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Nicotine dependence Clinical criteria: Treatment Phase: Completion of a short-term (24 weeks) course of treatment The treatment must be as an aid to achieving abstinence from smoking, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must have previously received PBS-subsidised treatment with this drug during this current course of treatment, AND Patient must have ceased smoking in the process of completing an initial 12-weeks or ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment. Treatment criteria: Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Varenicline is a partial agonist at α4β2 neuronal nicotinic acetylcholine receptors where it binds with high affinity and selectivity to produce an effect sufficient to alleviate symptoms of craving and withdrawal (agonist activity), while simultaneously resulting in blockade of the rewarding and reinforcing effects of smoking by preventing nicotine binding to α4β2 receptors (antagonist activity).”
“The elimination half-life of varenicline tartrate is approximately 24 hours (individual range 10-58 hr).”
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“In vitro studies demonstrate that varenicline tartrate does not inhibit cytochrome P450 enzymes (IC50 >6,400 ng/mL). The P450 enzymes tested for inhibition were: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5. Also, in human hepatocytes in vitro, varenicline was shown not to induce the activity of cytochrome P450 enzymes 1A2 and 3A4.”