DUETACT 30/4/MG TAB 30/TAB

Indications

Approved Uses

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with pioglitazone (or another thiazolidinedione) and glimepiride (or another sulfonylurea), or who have inadequate glycemic control on pioglitazone or glimepiride alone.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: 1 tablet (30 mg/4 mg) orally once daily with the first main meal; dose selection should be individualized based on prior therapy and risk of hypoglycemia/edema, and if a different component dose is needed, use separate pioglitazone and/or sulfonylurea products.

Initial Dose

30mg pioglitazone / 2mg glimepiride once daily (for patients not previously on glimepiride 4mg); 30mg pioglitazone / 4mg glimepiride once daily for patients already on glimepiride 4mg

Maintenance Dose

30 mg/2 mg or 30 mg/4 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability

Maximum Dose

The maximum recommended dose is 45mg for pioglitazone and 8mg for glimepiride daily; however, the maximum available combination dose is 30mg/4mg.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Titrate based on glycemic response and hypoglycemia risk; use conservative dosing in elderly and in renal impairment due to the sulfonylurea component (higher hypoglycemia risk), and if co-administered with strong CYP2C8 inhibitors (e.g., gemfibrozil) pioglitazone exposure increases-avoid or use a lower pioglitazone dose, which may require switching to individual components.

How to Take

Swallow tablet whole with water. Take with the first main meal of the day. Do not crush or split tablets.

Side Effects

Common Side Effects

Upper respiratory tract infection, hypoglycemia, weight gain, peripheral edema, headache, diarrhea, nausea, sinusitis.

Side Effect Frequency

Very common (≥10%): Hypoglycemia. Common (1-10%): Weight gain, peripheral edema, upper respiratory tract infection, headache. Uncommon (<1%): Macular edema, bone fractures, elevated liver enzymes, anemia, blurred vision.

Safety & Warnings

Contraindications

Contraindications: (1) Initiation in patients with established NYHA Class III or IV heart failure; (2) Diabetic ketoacidosis; (3) Hypersensitivity to pioglitazone, glimepiride, or any component of the product.

Warnings & Precautions

Warnings/precautions: heart failure risk (monitor for rapid weight gain, dyspnea, edema; avoid in symptomatic HF and do not initiate in NYHA III/IV), hypoglycemia risk (especially with missed meals/alcohol/renal impairment or interacting drugs), hepatic monitoring (baseline and if symptoms), fracture risk (notably in women), macular edema/visual changes, and bladder cancer signal with pioglitazone (evaluate hematuria and avoid use in active bladder cancer).

Age Restriction

Not approved under 18 years.

Drug Interactions

Interaction Severity

MAJOR: Gemfibrozil/strong CYP2C8 inhibitors (↑ pioglitazone exposure-avoid or require lower pioglitazone dose, often necessitating separate components); Insulin/insulin secretagogues (additive hypoglycemia and fluid retention/heart failure risk-may require dose reduction/close monitoring). MODERATE: Rifampin (↓ pioglitazone exposure), azole antifungals/CYP2C9 inhibitors (↑ glimepiride-hypoglycemia), beta-blockers (mask hypoglycemia), NSAIDs (potentiate hypoglycemia), bile-acid sequestrants such as colesevelam (↓ glimepiride absorption-separate dosing).

Food Interaction

Take once daily with the first main meal (food reduces hypoglycemia risk from the sulfonylurea component).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Liver Impairment

Do not initiate if there is active liver disease or baseline ALT >2.5× ULN; if used, monitor liver enzymes and discontinue if ALT rises to >3× ULN with symptoms or persistent elevation.

Storage & Patient Advice

Stopping the Medicine

Do not stop DUETACT without prescriber guidance; stopping can worsen glycemic control and therapy should be adjusted by a clinician.

Overdose

Overdose may cause prolonged, potentially life-threatening hypoglycemia (from glimepiride) and may worsen fluid retention/edema (from pioglitazone); treat hypoglycemia with oral carbohydrates if able or IV dextrose/glucagon as needed and monitor for recurrence for at least 24-48 hours with supportive care and urgent emergency evaluation.

Patient Counseling

Take once daily with the first main meal; do not skip meals and know/treat hypoglycemia symptoms; monitor and promptly report rapid weight gain, swelling, or shortness of breath (heart failure/edema risk); report symptoms of liver injury (e.g., jaundice/dark urine) and visual changes; discuss fracture risk (especially in women) and avoid excess alcohol; inform clinicians about all medicines due to interaction risks (e.g., gemfibrozil, rifampin).

Pharmacology

Mechanism of Action

Pioglitazone activates PPAR-γ to improve insulin sensitivity in adipose tissue, skeletal muscle, and liver; glimepiride (a sulfonylurea) stimulates pancreatic insulin secretion by closing ATP-sensitive K+ channels in beta cells, leading to depolarization and calcium-mediated insulin release.

Duration of Effect

Approximately 24 hours (supports once-daily dosing), with pioglitazone’s full glycemic effect developing over weeks.

Metabolism

Pioglitazone: hepatic metabolism primarily via CYP2C8 and to a lesser extent CYP3A4 to active metabolites; Glimepiride: hepatic metabolism primarily via CYP2C9 to M1 (active) and M2 (inactive) metabolites.

Protein Binding

Pioglitazone: >99%. Glimepiride: >99.5%.

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: Pioglitazone 30mg (as pioglitazone hydrochloride) + Glimepiride 4mg

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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