Sitagil M 50/1000 ER

Presentation: Each extended-release film-coated tablet contains 50 mg of sitagliptin (as sitagliptin phosphate monohydrate) and 1000 mg of metformin hydrochloride.

Indications: Sitagil M ER is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended-release is appropriate.  

Dosage and Administration: The recommended dose is one tablet once daily with a meal, preferably in the evening. Dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin extended-release. Patients already taking sitagliptin and metformin as separate tablets, or switching from immediate-release Sitagil M, should maintain the same total daily dose of sitagliptin and metformin. Gradual dose escalation is recommended to reduce gastrointestinal side effects associated with metformin. The tablet should be swallowed whole and not crushed, split, or chewed. Renal function should be assessed before initiating Sitagil M ER and at least annually thereafter. It is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²).

Side Effects:

• Very Common: Diarrhea, upper respiratory tract infection, headache.  
• Common: Hypoglycemia (when used in combination with sulfonylurea or insulin), nausea, vomiting, abdominal pain.

Precautions: Sitagil M ER is contraindicated in patients with severe renal impairment, acute or chronic metabolic acidosis (including diabetic ketoacidosis), and known hypersensitivity to sitagliptin or metformin hydrochloride. It is not recommended in patients with hepatic disease. Lactic acidosis is a rare but serious metabolic complication that can occur due to metformin accumulation. Risk factors include renal impairment, cardiopulmonary disease, and excessive alcohol intake. If lactic acidosis is suspected, the drug should be discontinued and the patient hospitalized immediately. Pancreatitis has been reported in patients receiving sitagliptin. If pancreatitis is suspected, Sitagil M ER should be promptly discontinued.

Storage: Store below 30°C, protected from moisture. Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.