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Author: Admin | 2025-04-28
Occurs during combination therapy with an insulin secretagogue (e.g., sulfonylurea), decrease dosage of the insulin secretagogue. If hypoglycemia occurs with concomitant pioglitazone and insulin therapy, reduce dosage of insulin by 10–25%; further adjustments to insulin dosage should be individualized according to glycemic response. Initiation or discontinuance of a CYP2C8 inducer during pioglitazone therapy may necessitate changes in antidiabetic therapy. (See Interactions.)If a potent CYP2C8 inhibitor is used concomitantly, reduction of the maximum daily pioglitazone dosage is recommended. (See Interactions.)AdultsType 2 Diabetes MellitusMonotherapyOralInitially, 15 or 30 mg once daily in patients without congestive heart failure; use lower initial dosages in patients with NYHA class I or II heart failure. (See Patients with Heart Failure under Dosage.) If response inadequate, increase dosage in increments of 15 mg based on glycemic response as determined by HbA1c up to maximum of 45 mg daily.Pioglitazone/Immediate-release Metformin Hydrochloride Fixed-combination TherapyOralBase initial dosage of fixed combination on patient's existing dosage of pioglitazone and/or immediate-release metformin hydrochloride and on usual initial dosages of these drugs, effectiveness, and tolerability.Initially, pioglitazone 15 mg/metformin hydrochloride 500 mg twice daily or pioglitazone 15 mg/metformin hydrochloride 850 mg once daily.Patients receiving metformin hydrochloride monotherapy: Initially, pioglitazone 15 mg/metformin hydrochloride 500 mg twice daily or pioglitazone 15 mg/metformin hydrochloride 850 mg once or twice daily depending on the patient's existing metformin dosage.Patients receiving pioglitazone monotherapy: Initially, pioglitazone 15 mg/metformin hydrochloride 500 mg twice daily or pioglitazone 15 mg/metformin hydrochloride 850 mg once daily.Patients switching from combined therapy with separate pioglitazone and metformin preparations: Usual initial dosage of the fixed combination is the same as the patient's existing dosage of the individual drugs.Gradually titrate dosage based on adequacy of therapeutic response and tolerability.Pioglitazone/Glimepiride Fixed-combination TherapyOralBase initial dosage of fixed combination on patient's existing dosage of pioglitazone and/or sulfonylurea (e.g., glimepiride). (See Patients with Heart Failure under Dosage.)Patients receiving glimepiride monotherapy: Initially, 30 mg of pioglitazone and 2 or 4 mg of glimepiride once daily.Patients receiving pioglitazone monotherapy: Initially, 30 mg of pioglitazone and 2 mg of glimepiride once daily.Patients switching from combined therapy with separate pioglitazone and glimepiride preparations: Usual initial dosage of the fixed combination is as close as possible to the patient's existing dosage of the individual drugs. When switching to the fixed combination, carefully monitor patients with inadequate glycemic control on pioglitazone 15 mg daily in combination with glimepiride.Patients switching from monotherapy with a sulfonylurea other than glimepiride (e.g., glyburide, glipizide, tolbutamide) or from combined therapy with pioglitazone plus a sulfonylurea other than glimepiride: Initially, 30 mg of pioglitazone and 2 mg of glimepiride once daily. Observe patients for hypoglycemia for 1–2 weeks following transition from a sulfonylurea with a prolonged half-life (e.g., chlorpropamide [no longer commercially available in the US]) due to potential overlapping hypoglycemic effect.Gradually titrate dosage based on adequacy of therapeutic response and tolerability.Prescribing LimitsAdultsType 2 Diabetes MellitusOralMaximum 45 mg daily (as monotherapy or in combination with a sulfonylurea, metformin, or insulin). Special PopulationsHepatic ImpairmentMonotherapyNo dosage adjustment necessary; initiate with caution in hepatic impairment. (See Hepatic Effects under Cautions.)Pioglitazone/Immediate-release
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