Medication safety

Varenicline

Generic name: VARENICLINE

Manufacturer: Aurobindo Pharma Limited

Active recall

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Class IIIInitiated: Nov 11, 2025

When to use

1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )

Dosage and administration

2 DOSAGE AND ADMINISTRATION Begin varenicline tablets dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. ( 2.1 ) Starting Week: 0.5 mg once daily on days 1 to 3 and 0.5 mg twice daily on days 4 to 7. ( 2.1 ) Continuing Weeks: 1 mg twice daily for a total of 12…

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Drug information is sourced from openFDA and is for educational purposes. It does not replace medical advice from a licensed professional. Always consult your healthcare provider before taking any medication.