Nicotrol (Nicotine)

NICOTROL®

Johnson & Johnson• Merck

Nicotine

Stop Smoking Aid

Action And Clinical Pharmacology: Nicotrol is a multilayered, laminated, flexible thin film containing nicotine as the active ingredient. Nicotrol has been specifically designed to provide a 16-hour rate controlled delivery of nicotine following its application to intact skin. It is intended to be applied during the day and removed at night prior to sleeping, thus minimizing the potential for any sleep disturbances. The Nicotrol system provides nicotine without the other ingredients in tobacco smoke (e.g. tar, carbon monoxide, hydrogen cyanide) thereby attenuating abstinence symptoms associated with nicotine withdrawal during the cessation of smoking. Nicotrol increases the success rate of cessation in smokers who are motivated to quit.

Indications And Clinical Uses: Nicotrol, applied while patients are awake, is indicated as a temporary aid to facilitate smoking cessation in smokers with a strong desire to quit and to provide partial substitution for the nicotine in cigarettes in order to lessen withdrawal symptoms of smoking cessation. Nicotrol 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 Nicotrol and should be advised of the possibility of acute hypersensitivity reactions to other forms of nicotine, including cigarettes.

Patients with generalized skin disorders.

Nonsmokers or occasional smokers.

Persons under 18 years of age (see Warnings).

Pregnant women or nursing mothers (see Warnings).

Patients during the immediate postmyocardial infarction period, patients with life-threatening arrhythmias, patients with severe or worsening angina pectoris and patients who have had a recent cerebral vascular accident (see Warnings).

Manufacturers’ Warnings In Clinical States: General: Nicotine from any source can be toxic and addictive. For any smoker, with or without concomitant disease, the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking.

Safety Note Concerning Children and Pets: The amounts of nicotine that are tolerated by adult smokers can cause severe poisoning and even prove fatal if the Nicotrol system is applied or ingested by children or pets. Used Nicotrol systems contain approximately 40% of their initial nicotine content. Therefore, patients should be cautioned to keep both the used and unused Nicotrol systems out of the reach of children and pets.

Children: Nicotrol is not to be used by persons under 18 years of age. The use of Nicotrol in children and adolescents who smoke has not been evaluated (see Contraindications).

Pregnancy and Lactation: Tobacco smoke (containing nicotine, hydrogen cyanide and carbon monoxide) has been shown to be harmful to the fetus. Nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that nicotine from Nicotrol systems can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to take adequate precautions to avoid becoming pregnant while using Nicotrol (see Contraindications).

Pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

The safety of Nicotrol therapy in nursing infants has not been examined. Nicotine passes freely into breast milk; the milk to plasma ratio averages 2.9. Nicotine is absorbed orally (see Contraindications).

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 recommended.

Palpitations occurring in association with the use of Nicotrol therapy have been reported occasionally. If serious cardiovascular symptoms occur with the use of Nicotrol therapy, it should be discontinued.

Accelerated Hypertension: Nicotrol 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.

Peptic Ulcer Disease: Nicotine delays healing in peptic ulcer disease; therefore, Nicotrol 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 are considered to outweigh the risks.

Precautions: General: The patient should stop smoking completely when initiating Nicotrol therapy (see Dosage). Patients should be informed that they should not continue to smoke while using Nicotrol systems, because 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 Nicotrol dose should be reduced or Nicotrol treatment discontinued (see Warnings). The use of Nicotrol systems beyond 10 weeks by patients who stop smoking should be discouraged because the chronic consumption of nicotine by any route can be harmful and addicting. If the patient continues to smoke, treatment should be discontinued.

Allergic Reactions: Patients should be instructed to discontinue promptly the use of Nicotrol systems and contact their physician if they experience severe or persistent local skin reactions (e.g., urticaria, hives, or generalized rash). Patients using Nicotrol 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. Serious allergic reactions may occur rarely. About 1% of patients dropped out of clinical trials due to skin reactions; none had classical contact sensitization.

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

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. Advice to remove the nicotine patch before engaging in strenuous exercise was recommended by; W. Dafoe and P. Huston, Current Trends in Cardiac Rehabilitation, Canadian Medical Association Journal, February 15, 1997; 156(4) 527-532. Until definitive studies have been undertaken to clarify this hazard, it is advisable to remove the nicotine patch prior to engaging in strenuous activity.

Geriatrics: Seventy-nine patients over the age of 60 participated in clinical trials of Nicotrol therapy. Nicotrol therapy appeared to be as effective in this age group as in younger smokers. The initial dose in elderly patients may have to be adjusted because their concomitant diseases may increase risk.

Endocrine Diseases: Nicotrol 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.

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.

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.

