This dosage information may not include all the information needed to use Pioglitazone safely and effectively. See additional information for Pioglitazone.
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Mellitus Type II
Initial dose: 15 mg to 30 mg orally once a day. Doses may be taken without regard to meals.
Maintenance dose: In patients who respond inadequately to the initial dose, it may be increased in increments up to 45 mg once daily.
15 mg to 30 mg orally once a day in combination with metformin, a sulfonylurea or insulin. Doses may be taken without regard to meals.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Patients with mildly elevated serum transaminase levels (ALT 1 to 2.5 times the upper limit of normal), at baseline or during therapy, should be evaluated to determine the cause of the liver enzyme elevation. Initiation or continuation of therapy should proceed with caution and include more frequent liver enzyme monitoring. If jaundice is observed, drug therapy should be discontinued.
Pioglitazone therapy should not be initiated in patients exhibiting clinical evidence of active liver disease or with increased serum transaminase levels (ALT > 2.5 times the upper limit of normal).
If at any time liver enzymes increase to > 3 times the upper limit of normal, liver enzymes should be rechecked as soon as possible. If ALT levels remain > 3 times the upper limit of normal, or the patient is jaundiced, pioglitazone should be discontinued.
For patients receiving pioglitazone as monotherapy, the dose may be increased to a maximum of 45 mg once daily. If the patient does not show adequate response, combination therapy with metformin, a sulfonylurea or insulin may be considered.
For patients receiving metformin, a sulfonylurea or insulin, the current dose of the first drug should be continued upon initiation of pioglitazone therapy. If the patient does not show adequate response, the dosage of pioglitazone may be increased to 30 mg per day. The dosage of pioglitazone should not exceed 45 mg per day as doses greater than this have not been studied.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for pioglitazone. It includes a Medication Guide. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.