Fortamet Dosage

Concomitant FORTAMET® and Oral Sulfonylurea Therapy in Adult Patients

If patients have not responded to four weeks of the maximum dose of FORTAMET® monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing FORTAMET® at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (also known as glibenclamide). With concomitant FORTAMET® and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant FORTAMET® and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see Package Insert of the respective sulfonylurea).

If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of FORTAMET® and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without FORTAMET®.

Concomitant FORTAMET® and Insulin Therapy in Adult Patients

The current insulin dose should be continued upon initiation of FORTAMET® therapy. FORTAMET® therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of FORTAMET® should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose for FORTAMET® Extended-Release Tablet is 2500 mg. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and FORTAMET®. Further adjustment should be individualized based on glucose-lowering response.

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 – 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 WARNINGS and PRECAUTIONS).

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.

Specific Patient Populations

FORTAMET® is not recommended for use in pregnancy, and is not recommended in patients below the age of 17 years.

The initial and maintenance dosing of FORTAMET® should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function.

Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly (see WARNINGS).