Description

Actos 45 mg (28 tablets)

Composition

Each tablet contains 45 mg of pioglitazone hydrochloride as the active ingredient.

Description

Actos is an oral antidiabetic agent from the thiazolidinedione class. It is used to treat type 2 diabetes mellitus by improving insulin sensitivity. Pioglitazone works primarily by decreasing insulin resistance in muscle and adipose tissue, and to a lesser extent by reducing hepatic glucose production. It does not stimulate insulin secretion.

Indications

• Monotherapy or combination therapy with metformin, sulfonylureas, or insulin in type 2 diabetes mellitus
• For adults who are inadequately controlled with diet and exercise alone

Contraindications

• Type 1 diabetes mellitus
• Diabetic ketoacidosis
• Known hypersensitivity to pioglitazone or any component of the product
• Active bladder cancer or history of bladder cancer
• Severe heart failure (NYHA Class III or IV)

Precautions

• Monitor for signs of heart failure, especially in combination therapy with insulin
• Increased risk of fractures, especially in women
• Regular liver function monitoring is advised
• Use caution in patients with macular edema or risk factors for bladder cancer

Adverse Reactions

• Edema, weight gain, headache, upper respiratory tract infection
• Fractures (especially distal upper and lower limb)
• Increased risk of congestive heart failure
• Bladder cancer (in long-term use)
• Hepatic dysfunction
• Ovulation in premenopausal anovulatory women

Drug Interactions

• Insulin and sulfonylureas: increased risk of hypoglycemia
• Gemfibrozil: increases pioglitazone plasma levels
• Rifampin: reduces pioglitazone efficacy
• Oral contraceptives: possible decreased efficacy

Dosage and Administration

• Start with 15 mg or 30 mg once daily with or without food
• May increase to 45 mg once daily depending on glycemic response
• Do not exceed 45 mg per day

Overdose

No specific antidote exists. Supportive and symptomatic treatment is recommended. Overdose symptoms may include hypoglycemia if taken with insulin or sulfonylureas.

Storage

• Store below 30°C (86°F)
• Protect from moisture and light
• Keep out of reach of children

Packaging

Each blister pack contains 28 tablets of Actos 45 mg.

Warnings

• May cause or exacerbate congestive heart failure
• Risk of bladder cancer with prolonged use
• Hepatic dysfunction possible—monitor liver enzymes regularly
• Hypoglycemia when used with insulin or sulfonylureas
• May cause ovulation in anovulatory women

Scientific References

• Pioglitazone efficacy in type 2 diabetes – PubMed
• Risk of bladder cancer with pioglitazone use – PubMed

Additional Information

Actos (pioglitazone) is a prescription-only medication. It should be used under the supervision of a healthcare provider. Regular monitoring of liver function and cardiac status is recommended during therapy. Women who may become pregnant should use effective contraception during treatment.

Disclaimer

This document is provided for informational purposes only and does not substitute professional medical advice. Always consult your doctor before starting or stopping any medication. This product should be used strictly as prescribed.