ديافانس Diavance لعلاج مرضى السكري من النوع الثاني

Diavance Tablets

SIGMA

PHARMACEUTICAL INDUSTRIES

Anti-Diabetic Drug Composition:

Diavance 1.25 mg Tablets Each tablet contains: Glyburide 1.25 mg / Metformin HCl 250 mg.

Diavance 2.5 mg Tablets Each tablet contains: Glyburide 2.5 mg / Metformin HCI 500 mg.

Diavance 5 mg Tablets Each tablet contains: Glyburide 5 mg/Metformin HCI 500 mg. Properties and Mechanism of Action: Diavance is an anti-diabetic product that combines two oral antihyperglycemic agents (Glyburide and Metformin HCI) with complimentary mechanism of action to improve glycemic control in patients with type 2 diabetes. Glyburide lowers blood glucose by stimulating the release of insulin from pancreas. Metformin HCl improves glucose tolerance in patients with type 2 diabetes by lowering both basal and postprandial plasma glucose. It also decreases hepatic glucose production, intestinal absorption of glucose, improves insulin sensitivity by increasing the peripheral glucose uptake and utilization. * FDA has approved this combination for use in combination with thiazolidinediones (as an adjunct to diet and exercise) when adequate glycemic control is not achieved with Glyburide and Metformin HCl combination, diet and exercise. Indications and Usage: Diavance is indicated in the following conditions: - As initial therapy (adjunct to diet and exercise) to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. - As second-line therapy when diet, exercise and initial treatment with a Sulfonylurea or Metformin alone dose not result in adequate glycemic control in patients with type 2 diabetes. - For patients requiring additional therapy, a thiazolidinedione may be added to Diavance to achieve additional glycemic control. Contraindications: .Known hypersensitivity to Metformoin HCl or glyburide. . Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. . Congestive heart failure requiring pharmacologic treatment. . Renal diseases or renal dysfunction which may also result from conditions such as cardiovascular

collapse (shock), acute myocardial infarction, and septicemia. Side Effects: The side effects of Diavance may include: Hypoglycemic symptoms such as dizziness, shakiness, sweating, and hunger. Gastrointestinal reactions such as diarrhea, nausea / vomiting and abdominal pain. Precautions: .Diavance is capable of producing hypoglycemia or hypoglycemic symptoms, therefore, proper patient selection, dosing, and instructions are important to avoid potential hypoglycemic episodes.

In patients who develop hypoglycemia when receiving Diavance and a thiazolidinedione, consideration should be given for reducing the dose of the glyburide component of Diavance. .Diavance should be temporarily discontinued in patients undergoing radiologic studies involving intravascular adminstration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

. Pregnancy: There are no adequate and well-controlled studies in pregnant woman with Diavance. It is not recommended to use Diavance during pregnancy, if it is used it should be discontinued at least two weaks before the expected delivery date. . Nursing Mothers: It is not known whether Glyburide is excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue Diavance, taking into account the importance of the drug to the mother. .Diavance should be used with caution in elderly patients. Drug Interactions:

Drugs produce hyperglycemia with Diavance: Such as thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Diavance, the patient should be closely observed for loss of blood glucose control and when such drugs are withdrawn, the patient should be observed closely for hypoglycemia.

Drugs produce hypoglycemia with Diavance: Such as non-steroidal anti-inflammatory agents and other drugs that are highly protien bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving Diavance, the patient should be observed closely for hypoglycemia and when such drugs are withdrawn, the patient should be observed closely for loss of blood glucose control.

Ciprofloxacin: A possible interaction between glyburide and ciprofloxacin has been reported resulting in potentiation of the hypoglycemic action of glyburide.

Oral Miconazole: A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Dosage and Administration:

- General considerations: . Diavance should be given with meals. . Diavance should be initiated at a low dose, with gradual dose escalation as described below. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Diavance and to identify the minimum effective dose for the patient. Thereafter, HbA1c (glycosylated hemoglobin) should be measured at intervals of approximately 3 months to assess the effectiveness of therapy.

- Initial Therapy: Recommended starting dose: One tablet (1.25 mg / 250 mg) once or twice daily with morning and evening meals. Dosage increases should be made in increments of 1.25 mg /250 mg per day every 2 weeks up to the maximum effective dose necessary to acheive adequate control of blood glucose.

- Second Line Therapy: Recommended starting dose: One tablet (2.5 mg/500 mg) or (5 mg / 500 mg) twice daily with morning and evening meals.

- Addition of Thiazolidinediones to Diavance Therapy: When a thiazolidinedione is added to Diavance therapy, the current dose of Diavance can be continued and the thiazolidinedione is initiated at its recommended dose. How Supplied: Diavance 1.25 mg: A carton box containing 3 blisters, each of 10 tablets. Diavance 2.5 mg: A carton box containing 3 blisters, each of 10 tablets. Diavance 5 mg: A carton box containing 3 blisters, each of 10 tablets.

Produced by SIGMA Pharmaceutical Industries . Egypt. S.A.E. 0412182