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Nicotine Polacrilex Drug Information, Professional. VA CLASSIFICATIONPrimary: AD6. Commonly used brand name(s): Habitrol; Nico. Derm CQ; Nicoderm; Nicorette; Nicorette Plus; Nicotrol; Prostep. Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s). Category: Smoking cessation adjunct—Indications. Accepted. Nicotine dependence (treatment adjunct)—Nicotine chewing gum and nicotine transdermal systems are indicated as temporary aids for the cigarette smoker who wants to give up smoking. They serve as alternative sources of nicotine and provide relief of nicotine withdrawal symptoms in nicotine- dependent individuals who are acutely withdrawing from cigarette smoking. Smoking withdrawal effects such as irritability, drowsiness, fatigue, headache, and nicotine craving are lessened with their use. However, there are insufficient data to support the safety and efficacy of nicotine for this use. In low concentrations, stimulates certain chemoreceptors in the pulmonary and coronary circulation, leading to reflex bradycardia and hypotension. Causes release of antidiuretic hormone (ADH) by stimulation of hypothalamus. Stimulation of emetic chemoreceptor trigger zone of medulla oblongata and vagal reflex activation may result in vomiting. Parasympathetic stimulation increases tone and motor activity of the gastrointestinal tract, leading to nausea, vomiting, and occasionally diarrhea. Effects of nicotine on exocrine glands cause an initial stimulation followed by inhibition of salivary and bronchial secretions. Action on the central nervous system (CNS) may result in respiratory failure due to both central paralysis and peripheral blockade of muscles of respiration. Absorption: Chewing gum: Buccal mucosa: Absorption enhanced by buffering of gum to p. H 8. 5; rate of absorption is slower than from lungs during smoking. Stomach: Not absorbed in significant amounts when gum is swallowed because of poor release of nicotine from gum in acidic p. H of stomach. All are believed to be less active than the parent compound. Cotinine is the primary metabolite. Even nicotine transdermal systems that have been used still contain enough nicotine to cause toxicity . However, no specific problems in nicotine- dependent adolescents have been documented to date. If gum is swallowed without chewing, nicotine will not be released or absorbed in significant amounts because of the acid p. H of the stomach. Clinical effects of overdose. The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive: Early effects of overdose (in possible order of occurrence) Nausea and/or vomiting. Do not use soap because it may increase nicotine absorption. Repeated doses of charcoal should be administered as long as the patch remains in the gastrointestinal tract because it will continue to release nicotine. However, while the use of nicotine replacement products is preferable to a return to smoking, . If left on, nicotine plasma concentrations may be increased as a result of increased absorption of nicotine from the skin depot, increased skin temperature, and increased cutaneous vasodilation and perfusion. Patients who have successfully abstained from smoking for eight weeks should have their dose reduced to one 1. The dosage should be further reduced to one 5- mg system applied for sixteen hours per day for two weeks. The dosage should be further reduced to one 7- mg system per day for two weeks. Systems are labeled by the dose actually absorbed by the patient, not by the total nicotine content. Store in the intact, . Because nicotine is volatile, the system may lose strength if removed from pouch prematurely. In: PDR Physicians' desk reference. Oradell, NJ: Medical Economics Company; 1. Nicorette (Merrell). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. Ottawa: Canadian Pharmaceutical Association; 1. Shinn AF, Shrewsbury RP. EDI, Evaluation of drug interactions. St Louis: Mosby; l. Hansten PD, Horn JR. Philadelphia: Lea & Febiger; 1. Nicoderm package insert (Marion Merrell Dow—US), Rev 1. Rec 1/1. 4/9. 2. Habitrol (Novartis Consumer Health). In: PDR Physicians' desk reference. Montvale, NJ: Medical Economics Company, Inc.; 1. Prostep (Lederle). In: PDR Physicians' desk reference. Montvale, NJ: Medical Economics Company, Inc., 1. Prostep product information (Lederle—US), Rev 1. Rec 2/2. 0/9. 2. Nicotine patches. Med Lett Drugs Ther 1. Manufacturer comment, 6/2. Benowitz NL, Jacob P III, Savanapridi C. Determinants of nicotine intake while chewing nicotine polacrilex gum. Clin Pharmacol Ther 1. Russell MAH, Feyerabend C, Cole PV. Adhesives are a critical component in transdermal drug delivery (TDD) devices. In addition to the usual requirements of functional adhesive properties, adhesives for TDD applications must have good biocompatibility. Plasma nicotine levels after cigarette smoking and chewing nicotine gum. BMJ 1. 97. 6; 1: 1. Reviewers' consensus on monograph revision of 5/2. Panel comment, 6/9. Panel comment, 6/9. The United States pharmacopeia. The national formulary. USP 2. 3rd revision (January 1, 1. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 1. First supplement, 1. Nicorette (Smith. Kline Beecham). In: PDR Physicians' desk reference for nonprescription drugs. Transdermale therapeutische Systeme Arzneistoffe zum Aufkleben von Marc Schiller und Peter C. Nur acht Wirkstoffe sind derzeit in Form von transdermalen therapeutischen Systemen (TTS) auf dem deutschen.
