Nicorette

Nicorette

nicotine

Manufacturer:

McNeil AB

Distributor:

JNTL Consumer Health
Concise Prescribing Info
Contents
Nicotine
Indications/Uses
Tobacco dependence by relieving nicotine craving & w/drawal symptoms in connection w/ smoking cessation in smokers motivated to quit. May be used to abruptly stop smoking in smokers motivated to quit (smoking cessation); cut down smoking before completely stopping (reduction to stop) or assist during times when unwilling or unable to smoke (temporary abstinence).
Dosage/Direction for Use
Individualized dosage. Highly dependent smokers (≥20 cigarettes daily or 1st cigarette in the morning ≤30 min after waking up) Initially 4 mg. Other smokers Initially 2 mg. Highly dependent smokers, smokers who experience breakthrough cravings or those who failed w/ single nicotine replacement therapy (NRT) treatment Flexible smoking cessation format, in combination w/ patch for fast relief of cravings. Do not exceed 30 gums (2 mg) & 24 gums (4 mg) in 24-hr period. Smoking cessation Monotherapy: 8-12 gums/day. Max: 30 gums (2 mg) & 24 gums (4 mg) in 24-hr period for at least 3 mth. Smokers should stop smoking completely during the course of treatment w/ medicated chewing gum. Initiate gradual tapering from gum & stop treatment when dose is reduced to 1-2 gum/day. Combination therapy: Same dosing recommendation for both patch & flexible format as in monotherapy. Smokers should stop smoking completely during the course of treatment w/ medicated chewing gum. Start w/ tapering patch as in monotherapy or use flexible format as in monotherapy if further tapering is needed. Reduction to stop Use as needed, between smoking episodes to prolong smoke-free intervals & w/ the intention to reduce smoking as much as possible. After having quit smoking, treatment/tapering recommendations for smoking cessation as previously mentioned should be followed. Temporary abstinence Safer alternative: Up to 30 gums/day (2 mg) or 24 gums/day (4 mg) during smoke-free periods.
Administration
Should be taken on an empty stomach: Chew gum slowly for approx 30 min w/ pauses until strong taste or mild burning sensation is experienced, then rest it between the cheek & the gums. When the taste &/or sensation have disappeared, chew it again slowly & repeat.
Contraindications
Hypersensitivity. Do not administer to adolescents <18 yr.
Special Precautions
Dependent smokers w/ recent MI, unstable or worsening angina including Prinzmetal's angina, severe cardiac arrhythmias, recent CVA, &/or who suffered w/ uncontrolled HTN should be encouraged to stop smoking w/ non-pharmacological interventions (eg, counselling). Caution in patients w/ phaeochromocytoma & uncontrolled hyperthyroidism; oesophagitis, gastric or peptic ulcers & NRT prep; w/ history of epilepsy or seizures during introduction of NRT. Closely monitor blood sugar levels in patients w/ DM. Transferred dependence. Concomitant use w/ drugs metabolized by CYP1A2; potential clinical importance of products w/ narrow therapeutic window (eg, theophylline, tacrine, clozapine & ropinirole). Chewing gum may stick to, & in rare cases damage dentures. Caution in patients w/ moderate to severe hepatic impairment &/or severe renal impairment. Pregnant smoker should always be advised to stop smoking completely w/o use of NRT. Avoid nicotine during breast feeding. Nicotine doses can produce severe toxicity in childn that may be fatal.
Adverse Reactions
Dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating & restlessness or impatience. Decreased heart rate; increased appetite or wt gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or aphthous ulceration, or nasopharyngitis. Diarrhoea.
Drug Interactions
May possibly enhance haemodynamic effects of adenosine ie, increase in BP & heart rate & also increased pain response (angina-pectoris type chest pain) provoked by adenosine administration.
MIMS Class
Drugs Used in Substance Dependence
ATC Classification
N07BA01 - nicotine ; Belongs to the class of drugs used in the management of nicotine dependence.
Presentation/Packing
Form
Nicorette medicated chewing gum 2 mg
Packing/Price
15's
Form
Nicorette medicated chewing gum 4 mg
Packing/Price
15's