Drug Dependency: Nicotrol 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). Dependency on Nicotrol has not been reported.

To minimize the risk of dependence, therapy should not exceed 10 weeks (see Dosage).

Information for Patients: A separate Patient Instruction Leaflet is included in the package of Nicotrol systems (see Blue Section – Information for the Patient). It contains important information on how to use and dispose of Nicotrol systems, properly. Patients should be encouraged to ask questions to ensure they understand the instructions. Patients must be advised to keep both used and unused Nicotrol systems out of the reach of children and pets.

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 Nicotrol is a mild, short-lived erythema and/or pruritus at the application site, which was seen at least once in 47% of patients on the Nicotrol system (versus 45% of patients on placebo) in the clinical efficacy trials. These signs were not considered clinically relevant and usually disappeared within 1 hour. After removal of the system, local erythema was noted at least once in 7% of patients and local edema in 3% of patients. Erythema generally resolved within 24 hours. About 1% of patients dropped out of the clinical trials due to skin reactions. None of these were classified as contact sensitization reactions. In the prescription to OTC switch trials approximately 32% of reported events were skin reactions.

Table II summarizes the adverse events with an incidence of greater than 1% in 2 placebo-controlled clinical trials and 2 prescription to nonprescription switch trials.

Symptoms And Treatment Of Overdose: Symptoms: There have been 2 reported cases of applying several nicotine patches simultaneously. Both people were attempting suicide and combined several nicotine patches, 21 mg, with other drugs. No serious effects resulted from either attempt.

Signs and symptoms of an overdose from a Nicotrol system are expected to be 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 acute, minimal, oral lethal dose of nicotine in human adults is reported to be 40 to 60 mg.

Treatment: The Nicotrol 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 Nicotrol 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 Nicotrol therapy.

If the patient is unable to avoid cigarette smoking within 2 weeks of starting treatment, Nicotrol therapy should be stopped, since few additional patients in clinical trials were able to quit after this time. The duration of treatment should not exceed 10 weeks.

The patient should be told to read the patient instruction leaflet on Nicotrol therapy and should be encouraged to ask questions.

Dosage And Administration: One patch daily for 6 weeks.

Smoking cessation should be accompanied by a behavioral support program.

Administration: The Nicotrol system should be applied promptly upon its removal from the protective pouch to prevent loss of nicotine from the system. A Nicotrol system should be applied only once a day to a nonhairy, clean, and dry skin site on the upper arm or the hip. A different site of application should be chosen each day. Each day a new Nicotrol system should be applied upon waking and removed at bedtime. It should not be worn for more than 16 hours/day.

Safety and Handling: Nicotrol systems can be a dermal irritant and can cause contact sensitization. Care should be taken to avoid unnecessary contact with active systems. If you do handle active systems, wash with water alone since soap may increase nicotine absorption. Do not touch your eyes.

Disposal: When the used system is removed from the skin, it should be folded over and placed in its pouch. The used system should be disposed of immediately 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: The Nicotrol system is a multilayered, rectangular-shaped, laminated thin film containing nicotine as the active ingredient. Proceeding from the visible surface toward the surface attached to the skin, there are 3 distinct layers: 1. An outer backing layer composed of a laminated polyester film. 2. A middle layer containing an adhesive, a structural nonwoven material and nicotine. The adhesive controls the rate of delivery of nicotine to the skin. 3. A disposable liner that protects the systems; the liner is removed prior to use.

Nicotrol systems are labeled with the average amount of nicotine absorbed by the patient over 16 hours. Nicotrol systems are available in 3 strengths as follows:

Nicotrol 15 mg/16 hours System: Each 30 cmsystem contains: nicotine 24.9 mg and provides a rate-controlled delivery of 15 mg/16 hours. The Backing Layer of each patch is imprinted with the phrase “Nicotrol 15 mg”. Boxes of 7 and 14.

Nicotrol 10 mg/16 hours System: Each 20 cmsystem contains: nicotine 16.6 mg and provides a rate-controlled delivery of 10 mg/16 hours. The Backing Layer of each patch is imprinted with the phrase “Nicotrol 10 mg”. Boxes of 7 and 14.

Nicotrol 5 mg/16 hours System: Each 10 cmsystem contains: nicotine 8.3 mg and provides a rate-controlled delivery of 5 mg/16 hours. The Backing Layer of each patch is imprinted with the phrase “Nicotrol 5 mg”. Boxes of 7 and 14.

Store at room temperature below 30°C. Once removed from the protective pouch, Nicotrol systems should be applied promptly since nicotine is volatile and the system may lose strength.

NICOTROL® Johnson & Johnson Merck Nicotine Stop Smoking Aid

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