Pioglitazone Hydrochloride Dispersible Tablets

This product belongs to the class of thiazolidinediones oral antidiabetic drugs, which is a highly selective peroxisome proliferator-activated receptor γ (PPARγ) agonist. It controls blood sugar levels by increasing peripheral and liver insulin sensitivity. Its main mechanism of action is to activate PPARγ nuclear receptors in tissues such as fat, skeletal muscle and liver where insulin acts, thereby regulating the transcription of insulin-responsive genes and controlling the production, transport and utilization of blood sugar. Toxicological studies: Repeated administration toxicity: Mice (100 mg/kg), rats (≥4 mg/kg) and dogs (3 mg/kg) were repeatedly given this product orally (converted by body surface area, equivalent to 11, 1 and 2 times the maximum clinically recommended dose, respectively), and heart enlargement was found. In a one-year oral administration test in rats, animals in the 160 mg/kg/day (converted by body surface area, equivalent to 35 times the maximum clinically recommended dose) group developed obvious heart failure, leading to premature death of animals related to administration. Monkeys were also found to have heart enlargement when they were orally administered this product at a dose of ≥8.9 mg/kg (equivalent to 4 times the maximum clinically recommended dose based on body surface area) for 13 weeks, but no heart enlargement was observed when the dose reached 32 mg/kg (equivalent to 13 times the maximum clinically recommended dose based on body surface area) for 52 weeks. Genetic toxicity: The results of Ames test, mammalian cell forward gene mutation test (CHO/HPRT and AS52/XPRT), CHL cell in vitro cytogenetics test, unscheduled DNA synthesis test and in vivo micronucleus test were all negative. Reproductive toxicity: Before mating and throughout pregnancy, oral administration of this product at a dose of 40 mg/kg/day (equivalent to 9 times the maximum clinically recommended dose based on body surface area) did not have adverse effects on the fertility of female and male rats. Oral administration during the period of organogenesis, the dose of rats reached 80 mg/kg/day and rabbits reached 160 mg/kg/day (equivalent to 17 and 40 times the maximum clinically recommended dose, respectively, based on body surface area), and no teratogenicity was observed. When the oral dose of ≥40 mg/kg/day was administered to rats, delayed delivery and embryotoxicity were observed, manifested as increased post-implantation loss rate, developmental delay and low birth weight. No toxic reactions were observed in the function and behavior of the offspring. Embryotoxicity was observed when the oral dose of 160 mg/kg was administered to rabbits. Embryotoxicity was observed when the oral dose of 160 mg/kg was administered to rats in late pregnancy and lactation. When the oral dose of ≥10 mg/kg was administered to rats in late pregnancy and lactation (equivalent to 2 times the maximum clinically recommended dose, based on body surface area), the offspring had delayed development after birth (weight loss). Carcinogenicity: A 2-year carcinogenicity study was conducted on female and male rats, with an oral dose of 63 mg/kg/day (equivalent to 14 times the maximum clinically recommended dose based on body surface area). The results showed that no tumors caused by administration appeared in other organs except the bladder. Benign and/or malignant transitional cell tumors were found in male rats when the dose was ≥4 mg/kg/day (almost equal to the maximum clinically recommended dose based on body surface area). The relevance of these results to humans is unclear. A 2-year carcinogenicity study was conducted on female and male mice, with an oral dose of 100 mg/kg/day (equivalent to 11 times the maximum clinically recommended dose based on body surface area). No tumors caused by administration appeared in any organ. In a prospective evaluation of urine cytology of more than 1,800 patients who received this product for one year in clinical trials, no bladder tumors were found.

Pioglitazone hydrochloride.

This product is white or off-white tablets.

For patients with type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM), pioglitazone hydrochloride can be combined with diet control and physical exercise to improve and control blood sugar. Pioglitazone hydrochloride can be used alone, or in combination with sulfonylurea, metformin or insulin when diet control, physical exercise and monotherapy cannot satisfactorily control blood sugar.

One tablet should be taken daily, regardless of whether the medicine is taken with food. This product is a dispersible tablet. When using it, add it to an appropriate amount of water, stir it evenly and then take it.

Not yet clear.

Not yet clear.

Precautions for children: Not yet determined. Precautions for pregnancy and lactation: Not yet determined. Precautions for the elderly: Not yet determined.

Drug interactions may occur if used with other drugs. Please consult your doctor or pharmacist for details.

seal.

15 mg (as pioglitazone)

24 months

Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.

• Founded in:

  1998-12-30

• Address:

  South side of Dongshan, Jinshanqiao Development Zone, Xuzhou City, Jiangsu Province

• Tax NO.:

  91320300714139872F

• Registered Funds:

  480.4554 million yuan

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