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There is no fixed dosage regimen for the management of hyperglycemia in patient with type 2 diabetes with FORBETES 500 XR or any other pharmacologic agent. Dosage of FORBETES 500 XR must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose of 2,000 mg for FORBETES 500 XR.
FORBETES 500 XR should generally be given once daily with the evening meals. FORBETES 500 XR 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 FORBETES 500 XR 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 FORBETES 500 XR, either when used as monotherapy or in combination with sulfonylurea or insulin.
Monitoring 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 FORBETES 500 XR may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
Recommended Dosing Schedule: In general, clinically significant responses are not seen at doses below 1,500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of FORBETES 500 XR is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2,000 mg once daily with the evening meal. If glycemic control is not achieved on FORBETES 500 XR 2,000 mg once daily, a trial of FORBETES 500 XR 1,000 mg twice daily should be considered.
Transfer form Other Antidiabetic Therapy: When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to FORBETES 500 XR, 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 FORBETES 500 XR and Oral Sulfonylurea Therapy: If patients have not responded to four weeks of the maximum dose of FORBETES 500 XR monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing FORBETES 500 XR at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug and drug interaction are currently available only from metformin plus glyburide (glibenclamide).
With concomitant FORBETES 500 XR 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 FORBETES 500 XR and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increase. Appropriate precautions should be taken.
If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of FORBETES 500 XR and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without FORBETES 500 XR.
Concomitant FORBETES 500 XR and Insulin Therapy: The current insulin dose should be continued upon initiation of FORBETES 500 XR therapy. FORBETES 500 XR therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of FORBETES 500 XR 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 is 2,000 mg for FORBETES 500 XR. 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 FORBETES 500 XR. Further adjustment should be individualized based on glucose lowering response.
Specific Patient Populations: FORBETES 500 XR is not recommended for use in pregnancy or for use in pediatric patients. The initial and maintenance dosing of FORBETES 500 XR 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 be titrated to the maximum dose of FORBETES 500 XR.
Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly.
