Forbetes Plus 500/5 Dosage/Direction for Use

General Considerations: Dosage of FORBETES PLUS must be individualized on the basic of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 2,000 mg Metformin/20 mg Glibenclamide. FORBETES PLUS should be given with meals and should be initiated at a low dose, with gradual dose escalation as described as follows, in order to avoid hypoglycemia (largely due to Glibenclamide), to reduce GI side effects (largely due to Metformin), and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to this product and to identify the minimum effective dose for the patient. Thereafter, HbA1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c (glycosylated hemoglobin), which is a better indicator of long-term glycemic control than FPG alone.
No studies have been performed specifically examining the safety and efficacy of switching to this product therapy in patients taking concomitant Glibenclamide (or other Sulfonylurea) plus Metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or possible. Any change in therapy of type 2 diabetes should undertaken with care and appropriate monitoring.
FORBETES PLUS Used In Previously Treated Patients (Second Line Therapy): Recommended starting dose: 500 mg/2.5 mg or 500 mg/5 mg twice daily with meals. For patients not adequately controlled on either Glibenclamide (or another Sulfonylurea) or Metformin alone, the recommended starting dose of FORBETES PLUS 500 mg/2.5 mg or 500 mg/5 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of FORBETES PLUS should not exceed the daily doses of Glibenclamide or Metformin already being taken. The daily dose should be titrated in increments of no more than 500 mg/5 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 2,000 mg/20 mg per day. For patients previously treated with combination therapy with Glibenclamide (or another Sulfonylurea) plus Metformin, if switched to FORBETES PLUS, the starting dose should not exceed the daily dose of Glibenclamide (or equivalent dose of another of Sulfonylurea) and Metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of FORBETES PLUS should be titrated as described previously to achieve adequate control of blood glucose. When FORBETES PLUS is co-administered with a bile acid sequestrant, it is recommended that FORBETES PLUS should be administered at least 4 hours prior to the bile acid sequestrant in order to minimize the risk of reduced absorption (see Interactions).
Pediatric use: Safety and effectiveness of FORBETES PLUS in pediatric patients have not been established.
Geriatric use: No overall differences in effectiveness or safety were observed between elderly patients and younger patients, and other reported has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Metformin Hydrochloride is known to be substantially excreted by the kidney and because the risk of serious adverse reactions to the drug is the greater in patients with impaired renal function, FORBETES PLUS should only be used in patients with normal renal function. Because aging is associated with reduced renal function, FORBETES PLUS should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of FORBETES PLUS.