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 hepatic glucose 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-gamma; [PPAR-gamma;] [1]. The activation of PPAR-gamma; 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, with the chemical name ()5-[4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride, molecular formula: C19H20N2O3SHCl, molecular weight: 392.90.

This product is white or off-white tablets.

Type 2 diabetes (or non-insulin-dependent diabetes mellitus, NIDDM).

The starting dose is 15 or 30 mg, and the maximum dose is 45 mg d-1, qd. Take it before breakfast. If you miss one dose, do not use a double dose on d2. Combination therapy: Sulfonylurea: When used in combination with sulfonylurea drugs, the initial dose of this product can be 1 or 2 tablets, once a day. The dose of sulfonylurea drugs can remain unchanged. When hypoglycemia occurs, the use of sulfonylurea drugs should be reduced. Metformin: When used in combination with metformin drugs, the initial dose of this product can be 1 or 2 tablets, and metformin drugs can remain unchanged. Generally speaking, metformin does not need to reduce the dose and will not cause hypoglycemia. Insulin: When used in combination with insulin, the initial dose of this product can be 1 or 2 tablets, and the insulin dose can remain unchanged. When hypoglycemia occurs or the blood sugar concentration drops below 100 mg/dL, the insulin dosage can be reduced by 10%-25%, and it can be adjusted according to individual conditions.

1 Hypoglycemia. 2 The incidence of anemia was 1.0% in the pioglitazone group and 0% in the placebo group. When used in combination with insulin, the incidence of anemia was 1.6% in both the pioglitazone and placebo groups. When used in combination with sulfonylureas, the incidence of anemia was 0.3% in the pioglitazone group and 1.6% in the placebo group. When used in combination with metformin, the incidence of anemia was 1.2% in the pioglitazone group and 0% in the placebo group. An average decrease in hemoglobin of 2% to 4%. 3 Edema. 4 May cause an increase in plasma volume, ultimately leading to preload-induced cardiac hypertrophy. 5 ALT elevation: 0.26% (4/1526) of patients in the pioglitazone group and 0.25 (2/793) of patients in the placebo group had ALT levels ge; 3 times the upper limit of normal.

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.

Calculated as C19H20N2O3S 15 mg

36 months.

Beijing Taiyang Pharmaceutical Industry Co., Ltd.

• Founded in:

  1992-06-13

• Address:

  Floor 1 to 3, Building 1, No. 10, Baocan South Street, Daxing Biomedicine Industry Base, Zhongguancun Science Park, Daxing District, Beijing

• Tax NO.:

  911101056259095800

• Registered Funds:

  130 million yuan

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