Osmoticdosage

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

Starting dose: 500 mg orally once daily with the evening meal Increase the dose in increments of 500 mg weekly, 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.

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 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 Swallow Metformin hydrochloride extended-release tablets whole and never crush, cut or chew. The recommended starting dose of Metformin hydrochloride extended-release tablet 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 2,000 mg once daily with the evening meal. If glycemic control is not achieved with Metformin hydrochloride extended-release tablets 2,000 mg once daily, consider a trial of Metformin hydrochloride extended-release tablets 1,000 mg twice daily. 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.

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/min/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/min/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.