Kecheng Pioglitazone Hydrochloride Tablets

1. Indications and Usage
Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Therapy: Can be used alone or in combination with sulfonylureas, metformin, or insulin.
2. Dosage and Administration
Dosage: The recommended starting dose is 15 mg or 30 mg once daily.
Maximum Dosage: The dose should not exceed 45 mg once daily.
Administration: Take once daily, with or without food.
Special Populations: No dose adjustment is necessary for patients with renal impairment. It is not recommended for pediatric patients.
3. Mechanism of Action
PPAR-γ Agonist: Pioglitazone is a peroxisome proliferator-activated receptor-gamma (PPAR-γ) agonist.
Metabolic Effects: It acts on target tissues including adipose, muscle, and liver to increase insulin sensitivity, thereby reducing peripheral insulin resistance and hepatic glucose production.
4. Safety and Warnings
Heart Failure: Thiazolidinediones, including pioglitazone, can cause fluid retention and exacerbate or precipitate heart failure. It is contraindicated in patients with NYHA Class III or IV heart failure.
Hepatotoxicity: Liver enzyme elevation may occur. Liver function tests should be monitored before starting and periodically thereafter.
Bladder Cancer: Long-term use has been associated with an increased risk of bladder cancer.
Hypoglycemia: Risk increases when combined with insulin or sulfonylureas.
OVulatory Function: May induce ovulation in premenopausal anovulatory women.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include edema, weight gain, anemia, upper respiratory tract infection, headache, and myalgia.
Clinical Research: Clinical trials demonstrate that pioglitazone significantly reduces fasting plasma glucose, postprandial glucose, and HbA1c levels.
6. Drug Interactions
CYP2C8 Inhibitors: Drugs like gemfibrozil may significantly increase pioglitazone plasma concentrations.
CYP2C8 Inducers: Drugs like rifampin may decrease pioglitazone plasma concentrations.
Oral Contraceptives: May decrease the effectiveness of hormonal contraceptives.
Other Antidiabetics: May potentiate hypoglycemic effects when used in combination.
7. Pharmaceutical Information
Active Ingredient: Pioglitazone Hydrochloride.
Excipients: Lactose, starch, magnesium stearate, and other film-coating agents.
Appearance: White to off-white tablets.
Storage: Store in a tight container, protected from light and moisture.