ACTOS 30/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus (as monotherapy or in combination with metformin, sulfonylurea, or insulin)

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (monotherapy or combination): start 15-30 mg orally once daily (15 mg if heart failure risk); titrate by 15 mg based on glycemic response to 45 mg once daily (max 45 mg/day).

Initial Dose

15mg or 30mg once daily.

Maintenance Dose

15-45mg once daily

Maximum Dose

45mg once daily.

Dose Adjustment Notes

Assess response and titrate in 15 mg increments up to 45 mg once daily, allowing ~8-12 weeks for full effect; in NYHA class I-II heart failure start 15 mg once daily; with strong CYP2C8 inhibitors (e.g., gemfibrozil) do not exceed 15 mg/day; when used with insulin or sulfonylurea, consider reducing the other agent to limit hypoglycemia and fluid retention/heart failure risk.

How to Take

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

Side Effects

Common Side Effects

Weight gain, edema (peripheral), upper respiratory tract infection, headache, sinusitis, myalgia/back pain; hypoglycemia mainly when combined with insulin or a sulfonylurea.

Safety & Warnings

Contraindications

Contraindications: (1) Hypersensitivity to pioglitazone or any component; (2) Initiation in patients with established NYHA Class III or IV heart failure. Not indicated (not contraindications): type 1 diabetes and diabetic ketoacidosis. Avoid/use with caution (warnings/precautions, not absolute contraindications in FDA labeling): active bladder cancer; active liver disease or ALT >2.5× ULN at baseline.

Warnings & Precautions

Warnings/precautions: boxed warning for CHF (monitor for rapid weight gain, dyspnea, edema; avoid initiation in NYHA III/IV; caution in patients at risk); fluid retention/edema (increased with insulin); bladder cancer risk signal-avoid in active bladder cancer and use caution with prior history; monitor liver enzymes before initiation and if symptoms occur (do not start if ALT >2.5× ULN; stop if significant elevations/jaundice); macular edema (prompt ophthalmologic evaluation if visual symptoms); increased fracture risk (especially women); may restore ovulation in anovulatory premenopausal women-counsel on contraception.

Drug Interactions

Food Interaction

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

Special Populations

Liver Impairment

Do not initiate if baseline ALT >2.5× ULN or in active liver disease; obtain LFTs before starting and if symptoms occur; if ALT rises to >3× ULN or jaundice develops, interrupt/discontinue and evaluate. No specific dose adjustment is defined for mild hepatic impairment-use caution.

Storage & Patient Advice

Missed Dose

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

Patient Counseling

Take once daily with or without food, ideally at the same time daily; expect gradual benefit (may take 8-12 weeks). Common effects include weight gain and ankle/leg swelling-seek urgent care for rapid weight gain, worsening swelling, or shortness of breath (heart failure). Report symptoms of liver injury (e.g., persistent nausea/vomiting, abdominal pain, dark urine, jaundice). Hypoglycemia is more likely if used with insulin or sulfonylureas. Increased fracture risk (especially in women). Report blood in urine or new urinary symptoms. Use effective contraception if of childbearing potential as ovulation may resume.

Pharmacology

Mechanism of Action

Selective agonist of PPAR-γ (nuclear receptor) that alters gene transcription to increase insulin sensitivity in adipose tissue, skeletal muscle, and liver, reducing insulin resistance and hepatic glucose output.

Product Information

Available Dosage Forms

Tablet

Diabetes Type

Type 2

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