Generic name: METFORMIN HYDROCHLORIDE 500mg
Dosage form: tablet, film coated, extended release
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The starting dose of GLUMETZA in patients who are not currently taking metformin is 500 mg orally, once daily with the evening meal. Increase the dose in 500 mg increments every 1-2 weeks if a higher dose of GLUMETZA is needed and there are no gastrointestinal adverse reactions. The dosage of GLUMETZA must be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000 mg.
Recommendations for Use in Renal Impairment
Assess renal function prior to initiation of GLUMETZA and periodically thereafter.
GLUMETZA is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.
Initiation of GLUMETZA in patients with an eGFR between 30 – 45 mL/minute/1.73 m2 is not recommended.
In patients taking GLUMETZA whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.
Switching from Immediate-Release Metformin to Glumetza
If switching from immediate-release metformin to GLUMETZA, initiate GLUMETZA once daily at the same total dose, up to 2000 mg once daily.
Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue GLUMETZA at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart GLUMETZA if renal function is stable [See Warnings and Precautions (5.1)].
Important Administration Instructions
Administer GLUMETZA orally, once daily with the evening meal. GLUMETZA tablets must be swallowed whole and never split, crushed or chewed. If a dose of GLUMETZA is missed, instruct patients not to take two doses the same day and to resume their usual dose of GLUMETZA with the next schedule dose [See Patient Counseling Information (17)].