Galvus Met 50 mg+850 mg (Tablet)

Indications

• Adjunct to diet and exercises for type 2 diabetes mellitus
• Improves glycaemic control
• Combination therapy with Metformin Hydrochloride
• Combination therapy with Vildagliptin
• Recommended for patients not adequately controlled on Metformin Hydrochloride or Vildagliptin alone
• Usable for patients already treated with separate tablets of Vildagliptin and Metformin Hydrochloride

Pharmacology

• Inhibits DPP-4 (Dipeptidyl peptidase-4)
• Rapid and complete inhibition of DPP-4 activity
• Increases fasting and postprandial endogenous levels of GLP-1 and GIP hormones
• Increases insulin secretion from pancreatic beta cell
• Decreases glucagon secretion from alpha cell
• Lowers both basal and postprandial plasma glucose
• Decreases hepatic glucose production
• Improves insulin sensitivity by increasing peripheral glucose uptake and utilization

Dosage & Administration

• Initiated at twice daily
• 1 tablet in the morning and evening
• May be switched from separate tablets to this combination
• Not recommended at doses higher than 100 mg of Vildagliptin
• Taking with or just after food may reduce gastrointestinal symptoms associated with Metformin

Interaction

• No clinically relevant pharmacokinetic interaction observed
• Low potential for drug interactions
• Not a cytochrome P (CYP) 450 enzyme substrate
• No significant interactions with other oral antidiabetics, amlodipine, digoxin, etc.
• Furosemide, nifedipine, and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance

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 including diabetic ketoacidosis
• Use of iodinated contrast materials during radiologic studies

Side Effects

• Headache
• Tremor
• Dizziness
• Nausea
• Hypoglycemia

Pregnancy & Lactation

• Not recommended during pregnancy unless potential benefit justifies potential risk to the foetus
• Not recommended for breastfeeding women due to unknown excretion in human milk

Precautions & Warnings

• Lactic acidosis risk due to Metformin accumulation
• Serum creatinine monitoring in patients with renal function and elderly patients
• Liver Function Tests (LFTs) monitoring prior to initiation and thereafter
• Caution in elderly patients with impaired renal function
• Discontinuation in case of jaundice or liver dysfunction
• Discontinuation before elective surgery with general anaesthesia

Use in Special Populations

• Not recommended for pediatric patients below 18 years of age
• Elderly patients should have renal function monitored regularly
• Not for use 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

Related Brands

• Dialiptin-M 50 mg+500 mg (Tablet) - drug-international-ltd
• Dialiptin-M 50 mg+850 mg (Tablet) - drug-international-ltd
• Galet M 50 mg+500 mg (Tablet) - the-white-horse-pharmaceuticals-ltd
• Gluvan Plus 50 mg+500 mg (Tablet) - aristopharma-ltd
• Gluvan Plus 50 mg+850 mg (Tablet) - aristopharma-ltd