Montvale, NJ: Medical Economics Company; 1. Nicorette (Hoechst Marion Roussel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. Ottawa: Canadian Pharmaceutical Association; 1. B1. 07. Nicorette Plus (Hoechst Marion Roussel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. Ottawa: Canadian Pharmaceutical Association; 1. B1. 07- 8. Prostep (Boehringer Ingelheim). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. Ottawa: Canadian Pharmaceutical Association; 1. B1. 29- 3. 0. Personal communication, 6/2. Nico. Derm CQ (Smith. Kline Beecham). In: PDR Physicians' desk reference for nonprescription drugs. Montvale, NJ: Medical Economics Company; 1. Canada JR, editor. USP dictionary of USAN and international drug names 1. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 1. The United States pharmacopeia. The national formulary. USP 2. 3rd revision (January 1, 1. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 1. Fifth supplement, 1. Nicotine transdermal system package insert (Sano—US), Rev 0. Rec 1. 0/3. 0/9. 7. Nicotrol (Mc. Neil). In: PDR Physicians' desk reference for nonprescription drugs. Montvale, NJ: Medical Economics Company; 1. Nicoderm (Hoechst Marion Roussel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. Ottawa: Canadian Pharmaceutical Association; 1. Habitrol product monograph (Novartis—Canada), New 0. Rec 0. 7/3. 1/9. 8. Nicotrol (Mc. Neil). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. Ottawa: Canadian Pharmaceutical Association; 1. B1. 08- 9. Reviewer comment, 9/9. Personal communication, 6/9/9. Sandborn WJ, Tremaine WJ, Offord KP, et al. Transdermal nicotine for mildly to moderately active ulcerative colitis. A randomized, double- blind, placebo- controlled trial. Ann Intern Med 1. Pullen RD, Rhodes J, Ganesh S, et al. Transdermal nicotine for active ulcerative colitis. N Engl J Med 1. 99. Thomas GAO, Rhodes J, Ragunath K, et al. Transdermal nicotine compared with oral prenisolone therapy for active ulcerative colitis. Eur J Gastroenterol Hepatol 1. Thomas GAO, Rhodes J, Mani V, et al. Transdermal nicotine as maintenance therapy for ulcerative colitis. N Engl J Med 1. 99. Guslandi M, Tittobello A. Pilot trial of nicotine patches as an alternative to corticosteroids in ulcerative colitis. J Gastroenterol 1. Lashner BA, Hanauer SB, Silverstein MD. Testing nicotine gum for ulcerative colitis patients. Experience with single- patient trials. Dig Dis Sci 1. 99. Guslandi M, Tittobello A. Steroid- sparing effect of transdermal nicotine in ulcerative colitis. J Clin Gastroenterol 1. Srivastava ED, Russell MAH, Feyerabend C, et al. Transdermal nicotine in active ulcerative colitis. Eur J Gastroenterol Hepatol 1. Panel comment on Nicotine (Inhalation- Systemic) monograph, 0. Mc. Conville BJ, Sanberg PR, Fogelson MH, et al. The effects of nicotine plus haloperidol compared to nicotine only and placebo nicotine only in reducing tic severity and frequency in Tourette's disorder. Biol Psychiatry 1. Dursun SM, Reveley MA. Differential effects of transdermal nicotine on microstructured analyses of tics in Tourette's syndrome: an open study. Psychol Med 1. 99. Silver AA, Shytle RD, Philipp MK, et al. Case study: long- term potentiation of neuroleptics with transdermal nicotine in Tourette's syndrome. J Am Acad Child Adolesc Psychiatry 1. Shytle RD, Silver AA, Philipp MK, et al. Transdermal nicotine for Tourette's syndrome. Drug Dev Res 1. 99. Silver AA, Sanberg PR. Transdermal nicotine patch and potentiation of haloperidol in Tourette's syndrome . Lancet 1. 99. 3; 3. Mc. Conville BJ, Fogelson MH, Norman AB, et al. Nicotine potentiation of haloperidol in reducing tic frequency in Tourette's disorder . Am J Psychiatry 1. Sanberg PR, Mc. Conville BJ, Fogelson HM, et al. Nicotine potentiates the effects of haloperidol in animals and in patients with Tourette syndrome. Biomed Pharmacother 1. Sanberg PR, Fogelson HM, Manderscheid PZ, et al. Nicotine gum and haloperidol in Tourette's syndrome . Lancet 1. 98. 8; 1: 5. Reviewers' consensus on monograph revision of 1. Panel comment, 1. Manufacturer comment, 1. Panel comment, 1. Homsy W, et al. Plasma levels of nicotine and safety of smokers wearing transdermal delivery systems during multiple sumultaneous intake of nicotine during exercise. J Clin Pharm 1. 99. Klemsdal TO, Gjesdal K, Zahlsen K. Physical exercise increases plasma concentrations of nicotine during treatment with a nicotine patch. Br J Clin Pharm 1. Manufacturer comment, 1. U. S. Department of Health and Human Services. Clinical practice guideline, number 1. Department of Health and Human Services, Public Health Service. Agency for Health Care Policy and Research, Centers for Disease Control and Prevention. AHCPR publication number 9.
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