Monograph Details
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Endocrine System
> Diabetes
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ACTOPLUS MET 15mg/850mg |
| 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 + biguanide. |
| Generic Name |
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Pioglitazone (as HCl) 15mg, metformin HCl 850mg; tabs. |
| Also |
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• ACTOPLUS MET 15mg/500mg
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| Indications |
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Adjunct to diet and exercise to improve glycemic control in type 2 diabetes in patients already on pioglitazone and metformin, or when response to metformin alone is inadequate, or for those who have responded to pioglitazone alone but need additional glycemic control. |
| Children |
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Not recommended. |
| Adults |
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Give in divided doses with meals. Previously on metformin alone: initially either 15mg/500mg or 15mg/850mg once or twice daily. Previously on pioglitazone alone: initially either 15mg/500mg twice daily or 15mg/850mg once daily. Previously on pioglitazone and metformin: switch on a mg/mg basis. For all: may increase after 8–12 weeks; max 45mg pioglitazone/2550mg metformin per day. Elderly: max doses are not recommended. |
| Contraindications |
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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). |
| Precautions |
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Not for treating type 1 diabetes or diabetic ketoacidosis. 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. Heart failure: NYHA Class II: start at lowest approved dose and titrate carefully. Edema. May increase plasma volume (monitor for heart failure); discontinue if cardiac status deteriorates, or if lactic acidosis, shock, acute MI, sepsis, or hypoxemia occurs. 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 |
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See Contraindications. 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 |
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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 |
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Tabs—60, 180 |
| Additional Resources |
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• Related Prescribing Note |
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