Nicotine Replacement Therapy (NRT) formulations COPY

Question 1

Nicorette, ZONNIC (nicotine) OTC 2mg, 4mg original, cinnamon, fruit & mint

Answer 1

Dosing:

(= 30 mins after waking: 2 mg weeks 1-6: 1 piece of gum q 1-2 hours weeks 7-9: 1 piece of gum q 2-4 hours weeks 10-12: 1 piece of gum q 4-8 hours - max, 24 pieces/day - chew each piece slowly - park between cheek and gum when peppery or tingling sensation appears (~15-30 chews) - resume chewing when tingle fades - repeat chew/park steps until most of the nicotine is gone (tingle does not return; generally 30 min) - park in different areas of mouth - no food or beverages 15 mins before or during use - duration: up to 12 weeks

Question 2

Nicorette Lozenge, Nicorette Mint Lozenge (nicotine) OTC 2mg, 4mg cherry & mint

Answer 2

Dosing: 1st cigarette 30 mins after waking: 2 mg, Weeks 1-6: 1 lozenge q 1-2 hours, Weeks 7-9: 1 lozenge q 2-4 hours, Weeks 10-12: 1 lozenge q 4-8 hours, - max, 20 lozenges/day - allow to dissolve slowly (20-30 mins for standard; 10 mins for mini) - nicotine release may cause a warm, tingling sensation - do not chew or swallow - occasionally rotate to different areas of mouth - no food or beverages 15 mins before or during use - duration: up to 12 weeks

Question 3

NicoDerm CQ (nicotine) OTC & RX (generic only) 7mg, 14mg, 21mg (24 hour release)

Answer 3

Dosing: >10 cigarettes/day: 21 mg/day x 4-6 weeks, 14 mg/day x 2 weeks, 7 mg/day x 2 weeks < 10 cigarettes/day: 14 mg/day x 6 weeks, 7 mg/day x 2 weeks - may wear patch for 16 hours if patient experiences sleep disturbances (remove at bedtime) - duration: 8-10 weeks

Question 4

Nicotrol NS (nicotine) RX metered spray 10 mg/mL aqueous solution

Answer 4

Dosing:

1-2 doses/hour (8-40 doses/day) one dose= 2 sprays (one in each nostril); each spray delivers 0.5 mg of nicotine to nasal mucosa - Max: 5 doses/hour or 40 doses/day - for best results, initially use at least 8 doses/day - do not sniff, swallow, or inhale through the nose as the spray is being administered - duration: 3-6 months

Question 5

Nicotrol Inhaler (nicotine inhalation system) RX 10 mg cartridge delivers 4 mg inhaled vapor

Answer 5

Dosing:

6-16 cartridges/day indicidualize dosing; initally use 1 cartridge q 1-2 hours - best effects with continuous puffing for 20 mins - initially use at least 6 cartridges/day - nicotine in cartridge is depleted after 20 mins of active puffing - inhale into back of throat or puff in short breaths - DO NOT inhale into the lungs (like a cigarette) but “puff” as if lighting a pipe - open cartridge retains potency for 24 hours - no food or beverages 15 mins before or during use - duration: 3-6 months

Question 6

Zyban (Bupropion SR) RX 150 mg sustained-release tablet

Answer 6

Warning: Black Boxed warning for neuropsychiatric symptoms

Contraindications: seizure disorder, concomitant bupropion therapy (Wellbutrin), 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 (linezolid, methylene blue)

Dosing:

150 mg qAM x 3 days, then 150 mg BID - do not exceed 300 mg/day - begin therapy 1-2 weeks prior to quit date - allow at least 8 hours between doses - avoid bedtime dosing to minimize insomnia - dose tapering is not necessary - duration: 7-12 weeks, with maintenance up to 6 months in selected patients

Question 7

Chantix (Varenicline) RX 0.5 mg, 1 mg tablet

Answer 7

Warning: Black Boxed Warning for neuropsychiatric symptoms

Dosing:

Days 1-3: 0.5 mg qAM, Days 4-7: 0.5 mg BID, Weeks 2-12: 1 mg BID - begin therapy 1 week prior to quit date - take dose after eating and with a full glass of water - dose tapering is not necessary unless patient has renal impairment - duration: 12 weeks; an additional 12 week course may be used in selected patients

Question 8

Gum Adverse Effects

Answer 8

mouth/jaw soreness hiccups dyspepsia hyper-salivation effects associated with incorrect chewing technique: - lightheadedness - nausea/vomiting - throat & mouth irritation

