Zoliget 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.
Recommended Dose: Selecting the starting dose of Zoliget 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 Zoliget 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, Zoliget 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), Zoliget 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 Zoliget.
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, Zoliget 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 Zoliget, especially from longer t_½ 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. Zoliget 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 Zoliget should be conservative to avoid hypoglycemic reactions. These patients should be started at glimepiride 1 mg prior to prescribing Zoliget. During initiation of Zoliget therapy and any subsequent dose adjustment, patients should be observed carefully for hypoglycemia. Therapy with Zoliget 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 Zoliget 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.