Sitagil M 500 ER - Tablet Metformin Hydrochloride + Sitagliptin - 500mg+50mg 4 Tablet(s) / Strip Incepta Pharmaceuticals Ltd. Introduction: Sitagil M 500 ER is a combination of two medicines that control high blood sugar levels in people with type 2 diabetes mellitus. This helps prevent serious complications of diabetes such as kidney damage and blindness and may reduce your chance of having a heart attack or stroke. Sitagil M 500 ER can be prescribed alone or together with other diabetes medications. All diabetes medicines work best when used along with a healthy diet and regular exercise. The dose you are given will depend on your condition, blood sugar levels and what other medicines you are taking. Taking it with... Uses of Sitagil M 500 ER: Type 2 diabetes mellitus Side effects of Sitagil M 500 ER: DiarrheaNauseaVomitingUpset stomachHeadacheNasal congestion (stuffy nose)Sore throatRespiratory tract infectionHypoglycaemia (low blood sugar level) in combination with insulin or sulphonylurea How to use Sitagil M 500 ER: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sitagil M 500 ER is to be taken with food. How Sitagil M 500 ER works: Sitagil M 500 ER is a combination of two antidiabetic medicines: Sitagliptin and Metformin. They help your pancreas produce more insulin, facilitate effective use of insulin by the body, and reduce excess sugar that your liver makes. Together, they provide better control of blood sugar. Indication: Type 2 DM Administration: Should be taken with food. Adult Dose: Oral Type 2 DM The recommended starting dose in patients not currently treated with Metformin Initially 50 mg/500 mg bd. 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. May adjust the dosing based on effectiveness and tolerability. Max daily dose: Sitagliptin 100 mg/metformin 2000 mg. Extended Release Tablet: Initially: Sitagliptin 50 mg or... Child Dose: <18 years: Safety and efficacy not established Renal Dose: Renal impairment Obtain eGFR before starting metformin eGFR <30 mL/min/1.73 m²: Contraindicated eGFR 30-45 mL/min/1.73 m²: Not recommended to initiate treatment Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly) If eGFR falls below 45mL/min/1.73 m² while taking metformin, risks and benefits of continuing therapy should be evaluated If eGFR falls below 30 mL/min/1.73 m²: while taking metformin, discontinue the drug Contraindication: Renal dysfunction, e.g., serum creatinine >1.5 mg/dL [males], >1.4 mg/dL [females] or abnormal creatinine clearance. Metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction (e.g., anaphylaxis or angioedema) to Sitagliptin + Metformin or to one of its components. Mode of Action: Sitagliptin: Dipeptidyl peptidase 4 (DPP-4) inhibitor, thereby increasing and prolonging incretin hormone activity which are inactivated by DPP-4 enzyme. Incretins increase insulin release and synthesis from pancreatic beta cells and reduce glucagon secretion pancreatic alpha cells. Metformin: Biguanide; acts by decreasing endogenous hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; improves glucose tolerance and lowers both basal and postprandial plasma glucose . Precaution: Not for use in type 1 DM or treatment of ketoacidosis. Discontinue use if pancreatitis is suspected. Renal & hepatic impairment. Sulfonylurea- or insulin-induced hypoglycemia, risk of lactic acidosis, hypoxic states, surgical procedures, alcohol intake, decreased vit B12 absorption, loss of glycemic control. Pregnancy. Elderly. Childn <18 yr. Lactation: not known if crosses into breast milk, use caution Pregnancy Categories Side Effect: 1-10% Abdominal pain (2.2%),Diarrhea (2.4%),Hypoglycemia (2.1%),Nausea (1.3%),Vomiting (1.1%) Frequency Not Defined Exfoliative disorder of skin of scalp,Stevens-Johnson syndrome,Lactic acidosis (rare ),Anaphylaxis/hypersensitivity reaction,Rhabdomyolysis,Acute renal failure,Angioedema Interaction: Additive effect w/ sulfonylureas. Thiazide diuretics, corticosteroids, phenothiazines, OC, sympathomimetics, niacin, Ca channel blockers and isoniazid may exacerbate loss of glycaemic control. ACE inhibitors may reduce fasting blood glucose concentrations. May increase serum level w/ cimetidine. Potentially Fatal: Concurrent use w/ iodinated contrast agents may increase the risk of metformin-induced lactic acidosis.