Question 9

Lozenge Adverse Effects

Answer 9

nausea hiccups cough heartburn headache flatulence insomnia

Question 10

Transdermal Patch Adverse Effects

Answer 10

local skin reactions (erythema, pruritus, burning) headache sleep disturbances (insomnia, abnormal/vivid dream); associated with nocturnal nicotine absorption

Question 11

Nasal Spray Adverse Effects

Answer 11

nasal and/or throat irritation (hot, peppery, or burning sensation) rhinitis tearing sneezing cough headache

Question 12

Oral Inhaler Adverse Effects

Answer 12

mouth and/or throat irritation cough headache rhinitis dyspepsia hiccups

Question 13

Bupropion SR Adverse Effects

Answer 13

insomnia dry mouth nervousness/difficulty concentrating nausea dizziness constipation rash seizures (risk is 0.1%) neuropsychiatric symptoms (rare; see PRECAUTIONS)

Question 14

Varenicline Adverse Effects

Answer 14

nausea sleep disturbances (insomnia, abnormal/vivid dreams) constipation flatulence vomiting neuropsychiatric symptoms (rare; see PRECAUTIONS)

Question 15

Gum Advantages/Disadvantages

Answer 15

ADVANTAGES: - might serve as an oral substitute for tobacco - might delay weight gain - can be titrated to manage withdrawal symptoms - can be used in combination with other agents to manage situational urges DISADVANTAGES: - need for frequent dosing can compromise adherence - might be problematic for patients with significant dental work - proper chewing technique is necessary for effectiveness and to minimize adverse effects - gum chewing might not be acceptable or desirable for some patients

Question 16

Lozenge Advantages/Disadvantages

Answer 16

ADVANTAGES: - might serve as an oral substitute for tobacco - might delay weight gain - can be titrated to manage withdrawal symptoms - can be used in combination with other agents to manage situational urges DISADVANTAGES: - need for frequent dosing can compromise adherence - gastrointestinal side effects (nausea, hiccups, heartburn) might be bothersome

Question 17

Transdermal Patch Advantages/Disadvantages

Answer 17

ADVANTAGES: - once daily dosing associated with fewer adherence problems - of all NRT products, its use is least obvious to others - can be used in combination with other agents; delivers consistent nicotine levels over 24 hours DISADVANTAGES: - when used as monotherapy, cannot be titrated to acutely manage withdrawal symptoms - not recommended for use by patients with dermatologic conditions (e.g. psoriasis, eczema, atopic dermatitis)

Question 18

Nasal Spray Advantages/Disadvantages

Answer 18

ADVANTAGES: - can be titrated to rapidly manage withdrawal symptoms - can be used in combination with other agents to manage situational urges DISADVANTAGES: - need for frequent dosing can compromise adherence - nasal administration might not be acceptable or desirable for some patients; nasal irritation often problematic - not recommended for use by patients with chronic nasal disorders or severe reactive airway disease

Question 19

Oral Inhaler Advantages/Disadvantages

Answer 19

ADVANTAGES: - might serve as an oral substitute for tobacco - can be titrated to manage withdrawal symptoms - mimics hand-to-mouth ritual of smoking - can be used in combination with other agents to manage situational urges DISADVANTAGES: - need for frequent dosing can compromise adherence - cartridges might be less effective in cold environments (= 60 F)

Question 20

Bupropion SR Advantages/Disadvantages

Answer 20

ADVANTAGES: - twice daily oral dosing is simple and associated with fewer adherence problems - might delay weight gain - might be beneficial in patients with depression - can be used in combination with NRT agents DISADVANTAGES: - seizure risk is increase - several contraindications and precautions preclude use in some patients (see PRECAUTIONS) - patients should be monitored for potential neuropsychiatric symptoms (see PRECAUTIONS)

Question 21

Varenicline Advantages/Disadvantages

Answer 21

ADVANTAGES: - twice daily oral dosing is simple and associated with fewer adherence problems - offers a different MOA for patients who have failed other agents DISADVANTAGES: - should be taken with food or a full glass of water to reduce the incidence of nausea - patients should be monitored for potential neuropsychiatric symptoms (see PRECAUTIONS)

Question 22

Cost/day Most-least

Answer 22

Varenicline (2 tabs) > oral inhaler (6 cartridges) > Bupropion SR (2 tabs) > lozenge (9 pieces) > gum (9 pieces) > transdermal patch (1 patch)