+-----------+-----------+------------+---------------+---------------+
| **VA      |           |            |               |               |
| Formulary |           |            |               |               |
| Choices   |           |            |               |               |
| for       |           |            |               |               |
| Pharma    |           |            |               |               |
| cotherapy |           |            |               |               |
| of        |           |            |               |               |
| Smoking   |           |            |               |               |
| Ce        |           |            |               |               |
| ssation** |           |            |               |               |
+-----------+-----------+------------+---------------+---------------+
|           | **        | *          | ***Nicotine   | **            |
|           | *Nicotine | **Nicotine | polacrilex    | *Bupropion*** |
|           | Tr        | polacrilex | lozenge***    |               |
|           | ansdermal | gum***     |               |               |
|           | Patch***  |            |               |               |
+-----------+-----------+------------+---------------+---------------+
| **Trade   | Nicoderm  | Nicorette  | Commit        | Bupropion SR  |
| Name and  | /Habitrol | Gum        | Lozenge       | (Zyban)       |
| Dose      | 21mg      |            |               |               |
| avail     | /14mg/7mg | 2mg, 4mg   | 2mg, 4mg      | 150mg, 300mg  |
| ability** |           |            |               | tab           |
|           | N         |            |               |               |
|           | icotrol\* |            |               | Bupropion IR  |
|           |           |            |               | 100mg tab     |
|           | 15mg      |            |               |               |
|           | /10mg/5mg |            |               |               |
+-----------+-----------+------------+---------------+---------------+
| **Re      | High      | High       | High          | *Bupropion SR |
| commended | De        | D          | Dependence†   | (Zyban)*      |
| Regimen** | pendence† | ependence† |               |               |
|           |           |            | 4mg           | 150mg qd x 3d |
|           | 21mg x    | 4mg        |               | then 150mg    |
|           | 4-6wks,   | q1-2hrs    | Low           | bid (8 hrs    |
|           |           | x6wks,     | Dependence    | apart)        |
|           | then 14mg |            |               |               |
|           | x 2wks,   | then       | 2mg           | patients with |
|           |           | q2-4hrs    |               | cirrhosis     |
|           | then 7mg  | x4wks,     | -Suck 1       | need adjusted |
|           | x 2wks    |            | lozenge       | dose: 150mg   |
|           |           | then       | q1-2hrs       | qod           |
|           | Low       | q4-6hrs    | x6wks, then 1 |               |
|           | D         | x2wks      | q2-4hrs       | *Bupropion    |
|           | ependence |            | x3wks, then 1 | IR*           |
|           |           | Low        | q4-8hrs x3wks |               |
|           | 14mg x    | Dependence |               | 100mg qd x3d, |
|           | 6-8wks,   |            | -No more than |               |
|           |           | 2mg        | 20            | then 100mg    |
|           | then 7mg  | q1-2hrs    | l             | tid           |
|           | x 2wks    | x6wks      | ozenges/24hrs |               |
|           |           |            | or 5          | patients with |
|           |           | then       | lozenges/6hrs | cirrhosis     |
|           |           | q2-4hrs    |               | need adjusted |
|           |           | x3wks      |               | dose: 75mg qd |
|           |           |            |               |               |
|           |           | then       |               |               |
|           |           | q4-6hrs    |               |               |
|           |           | x3wks      |               |               |
|           |           |            |               |               |
|           |           | -No more   |               |               |
|           |           | than 24    |               |               |
|           |           | pi         |               |               |
|           |           | eces/24hrs |               |               |
+-----------+-----------+------------+---------------+---------------+
| **Admin   | -Usually  | -Chew      | -Allow        | -start 1-2    |
| istration | worn for  | slowly     | lozenge to    | wks prior to  |
| c         | 24hrs     | (about 10  | dissolve      | quitting      |
| omments** |           | chews)     | slowly over   | smoking (to   |
|           | (         | until      | 20-30 minutes | achieve       |
|           | Nicotrol, | peppery    | shifting in   | steady-state  |
|           | 16hrs)    | taste then | mouth         | levels)       |
|           |           | "park"     | occasionally. |               |
|           | -Apply    | between    |               | -continue     |
|           | from neck | teeth and  | -Do not chew  | treatment for |
|           | to waist  | gums till  | or swallow    | 7-12 wks (if  |
|           |           | taste      | (increased    | no progress   |
|           | -Rotate   | d          | risk of GI    | is made by    |
|           | sites     | issipates. | side effects) | week 7,       |
|           |           | Repeat     |               | consider      |
|           | -Takes    | process on |               |               |
|           | 2-3d for  | and off    |               | discontinuing |
|           | effect    | for        |               | therapy)      |
|           | after     | 30         |               |               |
|           | ap        | mins/piece |               | -if insomnia, |
|           | plication |            |               | take PM dose  |
