Monograph Details
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Endocrine System
> Diabetes
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ACTOS |
| 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. |
| Generic Name |
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Pioglitazone (as HCl) 15mg, 30mg, 45mg; tabs. |
| Indications |
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Adjunct to diet and exercise in type 2 diabetes, as monotherapy or in combination with metformin, insulin, or a sulfonylurea. |
| Children |
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<18 years: not recommended. |
| Adults |
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≥18years: initially 15mg or 30mg once daily; max 45mg once daily. Reduce insulin or sulfonylurea dose if needed. |
| Contraindications |
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NYHA Class III or IV heart failure. |
| Precautions |
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Not for treating type 1 diabetes or diabetic ketoacidosis. 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. Heart failure: if 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. 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 |
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Monitor glycemic control more frequently with ketoconazole. Monitor for heart failure with insulin. May antagonize oral contraceptives. |
| Adverse Reactions |
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Upper respiratory tract infection, headache, sinusitis, pharyngitis, myalgia, anemia, edema, weight gain, hypoglycemia, dyspnea; changes in serum lipids (may be beneficial); also women: risk of fracture. |
| How Supplied |
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Tabs—30, 90, 500 |
| Additional Resources |
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• Related Prescribing Note |
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