NicoDerm (Nicotine)

NICODERM®

Hoechst Marion Roussel

Nicotine

Smoking Cessation Aid

Action And Clinical Pharmacology: Nicoderm is a multilayered rectangular film containing nicotine as the active ingredient. It provides 24 hour rate-controlled delivery of nicotine following its application to intact skin. Nicoderm reduces the withdrawal symptoms associated with smoking cessation and thus increases the success rate of smoking cessation programs.

Indications And Clinical Uses: As an aid to smoking cessation for partial relief of nicotine withdrawal symptoms. This treatment should be used as part of a comprehensive behavioral smoking-cessation program.

Contra-Indications: Patients with hypersensitivity or allergy to nicotine or the components of the transdermal system. Patients with acute hypersensitivity reactions should discontinue use of Nicoderm and should be advised of the possibility of acute hypersensitivity reactions to other forms of nicotine, including cigarettes.

Nonsmokers or occasional smokers.

In children under 18 years of age (see Precautions).

In patients during the immediate post-myocardial infarction period, in patients with life-threatening arrhythmias, in patients with severe or worsening angina pectoris, in patients who have had a recent cerebral vascular accident (see Warnings), in pregnant women (see Precautions: Pregnancy), in nursing mothers, and in patients with generalized skin disorders.

Manufacturers’ Warnings In Clinical States: Nicotine from any source can be toxic and addictive. The amounts of nicotine that are tolerated by adult smokers can produce symptoms of poisoning and could prove fatal if the Nicoderm system is applied or ingested by children or pets. Used NIcoderm systems contain approximately 70% of their initial drug content. Therefore, patients should be cautioned to keep both the used and unused Nicoderm systems out of the reach of children and pets.

Cardiovascular or Peripheral Vascular Disease: The risks of nicotine replacement in patients with certain cardiovascular and peripheral vascular diseases should be weighed against the benefits of including nicotine replacement in a smoking-cessation program for them. Specifically, patients with coronary heart disease (history of myocardial infarction and/or angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (Buerger’s disease, Prinzmetal’s variant angina) should be carefully screened and evaluated before nicotine replacement is prescribed.

Tachycardia occurring in association with the use of Nicoderm therapy has been reported occasionally. If serious cardiovascular symptoms occur with the use of Nicoderm therapy, it should be discontinued.

Precautions: General: The patient should be urged to stop smoking completely when initiating Nicoderm therapy (see Dosage). Patients should be informed that if they continue to smoke while using Nicoderm systems, they may experience adverse effects due to peak nicotine levels higher than those experienced from smoking alone. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the Nicoderm dose should be reduced or Nicoderm treatment discontinued (see Warnings). The use of Nicoderm systems beyond 3 months by patients who stop smoking should be discouraged. If the patient continues to smoke, treatment should be discontinued after 4 weeks.

Pregnancy: Women of childbearing age should be advised to take adequate precautions to avoid becoming pregnant while using Nicoderm. Nicoderm therapy should be discontinued if pregnancy is suspected (see Contraindications).

Drug Interactions: Physicians should anticipate that the pharmacokinetics of certain concomitant medications may be altered by smoking cessation with or without nicotine replacement. Therefore the dosage of certain concomitant medications may require adjustment.

Nicoderm Dose Adjustment of Concomitant Medications.

May require a decrease in dose at cessation of smoking.

Possible Mechanism Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, theophylline Deinduction of hepatic enzymes on smoking cessation .

Insulin Increase in s.c. insulin absorption with smoking cessation.

Adrenergic antagonists (e.g. prazosin, labetalol) Decrease in circulating catecholamines with smoking cessation May require an increase in dose at cessation of smoking Possible Mechanism Adrenergic agonists (e.g. isoproterenol, phenylephrine) Decrease in circulating catecholamines with smoking cessation.

Allergic Reactions: Patients should be instructed to promptly discontinue the use of Nicoderm systems and contact their physicians if they experience severe or persistent local skin reactions (e.g., severe erythema, pruritus, or edema) at the site of application or a generalized skin reaction (e.g., urticaria, hives, or generalized rash). Patients using Nicoderm therapy concurrently with other transdermal systems may exhibit local reactions at both application sites. In such patients use of one or both systems may have to be discontinued.

Skin Disease: Nicoderm systems are usually well tolerated by patients with normal skin, but may be irritating for patients with some skin disorders (atopic or eczematous dermatitis).

