ACTOS 15/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus: adjunct to diet and exercise to improve glycemic control; may be used as monotherapy or in combination with other antidiabetic agents (e.g., metformin, sulfonylurea, insulin).

Dosage & Administration

Initial Dose

15mg or 30mg once daily. [5, 6, 8]

Maintenance Dose

15mg to 45mg once daily.

How to Take

Swallow tablet whole with water; take orally once daily, with or without food, preferably at the same time each day.

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to pioglitazone; initiation in NYHA Class III or IV heart failure. Not indicated for type 1 diabetes or diabetic ketoacidosis. Avoid/use contraindicated per local labeling in active bladder cancer (and generally avoid with history of bladder cancer or uninvestigated macroscopic hematuria). Do not initiate with active liver disease or ALT >2.5× ULN.

Drug Interactions

Drug Interactions

Key interactions: insulin/insulin secretagogues (↑ hypoglycemia and edema/HF risk-may need dose reduction); strong CYP2C8 inhibitors (e.g., gemfibrozil) ↑ pioglitazone exposure; CYP2C8 inducers (e.g., rifampin) ↓ exposure/efficacy; may reduce ethinyl estradiol/norethindrone concentrations (reduced oral contraceptive efficacy).

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Liver Impairment

Do not initiate if active liver disease or ALT >2.5× ULN; if ALT rises >3× ULN during therapy, interrupt and evaluate; no specific dose adjustment is recommended for mild impairment but use caution with monitoring.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Monitoring Requirements

Monitor HbA1c about every 3 months until at goal then at least twice yearly; self-monitor/fasting glucose as clinically indicated; liver enzymes (ALT) at baseline and periodically and if symptoms occur; monitor weight/edema and signs of heart failure; consider eye evaluation if visual symptoms (macular edema); consider fracture risk (especially in women).

Pharmacology

Mechanism of Action

Selective PPAR-γ agonist that increases insulin sensitivity in adipose tissue, skeletal muscle, and liver, increasing peripheral glucose uptake and decreasing hepatic glucose output.

Product Information

Diabetes Type

Type 2

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