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Siglimet 50/500 Tablet, 1 Strip [Sitagliptin 50mg+ Metformin 500mg]
DOSAGE AND ADMINISTRATION
Dose of this combination should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin. Sitagliptin/Metformin combination should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. The recommended starting dose in patients not currently treated with metformin is 50 mg Sitagliptin & 500 mg Metformin Hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with Metformin. The starting dose in patients already treated with Metformin should provide Sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients taking Metformin 850 mg twice daily, the recommended starting dose of this combination is 50 mg Sitagliptin & 1000 mg Metformin Hydrochloride twice daily.
Do not use combination of Sitagliptin and Metformin in patients with hepatic disease. n Before initiating the combination and at least annually thereafter, assess renal function and verify as normal. n May need to discontinue the combination and temporarily use insulin during periods of stress and decreased intake of fluids and food as may occur with fever, trauma, infection or surgery.
Combination (Sitagliptin/Metformin HCl) is contraindicated in patients with: n Renal disease or renal dysfunction, e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] n Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. n History of a serious hypersensitivity reaction to the combination or Sitagliptin, such as anaphylaxis or angioedema.
The most common (>5%) adverse reactions due to initiation of Metformin therapy are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.
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