SB-Metvilda 50 mg+850 mg (Tablet)

Indications

• Adjunct to diet and exercise for type 2 diabetes mellitus
• Improves glycaemic control
• Not adequately controlled on Metformin Hydrochloride or Vildagliptin alone
• Already treated with the combination of Vildagliptin and Metformin Hydrochloride

Pharmacology

• Inhibits DPP-4 (Dipeptidyl peptidase-4)
• Inhibition of incretin hormone degradation
• Increases insulin secretion
• Decreases glucagon secretion
• Decreases hepatic glucose production
• Improves insulin sensitivity

Dosage & Administration

• Initiated at twice daily
• Morning and evening dosing
• May be switched from separate tablets containing same doses of each component
• Higher doses not recommended
• Should be taken with or just after food

Interaction

• No clinically relevant pharmacokinetic interaction observed
• Low potential for drug interactions
• Not likely to interact with CYP 450 enzymes
• No clinically relevant interactions with other oral antidiabetics
• Some medications increase Cmax and blood AUC of Metformin

Contraindications

• Known hypersensitivity to Vildagliptin or Metformin Hydrochloride
• Renal disease or dysfunction
• Acute myocardial infarction
• Septicaemia
• Congestive heart failure
• Acute or chronic metabolic acidosis
• Use during radiologic studies with intravascular administration of iodinated contrast materials

Side Effects

• Headache
• Tremor
• Dizziness
• Nausea
• Hypoglycemia

Pregnancy & Lactation

• No adequate and well controlled studies in pregnant women
• Not recommended during pregnancy
• Not known whether excreted in human milk

Precautions & Warnings

• Lactic acidosis can occur
• Serum creatinine monitoring
• Special caution in elderly patients
• Liver Function Tests (LFTs) monitoring
• Caution in patients with liver dysfunction
• Discontinue 48 hours before elective surgery with general anaesthesia

Use in Special Populations

• Not recommended for use in children below 18 years of age
• Elderly patients should have renal function monitored regularly
• Not recommended for use in patients with renal failure
• Not recommended in patients with 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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