TM Owner Pharmascience
PMS-Varenicline 1mg Tablet
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Indications & Clinical Uses
- pms-Varenicline is a Canadian brand of varenicline tartrate tablets made by Pharmascience Inc. (Montreal), supplied as 0.5 mg and 1 mg tablets; the sheet lists the 1 mg tablet.
- The Canadian monograph (revised 4 April 2019) authorises it for smoking-cessation treatment in adults, together with smoking-cessation counselling.
- Use in patients under 18 years has not been authorised.
- Treatment starts with 0.5 mg once daily for three days, then 0.5 mg twice daily for four days, then continues at 0.5 mg or 1 mg twice daily, and patients typically receive 12 weeks of treatment.
- In severe kidney impairment the dose is reduced to 0.5 mg twice daily.
- The starting 0.5 mg tablet and the 1 mg tablet are not interchangeable in the first week.
- It is taken by mouth at home.
- The current Health Canada marketing status of this brand should be confirmed.
Side Effects
- The most common side effects are nausea (about 30% at 1 mg twice daily, usually mild or moderate and often temporary), insomnia (18%), abnormal dreams (13%) and constipation (8%); flatulence and vomiting also occur in the related Mint-Varenicline monograph.
- Serious neuropsychiatric symptoms, including anxiety, mood changes and suicidal thoughts, have been reported after marketing, although a large randomised study (EAGLES) found no increased risk compared with placebo.
- Cardiovascular events were seen in some trial phases and seizures have been reported.
- The monograph retrieved does not report a boxed (serious warnings) warning.
- Stop the medicine and contact your healthcare provider straight away for changes in mood, behaviour or thoughts of self-harm, chest pain or seizures.
Precautions & Warnings
- Tell your healthcare provider if you have a history of mental illness, seizures or heart disease, as varenicline was not studied in patients with unstable heart disease and should be used cautiously with a seizure history.
- It is not authorised under 18.
- Severe kidney impairment needs the lower dose of 0.5 mg twice daily.
- Pregnancy: the monograph lists it as contraindicated, because animal studies showed reduced fetal weights and altered offspring development.
- Breastfeeding: it is unknown whether varenicline passes into human milk, so weigh stopping nursing against stopping the medicine.
- Do not drive or operate dangerous machines until you know how varenicline affects you.
- Storage temperature and pack sizes were not stated in the excerpts retrieved, so follow the instructions on your pack.
Avoid Interactions
- Alcohol: post-marketing reports describe increased intoxicating effects of alcohol, sometimes with unusual behaviour and memory loss, so limit or avoid alcohol while taking pms-Varenicline.
- Nicotine replacement therapy: combining it with varenicline increased nausea, headache, vomiting, dizziness, dyspepsia and fatigue compared with nicotine replacement alone, and the safety and efficacy of the combination have not been studied, so do not combine them unless your healthcare provider directs it.
- The monograph sections retrieved do not list specific drugs that lower varenicline's effect.
- Tell your healthcare provider and pharmacist about all prescription medicines, non-prescription products and supplements you take.
References
Frequently Asked Questions
pms-Varenicline (varenicline tartrate) helps adults stop smoking, alongside smoking-cessation counselling. It is not authorised for people under 18. Treatment typically lasts 12 weeks, and it is made by Pharmascience for the Canadian market. Do not use it for other purposes.
Take pms-Varenicline (varenicline) by mouth: 0.5 mg once daily for three days, 0.5 mg twice daily for four days, then 0.5 mg or 1 mg twice daily. Treatment usually lasts 12 weeks. In severe kidney impairment the dose is 0.5 mg twice daily.
Common pms-Varenicline side effects are nausea (about 30% at 1 mg twice daily), insomnia (18%), abnormal dreams (13%) and constipation (8%). Serious mood changes, suicidal thoughts, chest pain or seizures need urgent medical attention. Stop the tablets and call your healthcare provider.
Limit or avoid alcohol with pms-Varenicline (varenicline), as it can increase intoxication and cause unusual behaviour or memory loss. Using nicotine replacement at the same time raises nausea, headache and dizziness, and the combination has not been studied. Do not drive until you know how it affects you.
Avoid driving or operating dangerous machinery until you know how pms-Varenicline (varenicline) affects you. The monograph advises against hazardous activities until you know your reaction. Report any seizures or mood changes to your healthcare provider straight away, and tell them about any other symptoms.
No. The Canadian monograph for pms-Varenicline (varenicline) lists pregnancy as contraindicated, because animal studies showed reduced fetal weights and altered offspring development. It is unknown whether it passes into breast milk. Tell your healthcare provider if you are pregnant or breastfeeding.
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