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MINT-PIOGLITAZONE is a brand name for Pioglitazone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................3 CONTRAINDICATIONS ......................................................................................................4 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
MINT-PIOGLITAZONE (pioglitazone hydrochloride) is contraindicated in: • New York Heart Association (NYHA) Class I to IV cardiac status. • known hypersensitivity to this drug or any of its components; • serious hepatic impairment (see WARNINGS AND PRECAUTIONS, Hepatic); • pregnancy.
Insulin is recommended during pregnancy to control blood glucose levels. Oral antidiabetic agents should not be given (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). • Active bladder cancer or a history of bladder cancer • Uninvestigated macroscopic haematuria WARNINGS AND PRECAUTIONS General The effect of pioglitazone hydrochloride on morbidity and mortality has not been established.
Pioglitazone hydrochloride exerts its antihyperglycemic effect only in the presence of insulin. Therefore, MINT-PIOGLITAZONE (pioglitazone hydrochloride) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
The use of MINT-PIOGLITAZONE in combination with insulin is not indicated (See CLINICAL TRIALS). The use of MINT-PIOGLITAZONE in combination with metformin AND a sulfonylurea (triple therapy) is not indicated.
Weight Gain:
MINT-PIOGLITAZONE may be associated with weight gain. 8 kg. 0 kg. Treatment should be re-evaluated in patients with excessive weight gain (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics). 7%). The majority of these fractures were in the distal upper limb or distal lower limb.
The risk of fracture should be considered in the care of all patients treated with MINT- PIOGLITAZONE. Carcinogenesis and Mutagenesis See PART II, TOXICOLOGY, for animal studies.
Bladder Cancer:
Preclinical suggest an increased risk of bladder cancer in pioglitazone users. A two-year carcinogenicity study was conducted in male and female rats at oral doses up to Page 5 of 45 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m2).
Drug-induced tumours were not observed in any organ except for the urinary bladder. Benign and/or malignant transitional cell neoplasms were observed in male rats at 4 mg/kg/day and above (approximately equal to the maximum recommended human oral dose based on mg/m2).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A two-year carcinogenicity study was conducted in male and female mice at oral doses up to 100 mg/kg/day (approximately 11 times the maximum recommended human oral dose based on mg/m2). No drug-induced tumours were observed in any organ.
14%) in patients not taking pioglitazone. 05%) on placebo. 029). 02%) in control groups. Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Inconsistent findings and limitations inherent in these and other studies preclude conclusive interpretation of the available observational data. MINT-PIOGLITAZONE may be associated with an increase in the risk of urinary bladder tumours.
A possible risk after short term treatment cannot be excluded. There are insufficient data to determine whether pioglitazone is a tumour promoter for urinary bladder tumours. Consequently, MINT-PIOGLITAZONE should not be used in patients with active bladder cancer or a history of bladder cancer (see CONTRAINDICATIONS).
Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include age, current or past history of smoking, family history of bladder cancer, exposure to chemicals in the workplace or to certain cancer treatments such as cyclophosphamide and radiation therapy to abdomen or pelvis).
Any macroscopic haematuria should be investigated before starting pioglitazone therapy. Patients prescribed pioglitazone should be advised to seek medical attention if macroscopic haematuria or other symptoms such as dysuria, or urinary urgency develop during treatment, as these may be symptoms of bladder cancer.
Cardiovascular Congestive Heart Failure:
Thiazolidinediones, like pioglitazone hydrochloride, alone or in combination with other antidiabetic agents, can cause fluid retention, which can lead to congestive heart failure. The fluid retention may very rarely present as rapid and excessive weight gain.
All patients should be monitored for signs and symptoms of adverse reactions relating to fluid retention and heart failure. e. sulfonyureas) Page 6 of 45 should be closely monitored (see ADVERSE REACTIONS). Treatment with thiazolidinediones, like pioglitazone hydrochloride, has been associated with cases of congestive heart failure, some of which were difficult to treat unless medication was […]