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VHA Formulary Choices for Pharmacotherapy of Smoking Cessation

for Health Care Providers

Table 1: VHA Formulary Choices for Pharmacotherapy of Smoking Cessation

Back to Smoking Cessation Chapter

* Remove nicotine patch at bedtime.
# High dependence: in general, >20 cigarettes per day or use of first cigarette within 30 minutes of awakening.
§ All NRTs have been shown to double 6- to 12-month abstinence rates compared with placebo.
** Cost based on FSS or BIG4 pricing as listed on PBM website .

Note: Two additional prescription products, a nicotine inhaler and nicotine nasal spray, are FDA approved for NRT; however, these products are not available on the VHA National Formulary. For more information on these products, visit the American Lung Association Smoking Cessation SupportLink will take you outside the VA website. VA is not responsible for the content of the linked site..

BupropionNicotine Transdermal PatchNicotine Polacrilex GumNicotine Polacrilex LozengeVarenicline
Formulations

Bupropion SR 150 mg, 300 mg

Bupropion IR 100 mg

(Nicoderm/Habitrol) 21 mg, 14 mg, 7 mg

(Nicotrol) 15 mg, 10 mg, 5 mg

2 mg, 4 mg2 mg, 4 mg0.5 mg, 1 mg
Start instructions1-2 weeks before quit dateOn quit date1 week before quit date
Recommended regimen

Bupropion SR 150 mg QD for 3 days, then 150 mg BID (8 hours apart)

Reduce dosage for patients with cirrhosis: 150 mg QOD

Bupropion IR 100 mg QD for 3 days, then 100 mg TID; reduce dosage for patients with cirrhosis: 75 mg QD

High dependence#
21 mg for 4-6 weeks, then 14 mg for 2-3 weeks, then 7 mg for 2-3 weeks

Low dependence 14 mg for 6-8 weeks, then 7 mg for 2 weeks

High dependence#
4 mg Q1-2H for 6 weeks, then Q2-4H for 3-4 weeks, then Q4-6H for 2-3 weeks

Low dependence 2 mg Q1-2H for 6 weeks, then Q2-4H for 3 weeks, then Q4-6H for 3 weeks

Maximum: 24 pieces/24 hours

High dependence#
4 mg

Low dependence 2 mg

Suck 1 lozenge Q1-2H for 6 weeks, then 1 lozenge Q2-4H for 3 weeks, then 1 lozenge Q4-8H for 3 weeks

Maximum: 20 lozenges/24 hours or 5 lozenges/6 hours

Initial: 0.5 mg QD on days 1-3, then 0.5 mg BID on days 4-7, then 1 mg BID for total duration of 12 weeks

Reduce dosage for CrCl <30: maximum dosage 0.5 mg BID; end-stage renal disease or hemodialysis: 0.5 mg QD

Administration comments

Start 1-2 weeks before quitting smoking (to achieve steady-state levels)

Continue treatment for 8-12 weeks (if no progress is made by week 8, consider discontinuing therapy)

If insomnia, take evening dose in afternoon

Usually worn 16-24 hours; remove overnight

Apply between neck and waist

Rotate sites

Takes 2-3 days for effect after application of first patch

Chew slowly (about 10 chews) until peppery taste is released, then "park" between teeth and gums until flavor dissipates; repeat process on and off for 30 minutes per piece

Has been studied in combination with patch

Allow lozenge to dissolve slowly over course of 20-30 minutes, shifting in mouth occasionally

Do not chew or swallow (increased risk of GI side effects)

Avoid acidic beverages within 15 minutes of use (eg, citrus juices, soft drinks); these decrease absorption

Screen for suicide and violence risk before starting, and monitor before prescribing renewals

Start 1 week before quit date

Take drug after eating and with 8 oz of water

Instruct patient or caregiver to report depression, suicidal ideation, unusual changes in behavior, or worsening of preexisting psychiatric illness

An additional 12 weeks of treatment in patients who have successfully stopped smoking may increase likelihood of long-term abstinence

1-year abstinence rates§10-30% (up to 35% when combined with patch)16-30% (dose dependent); high-dose patch: 30%20-30%15-20%

18.5-23% (12-week course) vs 4-10% with placebo

43.6% (with additional 12-week course) vs 37% with placebo

ARV interactions

Metabolized by the cytochrome P450 system; EFV and TPV may ↓ bupropion levels 40-50%; when using with these ARVs, monitor for depression and titrate to clinical effect;

RTV may ↑ bupropion levels

NoneDoes not interact with the cytochrome P450 system; no ARV interactions identified to date
Time to peak blood concentrations3 hours (half life = 21 hours)4-10 hours15-30 minutesNo data3-4 hours
Absorption20%75-90%30%30%High; virtually complete absorption
Advantages (+) Disadvantages (-)

(+) Good adherence; ease of use; can be combined with patch; consistent rate of exposure; helps with withdrawal symptoms

