Pioglitazone Hydrochloride Capsules

This product belongs to the class of thiazolidinediones oral antidiabetic drugs, which is a highly selective peroxisome proliferator-activated receptor (PPAR) agonist, and controls blood sugar levels by increasing peripheral and liver insulin sensitivity. Its main mechanism of action is to activate PPAR nuclear receptors in tissues such as fat, skeletal muscle and liver where insulin acts, thereby regulating the transcription of insulin response genes and controlling the production, transport and utilization of blood sugar.

The main ingredient of this product is pioglitazone hydrochloride, whose chemical name is: 5-{4-[2-(5-ethyl-2-pyridine)-ethoxy]-phenyl}-2,4-thiazolidinedione hydrochloride

This product is a capsule, and the contents are white powder or white granules.

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.

Dosage: Once a day, 1-2 capsules each time

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. Occasionally, a transient increase in creatine kinase levels occurred. 6 No teratogenic effects were observed.

;;;Pioglitazone hydrochloride is contraindicated in patients who are allergic to this product or other thiazolidinedione drugs or any ingredients in this product.

Precautions for children: The safety and effectiveness of pioglitazone hydrochloride in children are uncertain. Precautions for pregnancy and lactation: Pioglitazone hydrochloride should be used during pregnancy only if the potential benefits to the fetus outweigh the potential risks. Because existing data strongly suggest that abnormal blood sugar levels during pregnancy are associated with congenital abnormalities and increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to control blood sugar levels to normal levels as much as possible. In lactating rats, pioglitazone is secreted into breast milk. It is not clear whether humans can secrete pioglitazone hydrochloride into breast milk. Because many drugs can be secreted into breast milk, women who are breastfeeding should not use pioglitazone hydrochloride. Precautions for the elderly: In placebo-controlled clinical trials of pioglitazone hydrochloride, approximately 500 patients were aged 65 years or older. There was no significant difference in the effectiveness and safety of pioglitazone hydrochloride between these patients and younger patients.

Oral contraceptives: When another thiazolidinedione and an oral contraceptive containing ethinyl estradiol or norethindrone are used simultaneously, the plasma concentrations of both will decrease by approximately 30%, which may result in the loss of contraceptive effect. The pharmacokinetics of pioglitazone hydrochloride and oral contraceptives have not been evaluated. Therefore, contraception should be more cautious for patients who use pioglitazone hydrochloride and oral contraceptives simultaneously. Glipizide: For healthy subjects, the simultaneous use of pioglitazone hydrochloride (45 mg once a day) and glipizide (5.0 mg once a day) for 7 days did not change the steady-state pharmacokinetics of glipizide. Digoxin: For healthy subjects, the simultaneous use of pioglitazone hydrochloride (45 mg once a day) and digoxin (0.25 mg once a day) for 7 days did not change the steady-state pharmacokinetics of digoxin. Warfarin: For healthy subjects, the simultaneous use of pioglitazone hydrochloride (45 mg once a day) and warfarin did not change the steady-state pharmacokinetic parameters of warfarin. Moreover, in patients receiving long-term warfarin therapy, taking pioglitazone hydrochloride did not have a clinically significant effect on prothrombin time. Metformin: For healthy subjects who took pioglitazone hydrochloride (45 mg once a day) for 7 days, and then gave metformin (1000 mg) and pioglitazone hydrochloride (45 mg) at the same time, the single-dose pharmacokinetic parameters of metformin were not changed. The metabolism of pioglitazone requires the CYP3A4 isoform of cytochrome P450. Other drugs that require this enzyme for metabolism include: erythromycin, astemizole, calcium channel blockers, cisapride, adrenocortical hormones, cyclosporine, HMG-COA reductase inhibitors, tacrolimus, triazolam, trimetrexate, etc. Drugs that inhibit this enzyme include: ketoconazole, itraconazole, etc. The interaction between pioglitazone hydrochloride and the above drugs has not been tested in specific, formal pharmacokinetic studies. In vitro, ketoconazole significantly inhibits the metabolism of pioglitazone. Because more data need to be collected, patients taking ketoconazole and pioglitazone hydrochloride at the same time should have their blood sugar control evaluated more frequently.

Sealed and stored in a dry place.

15mg*10s

36 months