Apo-Varenicline

Apo-Varenicline

varenicline

Manufacturer:

Apotex

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Varenicline tartrate
Indications/Uses
Dosage/Direction for Use
Wk 1: One 0.5-mg tab once a day on days 1-3, then one 0.5-mg tab bd (once in the morning & once in the evening) on days 4-7. Wk 2 (days 8-14) & wk 3-12 (day 15 until end of treatment): One 1-mg tab bd (once in the morning & once in the evening). If smoking is stopped after 12 wk of treatment, an additional 12 wk of treatment w/ 1-mg tab bd may be recommended to help avoid returning back to smoking.
Administration
May be taken with or without food: Swallow whole w/ water.
Special Precautions
Stop treatment in case of signs & symptoms of serious allergic reaction. Reports of neuropsychiatric symptoms; new or worse CV problems; seizures; potentially life-threatening skin rashes (SJS & erythema multiforme). Risk of returning to smoking may be elevated in the period immediately following the end of treatment. Gradually lower dose at the end of treatment. May impair ability to drive or operate machinery. Caution in patients w/ history of psychiatric disorder; pre-existing CV problems; history of seizures or other conditions that potentially lower seizure threshold; kidney problems. Avoid use during pregnancy. May pass into breast milk. Not recommended in paed patients.
Adverse Reactions
Inflammation of nose & throat, abnormal dreams, difficulty sleeping, headache; nausea. Chest infection, inflammation of sinuses; increased wt, decreased/increased appetite; sleepiness, dizziness, changes in taste; shortness of breath, cough; heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth; skin rash, itching; joint ache, muscle ache, back pain; chest pain, tiredness.
Drug Interactions
Potential interaction w/ theophylline, warfarin, & insulin; other therapies for smoking cessation. Increased blood levels w/ cimetidine in patients w/ severe kidney disease. Increased intoxicating effects of alcohol.
MIMS Class
Drugs Used in Substance Dependence
ATC Classification
N07BA03 - varenicline ; Belongs to the class of drugs used in the management of nicotine dependence.
Presentation/Packing
Form
Apo-Varenicline FC tab 0.5 mg
Packing/Price
56's
Form
Apo-Varenicline FC tab 1 mg
Packing/Price
56's
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