Each tablet contains:
Equivalent to Pioglitazone …………………… 15 mg
Pioglitazone is a thiazolidinedione oral antidiabetic. It is used in the management of type 2 diabetes mellitus.
Pioglitazone is rapidly absorbed after oral doses. Peak plasma concentrations are obtained within 2 hours and bioavailability exceeds 80%. Pioglitazone is more than 99% bound to plasma proteins. It is extensively metabolized by cytochrome P450 isoenzymes CYP2C9 to both active and inactive metabolites. It is excreted in urine and faeces and has a plasma half-life of up to 7 hours. The active metabolites have a half-life of up to 24 hours.
DOSAGE AND ADMINISTRATION
Pioglitazone is given as pioglitazone hydrochloride but doses are expressed in terms of the base; pioglitazone hydrochloride 1.1 mg is equivalent to about 1 mg of pioglitazone. the usual dose is 15 or 30 mg once daily. This may be increased to a maximum of 45 mg once daily if necessary, when used as monotherapy or with metformin or a sulfonylurea. The dose should not exceed 45 mg/day since doses higher than 45 mg/day have not been studied in clinical trials. Pioglitazone may be taken with or without food.
Safety and effectiveness in pediatric patients have not been established.
Elderly Use: No significant differences in safety and efficacy were observed between these patients and younger patients.
Use in Pregnancy: There are no adequate and well controlled studies in pregnant women.
Pioglitazone should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Use in lactation: It is not known whether Pioglitazone is secreted in human milk.Pioglitazone should not be administered to lactating women.
Pioglitazone is contraindicated in patients with known hypersensitivity or allergy to Pioglitazone or any of its excipients.
WARNINGS AND PRECAUTIONS
Liver function should be monitored periodically as there have been isolated reports of liver dysfunction, and the drug should be used with caution in patients with hepatic impairment.
Adverse effects reported include upper respiratory-tract infections, haematuria, myalgia, and visual disturbances. Effects of lipids: Thiazolidinediones are reported to affect serum concentrations of lipids. Compared with placebo, pioglitazone has been found to reduce triglycerides, increase high-density lipoprotein (HDL)_-choIesteroI, and have little or no effect on low-density lipoprotein (LDL) – and total cholesterol. Effects on the liver: There have been isolated reports of hepatocellular injury in patients receiving pioglitazone. liver enzymes should be checked before starting therapy with pioglitazone; patients with aminotransterase (ALT) concentrations more than 2.5 times the upper limit of normal should not be given Pioglitazone concentrations should than be monitored every 2 months during the first 12 months of treatment and periodically thereafter. If ALT concentrations rise to more than 3 times the upper limit of normal and remains so after retesting then treatment with pioglitazone should be stopped; treatment should also be stopped if jaundice develops.
Antibacterials: A report of hypoglycemia when gatifloxacin was given to a patient already receiving oral hypoglycaemics.
Gemfibrozil: reported to result in a 3-fold increase in the AUC of pioglitazone.
Rifampicin: reported to result in a 54% decrease in the AUC of pioglitazone.
Oral contraceptives reduced the plasma concentrations of hormones by approximately 30%. Glipizide: does not alter the steady state pharmacokinetics of glipizide.
Digoxin: does not alter the steady-state pharmacokinetics of digoxin.
Warfarin: does not alter the steady-state pharmacokinetics ofwarfrain.
Metformin: does not alter the steady-state pharmacokinetics of metformin.
Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription.
|15mg Alu/Alu Blister Pack of 10’s (Box of 100’s)||SRP 1,200.00|
Store at temperatures not exceeding 300C.
Protect from light.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph“