Generic Name and Formulations:
Pioglitazone (as HCl), glimepiride; 30mg/2mg, 30mg/4mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc.

Indications for DUETACT:
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.

Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:
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. Concomitant insulin or sulfonylurea: reduce dose of these if needed. Concomitant strong CYP2C8 inhibitors: max pioglitazone 15mg daily. Concomitant colesevelam: give dose at least 4hrs prior to colesevelam.

Children:
Not recommended.

Contraindications:
NYHA Class III or IV heart failure. Sulfonamide allergy.

Warnings/Precautions:
Symptomatic HF: not recommended. Monitor for signs/symptoms of CHF; discontinue or reduce dose if occurs. Edema. Glimepiride: potential increased risk of cardiovascular mortality. Hepatic disease. Monitor liver function before initiating therapy; if abnormalities detected, interrupt and assess probable cause; do not restart if ALT >3XULN with total bilirubin >2XULN. Routine monitoring LFTs during therapy without liver disease: not recommended. Active bladder cancer: not recommended. Risk of fractures (esp. females). Stress. Elderly, debilitated, uncompensated strenuous excercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. G6PD deficiency: consider non-sulfonylurea alternative. Renal impairment. Perform regular eye exams. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy (Cat.C): consider using insulin instead. Nursing mothers: not recommended.

Interactions:
Pioglitazone potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Antagonizes oral midazolam. Monitor for heart failure with insulin. Glimepiride potentiated by highly protein-bound drugs, NSAIDs, aspirin, salicylates, chloramphenicol, sulfonamides, coumarins, probenecid, MAOIs, β-blockers (monitor for hypoglycemia). Severe hypoglycemia with oral miconazole. May be antagonized by diuretics, corticosteroids, phenothiazines, thyroid drugs, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, isoniazid, colesevelam. May be affected by CYP2C9 substrates (eg, fluconazole, rifampin); monitor.

Pharmacological Class:
Thiazolidinedione + sulfonylurea.

Adverse Reactions:
Hypoglycemia, upper respiratory tract infection, accidental injury, weight gain, edema, headache, UTIs, GI upset; macular edema, hypersensitivity reactions (eg, angioedema, Stevens-Johnson syndrome); discontinue if occurs.

Generic Availability:
NO

How Supplied:
Tabs—30, 90