Vigamet 50 mg+850 mg (Tablet)

Indications

• Adjunct to diet and exercises for type 2 diabetes mellitus
• Improves glycaemic control
• Not adequately controlled on Metformin Hydrochloride alone
• Not adequately controlled on Vildagliptin alone
• Already treated with the combination of Vildagliptin and Metformin Hydrochloride
• Administered as separate tablets

Pharmacology

• Inhibits DPP-4
• Increases insulin secretion
• Decreases glucagon secretion
• Increases fasting and postprandial endogenous levels of incretin hormones
• 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
• Taking with or just after food to reduce gastrointestinal symptoms
• No clinical experience in triple combination with other antidiabetic agents

Interaction

• No clinically relevant pharmacokinetic interaction observed
• Low potential for drug interactions
• Unlikely to interact with cytochrome P 450 enzymes
• No clinically relevant interactions with other oral antidiabetics
• Increased Cmax and blood AUC of Metformin with certain medications

Contraindications

• Known hypersensitivity to Vildagliptin or Metformin Hydrochloride
• Renal disease or renal dysfunction
• Acute myocardial infarction
• Septicaemia
• Congestive heart failure
• Acute or chronic metabolic acidosis

Side Effects

• Headache
• Tremor
• Dizziness
• Nausea
• Hypoglycaemia

Pregnancy & Lactation

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

Precautions & Warnings

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

Use in Special Populations

• Not recommended in pediatric patients
• Renal function monitoring in elderly patients
• Use with normal renal function in elderly patients
• Not recommended 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

Related Brands

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• Vida Plus 50 mg+850 mg (Tablet) - pacific-pharmaceuticals-ltd
• Vida Plus 50 mg+500 mg (Tablet) - pacific-pharmaceuticals-ltd