Pioglitazone
Dosing in kidney impairment
Recommendations for Use in Patients with Renal Impairment Assess renal function prior to initiation of pioglitazone and metformin hydrochloride tablets and periodically thereafter [see Use in Specific Populations ]. Pioglitazone and metformin hydrochloride tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min.
Initiation of pioglitazone and metformin hydrochloride tablets in patients with an eGFR between 30 to 45 mL/min is not recommended. In patients taking pioglitazone and metformin hydrochloride tablets whose eGFR later falls below 45 mL/min, assess the benefit and risk of continuing therapy. Discontinue pioglitazone and metformin hydrochloride tablets if the patient's eGFR later falls below 30 mL/min [see Contraindications , Warnings and Precautions ].
| *For dosage recommendations for patients with renal impairment and/or congestive heart failure, see Dosage and Administration (2.3, 2.4) | |
| Current Regimen | Starting Dosage of Pioglitazone and Metformin Hydrochloride tablets (15 mg of pioglitazone and 850 mg of metformin hydrochloride per tablet)* |
| Not treated with either pioglitazone or metformin hydrochloride | One tablet orally once daily |
| Metformin hydrochloride | One tablet orally once or twice daily. Select a dosage that is as close as possible to the current dosage of metformin hydrochloride |
| Pioglitazone | One tablet orally once daily |
| Pioglitazone and metformin hydrochloride | Select a dosage that is as close as possible to the current dosage of pioglitazone and metformin hydrochloride while not exceeding three tablets orally per day. |
Dosing in liver impairment
Important Dosage and Administration Information Obtain liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) prior to initiating pioglitazone and metformin hydrochloride tablets [see Warnings and Precautions ]. Pioglitazone and metformin hydrochloride tablet contains 15 mg of pioglitazone and 500 mg of metformin hydrochloride or 15 mg of pioglitazone and 850 mg of metformin hydrochloride in each tablet.
Take pioglitazone and metformin hydrochloride tablets with meals to reduce gastrointestinal adverse reactions with metformin [see Adverse Reactions ]. If a dose is missed, do not double the next dose.
Preparation and administration
Recommended Dosage and Administration Recommended Starting Dosage Based on Current Regimen Individualize the starting dosage of pioglitazone and metformin hydrochloride tablets based on the patient's current regimen and the available strength of pioglitazone and metformin hydrochloride tablets (see Table 1). [See table below.] Dosage Titration for Additional Glycemic Control Titrate the pioglitazone and metformin hydrochloride tablets dosage gradually, as needed, after assessing therapeutic response and tolerability.
Pioglitazone and metformin hydrochloride tablets may be increased to a maximum recommended total daily dosage of three tablets per day (45 mg of pioglitazone and 2,550 mg of metformin hydrochloride). Total daily dosages of 2,550 mg of metformin hydrochloride may be taken in divided doses three times a day to reduce gastrointestinal adverse reactions [see Adverse Reactions ].
Coadministration with Strong CYP2C8 Inhibitors The maximum recommended dosage of pioglitazone and metformin hydrochloride tablets is one tablet (15 mg of pioglitazone and 850 mg of metformin hydrochloride) once daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Drug Interactions , Clinical Pharmacology ] .