Asenza Plus

Asenza Plus Dosage/Direction for Use

pioglitazone + glimepiride

Manufacturer:

Ajanta Pharma Phil

Distributor:

Ajanta Pharma Phil
Full Prescribing Info
Dosage/Direction for Use
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.
Dosage Recommendations: Selecting the starting dose of Pioglitazone plus Glimepiride tablet should be based on the patient's current regimen of Pioglitazone and/or sulfonylurea. Those patients who may be more sensitive to antihyperglycemic drugs should be monitored carefully during dose adjustment. It is recommended that a single dose of Pioglitazone plus Glimepiride tablet be administered once daily with the first main meal.
Starting dose for patients currently on Glimepiride monotherapy: Based on the usual starting dose of Pioglitazone (15 mg or 30 mg daily), Pioglitazone plus Glimepiride tablet may be initiated at 30 mg/2 mg or 30 mg/4 mg tablet strengths once daily, and adjusted after assessing adequacy of therapeutic response. Or as prescribed by the physician.
For patients with type 2 diabetes and systolic dysfunction, see Special Patient Populations as follows.
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. Pioglitazone plus Glimepiride tablet may be initiated at 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.
For patients who are not currently on Glimepiride and may be more sensitive to hypoglycemia, see as follows.
Starting dose for patients switching from combination therapy of Pioglitazone plus Glimepiride as separate tablets: Pioglitazone plus Glimepiride tablet 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 Pioglitazone plus Glimepiride tablet.
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, based on the maximum starting dose of 2 mg Glimepiride, Pioglitazone plus Glimepiride tablet should be limited initially to a starting dose of 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.
Any change in diabetic therapy should be undertaken with care and appropriate monitoring as changes in glycemic control can occur. Patients should be observed carefully for hypoglycemia (1-2 weeks) when being transferred to Pioglitazone plus Glimepiride tablet, especially from longer half-life sulfonylureas (e.g. chlorpropamide) due to potential overlapping of drug effect.
Sufficient time should be given to assess adequacy of therapeutic response. Ideally, the response to therapy should be evaluated using A1C, which is better indicator of long-term glycemic control than FPG alone. A1C reflects glycemia over the past two to three months. In clinical use, it is recommended that patients be treated with Pioglitazone plus Glimepiride tablet for a period of time adequate to evaluate change in A1C (8-12 weeks) unless glycemic control as measured by FPG deteriorates.
Special Patient Populations: Pioglitazone plus Glimepiride tablet is not recommended for use in pregnancy, nursing mothers or for use in pediatric patients.
In elderly, debilitated, or malnourished patients, or in patients with renal or hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage of Pioglitazone plus Glimepiride tablet should be conservative to avoid hypoglycemic reactions. These patients should be started at 1 mg Glimepiride prior to prescribing Pioglitazone plus Glimepiride tablet. During initiation of Pioglitazone plus Glimepiride tablet therapy and any subsequent dose adjustment, patients should be observed carefully for hypoglycemia.
Therapy with Pioglitazone plus Glimepiride tablet should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with Pioglitazone plus Glimepiride tablet and periodically thereafter.
The lowest approved dose of Pioglitazone plus Glimepiride tablet therapy should be prescribed to patients with type 2 diabetes and systolic dysfunction only after titration from 15 mg to 30 mg of Pioglitazone has been safely tolerated. If subsequent dose adjustment is necessary, patients should be carefully monitored for weight gain, edema, or signs and symptoms of CHF exacerbation.
Maximum Recommended Dose: Pioglitazone plus Glimepiride tablet are available as a 15 mg Pioglitazone plus 2 mg Glimepiride or a 30 mg Pioglitazone plus 2 mg Glimepiride or a 30 mg Pioglitazone plus 4 mg Glimepiride formulation for oral administration. The maximum recommended daily dose for Pioglitazone is 45 mg and the maximum recommended daily dose for Glimepiride is 8 mg.
Pioglitazone plus Glimepiride tablet should therefore not be given more than once daily at any of the tablet strengths.
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