Generic Name and Formulations:
Pioglitazone (as HCl), metformin HCl extended-release; 15mg/1000mg, 30mg/1000mg; tabs.
Company:
Takeda Pharmaceuticals North America, Inc.
Indications for ACTOPLUS MET XR:
Adjunct to diet and exercise to improve glycemic control in type 2 diabetes in patients already on pioglitazone and metformin, or when response to pioglitazone or metformin alone is inadequate.
Adult Dose for ACTOPLUS MET XR:
Swallow whole. Give once daily with the evening meal. Individualize. Previously on pioglitazone and/or metformin: switch on a mg/mg basis. Initially 15mg/1000mg or 30mg/1000mg once daily; may adjust after 8–12 weeks; max 45mg pioglitazone/2000mg metformin per day. Elderly, debilitated, malnourished: max doses not recommended.
Children's Dose for ACTOPLUS MET XR:
Not recommended.
See Also:
ACTOPLUS MET
Pharmacological Class:
Thiazolidinedione + biguanide.
Contraindications:
NYHA Class III or IV heart failure. Renal disease or dysfunction. Metabolic acidosis, ketoacidosis. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hours after use).
Warnings/Precautions:
Not for treating type 1 diabetes. Symptomatic HF: not recommended. CHF: NYHA Class II: start at lowest approved dose and titrate carefully. Edema. May increase plasma volume (monitor for signs/symptoms of heart failure); discontinue if cardiac status deteriorates, or if lactic acidosis, shock, acute MI, sepsis, or hypoxemia occurs. Confirm normal renal function before starting and monitor (esp. in patients ≥80yrs). Avoid in 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, follow-up and monitor closely; discontinue if ALT >3xULN persists or if jaundice occurs. Not for use in patients with history of troglitazone-associated jaundice. Suspend therapy if dehydration occurs or before surgery. Monitor blood (esp. serum Vit. B12 in susceptible patients). Stress. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy (Cat.C; not recommended; consider using insulin instead). Nursing mothers: not recommended.
Interactions:
See Contraindications. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Antagonizes oral contraceptives, midazolam. Monitor for heart failure with insulin. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Cationic drugs eliminated by renal tubular secretion, furosemide, nifedipine: may increase metformin levels. Increased risk of hyperglycemia with diuretics, steroids, phenothiazines, phenytoin, sympathomimetics, calcium channel blockers, niacin, thyroid products, estrogens, oral contraceptives, isoniazid. β-blockers may mask hypoglycemia.
Adverse Reactions:
Upper respiratory tract infection, GI upset, edema, headache, urinary tract infection, dizziness, weight gain, lactic acidosis (rare, half the cases are fatal); also women: risk of fracture.
How Supplied:
Tabs—60, 180; XR tabs—30, 60, 90