Modifieddosage

Starting dose: 500 mg orally once daily with the evening meal

Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 mg once daily with the evening meal.

Patients receiving metformin hydrochloride (HCl) tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily.

Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. Renal Impairment:

Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR).

Do not use in patients with eGFR below 30 mL/minute/1.73 m 2.

Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2.

Assess risk/benefit of continuing metformin hydrochloride extended-release tablets if eGFR falls below 45 mL/minute/1.73 m 2.

Discontinue if eGFR falls below 30 mL/minute/1.73 m 2. Discontinuation for Iodinated Contrast Imaging Procedures:

Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

2.1 Adult Dosage and

Administration

The recommended starting dose of metformin hydrochloride extended-release tablets 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 metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily.

Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew.

If a dose of metformin hydrochloride extended-release tablet is missed, instruct patients not to take two doses the same day and to resume their usual dose of metformin hydrochloride extended-release tablets with the next schedule dose.

2.2 Recommendations for

Use in Renal Impairment

Assess renal function prior to initiation of metformin hydrochloride extended-release tablets and periodically thereafter.

Metformin hydrochloride extended-release tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2.

Initiation of metformin hydrochloride extended-release tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended.

In patients taking metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/minute/1.73 m 2, assess the benefit risk of continuing therapy.

Discontinue metformin hydrochloride extended-release tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2.

2.3 Discontinuation for

Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride extended-release tablets 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 m 2; 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 metformin hydrochloride extended-release tablets if renal function is stable.