|           | of first  | -Has been  |               | in afternoon  |
|           | patch     | studied in |               |               |
|           |           | c          |               |               |
|           |           | ombination |               |               |
|           |           | with patch |               |               |
+-----------+-----------+------------+---------------+---------------+
| **1-year  | 16-30%    | 20-30%     | 15-20%        | 10-30%        |
| A         |           |            |               |               |
| bstinence | (dose     |            |               | (up to 35%    |
| rates**‡  | de        |            |               | when combined |
|           | pendent); |            |               | with patch)   |
|           |           |            |               |               |
|           | high dose |            |               |               |
|           | patch:    |            |               |               |
|           | 30%       |            |               |               |
+-----------+-----------+------------+---------------+---------------+
| **Time to | 4-10hrs   | 15-30 mins | No data on    | 3 hours       |
| Peak      |           |            | *time* to     |               |
| blood     |           |            | peak          | (half-life =  |
| concent   |           |            | concentration | 21 hrs)       |
| rations** |           |            |               |               |
+-----------+-----------+------------+---------------+---------------+
| **Abs     | 75-90%    | 30%        | 30%           | 20%           |
| orption** |           |            |               |               |
+-----------+-----------+------------+---------------+---------------+
| **A       | (+)best   | (+) helps  | (+)easy to    | (+) better    |
| dvantages | a         | prevent    | use;          | compliance;   |
| (+) and** | dherence; | sudden     | discreet;     | ease of use;  |
|           | easy to   | urges; can | higher        | can be        |
| **Disa    | use;      | titrate to | immediate     | combined with |
| dvantages | c         | adjust for | levels; can   | patch;        |
| (-)**     | onsistent | cravings;  | titrate to    | consistent    |
|           | rate of   | oral       | adjust for    | rate of       |
|           | exposure; | substitute | cravings;     | exposure;     |
|           | un        | for        | reduces       | helps with    |
|           | obtrusive | cigarettes | self-reported | withdrawal    |
|           |           |            | withdrawal    | symptoms      |
|           | (-)less   | (-         | symptoms      |               |
|           | effective | )difficult |               | (-) many drug |
|           | for       | for those  | (-)must       | interactions  |
|           | cravings; | with poor  | abstain from  | due to        |
|           | difficult | dentition  | dr            | metabolism by |
|           | to        | or         | inking/eating | CYP2B6; CNS   |
|           | control   | dentures;  | during        | side effects; |
|           | t         | must learn | lozenge use   | must be       |
|           | itration; | proper     |               | adjusted for  |
|           | a         | chewing    |               | hepatic       |
|           | bsorption | technique; |               | i             |
|           | increased | must       |               | nsufficiency; |
|           | at        | abstain    |               | increased     |
|           | elevated  | from       |               | risk of       |
|           | tem       | drink      |               | seizures      |
|           | peratures | ing/eating |               |               |
|           |           | during gum |               |               |
|           |           | use        |               |               |
+-----------+-----------+------------+---------------+---------------+
| **Adverse | -sleep    | -local     | -local mouth  | -anxiety      |
| Effects** | dis       | mouth      | irrita        |               |
|           | turbances | irritation | tion/tingling | -disturbed    |
|           |           |            |               | concentration |
|           | -local    | -jaw pain  | -heartburn,   |               |
|           | skin      |            | indigestion,  | -dizziness    |
|           | i         | -hiccups   | nausea (if    |               |
|           | rritation |            | chewed)       | -insomnia     |
|           |           | -dyspepsia |               |               |
|           | -bone     |            | -headache     | -constipation |
|           | pain      | -rhinitis  |               |               |
|           |           |            | -nausea,      | -dry mouth    |
|           | -headache | -nausea    | diarrhea      |               |
|           |           |            |               | -nausea       |
|           | -nausea   |            | -flatulence   |               |
|           |           |            |               | -seizures     |
|           |           |            |               | (risk 1:1000) |
+-----------+-----------+------------+---------------+---------------+
| **VA      | None      | None       | Yes -         | None          |
| National  |           |            | restricted to |               |
| Formulary |           |            | patients who  |               |
| Restr     |           |            | cannot        |               |
| ictions** |           |            | tolerate gum  |               |
|           |           |            | (i.e.         |               |
|           |           |            | dentures,     |               |
|           |           |            | missing       |               |
|           |           |            | teeth, TMJ,   |               |
|           |           |            | s/p head and  |               |
|           |           |            | neck surgery) |               |
