Pharmacotherapeutic Group: Drug used in nicotine dependence. ATC Code: N07BA01.
Pharmacology: Pharmacodynamics/Pharmacokinetics: The amount of nicotine absorbed from a piece of nicotine chewing gum depends on the quantity of nicotine that is released into the oral cavity and the amount that is lost via swallowing. The greater part of nicotine that is released is absorbed through the oral mucosa. The systemic bioavailability of swallowed nicotine is lower because of first-passage elimination. The high and rapidly rising nicotine concentrations that are seen with smoking are seldom reached with treatment with chewing gum.
Nicorette is used for the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms. Facilitating smoking cessation in smokers motivated to quit. As an aid to reduce smoking.
Should follow the physician's or pharmacists's instruction only because extent and duration of use depend on severity of nicotine addiction.
(See Table 1.)
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The Nicorette chewing gum should be used when cigarettes normally would have been smoked or if cravings emerge. Sufficient Nicorette chewing gum should be used each day. In order to maximize the chances of success it is important not to under dose. The dosage should be individualized on the basis of the smoker's nicotine dependence.
The full course for using Nicorette Gum lasts around 12 weeks, from quitting cigarettes to no longer requiring Nicorette Gum. During that time the patient should gradually reduce the intake of nicotine, until the patient can do without it. Patient is suggested to use of Nicorette Gum for 12 weeks, reducing the number of pieces used divided into 3 phases. (See Table 2.)
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Do not exceed 24 gums per day.
Treatment should be stopped when the dose is reduced to Nicorette 1 to 2 Nicorette chewing gum per day. Each piece of Nicorette chewing gum should be chewed slowly for approximately 30 mins, with pauses. The gum should be chewed until a strong taste or mild burning sensation is experienced, then rested between the cheek and gums until the taste and/or sensation have disappeared, then chew again slowly and repeat.
Children and Adolescents:
Nicorette chewing gum should not be administered to a person under 18 years of age with recommendation from healthcare professional.
Symptoms of overdosage with nicotine may occur if patient has low nicotine consumption before the treatment or uses other sources of nicotine at the same time.
The symptoms of overdosage are the same as the symptoms of acute nicotine poisoning such as nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, disturbed hearing and prostration. At high doses, these symptoms may be accompanied by low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse and general convulsions.
Nicotine doses that are tolerated by adult smokers during treatment may cause serious symptoms of poisoning in young children which may have fatal outcome. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Treatment: All administration of nicotine is stopped immediately and the patient should be treated for the symptoms.
Hypersensitivity to nicotine or any excipients in the chewing gum.
The chewing gum may adhere to and in rare cases damage, dentures and dental bridges.
Nicorette chewing gum should only be used after consulting a physician by certain cardiovascular patient groups: Those who have experienced a serious cardiovascular event, or hospitalization for a cardiovascular complaint, in the previous 4 weeks (e.g. stroke, myocardial infarction, unstable angina, cardiac arrhythmia, coronary artery by-pass graft and angioplasty) or where they suffer with uncontrolled hypertension.
Nicorette chewing gum should be used with caution in patients with severe/moderate hepatic impairment, severe renal impairment, active duodenal and gastric ulcer, inflammation of the stomach and inflammation of the esophagus.
Nicotine, both from nicotine medications and from smoking, causes release of catecholamines from the adrenal medulla. Therefore, Nicorette chewing gum should also be used with caution by patients with hyperthyroidism or phaeochromocytoma.
Patients with diabetes mellitus may need lower level doses of insulin as a result of smoking cessation.
Nicotine dependence may continue but at a lower level. However, use of pure nicotine is less harmful than tobacco.
Use in Pregnancy: Nicotine passes to the fetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Pregnant smoker should therefore always be recommended to give up smoking without using nicotine substitute at all. The risk of continued smoking may however constitute a greater hazard to the fetus than use of nicotine substitution preparations within the framework of a smoking cessation program. Nicorette chewing gum should not be used by pregnant patients other than where there is a high level of nicotine dependence and on physician's advice.
Use in Lactation: Nicotine passes into breastmilk in small quantities that may affect the infant, even at therapeutic doses. Nicorette chewing gum should therefore be avoided when breastfeeding.
Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent. Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette. The chewing gum may stick to, and in rare cases, damage dentures.
Side effects observed in post-marketing experience (frequency category estimated from clinical trial): Common (≥1/100 and <1/10): Diarrhoea.#
Uncommon (≥1/1,000 and <1/100): Palpitations**, tachycardia.**, increase sweating**, itching.**, rash.**
Rare ≥1/10,000 and <1/1,000: Reversible atrial fibrillation.
Smoking (but not nicotine) is associated with increased activity of CYP1A2. After giving up smoking, clearance of certain medications which are metabolized via CYP1A2 may be reduced. This may lead to increased plasma levels of certain medications. The increase may be of clinical significance for products with narrow therapeutic windows.
N07BA01 - nicotine ; Belongs to the class of drugs used in the management of nicotine dependence.
Chewing gum 2 mg (white coloured coated square, with a size of about 15 x 15 x 6 mm) x 105's. 4 mg (creme coloured coated square, with a size of about 15 x 15 x 6 mm) x 105's.