Vildapin Plus 50 mg+850 mg

Vildapin Plus 50 mg+850 mg

Description

Vildapin Plus combines two antihyperglycemic agents with different mechanisms of action to improve glycaemic control in patients with type 2 diabetes : Vildagliptin, a member of the DPP4 (dipeptidyl-peptidase-4) inhibitor class and metformin hydrochloride, a member of the biguanide class.

Composition

Vildapin Plus 500: Each film-coated tablet contains Vildagliptin

INN 50 mg & Metformin Hydrochloride BP 500 mg.

Vildapin Plus 850: Each film-coated tablet contains Vildagliptin

INN 50 mg & Metformin Hydrochloride BP 850 mg.

Indications

Vildapin Plus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.

Dosage and Administration

The recommended starting dose of Vildapin Plus should be based on the patient’s current regimen of vildagliptin and/or metformin hydrochloride. In using Vildapin Plus do not exceed the maximum daily dose of vildagliptin (100 mg).

Starting dose for patients inadequately controlled on metformin hydrochloride monotherapy : Based on the patient’s current dose of metformin hydrochloride, Vildapin

Plus may be initiated at either the 50 mg/500 mg or 50 mg/850 mg tablet strength twice daily.

Starting dose for patients switching from combination therapy of Vildagliptin Plus metformin hydrochloride as separate tablets : Vildapin Plus may be initiated with either the 50 mg/500 mg or 50 mg/850 mg tablet strength based on the dose of vildagliptin or metformin already being taken.

Or as directed by the physician.

Contraindication

Contraindicated in patients with known hypersensitivity to the active substances or to any of the excipients, Diabetic Keto acidosis, Cogestive heart failure & severe renal impairment.

Side effects

The most common side effects include tremor, headache, dizziness, low blood sugar, nausea and weakness. Patients taking vildagliptin may also experience weight gain and swelling of the legs and ankles due to excess fluid retention.

Precautions

Vildapin Plus is not a substitute for insulin in insulin-requiring patients. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Patients with serum creatinine levels above the normal limit should not receive

Vildapin Plus

Patients with renal impairment: Vildapin Plus should not be used in patients with renal failure or renal dysfunction.

Patients with hepatic impairment : Vildapin Plus is not recommended in patients with clinical or laboratory evidence of hepatic impairment

Elderly: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Vildapin Plus should have their renal function monitored regularly.

Paediatric patients: Safety and effectiveness of Vildapin

Plus in paediatric patients (18 years) have not been established.

Use in Pregnancy and Lactation

Pregnancy : There are no adequate and well-controlled studies in pregnant women. Therefore Vildapin Plus should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.

Lactation : As it is not known whether vildagliptin and/or metformin hydrochloride is excreted in human milk, Vildapin

Plus should not be administered to breast-feeding women.

Drug interaction

Vildagliptin

Vildagliptin has a low potential for drug interactions Vildagliptin is not a cytochrome P450 enzyme substrate and it dose not inhibit or induce cytochrome P450 enzymes. So it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. No clinically relevant interactions with other oral anti diabetics (Glibenclamide, Pioglitazone, Metformin),

Amlodipin, Digoxin, Ramipril, Simvastatin, Valsartan or warfarin were observed after co-administration with vildagliptin.

Metformin

Metformin decreased Cmax, blood AUC of furosemide. Nifedipine increased absorption, Cmax and AUC of metformin. Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems.

Supply

Vildapin Plus 500: Each box contains 2×10 tablets in alu-alu blister pack

Vildapin Plus 850: Each box contains 2×10 tablets in alu-alu blister pack