February 13, 2016
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Fortamet

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Fortamet




Indications
Dosage
How Supplied

INDICATIONS

FORTAMET® (metformin hydrochloride) Extended-Release Tablets, used as a once per day monotherapy, are indicated as an adjunct to diet and exercise to lower blood glucose. FORTAMET® (metformin hcl) can be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults. FORTAMET® (metformin hcl) is indicated in patients 17 years of age and older as either monotherapy or in combination therapy.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with FORTAMET® (metformin hcl) or any other pharmacologic agent. Dosage of FORTAMET® (metformin hcl) must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of FORTAMET® (metformin hcl) Extended-Release Tablets in adults is 2500 mg.

FORTAMET® (metformin hcl) should be taken with a full glass of water once daily with the evening meal. FORTAMET® (metformin hcl) should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to FORTAMET® (metformin hcl) and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of FORTAMET® (metformin hcl) , either when used as monotherapy or in combination with sulfonylurea or insulin.

Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

Short-term administration of FORTAMET® (metformin hcl) may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

Recommended Dosing Schedule

The usual starting dose of FORTAMET® (metformin hydrochloride) Extended-Release Tablets is 1000 mg taken with a full glass of water once daily with the evening meal, although 500 mg may be utilized when clinically appropriate. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2500 mg once daily with the evening meal (see CLINICAL PHARMACOLOGY, Clinical Studies).

In randomized trials, patients currently treated with immediate-release metformin were switched to FORTAMET® (metformin hcl) . Results of this trial suggest that patients receiving immediate-release metformin treatment may be safely switched to FORTAMET® (metformin hcl) once daily at the same total daily dose, up to 2500 mg once daily. Following a switch from immediate-release metformin to FORTAMET® (metformin hcl) , glycemic control should be closely monitored and dosage adjustments made accordingly (see CLINICAL PHARMACOLOGY, Clinical Studies).

Pediatrics - There is no pediatric information available for FORTAMET® (metformin hcl) .

Transfer From Other Antidiabetic Therapy

When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to FORTAMET® (metformin hcl) , no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant FORTAMET® (metformin hcl) and Oral Sulfonylurea Therapy in Adult Patients

If patients have not responded to four weeks of the maximum dose of FORTAMET® (metformin hcl) monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing FORTAMET® (metformin hcl) 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® (metformin hcl) 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® (metformin hcl) 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® (metformin hcl) and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without FORTAMET® (metformin hcl) .

Concomitant FORTAMET® (metformin hcl) and Insulin Therapy in Adult Patients

The current insulin dose should be continued upon initiation of FORTAMET® (metformin hcl) therapy. FORTAMET® (metformin hcl) therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of FORTAMET® (metformin hcl) 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® (metformin hcl) Extended-Release Tablets 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® (metformin hcl) . Further adjustment should be individualized based on glucose-lowering response.

Specific Patient Populations

FORTAMET® (metformin hcl) 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® (metformin hcl) 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. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of FORTAMET® (metformin hcl) .

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

HOW SUPPLIED

FORTAMET®(metformin hydrochloride) Extended-Release Tablets are supplied as biconvex-shaped, film-coated extended-release tablets containing 500 mg or 1000 mg of metformin hydrochloride.

NDC 59630-574-60: 500 mg extended-release, white-colored tablets imprinted with Andrx logo and 574 on one side: bottles of 60.

NDC 59630-575-60: 1000 mg extended-release, white-colored tablets imprinted with Andrx logo and 575 on one side: bottles of 60.

Storage

Store at 20-25C (68-77C)- Excursions permitted to 15° - 30°C (59°-86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Avoid excessive heat and humidity.

Distributed by: Sciele™ Pharma, Inc. Atlanta, GA 30328. Manufactured by: Watson Laboratories - Florida. Ft. Lauderdale, FL 33314. FDA Rev date: 4/19/2007

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/25/2008

Indications
Dosage
How Supplied

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