(-) Many drug interactions resulting from metabolism by CYP 2B6; CNS side effects; must be adjusted for hepatic insufficiency; increased risk of seizures

(+) Best adherence; easy to use; consistent rate of exposure; unobtrusive

(-) Less effective than gum for cravings; difficult to control titration; absorption increased at elevated temperatures; should abstain from smoking while using NRT

(+) Helps prevent sudden urges; can titrate to adjust for cravings; oral substitute for cigarettes; slow release of nicotine reduces addiction potential

(-) Difficult for those with poor dentition or dentures; must learn proper chewing technique; should abstain from smoking while using NRT; must abstain from drinking/eating during gum use; swallowing nicotine causes GI side effects (hiccups, diarrhea or constipation, flatulence, belching)

(+) Easy to use; discreet; higher immediate levels; can titrate to adjust for cravings; reduces self-reported withdrawal symptoms

(-) Must abstain from drinking/eating during lozenge use; should abstain from smoking while using NRT

(+) Good adherence; ease of use; consistent rate of exposure; higher rate of abstinence compared with bupropion and placebo

(-) Potential for serious neuropsychiatric side effects, particularly in patients with underlying psychiatric disease or violence risk; dosage adjust for renal insufficiency (CrCl <30); high incidence of nausea; not studied in patients with underlying mental illness

Adverse effects

Anxiety

Disturbed concentration

Dizziness

Insomnia

Constipation

Dry mouth

Nausea

Seizures (risk: 1:1,000)

Sleep disturbances

Local skin irritation

Bone pain

Headache

Nausea

Local mouth irritation

Jaw pain

Hiccups

Dyspepsia

Rhinitis

Nausea

Local mouth irritation/tingling

Heartburn, indigestion, nausea (if chewed)

Headache

Nausea, diarrhea

Flatulence

Dream disorders

Headache

Insomnia

Abnormal behavior

Agitation

Depressed mood

Suicidal thoughts

Constipation

Flatulence

Nausea, vomiting

Consider dosage reduction for patients sensitive to adverse effects (eg, nausea, headache, insomnia)

VHA National Formulary restrictionsNoneNoneNoneRestricted to patients who cannot tolerate gum (eg, dentures, missing teeth, TMJ, previous head or neck surgery)

Must meet criteria for use

Restricted to patients without active mental health disorders or with clinically stable mental health disorders who have had >1 relapse on NRT or bupropion

VHA cost** and average cost per day based on above regimens

SR:

$0.48/tablet

$0.96/day

IR:

$0.28/tablet

$0.84/day

14 mg patches:

$2.50/patch

$2.50/day

2 mg gum:

$12.62/50 pieces

$20.12/110 pieces

$0.18-$0.25/piece

$2.20-$6/day

4 mg gum:

$13.70/50 pieces

$25.69/110 pieces

$0.23-$0.27/piece

$2-$6.50/day

2 mg or 4 mg lozenge:

$29.45/72 lozenges

$0.41/lozenge

$5-8/day

0.5 mg and 1mg tablets:

$1.17/tablet

$2.34/day

Contraindications and relative contraindicationsContraindications:

History of seizures

Predisposition to seizures (eg, severe head trauma, CNS tumor, cirrhosis)

Abrupt withdrawal from heavy, daily alcohol or other sedative

MAO inhibitor within 14 days

Bulimia, anorexia nervosa

Relative contraindications:

Hypersensitivity

Pregnancy category B

Relative contraindications:

Hypersensitivity

Pregnancy category D

Use within 14 days post MI, or in patients with serious or worsening angina

Patients should be advised not to smoke while on NRT

Relative contraindications:

Serious neuropsychiatric disorders (including suicidal and homicidal ideation)

History of suicidal, homicidal, or assaultive behavior in the past 12 weeks

Untreated or unstable mental disorder such as psychotic disorder, bipolar disorder, major depressive disorder, and PTSD

Severe renal impairment

Pregnancy category C

Comments

Use with caution in patients with liver, kidney failure

Avoid in patients on MAO inhibitors

In combination with behavioral program, patch doubles the quit rate

Durability of cessation is better with 21 mg patches than with 14 or 7 mg patches

Using the 21 mg patch yields roughly 40-50% the plasma nicotine levels of smoking 1.5 packs per day

In combination with an intensive behavioral program, nicotine gum can double the quit rate

Using 2 mg ad lib yields roughly 40% plasma nicotine levels of smoking 1 pack per day

In combination with an intensive behavioral program, nicotine lozenges can increase the quit rate

Not first-line therapy for smoking cessation

Ask patients about any psychiatric history before prescribing varenicline,as above

Monitor for signs/symptoms of psychiatric illness during use

Monitor serum creatinine levels; as renal function decreases (as seen in elderly patients), dosage reductions may be necessary

From Smoking Cessation
Primary Care of Veterans with HIV
Office of Clinical Public Health Programs
Veterans Health Administration, 2009