Vildagliptin- (FDC- List )- (2008)
Drug Name:
Vildagliptin- (FDC- List )- (2008)
List Of Brands:
Indication Type Description:
Drug Interaction:
Not reported
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
16. Vildagliptin Tablets 50mg/100mg 18-01-08
As an adjunct to diet and excercise to improve
glycemic control in patients with Type II diabetes
mellitus
159. Vildagaliptin 50mg/50mg/50mg 21-07-08
+ Metformin Hcl 500mg+850mg+1000mg
tablets
For the treatment of type II diabetes melitus when
single drug therapy along with diet,excercise do
not result in adequate glycemic control
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Vildagliptin 50mg/50mg/50mg 21-07-2008
+ Metformin Hcl 500mg +850mg+ 1000mg
Tablets
For the treatment of Type II Diabetes Mellitus when Single drug therapy
along with diet, Excercise Do not result in Adequate Glycemic Control
2.Vildagliptin Tablets 50mg/100mg 18-01-2008
As an adjunct to diet and excercise to improve Glycemic Control in
Type - II Diabetes Mellitus
Treatment of Type II diabetes with metamorfmin
Adverse Reaction:
With metmorfin- Tremor, headache, dizziness, nausea, hypoglycemia With sulfonyl urea- Tremor, headache, dizziness, asthenia, hypoglycemia With glitazone- Weight gain, peripheral odema
Contra-Indications:
Moderate or severe renal impairment Dialysis patients with end stage renal disease, hepatic impairment Congestive heart failure ( NYHA class III- IV ) Diabetic ketoacidosis Pregnancy, Lactation
Special Precautions-
Measure liver enzymes before treatment, every 3 months during first year and then periodically If tranaminase levels increased , monitor frequently until return to normal.
Withdraw and do not re- start, if persistent incrrease in ALT or AST equals or over 3 times ULN, or if the patient develops jaundice or other suggestive of liver dysfunction. Congestive heart failure ( NYHA - Class I -II ) Elderly
Dosages/ Overdosage Etc:
Treatment of Type II diabetes with metmorfmin With metmorfin or a glitazone-
Dosage-
100mg daily (50mg morning and evening)
With a sulfonylurea- 50mg once daily in the morning Patients under 18 years not recommended 9 (
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation Observe caution