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.

The main ingredient of this product is pioglitazone 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.

This product is a dispersible tablet. When using, add it to an appropriate amount of water, stir it evenly and disperse it before taking it. It can also be taken directly with water. Pioglitazone hydrochloride should be taken once a day, and the medication has nothing to do with eating. Diabetes treatment should be individualized.

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: It is not yet clear whether pioglitazone hydrochloride is safe and effective for children. 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). Rats Oral 10 mg/kg in late pregnancy and lactation Elderly Note: 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.

Drug interactions may occur if used with other drugs. Please consult your doctor or pharmacist for details.

Keep sealed.

15 mg (as pioglitazone)

24 months

Tongliao Huabang Pharmaceutical Co., Ltd.

• Founded in:

  2005-04-15

• Address:

  Tiedong, Ganqika Town, Kezuohou Banner, Tongliao City, Inner Mongolia Autonomous Region

• Tax NO.:

  91150522772224493R

• Registered Funds:

  50 million yuan

• Email:

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