Torque’s Dapsimet 500 Tablets contains Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2, Sitagliptin, a potent and highly selective inhibitor of the enzyme DPP-4 and Metformin, a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Pharmaceutical Dosage Form:
Tablet
Route of Administration:
Oral
Composition:
Each film-coated bilayered tablet contains:
- Dapagliflozin Propanediol Eq. to Dapagliflozin U.S.P. 10 mg
- Sitagliptin Phosphate Monohydrate Eq. to Sitagliptin I.P. 100 mg
- Metformin Hydrochloride (As extended release form) I.P. 500 mg
- Excipients q.s.
Mechanism of Action:
Dapagliflozin inhibits SGLT2, thus reducing reabsorption of glucose from the glomerular filtrate in the proximal renal tubule, with a concomitant reduction in sodium reabsorption, leading to urinary excretion of glucose and osmotic diuresis. Dapagliflozin improves both fasting and postprandial plasma glucose levels. Sitagliptin, by inhibiting the DPP-4 enzyme, increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilisation.
Indications:
Torque’s Dapsimet 500 is indicated for the treatment of patients with type II diabetes mellitus when diet, exercise and single agent does not result in adequate glycemic control.
Dosage:
As directed by the physician.
Storage:
Store protected from light & moisture, at a temperature not exceeding 30°C.
Side effects:
The following adverse reactions may occur: Lactic Acidosis, Taste Disturbance, Loss of Appetite, Hypoglycaemia, Flatulence, Nausea, Vomiting, Constipation, Diarrhoea, Abdominal Pain, Peripheral Oedema, Headache, Dizziness.
Contraindications:
Torque’s Dapsimet 500 is contraindicated in patients with: Known hypersensitivity to metformin or any of the components of this product. any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), diabetic pre-coma, severe renal impairment. Acute conditions with the potential to alter renal function, such as dehydration, severe infection, shock, diseases which may cause tissue hypoxia, decompensated heart failure, respiratory failure, recent myocardial infarction, hepatic insufficiency, acute alcohol intoxication, and alcoholism.
Drug Interactions:
Alcohol NSAIDs ACE Inhibitors Angiotensin II Receptor Antagonists Diuretics Verapamil Rifampicin Cimetidine, Ranolazine, Trimethoprime Isavuconazole, ketoconazole, itraconazole Vandetanib, Crizotinib, Olaparib ritonavir, Dolutegravir, clarithromycin Ciclosporin Digoxin
