Product Description
Description: 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 USP
Eq. to Dapagliflozin 10 mg
Sitagliptin Phosphate Monohydrate IP
Eq. to Sitagliptin 100 mg
Metformin Hydrochloride IP
(As extended release form) 500 mg
Excipients q.s.
Mechanism of Action: Dapagliflozin inhibits SGLT2 thus reduces 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 post-prandial 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 utilization.
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.
Presentation: 10 x 15
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
Disease which may cause tissue hypoxia
Decompensated Heart Failure
Respiratory Failure
Recent Myocardial Infarction
Shock
Hepatic insufficiency, acute alcohol intoxication, 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
