Full Generic Medicine Info
Dosage/Direction for Use

Type 2 diabetes mellitus
Adult: 15 or 30 mg once daily, increased gradually if necessary. Max: 45 mg/day.
Elderly: No dosage adjustment needed.
Renal impairment: No dosage adjustment needed.
Hepatic impairment: Moderate to severe: Avoid.
May be taken with or without food.
Type 1 DM or diabetic ketoacidosis. Severe heart failure (NYHA class III or IV). Active or history of bladder cancer. Moderate to severe hepatic impairment. Patients w/ uninvestigated macroscopic haematuria.
Special Precautions
Symptomatic and congestive heart failure (NYHA class I or II). Mild hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor for signs and symptoms of heart failure (e.g. dyspnoea, rapid wt. gain, unexplained fatigue or cough), bladder cancer (e.g. blood in urine, urinary urgency, pain on urination, or back or abdominal pain), and fluid retention. Periodically monitor fasting plasma glucose levels. LFT should be performed prior to treatment and monitor periodically. Patient Counselling Adequate contraception is recommended in premenopausal anovulatory women as pioglitazone may cause resumption of ovulation.
Adverse Reactions
Oedema, wt. gain, sinusitis, upper resp tract infections, hepatic dysfunction (e.g. vomiting, unexplained nausea, anorexia, dark urine, abdominal pain, fatigue), bone loss and fracture, myalgia, visual disturbances; decreased haemoglobin and haematocrit counts (dose related); decreased serum triglycerides, increased HDL-cholesterol; abnormal LFT.
Potentially Fatal: Rare: Mixed hepatocellular-cholestatic liver injury and liver failure; hepatitis.
Drug Interactions
Increased risk of oedema w/ insulin, metformin and sulfonylureas. Increased plasma levels w/ gemfibrozil and ketoconazole. Decreased plasma levels w/ rifampicin.
Pioglitazone is as a potent and highly selective agonist for the peroxisome proliferator activated receptor-γ (PPAR-γ). Activation of these receptors promotes the production of gene products involved in lipid and glucose metabolism. It also improves insulin response to target cells w/o increasing the pancreatic secretion of insulin.
Onset: Delayed.
Absorption: Rapidly absorbed. Bioavailability: >80%. Time to peak plasma concentration: Approx 2 hr.
Distribution: Volume of distribution: 0.63 L/kg. Plasma protein binding: >99% (mainly to albumin).
Metabolism: Extensive hepatic metabolism via CYP2C8 and CYP3A4 isoenzymes to its active and inactive metabolites.
Excretion: Via urine (15-30%); faeces (as metabolites). Elimination half-life: 3-7 hr (parent drug).
Oral: Store at 25°C.
CIMS Class
Antidiabetic Agents
ATC Classification
A10BG03 - pioglitazone ; Belongs to the class of thiazolidinediones. Used in the treatment of diabetes.
Disclaimer: This information is independently developed by CIMS based on pioglitazone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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