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 (based on body surface area, equivalent to 17 and 40 times the maximum clinically recommended dose, respectively), and no teratogenicity was observed. Oral administration of ≥40 mg/kg/day to rats can cause delayed delivery and embryotoxicity, manifested as increased post-implantation loss rate, developmental delays, and low birth weight. No toxic reactions were observed in the function and behavior of offspring. Embryotoxicity was observed when the oral dose of rabbits was 160 mg/kg.

Pioglitazone hydrochloride. Molecular weight: C19H20N2O3S·HCl

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.

This product is a dispersible tablet. When using, add it to an appropriate amount of water, stir evenly and then take it.

When pioglitazone hydrochloride was used in combination with sulfonylureas (N=373), metformin (N=168), or insulin (N=379), the types of clinical adverse reactions were similar to those of pioglitazone hydrochloride monotherapy, with the only exception of an increased incidence of edema when used in combination with insulin (15% for pioglitazone hydrochloride and 7% for placebo). The incidence of withdrawal from the clinical trial due to adverse reactions (except hyperglycemia) was similar in the placebo group (2.8%) and the pioglitazone hydrochloride group (3.3%). Mild to moderate hypoglycemia has occurred in patients when used in combination with sulfonylureas or insulin. When used in combination with a sulfonylurea, the incidence of hypoglycemia was 1% in the placebo group and 2% in the pioglitazone hydrochloride group. When used in combination with insulin, the incidence of hypoglycemia was 5% in the placebo group, 8% in the pioglitazone hydrochloride 15 mg group, and 15% in the pioglitazone hydrochloride 30 mg group. Double-blind studies conducted in the United States showed that when used as monotherapy, the incidence of anemia in patients treated with pioglitazone hydrochloride was 1.0%, while that in patients treated with placebo was 0.0%. When used in combination with insulin, the incidence of anemia in the pioglitazone hydrochloride group was 1.6%, while that in patients treated with placebo was 1.6%. When used in combination with sulfonylureas, the incidence of anemia in the pioglitazone hydrochloride group was 0.3%, while that in patients treated with placebo was 1.6%.

Not yet clear.

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

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

seal.

15mg (as pioglitazone)

24 months

Beijing Tide Pharmaceutical Co., Ltd.

• Founded in:

  1995-05-29

• Address:

  No. 8 Rongjing East Street, Beijing Economic and Technological Development Zone, Beijing

• Tax NO.:

  911103026000314683

• Registered Funds:

  500 million yuan

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