Asenza Plus Dosage/Direction for Use

General: The use of anti-hyperglycemic 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.
Recommended Dose: Selecting the starting dose of Pioglitazone/Glimepiride Tablets 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/Glimepiride Tablets be administered once daily with the first main meal.
Patients Currently on Pioglitazone HCl Monotherapy: Usual Starting Dose: Glimepiride (1 or 2 mg once daily) and pioglitazone HCl 15 or 30 mg, Pioglitazone/Glimepiride Tablets may be initiated at 15 mg/2 mg once daily and adjusted after assessing adequacy of therapeutic response.
Patients Currently on Glimepiride Monotherapy: Usual Starting Dose: Pioglitazone HCl (15 or 30 mg daily), Pioglitazone/Glimepiride Tablets may be initiated at 15 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.
Patients Switching from Combination Therapy of Pioglitazone plus Glimepiride as Separate Tablets: May be initiated with 15 mg/2 mg tablet based on the dose of pioglitazone HCl and glimepiride already being taken. Patients who are not controlled with pioglitazone HCl 15 mg in combination with glimepiride should be carefully monitored when switched to Pioglitazone/Glimepiride Tablets.
Patients Currently on a Different Sulfonylurea Monotherapy or Switching from Combination Therapy of Pioglitazone Plus a Different Sulfonylurea: No exact dosage relationship exists between glimepiride and the other sulfonylurea agents. Therefore, based on the maximum starting dose of glimepiride 2 mg, Pioglitazone/Glimepiride Tablets should be limited initially to a starting dose of 15 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 change in glycemic control can occur. Patients should be observed carefully for hypoglycemia (1-2 weeks) when being transferred to Pioglitazone/Glimepiride Tablets, especially from longer t½ sulfonylureas due to potential overlapping of drug effect.
Maximum Recommended Dose: The maximum recommended daily dose for pioglitazone is 15 mg plus glimepiride 2 mg or a pioglitazone 30 mg plus glimepiride 4 mg formulation for oral administration.
Maximum Recommended Daily Dose: Pioglitazone is 45 mg and glimepiride is 8 mg. Pioglitazone/Glimepiride Tablets should therefore not be given more than once daily at any of the tablet strengths.
Elderly, Debilitated or Malnourished Patients, or in Patients with Renal or Hepatic Impairment: Initial dosing, dose increments, and maintenance dosage of Pioglitazone/Glimepiride Tablets should be conservative to avoid hypoglycemic reactions. These patients should be started at glimepiride 1 mg prior to prescribing Pioglitazone/Glimepiride Tablets.
During initiation of Pioglitazone/Glimepiride Tablets therapy and any subsequent dose adjustment, patients should be observed carefully for hypoglycemia.
Therapy with Pioglitazone/Glimepiride Tablets should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5 x ULN) at start of therapy.
The lowest approved dose of Pioglitazone/Glimepiride Tablets therapy should be prescribed to patients with type 2 diabetes and systolic dysfunction only after titration from pioglitazone HCl 15-30 mg has been safely tolerated. If subsequent dose adjustment is necessary, patients should be carefully monitored for weight gain, edema or signs and symptoms of congestive heart failure exacerbation.
Concomitant Use with an Insulin Secretagogue or Insulin: If hypoglycemia occurs in a patient co-administered Pioglitazone/Glimepiride Tablets and an insulin secretagogue, the dose of the insulin secretagogue should be reduced.
If hypoglycemia occurs in a patient co-administered Pioglitazone/Glimepiride Tablets and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.
Concomitant Use with Strong CYP2C8 Inhibitors: Co-administration of pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of pioglitazone is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors. If gemfibrozil or other CYP2C8 inhibitors need to co-administered, patients should switch to individual components of Pioglitazone/Glimepiride Tablets because the minimum dose of pioglitazone in Pioglitazone/Glimepiride Tablets exceeds 15 mg.
Concomitant Use with Colesevelam: When colesevelam is co-administered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, Pioglitazone/Glimepiride Tablets should be administered at least four hours prior to colesevelam.
Pediatric Use: Safety and effectiveness of Pioglitazone/Glimepiride Tablets in pediatric patients have not been established.
Geriatric Use: To minimize the risk of hypoglycemia, the initial dosing, dose increments, and maintenance dosage of Pioglitazone/Glimepiride Tablets should be conservative. During initiation of Pioglitazone/Glimepiride Tablets therapy and any subsequent dose adjustments, geriatric patients should be observed carefully for hypoglycemia.
Renal Impairment: To minimize the risk of hypoglycemia, the initial dosing, dose increments and maintenance dosage of Pioglitazone/Glimepiride Tablets should be conservative. During initiation of Pioglitazone/Glimepiride Tablets therapy and any subsequent dose adjustments, these patients should be observed carefully for hypoglycemia.