Pioglitazone Hydrochloride Tablets

This product is a thiazolidinedione antidiabetic drug, an insulin sensitizer. Its mechanism of action is related to the presence of insulin. It can reduce insulin resistance in peripheral tissues and the liver, increase insulin-dependent glucose processing, and reduce glycogen output. Unlike sulfonylureas, this product is not an insulin secretagogue. Its mechanism of action is highly selective stimulation of peroxisome proliferator-activated growth factor receptor-γ [PPAR-γ][1]. The activation of PPAR-γ can regulate the transcription of many insulin-related genes that control glucose and lipid metabolism. Experiments have shown that this product can reduce insulin-resistant hyperglycemia, hyperinsulinemia and high triglycerides. The metabolic changes caused by this product lead to an increase in insulin-dependent tissue responses. Because this product increases the effect of circulating insulin (i.e., reduces insulin resistance), it cannot lower blood sugar in the absence of endogenous insulin.

The main ingredient of this product is pioglitazone hydrochloride, and its chemical name is (±) 5-[4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride.

This product is white or off-white tablets.

For the treatment of type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM), pioglitazone hydrochloride can be used alone; when diet control, physical exercise and monotherapy cannot satisfactorily control blood sugar, it can also be used in combination with sulfonylureas, metformin or insulin.

Oral administration, once daily, the maximum recommended dose is 3 tablets (45 mg) at a time; the medication is not taken with or without meals.

The main ones are: ① Hypoglycemia. ② The incidence of anemia in the pioglitazone group was 1.0%, and that in the placebo group was 0. When used in combination with insulin, the incidence of anemia in both the pioglitazone and placebo groups was 1.6%. When used in combination with sulfonylureas, the incidence of anemia in the pioglitazone group was 0.3%, and that in the placebo group was 1.6%. When used in combination with metformin, the incidence of anemia in the pioglitazone group was 1.2%, and that in the placebo group was 0. Hemoglobin decreased by an average of 2% to 4%. ③ Edema. ④ It may cause an increase in plasma volume, ultimately leading to preload-induced cardiac hypertrophy. ⑤ ALT increased. 0.26% (4/1526) of patients in the pioglitazone group and 0.25 (2/793) of patients in the placebo group had ALT levels ≥ 3 times the upper limit of normal. Occasionally, a transient increase in creatine kinase levels occurred. ⑥ No teratogenic effects were observed.

Patients who are allergic to this product or its ingredients are contraindicated.

Precautions for children: It is still unclear whether pioglitazone hydrochloride is safe and effective for children. Precautions for pregnancy and lactation: Pregnant women: Pregnancy type C. During organogenesis, rats were given 80 mg/kg orally and rabbits were given 160 mg/kg orally (based on mg/m2, approximately 17 times and 40 times the maximum recommended oral dose for humans, respectively), and no teratogenicity was observed with pioglitazone. When rats were given oral doses of more than 30 mg/kg/day (based on mg/m2, approximately equivalent to 10 times the maximum recommended oral dose for humans), delayed labor and embryotoxicity (manifested as increased post-implantation abortions, delayed development, and decreased birth weight) were observed. No functional or behavioral toxicity was observed in the offspring of rats. Embryotoxicity was observed when rabbits were given oral doses of 160 mg/kg (based on mg/m2, approximately equivalent to 40 times the maximum recommended oral dose for humans). When rats were given oral doses of 10 mg/kg and above (approximately 2 times the maximum recommended oral dose for humans, based on mg/m2) during late pregnancy and lactation, their offspring had reduced body weight and postnatal growth retardation. In women, there are no adequate and well-controlled studies, and pioglitazone hydrochloride should be used during pregnancy only when the potential benefits to the fetus outweigh the potential risks. Because the available data strongly suggest that dysglycemia during pregnancy is associated with increased congenital anomalies and neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to try to control blood sugar to normal levels. Lactating mothers: In lactating rats, pioglitazone is secreted into breast milk. It is not clear whether humans can secrete pioglitazone hydrochloride into human milk. Because many drugs are secreted into breast milk, women who are breastfeeding should not use pioglitazone hydrochloride. Elderly precautions: In placebo-controlled clinical trials of pioglitazone hydrochloride, approximately 500 patients were aged 65 years and older. There was no significant difference in the efficacy and safety of pioglitazone hydrochloride between these patients and younger patients.

① When used in combination with ethinyl estradiol and norethindrone, the plasma concentration of the two hormones can be reduced by about 30%. ② This product has no effect on glipizide, digoxin, warfarin and metformin. ③ CYP3A4 has a certain effect on the metabolism of this product. ④ Ketoconazole can significantly inhibit the metabolism of this product in vitro. ⑤ No drug-induced tumors were found in other organs except the bladder.

Store in a sealed, dry place at 25℃ (15～30℃) to avoid moisture. Valid for 3 years.

15mg

36 months.

Chongqing KERUI Pharmaceutical (GROUP) Co., Ltd.

• Founded in:

  1999-03-03

• Address:

  No. 2 Dashizhi Road, Nan'an Economic and Technological Development Zone, Chongqing

• Tax NO.:

  915001082031636780

• Registered Funds:

  110.6375 million yuan

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