Monograph Details
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Endocrine System
> Diabetes
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JANUMET 50mg/500mg |
| Manufacturer |
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Merck & Co., Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Dipeptidyl peptidase-4 inhibitor + biguanide. |
| Generic Name |
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Sitagliptin 50mg, metformin (as HCl) 500mg; tabs. |
| Also |
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• JANUMET 50mg/1000mg
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| Indications |
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Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Individualize. Take twice daily with meals. Previously on metformin alone: initially 50mg twice daily of sitagliptin plus metformin dose. Previously on metformin 850mg twice daily: start with 50mg/1000mg twice daily. Previously on sitagliptin alone: initially 50mg/500mg twice daily; may increase to 50mg/1000mg twice daily. Previously on sitagliptin and metformin: switch on a mg/mg basis. Max 100mg sitagliptin/2000mg metformin per day. |
| Contraindications |
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Renal disease or dysfunction. Metabolic acidosis, ketoacidosis. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hours after use). Type 1 diabetes. |
| Precautions |
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Confirm normal renal function before starting and monitor (esp. in elderly). Avoid if clinical or lab evidence of hepatic disease. Discontinue if lactic acidosis, ketoacidosis, renal impairment, shock, acute MI, acute CHF, sepsis, or hypoxemia occurs. May need to suspend therapy during periods of stress or if dehydration occurs or before surgery. Monitor hematology (esp. serum Vit. B12 in susceptible patients). Elderly, debilitated, malnourished, deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Pregnancy (Cat.B). Nursing mothers. |
| Interactions |
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Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinine, quinidine, ranitidine, triamterene, trimethoprim, vancomycin), furosemide, nifedipine, cimetidine: may increase metformin levels. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Monitor digoxin. Diuretics, steroids, estrogens, oral contraceptives, phenothiazines, phenytoin, thyroid products, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid, others that may cause hyperglycemia. β-blockers may mask hypoglycemia. |
| Adverse Reactions |
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Nasopharyngitis, GI disturbances, asthenia, headache; lactic acidosis (rare, half of the cases are fatal). |
| How Supplied |
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Tabs—60, 180, 1000 |
| Additional Resources |
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• Related Prescribing Note |
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