Actos Pioglitazone Hydrochloride Tablets

1. Indications and Usage
Type 2 Diabetes: Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Therapy: It may be used alone or in combination with a sulfonylurea, metformin, or insulin.
2. Dosage and Administration
Monotherapy: The initial dose may be 15 mg or 30 mg once daily. If the initial dose is ineffective, the dose may be increased up to 45 mg once daily.
Combination Therapy: The initial dose is 15 mg or 30 mg once daily.
Maximum Dosage: The maximum recommended daily dose is 45 mg.
Administration: Take once daily, with or without food.
Special Populations: No dosage adjustment is necessary for patients with renal impairment.
3. Mechanism of Action
PPAR-γ Agonist: Pioglitazone belongs to a class of antidiabetic agents known as thiazolidinediones. It acts as an agonist for peroxisome proliferator-activated receptor-gamma (PPAR-γ).
Metabolic Effects: Activation of PPAR-γ regulates insulin-responsive genes involved in glucose production, transport, and utilization. This results in decreased hepatic glucose production and increased peripheral glucose uptake, thereby reducing insulin resistance.
4. Safety and Warnings
Heart Failure: Thiazolidinediones can cause fluid retention and may exacerbate or precipitate heart failure. It is contraindicated in patients with New York Heart Association (NYHA) Class III or IV heart failure.
Hepatotoxicity: Elevations in liver transaminases may occur. Liver function tests should be monitored before starting treatment and periodically thereafter.
Bladder Cancer: Long-term use has been associated with an increased risk of bladder cancer.
Hypoglycemia: The risk of hypoglycemia increases when pioglitazone is 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 mild to moderate edema, anemia, upper respiratory tract infection, headache, myalgia, and sinusitis.
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: Microcrystalline cellulose, lactose, magnesium stearate, and film-coating agents.
Appearance: White to off-white tablets.
Storage: Protect from light and moisture. Store in a tight container.