Vildaglit

Vildaglit

vildagliptin

Manufacturer:

Healthcare Pharma

Distributor:

San Lwin Trading

Marketer:

San Lwin Trading
Full Prescribing Info
Contents
Vildagliptin.
Description
Vildaglit 50 mg Tablet: Each tablet contains Vildagliptin INN 50 mg.
Indications/Uses
Vildagliptin inhibits dipeptidylpeptidase-4 to increase insulin secretion and lower glucagon secretion.
Vildaglit is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus: As monotherapy; In dual combination with Metformin, a Sulphonylurea, a Thiazolidinedione, or Insulin when diet, exercise and a single antidiabetic agent do not result in adequate glycaemic control.
Dosage/Direction for Use
The recommended dose of a Vildaglit is 50 mg or 100 mg daily for monotherapy; 50 mg twice daily (morning and evening) when used in dual combination with Metformin or a Thiazolidinedione; 50 mg once daily in the morning when used in dual combination with a Sulphonylurea.
Vildaglit may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.
Overdosage
If more than the prescribed dosage of Vildaglit is taken then contact the physician immediately.
Contraindications
Ketoacidosis.
Special Precautions
Monitor liver function, heart failure (avoid if moderate or severe); discontinue if symptoms of acute pancreatitis (persistent, severe abdominal pain).
Use in Children: Vildagliptin is not recommended in patients 18 years of age.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate data on the use of Vildagliptin in pregnant women; hence the potential risk for human is unknown.
Nursing mothers: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin should not be used during lactation.
Adverse Reactions
Nausea, peripheral oedema, headache, tremor, asthenia, dizziness; less commonly constipation, hypoglycaemia, arthralgia; rarely hepatic dysfunction; very rarely nasopharyngitis, upper respiratory tract infection; also reported pancreatitis, exfoliative and bullous skin reactions.
Drug Interactions
In pharmacokinetic studies, no interactions were seen with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.
Storage
Store at temperature not exceeding 30 °C in a dry place. Protect from light.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Tab 50 mg x 2 x 10's.
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