mg waking: 2 mg 7 mg/day x 2 weeks each nostril); each spray delivers 0.5 mg po bid • Begin therapy 1–2 weeks prior to quit 0.5 mg of nicotine to the nasal • Best effects with continuous Weeks 2–12: Weeks 1–6: Weeks 1–6: date 10 cigarettes/day: mucosa puffing for 20 minutes 1 mg po bid 1 piece q 1–2 hours 1 lozenge q 1–2 hours ≤ • Allow at least 8 hours between doses 14 mg/day x 6 weeks • Initially use at least 6 Weeks 7–9: Weeks 7–9: • Maximum • Avoid bedtime dosing to minimize • Begin therapy 1 week prior to 7 mg/day x 2 weeks cartridges/day 1 piece q 2–4 hours 1 lozenge q 2–4 hours – 5 doses/hour or insomnia quit date • Nicotine in cartridge is Weeks 10–12: Weeks 10–12: • Rotate patch application site – 40 doses/day • Dose tapering is not necessary • Take dose after eating and with depleted after 20 minutes of 1 piece q 4–8 hours 1 lozenge q 4–8 hours daily; do not apply a new patch • For best results, initially use at • Duration: 7–12 weeks, with a full glass of water active puffing to the same skin site for at least least 8 doses/day maintenance up to 6 months in • Dose tapering is not necessary • Maximum, 24 pieces/day • Maximum, 20 lozenges/day • Inhale into back of throat or puff one week • Do not sniff, swallow, or inhale selected patients • Dosing adjustment is necessary • Chew each piece slowly • Allow to dissolve slowly in short breaths • May wear patch for 16 hours through the nose as the spray is for patients with severe renal • Park between cheek and gum (20–30 minutes) • Do NOT inhale into the lungs DOSING if patient experiences sleep being administered impairment when peppery or tingling sensa- • Nicotine release may cause a (like a cigarette) but “puff” as if disturbances (remove at • Duration: 3 months • Duration: 12 weeks; an additional tion appears ( 15–30 chews) warm, tingling sensation lighting a pipe ~ bedtime) 12-week course may be used in • Resume chewing when tingle • Do not chew or swallow • Open cartridge retains potency • Duration: 8–10 weeks selected patients fades • Occasionally rotate to different for 24 hours • May initiate up to 35 days before • Repeat chew/park steps areas of the mouth • No food or beverages 15 minutes target quit date OR may reduce until most of the nicotine is gone • No food or beverages 15 min- before or during use smoking over a 12-week period (tingle does not return; generally utes before or during use • Duration: 3–6 months of treatment prior to quitting 30 min) • Duration: up to 12 weeks and continue treatment for an • Park in different areas of mouth additional 12 weeks • No food or beverages 15 minutes before or during use • Duration: up to 12 weeks NICOTINE REPLACEMENT THERAPY (NRT) FORMULATIONS BUPROPION SR VARENICLINE GUM LOZENGE TRANSDERMAL PATCH NASAL SPRAY ORAL INHALER • Mouth and throat irritation • Mouth and throat irritation • Local skin reactions • Nasal and/or throat irritation • Mouth and/or throat irritation • Insomnia •Nausea •Jaw muscle soreness • Hiccups (erythema, pruritus, burning) (hot, peppery, or burning • Cough • Dry mouth • Sleep disturbances (insomnia, • Hiccups • GI complaints (dyspepsia, • Sleep disturbances sensation) • Hiccups • Nausea abnormal/vivid dreams) •GI complaints (dyspepsia, nausea) (abnormal/vivid dreams, •Ocular irritation/tearing • GI complaints (dyspepsia, •Anxiety/difficulty concentrating •Headache nausea) insomnia); associated with • Sneezing nausea) • Constipation •Flatulence • May stick to dental work nocturnal nicotine absorption • Cough •Tremor •Constipation • Rash •Taste alteration EFFECTS • Seizures (risk is 0.1%) • Neuropsychiatric symptoms • Neuropsychiatric symptoms (rare; see PRECAUTIONS) (rare; see PRECAUTIONS) • Adverse effects more commonly experienced when chewing the ADVERSE lozenge or using incorrect gum chewing technique (due to rapid nicotine release): – Lightheadedness/dizziness – Nausea/vomiting – Hiccups – Mouth and throat irritation • Might serve as an oral substitute • Might serve as an oral substi- • Once-daily dosing associated • Can be titrated to rapidly • Might serve as an oral substitute • Twice-daily oral dosing is simple and • Twice-daily oral dosing is simple for tobacco tute for tobacco with fewer adherence problems manage withdrawal symptoms for tobacco associated with fewer adherence and associated with fewer adher- • Might delay weight gain • Might delay weight gain • Of all NRT products, its use is • Can be used in combination • Can be titrated to manage problems ence problems • Can be titrated to manage • Can be titrated to manage least obvious to others with other agents to manage withdrawal symptoms • Might delay weight gain • Offers a different withdrawal symptoms withdrawal symptoms • Can be used in combination with situational urges • Mimics hand-to-mouth ritual of • Might be beneficial in patients with mechanism of action for patients • Can be used in combination • Can be used in combination other agents; delivers consistent smoking depression who have failed other agents with other agents to manage with other agents to manage nicotine levels over 24 hours • Can be used in combination • Can be used in combination with • Most effective cessation agent ADVANTAGES situational urges situational urges •Relatively inexpensive with other agents to manage NRT agents when used as monotherapy •Relatively inexpensive •Relatively inexpensive situational urges • Relatively inexpensive (generic formulations) • Need for frequent dosing can • Need for frequent dosing can • When used as monotherapy, • Need for frequent dosing can • Need for frequent dosing can • Seizure risk is increased • Patients should be compromise adherence compromise adherence cannot be titrated to acutely compromise adherence compromise adherence • Several contraindications and monitored for potential • Might be problematic for patients • Gastrointestinal side effects manage withdrawal symptoms • Nasal administration might not • Cartridges might be less precautions preclude use in some neuropsychiatric with significant dental work (nausea, hiccups, heartburn) • Not recommended for use by be acceptable or desirable for effective in cold environments patients (see PRECAUTIONS) symptoms4 • Proper chewing technique is might be bothersome patients with dermatologic some patients; nasal irritation (≤60°F) • Patients should be monitored for (see PRECAUTIONS) necessary for effectiveness and conditions (e.g., psoriasis, often problematic •Cost of treatment potential neuropsychiatric symptoms4 •Cost of treatment to minimize adverse effects eczema, atopic dermatitis) • Not recommended for use by (see PRECAUTIONS) • Gum chewing might not be patients with chronic nasal DISADVANTAGES acceptable
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