GLUMETZA Film coated tablet, extended release Ref.[10822] Active ingredients: Metformin

2.1 Adult Dosage and Administration

• The recommended starting dose of GLUMETZA is 500 mg orally once daily with the evening meal.
• Increase the dose in increments of 500 mg every 1 to 2 weeks on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg once daily with the evening meal.
• Patients receiving metformin hydrochloride (HCl) may be switched to GLUMETZA once daily at the same total daily dose, up to 2,000 mg once daily.
• Swallow GLUMETZA whole and never crush, cut or chew.
• 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.

2.2 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 to 45 mL/minute/1.73 m² is not recommended.
• In patients taking GLUMETZA whose eGFR later falls below 45 mL/minute/1.73 m², assess the benefit risk of continuing therapy.
• Discontinue GLUMETZA if the patient’s eGFR later falls below 30 mL/minute/1.73 m² [see Contraindications (4) and Warnings and Precautions (5.1)].

2.3 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/minute/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)].

Overdose of metformin HCl has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1)]. Metformin is dialyzable with a clearance of up to 170 mL/minute under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].