Galet M 50 mg+850 mg (Tablet)

Unit Price: ৳ 22.00 (30's pack: ৳ 660.00)

Medicine Details

Category Details
Generic Vildagliptin metformin hydrochloride
Company The white horse pharmaceuticals ltd
Also available as
Galet m 50 mg tablet

Indications

  • Adjunct to diet and exercises
  • Improves glycaemic control
  • Type 2 diabetes mellitus
  • Not adequately controlled on Metformin Hydrochloride or Vildagliptin alone
  • Can be used in combination with Metformin Hydrochloride and Vildagliptin as separate tablets

Pharmacology

  • Inhibits DPP-4 (Dipeptidyl peptidase-4)
  • Increases fasting and postprandial endogenous levels of GLP-1 and GIP
  • Increases insulin secretion
  • Decreases glucagon secretion
  • Decreases hepatic glucose production
  • Lowers both basal and postprandial plasma glucose
  • Improves insulin sensitivity
  • Increase in peripheral glucose uptake and utilization

Dosage & Administration

  • Initiated at twice daily
  • 1 tablet in the morning and evening
  • Patients receiving Vildagliptin and Metformin separately can be switched to this combination
  • Doses higher than 100 mg of Vildagliptin are not recommended
  • May be taken with or just after food to reduce gastrointestinal symptoms

Interaction

  • No clinically relevant pharmacokinetic interaction observed
  • Vildagliptin has low potential for drug interactions
  • Unlikely to interact with medications that are substrates, inhibitors or inducers of CYP 450 enzymes
  • No clinically relevant interactions with other oral antidiabetics, amlodipine, digoxin, ramipril, simvastatin, valsartan, or warfarin
  • Furosemide, nifedipine, and glyburide increase Cmax and blood AUC of Metformin

Contraindications

  • Known hypersensitivity to Vildagliptin or Metformin Hydrochloride or excipients
  • 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 for radiologic studies

Side Effects

  • Headache
  • Tremor
  • Dizziness
  • Nausea
  • Hypoglycaemia

Pregnancy & Lactation

  • Not recommended during pregnancy unless potential benefit justifies potential risk to the fetus
  • No adequate and well-controlled studies in pregnant women
  • Not known whether Vildagliptin and/or Metformin Hydrochloride is excreted in human milk
  • Not recommended for use in breastfeeding women

Precautions & Warnings

  • Lactic acidosis can occur due to Metformin accumulation
  • Hospitalization and discontinuation of treatment if metabolic acidosis is suspected
  • Monitoring of serum creatinine at least once a year
  • Special caution in elderly patients where renal function may become impaired
  • Monitoring of Liver Function Tests (LFTs) prior to initiation and periodically thereafter
  • Discontinuation and non-reinitiation in case of liver dysfunction
  • Discontinuation 48 hours before elective surgery with general anaesthesia

Use in Special Populations

  • Not recommended for pediatric patients
  • Renal function monitoring in elderly patients
  • Use only in elderly patients with normal renal function
  • Not recommended in patients with renal failure or renal dysfunction
  • 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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