Product:
Duetact
Company:
Takeda
Pharmacologic class:
Antidiabetic (thiazolidinedione + sulfonylurea)
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Active ingredients:
Pioglitazone (as HCl) 30 mg, glimepiride 2 mg; tabs.
Also:
Duetact 30 mg/4 mg
Active ingredients:
Pioglitazone (as HCl) 30 mg, glimepiride 4 mg; tabs.
Indication:
Adjunct to diet and exercise in type 2 diabetes in patients already on pioglitazone + a sulfonylurea, or in patients on either pioglitazone or a sulfonylurea who need additional glycemic control.
Pharmacology:
Duetact is a combination product that combines the two antidiabetic agents pioglitazone and glimepiride.
Pioglitazone, a thiazolidinedione, decreases insulin resistance, while glimepiride, a sulfonylurea, stimulates the release of insulin from functioning pancreatic beta cells.
Clinical trials:
The approval of this product was based on the established safety and efficacy of the individual components.
The co-administration of pioglitazone and a sulfonylurea, including glimepiride, was evaluated for safety and efficacy in two clinical studies that established an added benefit of pioglitazone in glycemic control of patients whose type 2 diabetes was inadequately controlled on a sulfonylurea. Both the 30 mg/2 mg and the 30 mg/4 mg strengths of Duetact were shown to be bioequivalent to the individually administered single-drug products.
Adults:
Individualize.
Take with first main meal of the day. Previously on glimepiride or glimepiride + pioglitazone: Initially one 30 mg/2 mg or one 30 mg/4 mg tab once daily.
Previously on pioglitazone or pioglitazone + other sulfonylurea: initially one 30 mg/2 mg tab once daily. Renal or hepatic dysfunction, elderly, debilitated,malnourished: use glimepiride monotherapy first (see literature). Max 1 tab once daily.
Children:
Not recommended.
Contraindication:
Diabetic ketoacidosis.
Precautions:
Not for treating type 1 diabetes.
Hepatic disease. Do not initiate therapy in active liver disease or if ALT >2.5 x ULN. Monitor ALT at baseline, then periodically. If ALT 1-2.5 x ULN, followup and monitor closely; discontinue if ALT >3 x ULN persists or if jaundice occurs. Heart failure: if NYHA Class II: start at lowest approved dose; monitor and titrate carefully; if NYHA Class III or IV: not recommended. Edema. May increase plasma volume (monitor for heart failure). Discontinue if cardiac status deteriorates. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Elderly. Debilitated. Malnourished. Adrenal or pituitary insufficiency. Stress. Pregnancy (Cat. C): consider using insulin instead. Nursing mothers: not recommended.
Interactions:
Glimepiride potentiated by highly protein-bound drugs (e.g., NSAIDs, aspirin, salicylates, chloramphenicol,sulfonamides, coumarins, probenecid, MAOIs, beta blockers (monitor for hypoglycemia). May be antagonized by diuretics, corticosteroids, phenothiazines, thyroid drugs, estrogens, phenytoin, nicotinic acid, sympathomimetics, isoniazid. May be affected by CYP2C9 substrates (e.g., fluconazole, rifampicin); monitor.
Adverse reactions:
Increased risk of cardiovascular mortality. Hypoglycemia, upper respiratory tract infection, increased weight, edema, headache, GI upset.
How supplied:
Tabs—30, 90.
For more information, call (877) 825-3327.