Renal or Hepatic Insufficiency: The pharmacokinetics of nicotine have not been studied in the elderly or in patients with renal or hepatic impairment; however, given that nicotine is extensively metabolized and that its total system clearance is dependent on liver blood flow, some influence of hepatic impairment on drug kinetics (reduced clearance) should be anticipated. Only severe renal impairment would be expected to affect the clearance of nicotine or its metabolites from the circulation.

Endocrine Diseases: Nicoderm therapy should be used with caution in patients with hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes since nicotine causes the release of catecholamines by the adrenal medulla.

Peptic Ulcer Disease: Nicotine delays healing in peptic ulcer disease; therefore, Nicoderm therapy should be used with caution in patients with active peptic ulcers and only when the benefits of including nicotine replacement in a smoking-cessation program outweigh the risks.

Accelerated Hypertension: Nicotine therapy constitutes a risk factor for development of malignant hypertension in patients with accelerated hypertension; therefore, Nicoderm therapy should be used with caution in these patients and only when the benefits of including nicotine replacement in a smoking-cessation program outweigh the risks.

Children and Geriatrics: Nicoderm therapy is not recommended for use in children under 18 years of age, because its safety and effectiveness in children and adolescents who smoke has not been evaluated. In clinical trials Nicoderm therapy appeared to be as effective in the over 60 age group as in younger adult smokers. However, asthenia, various body aches and dizziness occurred slightly more often in patients over 60 years of age.

Drug Dependency: Nicoderm therapy is likely to have a low abuse potential based on differences between it and cigarettes in 4 characteristics commonly considered important in contributing to abuse: much slower absorption, much smaller fluctuations in blood levels, lower blood levels of nicotine, and less frequent use (i.e., once daily).

Dependence on nicotine polacrilex chewing gum replacement therapy has been reported. Such dependence might also occur from transference to Nicoderm systems of tobacco-based nicotine dependence. The use of the system beyond 3 months has not been evaluated and should be discouraged. To minimize the risk of dependence, patients should be encouraged to withdraw gradually from Nicoderm treatment after 4 to 8 weeks of use. Recommended dose reduction is to progressively decrease the dose every 2 to 4 weeks (see Dosage).

Strenuous Exercise: Preliminary evidence suggests that wearing a nicotine transdermal patch during periods of strenuous exercise may lead to nicotine toxicity as a result of increased absorption of nicotine from the depot of nicotine in the skin under the patch, due to increased skin temperature and increased cutaneous vasodilation and perfusion from exercising. Three cases illustrating this phenomenon were described in Health Canada Adverse Reaction Newsletter, Volume 6, Number 1, January, 1996. Advise to remove the nicotine patch before engaging in strenuous exercise was recommended by W. Dafoe and P. Huston. Until definitive studies have been undertaken to clarify this hazard, it is advisable to remove the nicotine patch prior to engaging in prolonged strenuous activity.

Adverse Reactions: Assessment of adverse events in patients who participated in controlled clinical trials is complicated by the occurrence of gastrointestinal and CNS effects of nicotine withdrawal as well as nicotine excess. The actual incidence of both are confounded by concurrent smoking by many of the patients. When reporting adverse events in the clinical trials, the clinical investigators did not attempt to identify the cause of the symptom.

The most common adverse event associated with Nicoderm is a short-lived erythema, pruritus and/or burning at the application site, which was seen at least once in 47% of patients on the Nicoderm system in the clinical trials. Local erythema after system removal was noted at least once in 14% of patients and local edema in 3%. Erythema generally resolved within 24 hours. Cutaneous hypersensitivity (contact sensitization) occurred in 2% of patients on Nicoderm systems (see Precautions).

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Treatment of overdosage generally involves symptomatic and supportive care; there is no specific antidote for nicotine intoxication. Signs and symptoms of an overdose from a Nicoderm system are generally the same as those of acute nicotine poisoning, including pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness. Prostration, hypotension and respiratory failure may ensue with large overdoses. Lethal doses of nicotine produce convulsions quickly and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure. The oral minimum single acute lethal dose for nicotine in human adults is reported to be 40 to 60 mg.

The Nicoderm system should be removed immediately if the patient shows signs of overdosage, and the patient should seek immediate medical care, by contacting a physician or local poison control centre. The skin surface should be flushed with water and dried. Soap must not be used since it may increase nicotine absorption. Nicotine will continue to be delivered into the bloodstream for several hours after removal of the system because of a depot of nicotine in the skin.

