(Amfebutamone hydrochloride)

Indications & Dose:

To aid smoking cessation in combination with motivational support in nicotine-dependent patients

• BY MOUTH

Adult: Initially 150 mg daily for 6 days, then 150 mg twice daily (max. per dose 150 mg),minimum 8 hours between doses; period of treatment 7–9 weeks, start treatment 1–2 weeks before target stop date, discontinue if abstinence not achieved at 7 weeks, consider maximum 150mg daily in patients with risk factors for seizures; maximum 300 mg per day

Elderly: 150 mg daily for 7–9 weeks, start treatment 1–2 weeks before target stop date, discontinue if 

Contraindications:

Hypersensitivity to bupropion or any of the other components of the preparation, patients with a seizure disorder., patients undergoing abrupt discontinuation of alcohol or sedatives, patients currently being treated with any other preparation containing bupropion as the incidence of seizures is dose dependent, patients with a current or previous diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was seen in this patient population when an immediate release form of bupropion was administered. 

Side Effects:

Cautions:

Precautions:

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Body (general): Fever, chest pain, asthenia.

Cardiovascular: Tachycardia, palpitations, vasodilation, postural hypotension, increased blood pressure (in some cases severe), flushing, syncope.

CNS: Seizures  , insomnia, tremor, dystonia, ataxia, Parkinsonism, twitching, incoordination, concentration disturbance, headache, dizziness, depression, confusion, delusions, paranoid ideation hallucinations, agitation, restlessness, anxiety, irritability, hostility, aggression depersonalisation, abnormal dreams, memory impairment, paraesthesia.

Endocrine and metabolic: Anorexia, weight loss, blood glucose disturbances.

Gastrointestinal: Dry mouth, gastrointestinal disturbance including nausea and vomiting, abdominal pain, constipation. Genitourinary: Urinary frequency and/or retention.

Hepatobiliary: Elevated liver enzymes, jaundice, hepatitis.

Skin / Hypersensitivity: Rash, prunitus, sweating. Hypersensitivity reactions ranging in severity from urticaria to angioedema, dyspnoea/bronchospasm and rarely anaphylactic shock. Arthralgia, myalgia and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness.

Erythema multiforme and Stevens Johnson syndrome have also been rarely reported.

Patient And Carer Advice: