TORFORMIN ST 500

Torformin ST 500 Tablets contains 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.

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Product Description

Description: Torformin ST 500 Tablets contains 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 tablet contains:

Sitagliptin Phosphate Monohydrate IP

equivalent to Sitagliptin                               50 mg

Metformin Hydrochloride IP                        500 mg

Excipients                                                   q.s.

Mechanism of Action: 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: Torformin ST 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 at a temperature not exceeding 30°C, protect from light & moisture.

Presentation: 10 x 2 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:

Torformin ST 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