Microsoft word - $asqappendix b - drug protocol
Pharmacotherapy Guide for Smoking Cessation Medications
Standard dosing schedule:
Use for acute episodes of craving or tapering of
fixed schedule preferred to prn use
Individualize drug dose:
Weeks 1-6: 1 every 1 to 2 hrs not more than
Severe renal function impairment (est CrCl
2mg if first cigarette after 30 min of waking
<30ml/min)=Starting dose is 0.5 mg once daily, then
Weeks 1-6: 1 every 1-2 hours not more than
titrate as needed to a maximum dosage of 0.5 mg twice
ESRD undergoing hemodialysis=max dose of 0.5 mg
once daily may be administered if tolerated well
Active temporomandibular joint (TMJ) disease
Undergoing abrupt d/c ofalcohol or sedatives
threatening arrhythmias, active stomach ulcer
Phenylketonurics (lozenge contains aspartame)
Start varenicline 1 week before quit date
Patient instruction for nicotine lozenge:
Take after eating and with a full glass of water
Once placed in mouth move from one side to the
Patients who cannot tolerate the adverse reactions
Patient instructions for nicotine gum:
Chew gum slowly until “peppery” or “minty” taste
emerges, then “park” between cheek and
Repeat cycle of chewing and parking for ~30
Screening questions for head trauma suggesting a predisposition to seizures years after event (4,5)
1) Have you had closed head trauma resulting in any loss of consciousness or amnesia within the past 5 years?2) Have you had closed head trauma at any time resulting in resulting in loss of consciousness or amnesia for >30 minutes?3) Have you had closed head trauma at any time resulting in skull fracture?4) Have you had closed head trauma at any time resulting in a subdural hematoma or brain contusion?
• Strongest risk factors for post-traumatic seizures persisting for at least 20 years
in patients with:
• Moderate (two-fold) increase in the risk of post-traumatic seizures for at least 5 years
in patients with:
• mild closed head injury and loss of consciousness or post-traumatic amnesia <30 minutes
In 2001 twelve percent of all women giving birth in the US reported smoking throughout pregnancy despite the obvious risk.
Women can reduce the risks of smoking-related complications to almost the nonsmoker level if they quit during the first trimester.
Treatment remains controversial due to variation in pregnancy categories and lack of clinical trials.
The FDA assigned pregnancy categories vary depending on the reference. For instance, USPHS guidelines list all NRT
products to be category D with the exception of the patch which is category C. Facts and Comparisons is the opposite with allNRT products Category D with the nicotine gum being Category C.
To date no clinical efficacy trials have addressed bupropion use in pregnancy. Two studies with the nicotine patch have
been conducted and neither showed increase in cessation rate possibly due to inadequate levels of nicotine replacement due tofaster metabolism.
The harmful effects of cigarette smoking on maternal and fetal health are clearly established, however some studies have shownthat nicotine itself is neuroteratogenic so treatment with nicotine replacement therapy should be guided by the followingrecommendations:
• Use medication doses that are at the low end of the effective dose range e.g. 7 and 14mg patch and the 2mg gum
• Intermittent rather than continuous drug exposure is preferred e.g., nicotine gum rather than the nicotine patch and if patch is
used remove at bedtime since 16mg hour dosing is as effective as 24 hour thus minimizing nicotine exposure
• Begin treatment early in pregnancy as possible preferably in the first instead of second or third trimester which is contrary to
classical views of teratogenesis. Nicotine receptors which are the specific target for adverse effects develop after the majorphase of systemic organogenesis
• Individualize treatment based on contraindications and mother preference. For instance patients with nausea/vomiting of
pregnancy oral NRT may be poorly tolerated
High dose nicotine patch therapy (7,9,10,11)
• More than two dozen studies have been performed with nicotine patches showing doubling or tripling of quit rates, yet
• Possibly due to under dosing of the standard nicotine patch of 21-22mg/d which results in less than 50% of the serum nicotine
levels produced by smoking one pack of cigarettes per day
• Light smokers with lower baseline cotinine (nicotine metabolite) levels have higher stop rates, suggesting that their nicotine
• Small number of clinical trials addressing high dose nicotine patches have shown mixed results in long term abstinence rates
though short term rates have been higher thus some experts recommend that heavier smokers may need higher doses toachieve initial abstinence rates. It should be noted that doses above 21mg are not yet FDA approved.
Treatment of spit tobacco (12)
Initial patch dosing
• Behavioral interventions are effective
1) Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence.
Clinical Practice Guideline. Rockville, MD: U.S.
Department of Health and Human Services. Public Health Service. June 2000.
2) Peterson E, Fenaughty A, Eberhart-Phillips JE, Tobacco in the Great Land, A Portrait of Alaska’s Leading Cause of Death. Anchorage, AK:
Section of Epidemiology, Division of Public Health, Alaska Department of Health and Social Services, 2004.
3) Prochaska, J.O. DiClemente, C.C., Norcross, J.C., (1992). In search of how people change. American Psychologist. Vol. 47, No 9. 1102-
4) Annegers JF, Hauser WA, Coan SP, Rocca WA. A population-based study of seizures after traumatic brain injuries. N Engl J Med
5) Hays JT, Ebbert JO. Bupropion for the treatment of tobacco dependence. CNS Drugs 2003;17(2):71-83.
6) Dale LC, Ebbert JO, Hays JT, Hurt RD. Treatment of Nicotine Dependence. Mayo Clin Proc 2000;75:1311-11
7) Jorenby DE, Smith SS, Fiore M, et al. Varying nicotine patch dose and type of smoking cessation counseling. JAMA 1995;274:1347-1352.
8) Benowitz NL. Zevin S, Jacob P. Suppression of nicotine intake during ad libutum cigarette smoking by high-dose transdermal nicotine.
Pharm and Exp Ther 1998;287(3):958-962.
9) Killen JK, Fortman SP, Davis L, Strausberg L, Varady A. Do heavy smokers benefit from higher dose nicotine patch therapy? Exp and Clin
10) Kozak J, Fagerstrom KO, Sawe U. High-dose treatment with nicotine patch. International Journal of Smoking Cessation 1995:4:26-28.
11) Hughes JR, Lesmes GR, Hatsukami DK, Richmond RL, Lichtenstein E, Jorenby DE, Broughton JO, Fortmann SP, Leischow SJ, McKenna
JP, Rennard SI, Wadland WC, Heatley SA. Are higher doses of nicotine replacement more effective for smoking cessation? Nicotine Tob Res
12) Ebbert JO, Rowland LC, Montori VM, Vickers KS, Erwin PJ, Dale LC. Treatments for spit tobacco use: a quantitative systematic review.
13) Slotkin TA. Fetal Nicotine or Cocaine Exposure: Which one is worse? Journal of Pharmacology and Experimental Therapeutics. 285;931-
14) Benowitz NL, Dempsey DA. Pharmacotherapy for smoking cessation during pregnancy. Nicotine & Tobacco Research. April
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