Monograph Details
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Endocrine System
> Diabetes
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DUETACT 30mg/4mg |
| Manufacturer |
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Takeda Pharmaceuticals America, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Thiazolidinedione + sulfonylurea. |
| Generic Name |
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Pioglitazone (as HCl) 30mg, glimepiride 4mg; tabs. |
| Also |
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• DUETACT 30mg/2mg
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| Indications |
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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. |
| Children |
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Not recommended. |
| Adults |
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Individualize. Take with first main meal of the day. Previously on glimepiride, or glimepiride + pioglitazone: Initially one 30mg/2mg or one 30mg/4mg tab once daily. Previously on pioglitazone, or pioglitazone + other sulfonylurea: initially one 30mg/2mg tab once daily. Renal or hepatic dysfunction, elderly, debilitated, malnourished: use glimepiride monotherapy first (see literature). Max 1 tab once daily. |
| Contraindications |
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Diabetic ketoacidosis. NYHA Class III or IV heart failure. |
| Precautions |
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Not for treating type 1 diabetes. Hepatic disease. Do not start therapy in active liver disease or if ALT >2.5XULN. Monitor ALT at baseline, then periodically. If ALT 1–2.5XULN, followup and monitor closely; discontinue if ALT >3XULN persists or if jaundice occurs. Heart failure: if NYHA Class II: start at lowest approved dose; monitor and titrate carefully. 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 |
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Glimepiride potentiated by highly protein-bound drugs (eg, NSAIDs, aspirin, salicylates, chloramphenicol, sulfonamides, coumarins, probenecid, MAOIs, β-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 (eg, fluconazole, rifampicin); monitor. |
| Adverse Reactions |
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Increased risk of cardiovascular mortality. Hypoglycemia, upper respiratory tract infection, increased weight, edema, headache, GI upset; also women: risk of fracture. |
| How Supplied |
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Tabs—30, 90 |
| Additional Resources |
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• Related Prescribing Note |
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