TM Owner Teva Pharmaceuticals
TEVA-Varenicline 1mg Tablet
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Indications & Clinical Uses
- TEVA-Varenicline 1 mg tablets contain varenicline tartrate, a nicotinic receptor partial agonist, and are approved in Canada (Health Canada) as a generic version of the originator brand Champix (sold as Chantix in the United States) to help adults stop smoking.
- Treatment starts with a lower 0.5 mg dose titrated upward over the first week, then continues at 1 mg twice daily for 12 weeks, with a further 12-week course sometimes recommended for people who have successfully quit, to reduce the chance of relapse.
- It is taken by the patient at home, by mouth, after eating, with a full glass of water, and is not intended for people who do not currently smoke or for children.
Side Effects
- TEVA-Varenicline has no current boxed warning; the FDA removed the earlier boxed warning on neuropsychiatric symptoms from varenicline labelling in December 2016 after further safety trial data, but the warning itself remains in the regular precautions.
- The most common effect is nausea, affecting up to around 3 in 10 people, along with abnormal or vivid dreams, headache, insomnia, constipation, flatulence and vomiting.
- Seek urgent help for new or worsening mood changes, agitation, depressed mood or thoughts of self-harm, for a first seizure, for chest pain or irregular heartbeat, or for a severe skin reaction with blistering or swelling of the face.
Precautions & Warnings
- Tell your prescriber before starting if you have ever had depression, another mental illness, or seizures, since varenicline has been linked to mood and behaviour changes and can occasionally trigger seizures.
- Limit alcohol, as it may increase these effects and reduce your tolerance to it.
- Use caution when driving or operating machinery until you know how the tablets affect you, since dizziness and sleep disturbance can occur.
- People with significant kidney impairment may need a lower dose.
- Varenicline has not been fully studied in pregnancy or breastfeeding, or in people under 18, so it is not generally recommended in these groups.
Avoid Interactions
- No major drug interactions affecting varenicline's own blood levels have been identified, since it is cleared largely unchanged by the kidneys rather than by liver enzymes.
- However, stopping smoking itself, with or without TEVA-Varenicline, can change how the body handles certain other medicines, including theophylline, warfarin and insulin, so doses of these may need adjusting as you cut down.
- Combining varenicline with nicotine replacement therapy has not shown clear extra benefit and may increase nausea and other side effects.
- Avoid or limit alcohol.
- Tell your healthcare provider about all medicines and supplements you take before starting treatment.
References
Frequently Asked Questions
TEVA-Varenicline (varenicline) is a generic stop-smoking tablet, equivalent to Champix/Chantix. It reduces cravings and withdrawal symptoms and blunts the pleasure from smoking by acting on nicotine receptors in the brain, helping adults quit over a 12-week course, sometimes extended for another 12 weeks.
Start at 0.5 mg once daily for 3 days, then 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily for the rest of the 12-week course. Take each dose after food with a full glass of water, roughly 12 hours apart.
Nausea is the most common effect, along with vivid dreams, headache and constipation. Watch for mood changes, agitation or low mood, a first seizure, irregular heartbeat, or a severe skin reaction, and contact your prescriber urgently if these occur; there is no current boxed warning.
Limit alcohol, since it can worsen mood-related side effects and lower your tolerance. Avoid driving until you know how the tablets affect you. Combining with nicotine replacement isn't well studied and may add to nausea. Tell your prescriber about every other medicine you take.
Take it as soon as you remember that day; if it's almost time for your next dose, skip the missed one and continue your normal schedule. Don't take a double dose. Missing occasional doses can make quitting harder, so try to take TEVA-Varenicline at the same times each day.
The key warning is for mood and behaviour changes: contact your prescriber or seek urgent help for new agitation, depressed mood, unusual behaviour, or thoughts of self-harm. This neuropsychiatric warning was downgraded from a boxed warning in 2016 but remains an important precaution to watch for.
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