Tagipmet XR

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Tagipmet XR Product Information Leaflets
Brand Name:
Tagipmet XR
Generic Name:
Sitagliptin+Metformin HCl Sustained Release

DESCRIPTION:

Tagipmet tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: sitagliptin and metformin hydrochloride sustained release. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme, while Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia

COMPOSITION:

Tagipmet XR 50mg/500mg Tablets:Each film coated tablet contains:
Sitagliptin (as phosphate) .............................. 50 mg
Metformin HCl Sustained Release B.P........... 500 mg
Tagipmet XR 50mg/1000mg Tablets: Each film coated tablet contains:
Sitagliptin (as phosphate) ............................ 50 mg
Metformin HCl Sustained Release B.P. ........1000 mg
Tagipmet XR 100mg/1000mg Tablets:Each film coated tablet contains:
Sitagliptin (as phosphate) ............................. 100 mg
Metformin HCl Sustained Release B.P. .........1000 mg

INDICATIONS:

Tagipmet XR 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 is appropriate. Tagipmet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

DOSAGE & ADMINISTRATION:

The dosage of Tagipmet XR should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider. Tagipmet XR should generally be given once daily with evening meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. Tagipmet XR must not be split or divided before swallowing. The starting dose of Tagipmet XR should be based on the patient's current regimen and should be given once daily with evening meals. The recommended starting dose in patients not currently treated with metformin is 100 mg Sitagliptin / 1000 mg metformin hydrochloride sustained release once daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin. The starting dose in patients already treated with metformin should provide sitagliptin dosed as 100 mg once 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 Tagipmet XR is 50 mg Sitagliptin / 1000 mg metformin hydrochloride 2 Tablets stat. Co-administration of Tagipmet XR with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

CONTRAINDICATIONS:

Tagipmet XR (Sitagliptin and Metformin Hydrochloride Sustained Release) is contraindicated in patients with: Renal impairment or renal dysfunction (e.g., serum creatinine levels greater than or equal to 1.5 mg/dL for men, greater than or equal to 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute nsepticemia. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to Tagipmet XR (or any of its components), such as anaphylaxis or angioedema.

PRESENTATION:

Tagipmet XR 50mg/500mg tablets: Blister pack of 2 x 7's tablet.
Tagipmet XR 50mg/1000mg tablets: Blister pack of 2 x 7's tablet.
Tagipmet XR 100mg/1000mg tablets: Blister pack of 2 x 7's tablet.

Patients should consult with their physician before taking any medicine.