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Pioglitazone information from DrugsUpdate  

See Available Brands of Pioglitazone in India

P - Caution when used during pregnancy
L - Contraindicated in lactation
LI - Lab *

Pioglitazone is a prescription drug of the class thiazolidinedione (TZD) with hypoglycemic (antihyperglycemic, antidiabetic) action. It is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes. Pioglitazone is marketed as trademarks Actos in the USA and UK, Glustin in Europe, Zactos in Mexico by Takeda Pharmaceuticals & Piozer in Pakistan by Hilton Pharmaceuticals. Actos was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion.

Pharmacodynamics

Pharmacokinetics

Pioglitazone is as a potent and highly selective agonist for the peroxisome proliferator activated receptor-gamma (PPAR). Activation of these receptors promotes the production of gene products involved in lipid and glucose metabolism. It also improves insulin response to target cells witho increasing the pancreatic secretion of insulin.

Onset
Delayed

Absorption
Peak plasma concentrations after 2 hours.

Distribution
Protein-binding: >99%.

Metabolism
Extensively metabolised by hydroxylation and oxidation.

Excretion
Urine (15-30%); faeces (as metabolites); 3-7 hours (elimination half-life, parent drug).

Pioglitazone Indications / Pioglitazone Uses

Information Not Available

Pioglitazone Adverse Reactions / Pioglitazone Side Effects

Pharyngitis, oedema, headache, upper resp tract infection, sinusitis, anaemia; GI disturbances, weight gain, visual disturbances, dizziness, arthralgia, haematuria, impotence.

Precautions

Warnings
Pioglitazone can cause or exacerbate CHF in some patients. Consider discontinuing or reducing the dose if symptoms of heart failure occur. Treatment of patients with symptomatic heart failure is not recommended.

Monitor
After starting treatment or increasing the dose, carefully observe patients for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema). Monitor liver enzymes prior to the start of therapy and periodically thereafter.

Fasting blood glucose and hemoglobin A 1c (HbA 1c ) measurements should be performed periodically to monitor glycemic control and therapeutic response.

Special Precautions

Increased risk of hypoglycaemia when used with insulin or oral hypoglycaemics. Oedema, congestive heart failure, hepatic dysfunction, jaundice, anaemia. May cause ovulation in premenopausal, anovulatory women. Monitor liver function before and during treatment. Monitor glycaemic control. Pregnancy. Caution when oral contraceptives or hormonal replacement therapy is used in diabetics due to increased risk of arterial diseases. Stop treatment if ALT increases and remains >3 times above the upper limit of normal or if jaundice develops.

Other Drug Interactions

Ketoconazole and gemfibrozil may increase the plasma concentrations of pioglitazone while enzyme inducers such as rifampicin may decrease the plasma concentrations. Increased risk of fluid retention when used with NSAIDs.

Other Interactions

Information Not Available

Dosage

Oral
Type 2 diabetes mellitus
Adult: 15-30 mg once daily increased in increments if necessary. Max dose: 45 mg/day.

Food(before/after)

May be taken with or without food

List of Contraindications

Pioglitazone and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Pioglitazone and Lactation

Contraindicated in lactation

Pioglitazone and Children

Safety and efficacy not established

Pioglitazone and Geriatic

Information Not Available

Pioglitazone and Other Contraindications

Hypersensitivity. Type 1 diabetes mellitus, symptomatic or history of heart failure, diabetic ketoacidosis, childn <18 years. Lactation.

Storage

Oral
Store at 25°C.

Lab interference

Oral
Store at 25°C.

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