Persons ingesting Nicoderm systems should be referred to a health care facility for management. Due to the possibility of nicotine-induced seizures, activated charcoal should be administered. In unconscious patients with a secure airway, instill activated charcoal via a nasogastric tube. Repeated doses of activated charcoal should be administered as long as the system remains in the gastrointestinal tract since it will continue to release nicotine for many hours. A saline cathartic or sorbitol added to the first dose of activated charcoal may speed gastrointestinal passage of the system.

Other supportive measures include diazepam or barbiturates for seizures, atropine for excessive bronchial secretions or diarrhea, respiratory support for respiratory failure, and vigorous fluid support for hypotension and cardiovascular collapse.

Dosage And Administration: Patients must desire to stop smoking and should be instructed to stop smoking immediately as they begin using Nicoderm therapy. The patient should read the patient instruction sheet on Nicoderm therapy and be encouraged to ask questions.

Therapy should begin with the Nicoderm 21 mg/day system and continue for 6 weeks. The patient should stop smoking cigarettes completely during this period. If the patient is unable to stop smoking within 4 weeks, Nicoderm therapy should be stopped, since few additional patients in clinical trials were able to quit after this time. Patients who have successfully abstained from smoking should have their dose of Nicoderm reduced after 6 weeks of treatment. Treatment with Nicoderm 14 mg/day should then be initiated for 2 weeks followed by 2 weeks on Nicoderm 7 mg/day. For patients who have cardiovascular disease, who weigh less than 45 kg or who smoke less than 1/2 pack of cigarettes a day, treatment should be started with Nicoderm 14 mg/day for 6 weeks. The dose should then be decreased to Nicoderm 7 mg/day for the final 2 to 4 weeks of treatment.

In all patients the need for dosage adjustment should be assessed during the first 2 weeks of therapy. The entire course of nicotine replacement and gradual withdrawal should take 8 to 12 weeks, depending on the size of the initial dose.

As the use of Nicoderm beyond 3 months has not been studied, this duration of treatment should not be exceeded.

The Nicoderm system should be applied promptly upon its removal from the protective pouch to prevent evaporative loss of nicotine from the system. Nicoderm systems should be used only when the pouch is intact to assure that the product has not been tampered with.

Nicoderm systems should be applied only once a day to a non-hairy, clean, dry skin site on the upper body or outer upper arm. After 24 hours, the used Nicoderm system should be removed and a new system applied to an alternate skin site. Skin sites should not be reused for at least a week. Patients should be cautioned not to continue to use the same system for more than 24 hours.

Safety and Handling: The Nicoderm system can be a dermal irritant and can cause contact sensitization. Patients should be instructed in the proper use of Nicoderm systems by using demonstration systems. Although exposure of health care workers to nicotine from Nicoderm systems should be minimal, care should be taken to avoid unnecessary contact with active systems. When handling active systems, wash with water alone, since soap may increase nicotine absorption. Do not touch the eyes.

Disposal: When the used system is removed from the skin, it should be folded over and placed in the protective pouch that contained the new system. The used system should be immediately disposed of in such a way as to prevent its access by children or pets. See Information for the Patient for further directions on handling and disposal.

Availability And Storage: Each Nicoderm (nicotine transdermal system) contains nicotine base in an ethylene-vinyl acetate copolymer matrix. Proceeding from the visible surface toward the surface attached to the skin are (1) an occlusive backing (polyethylene/aluminum/polyester/ethylene-vinyl acetate copolymer); (2) a drug reservoir containing nicotine (in an ethylene-vinyl acetate copolymer matrix); (3) a rate-controlling membrane (polyethylene); (4) a polyisobutylene adhesive; and (5) a protective liner that covers the adhesive layer and which must be removed before application to the skin.

Nicoderm 21 mg/day: Each rectangular 22 cmsystem contains: nicotine 114 mg and provides 24 hour rate-controlled delivery of 21 mg/day to the patient. Boxes of 7 and 14 with user’s guide.

Nicoderm 14 mg/day: Each rectangular 15 cmsystem contains: nicotine 78 mg and provides 24 hour rate-controlled delivery of 14 mg/day to the patient. Boxes of 7 with user’s guide.

Nicoderm 7 mg/day: Each rectangular 7 cmsystem contains: nicotine 36 mg and provides 24 hour rate-controlled delivery of 7 mg/day to the patient. Boxes of 7 with user’s guide.

Store at room temperature, between 15 and 30°C. Apply immediately upon removal from pouch, and do not store after the pouch has been opened.

NICODERM® Hoechst Marion Roussel Nicotine Smoking Cessation Aid

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