+-----------+-----------+------------+---------------+---------------+
| **VA      | All       | 2mg gum:   | 2mg or 4mg    | SR:           |
| Cost║ and | s         |            | lozenge:      |               |
| Average   | trengths: | \$12.62/50 |               | \$0.48/tab    |
| cost per  |           | pieces     | \$29.45/72    |               |
| day based | \$35.07 / |            | lozenges      | \$0.96/day    |
| on above  | 14patches | \          |               |               |
| regimens  |           | $20.12/110 | \             | IR:           |
| (avg)**   | \$2       | pieces     | $0.41/lozenge |               |
|           | .50/patch |            |               | \$0.28/tab    |
|           |           | \$0.       | avg           |               |
|           | avg       | 18-\$0.25/ | \$5-\$8/day   | \$0.84/day    |
|           | \         | piece      |               |               |
|           | $2.50/day |            |               |               |
|           |           | avg        |               |               |
|           |           | \$2.       |               |               |
|           |           | 20-\$6/day |               |               |
|           |           |            |               |               |
|           |           | 4mg gum    |               |               |
|           |           |            |               |               |
|           |           | \$13.70/50 |               |               |
|           |           | pieces     |               |               |
|           |           |            |               |               |
|           |           | \          |               |               |
|           |           | $25.69/110 |               |               |
|           |           | pieces     |               |               |
|           |           |            |               |               |
|           |           | \$0.23-\$  |               |               |
|           |           | 0.27/piece |               |               |
|           |           |            |               |               |
|           |           | avg        |               |               |
|           |           | \$2-       |               |               |
|           |           | \$6.50/day |               |               |
+-----------+-----------+------------+---------------+---------------+
| *         | **        |            |               | ***Contrain   |
| *Contrain | *Relative |            |               | dications:*** |
| dications | Con       |            |               |               |
| /Relative | traindica |            |               | -history of   |
| C         | tions:*** |            |               | seizures      |
| ontraindi |           |            |               |               |
| cations** | -Hyperse  |            |               | -p            |
|           | nsitivity |            |               | redisposition |
|           |           |            |               | to seizures   |
|           | -P        |            |               | (i.e. severe  |
|           | regnancy: |            |               | head trauma,  |
|           | Category  |            |               | CNS tumor,    |
|           | D         |            |               | hepatic       |
|           |           |            |               | cirrhosis)    |
|           | -Use      |            |               |               |
|           | within 14 |            |               | -abrupt       |
|           | days post |            |               | withdrawal    |
|           | MI, or    |            |               | from heavy,   |
|           | serious   |            |               | daily alcohol |
|           | or        |            |               | or other      |
|           | worsening |            |               | sedative      |
|           | angina    |            |               |               |
|           |           |            |               | -MAO          |
|           | -Patients |            |               | inhibitor     |
|           | should be |            |               | within 14     |
|           | advised   |            |               | days          |
|           | not to    |            |               |               |
|           | smoke     |            |               | -bulimia,     |
|           | while on  |            |               | anorexia      |
|           | nicotine  |            |               | nervosa       |
|           | re        |            |               |               |
|           | placement |            |               | ***Relative   |
|           | therapy   |            |               | Contrain      |
|           |           |            |               | dications:*** |
|           |           |            |               |               |
|           |           |            |               | -hy           |
|           |           |            |               | persensitvity |
|           |           |            |               |               |
|           |           |            |               | -pregnancy:   |
|           |           |            |               | category B    |
+-----------+-----------+------------+---------------+---------------+

\*remove Nicotrol patch at bedtime

†In general, greater than 20 cigarettes per day or use of first
cigarette within 30 minutes of awakening is considered high dependence

‡all NRTs have been shown to double 6-12month abstinence rates compared
to placebo

║ cost based on FSS or BIG4 pricing as listed on PBM website
(<http://www.pbm.va.gov/PBM/prices.htm>) Accessed: Jan 2006

**Note:** Two additional prescription products, a nicotine inhaler and
nicotine nasal spray, are also FDA approved for nicotine replacement
therapy however these products are not available on the VA National
Formulary. For more information on these products, visit the American
Lung Association Smoking Cessation Support website at:
<http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=33566>