Pioglitazone Hydrochloride Dispersible Tablets

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 generation, transport and utilization of blood sugar.

Pioglitazone hydrochloride, its chemical name is: (±) 5-{4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl}-2,4-thiazolidinedione 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.

Oral administration, regardless of food intake. Once daily, the starting dose is 15mg or 30mg; if the initial dose is not effective, the dose can be increased to 45mg.

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%.

Pioglitazone hydrochloride is contraindicated in patients who are allergic to this product or any of its ingredients.

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

1. Oral contraceptives: When another thiazolidinedione and an oral contraceptive containing ethinyl estradiol and norethindrone are used simultaneously, the plasma concentrations of both will decrease by approximately 30%, which may cause the contraceptive effect to disappear. The pharmacokinetic evaluation of the simultaneous use of pioglitazone hydrochloride and oral contraceptives has not been conducted. Therefore, for patients who use pioglitazone hydrochloride and oral contraceptives simultaneously, contraception should be more cautious. 2. 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 pharmacokinetic parameters of glipizide. 3. 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 pharmacokinetic parameters of glipizide.

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30mg (calculated as piroglitazone)

24 months

Shuanghe Tian'an Pharmaceutical (Guizhou) Co., Ltd.

• Founded in:

  2002-12-13

• Address:

  No. 25 Gaoxin Road, Wudang District, Guiyang City, Guizhou Province

• Tax NO.:

  91520000750185534P

• Registered Funds:

  36.7 million yuan

• Email:

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