Vildamet 50 mg+500 mg (Tablet)

Indications

• Adjunct to diet and exercises for type 2 diabetes mellitus
• Improves glycaemic control
• Used when diabetes is not controlled on Metformin or Vildagliptin alone

Pharmacology

• Inhibits DPP-4 (Dipeptidyl peptidase-4)
• Increases insulin secretion
• Decreases glucagon secretion
• Lowers basal and postprandial plasma glucose
• Improves insulin sensitivity

Dosage & Administration

• Initiated at twice daily
• 1 tablet in the morning and 1 tablet in the evening
• May be switched from separate tablets with same doses of each component
• Taking with or just after food may reduce gastrointestinal symptoms

Interaction

• No clinically relevant pharmacokinetic interaction observed with Metformin Hydrochloride
• Low potential for drug interactions with CYP 450 enzymes
• No clinically relevant interactions with other oral antidiabetics, amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin

Contraindications

• Known hypersensitivity to Vildagliptin or Metformin Hydrochloride
• Renal disease or dysfunction
• Acute myocardial infarction
• Septicaemia
• Congestive heart failure
• Acute or chronic metabolic acidosis including diabetic ketoacidosis
• Use with iodinated contrast materials

Side Effects

• Headache
• Tremor
• Dizziness
• Nausea
• Hypoglycaemia

Pregnancy & Lactation

• Not recommended during pregnancy unless potential benefit justifies potential risk to the foetus
• Not known whether excreted in human milk

Precautions & Warnings

• Lactic acidosis can occur due to Metformin accumulation
• Serum creatinine should be monitored regularly
• Special caution in elderly patients and those with impaired renal or hepatic function
• Liver Function Tests (LFTs) should be monitored prior to initiation and periodically thereafter
• Discontinue 48 hours before elective surgery with general anaesthesia

Use in Special Populations

• Not recommended for use in children below 18 years of age
• Regular renal function monitoring in elderly patients
• Not recommended in patients with renal or hepatic impairment

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Keep in a dry place away from light and heat
• Keep out of the reach of children

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