Pioglitazone Hydrochloride Capsules

This product belongs to the class of thiazolidinediones oral antidiabetic drugs, and is a highly selective peroxisome proliferator-activated receptor γ (PPARγ) agonist, which 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.

The main ingredient of this product is pioglitazone hydrochloride. Its chemical name is () 5-[4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride. Molecular formula: C19H20N2O3SHCl. Molecular weight: 392.90

This product is capsule

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. The average decrease in hemoglobin was 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 ≥ 3 times the upper limit of normal. Occasionally, transient increases 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: The safety and effectiveness of pioglitazone hydrochloride in children are uncertain. Precautions for pregnancy and lactation: 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. Post-term labor and embryotoxicity (manifested as increased post-implantation abortions, delayed development, and decreased birth weight) were observed in rats when they were given oral doses of 30 mg/kg/day and above (based on mg/m2, approximately equivalent to 10 times the maximum recommended oral dose for humans). No functional or behavioral toxicity was observed in the offspring of rats. Embryotoxicity was observed in rabbits when the oral dose reached 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 (based on mg/m2, approximately 2 times the maximum recommended oral dose for humans) 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. 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 dysglycemia during pregnancy is associated with increased congenital anomalies and neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to control blood sugar to normal levels as much as possible. In lactating mothers, pioglitazone can be secreted into breast milk in lactating rats. It is not clear whether humans can secrete pioglitazone hyclate into breast milk. Because many drugs can be 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 or older. There was no significant difference in the efficacy 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.

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

15mg (based on pioglitazone)

18 months

Shandong Zibo Xinda Pharmaceutical Co., Ltd.

• Founded in:

  1993-03-11

• Address:

  No. 1, Lutai Avenue, Zibo High-tech Zone

• Tax NO.:

  9137030361328152XT

• Registered Funds:

  84.93 million yuan

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