GLUCOPHAGE Tablet / Extended-release tablet Ref.[10564] Active ingredients: Metformin

2.1 Adult Dosage

GLUCOPHAGE:

• The recommended starting dose of GLUCOPHAGE is 500 mg orally twice a day or 850 mg once a day, given with meals.
• Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2550 mg per day, given in divided doses.
• Doses above 2000 mg may be better tolerated given 3 times a day with meals.

GLUCOPHAGE XR:

• Swallow GLUCOPHAGE XR tablets whole and never crush, cut or chew.
• The recommended starting dose of GLUCOPHAGE XR is 500 mg orally once daily with the evening meal.
• Increase the dose in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg once daily with the evening meal.
• If glycemic control is not achieved with GLUCOPHAGE XR 2000 mg once daily, consider a trial of GLUCOPHAGE XR 1000 mg twice daily. If higher doses are required, switch to GLUCOPHAGE at total daily doses up to 2550 mg administered in divided daily doses, as described above.
• Patients receiving GLUCOPHAGE may be switched to GLUCOPHAGE XR once daily at the same total daily dose, up to 2000 mg once daily.

2.2 Pediatric Dosage for GLUCOPHAGE

• The recommended starting dose of GLUCOPHAGE for pediatric patients 10 years of age and older is 500 mg orally twice a day, given with meals.
• Increase dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg per day, given in divided doses twice daily.

2.3 Recommendations for Use in Renal Impairment

Assess renal function prior to initiation of GLUCOPHAGE/GLUCOPHAGE XR and periodically thereafter.

GLUCOPHAGE/GLUCOPHAGE XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m².

Initiation of GLUCOPHAGE/GLUCOPHAGE XR in patients with an eGFR between 30–45 mL/minute/1.73 m² is not recommended.

In patients taking GLUCOPHAGE/GLUCOPHAGE XR whose eGFR later falls below 45 mL/min/1.73 m², assess the benefit risk of continuing therapy.

Discontinue GLUCOPHAGE/GLUCOPHAGE XR if the patient’s eGFR later falls below 30 mL/minute/1.73 m² [see Warnings and Precautions (5.1)].

2.4 Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue GLUCOPHAGE/GLUCOPHAGE XR 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 GLUCOPHAGE/GLUCOPHAGE XR if renal function is stable.

Overdose of metformin hydrochloride 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/min 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°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature].

Dispense in light-resistant containers.