Страна: Танзанія
мова: англійська
Джерело: Tanzania Medicinces & Medical Devices Authority
Glimepiride
Mankind Pharma Limited, INDIA
Blood glucose lowering drugs, excl. insulins, Sulf
Glimepiride
2mg
Tablets
Aurochem Pharmaceuticals Pvt. (I) Limited, INDIA
Physical description: White to off white, circular, flat, bevel edged, scored on one side, uncoated tablets; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)
Registered/Compliant
2020-05-12
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glimestar-2 tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of glimepiride. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. White to off white, circular, flat, bevel edged, scored on one side, uncoated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glimepiride is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet. Posology The dosage is determined by the results of blood and urinary glucose determinations. The starting dose is 1 mg glimepiride per day. If good control is achieved, this dosage should be used for maintenance therapy. For the different dosage regimens appropriate strengths are available. If control is unsatisfactory, the dosage should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3, or 4 mg glimepiride per day. 2 A dosage of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day. In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated. While maintaining the metformin dose, the glimepiride therapy is started with a low dose, and is then titrated up depending on the desired level of metabolic control up to the maximum daily dose. The combination therapy should be initiated under close medical supervision. In patients not adequately controlled with the maximum daily dose of glimepiride, concomitant insulin therapy can be initiated if necessary. While maint Прочитайте повний документ