Diatag^® Plus

Diatag^® Plus is a combination of two oral antihyperglycemic agents Pioglitazone hydrochloride and Glimepiride which are used in the management of type 2 diabetes mellitus. Pioglitazone hydrochloride is a member of the thiazolidinedione class which enhances peripheral glucose utilization and decreases insulin resistance by activating peroxisome proliferator-activated receptor-gamma (PPAR_Υ) in adipose tissue, skeletal muscle, and liver. Glimepiride is sulfonylurea and decreases blood glucose by stimulating insulin release from pancreatic beta cells.

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Diatag ® Plus is indicated as an adjunct to diet and exercise as a once-daily therapy

• To improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and a sulfonylurea or
• whose diabetes is not adequately controlled with a sulfonylurea alone, or
• For those patients who have initially responded to pioglitazone alone and require additional glycemic control.

General
The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia.

Starting dose for patients currently on glimepiride monotherapy Based on the usual starting dose of pioglitazone (15 mg or 30 mg daily), Diatag Plus ® may be initiated at 30 mg/2 mg or 30 mg/4 mg tablet strengths once daily, and adjusted after a sessing adequacy of therapeutic response.

Starting dose for patients currently on pioglitazone monotherapy
Based on the usual starting doses of glimepiride (1 mg or 2 mg once daily), and pioglitazone 15 mg or 30 mg, Diatag Plus ® may be initiated at 30 mg/2 mg once daily, and adjusted after assessing adequacyof therapeutic response

Starting dose for patients switching from combination therapy of pioglitazone plus glimepiride as separate tablets

Diatag Plus ® may be initiated with 30 mg/2 mg or 30 mg/4 mg tablet strengths based on the dose of pioglitazone and glimepiride already being taken. Patients who are not controlled with 15 mg of pioglitazone in combination with glimepiride should be carefully monitored when switched to Diatag Plus ® Starting dose for patients currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea (e.g. glyburide,glipizide, chlorpropamide,tolbutamide, acetohexamide)

No exact dosage relationship exists between glimepiride and the other sulfonylurea agents. Therefore, basedon the maximum starting dose of 2 mg glimepiride, Diatag Plus ® should b limited initially to a starting dose of 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.

Maximum recommended dose:
The maximum recommended dose for Pioglitazone is 45mg and the maximum recommended dose for Glimepiride is 8 mg.Diatag Plus should therefore not be given more than once daily at any of the tablet strength.

Use in children:

Diatag Plus ® has not been studied for children and is not recommended for children.

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Pioglitazone

Pioglitazone exerts its antihyperglycemic effect only in the presence of insulin. Therefore, Diatag Plus ® should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, Hypoglycemia: Patients receiving pioglitazone in combination with insulin or oral hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary. Since thiazolidinediones, including pioglitazone, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Diatag Plus ® should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure. Therapy with a thiazolidinedione, including the active pioglitazone component of the Diatag Plus ® tablet, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking Diatag Plus ®. Thus, adequate contraception in premenopausal women should be recommended. Dose related weight gain was observed with pioglitazone alone and in combinationwith other hypoglycemic agents.

Glimepiride

All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of glimepiride. The effectiveness of this combination in lowering blood glucose desired level which maybe due to progression of the severity of the diabetes or to diminished responsiveness to the drug. FBG and HbA₁ c% measurements should be performed periodically to monitor glycemic control and therapeutic response to this drug. Liver enzyme monitoring is recommended prior to initiation of therapy with this combination in all patients.

Generally Pioglitazone hydrochloride and Glimepiride combination is well tolerated. Few side effects of this preparation are upper respiratory tract infection, diarrhea, nausea, pain in limb, accidental injury and combined edema.

Diatag^® Plus is contraindicated in patients with Known hypersensitivity to pioglitazone, glimepiride or any other component of Diatag^® Plus Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Administration of pioglitazone with an oral contraceptive containing ethinyl oestradiol and norethindone could result in loss of contraception. Gemfibrozil may significantly increase the AUC of pioglitazone where as rifampin may significantly decrease the AUC of pioglitazone. Co-administration of pioglitazone with ketokonazole, pioglitazone plasma levels may be elevared. The hypoglycemic action of glimepiride may be potentiated by nonsteroidal anti-inflammatory drugs and other highly protein bound drugs such as salicylates ,sulfonamides, chloramphenicol, coumarins, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents.Certain drugs tend to produce hyperglycemia and may lead to loss of control. These include thiazide and other diuretics, coticosteroids, phenothiazines, thyroid products, estrogens,oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, and isoniazid. Due to potential drug interaction between these drugs and glimepiride, the patient should be observed closely for loss of glycemic control when these drugs are co-administered.

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Store in a cool and dry place. Protect from light.