Adult Dosage and Administration

• Swallow FORTAMET whole and never crush, cut or chew.
• The recommended starting dose of FORTAMET 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 FORTAMET 2,000 mg once daily, consider a trial of FORTAMET 1,000 mg twice daily.
• Patients receiving metformin hydrochloride (HCl) may be switched to FORTAMET once daily at the same total daily dose, up to 2,000 mg once daily.

Recommendations for Use in Renal Impairment

• Assess renal function prior to initiation of FORTAMET and periodically thereafter.
• FORTAMET is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.
• Initiation of FORTAMET in patients with an eGFR between 30 to 45 mL/minute/1.73 m2 is not recommended.
• In patients taking FORTAMET whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.
• Discontinue FORTAMET 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 FORTAMET 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 FORTAMET if renal function is stable.