BIO-STAT
Manufacturer Details
INVISION
Idalis Invision Medi Sceiences Ltd
# 251 2nd cross Bhagyalakshmi Complex
3rd Main road
Chamrajpet
Bangalore 560018
idalis.invision@yahoo.com
Compositions:
Transexamic acid 500mg/5ml injection,
|
Strength
|
Rate
|
Packing Style
|
|
500mg/5ml
|
55.00
|
5ml injection
|
List of Related Indications:
List Of Drugs:
- Tranexamic acid - @- Hemostatic -systemic- (FDC- List )- (2002)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Not available
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 89
Name of the Drug- Tranexamic acid mouthwash
(50mg/ml)
Pharmacological Classification- For prevention of oral hemorrhage in
anticoagulant treated patients undergoing
oral surgery
Date of Approval- 15-06-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Hemorrhage
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Tranexamic acid Anti-Fibrinolytic 06-03-2002
2.Tranexaamic acid 15-06-2007
Mouth wash 50mg/ml
For prevention of Oral Hemorrhage in an Anticogulant treated Patient
undergoing Oral Surgery
3.Tranexamic acid Tablets 20-02-2009
SR 750mg
For the Treatment of Menorrhagia
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Tranexamic Acid 500mg + 22-02-2005
Mefanamic acid 250mg tablet
For primary dysmeorrhoea and pain associated
with menorrhagia in women
2.Tranexamic acid 250mg + 29-12-2004
Ethamsylate 250mg film coated tablets
For the treatment of abnormal blood loss due to
menorrhagia, local fibronlysis and intraoperative/
post operative hemorrhage
3.Tranexamic acid 25mg/50mg + 13-01-2005
Ethamsylate 12.5mg/12.5mg tablet
For the treatment of hypertension only
Adverse Reaction:
Diarrhoea, Giddiness, hypotension. Nausea, vomiting, disturbance in color vision hypotension,( after rapid IV inj ) thromboembolic events
Contra-Indications:
Severe renal failure, active intravascular clotting, thromboembolitic disease, color vision disorders, subarcachoid bleeding
Special Precautions:
Mild to moderate renal impairment, irregular menstrual bleeding, previous history of thromboembolic disease, hematuria, Monitor closely in disseminated intravascular coagulation. Monitor closely LFT and eye exam regularly during long term use. Discontinue disturbance in color vision occurs Avoid IV inj rate > 1 ml.minute due to risk of hypotension Pregnancy Lactation
Dosages/ Overdosage Etc:
Date of Approval 2002
Indications:
Hemorrhage
Dosage:
Give 25mg/kg orally, 3 to 4 times daily beginning 1 day before surgery. Parentral: 10mg/kg bid or tid for patients unable to take oral medication.
Patient Information:
Antifibrinolytic agents- include amionocaproic acid , tranexamic acid- Refer aminocaproicacid
Pharmacology/ Pharmacokinetics:
Pharmacology:
Tranexamic acid is a competitive inhibitor of plasminogen activation, and at a much higher concentration, a noncompetitive inhibitor of plasmin. It has action similar to aminocaproic acid.
Pharmacokinetics:
Absorption of tranexamic acid after oral use is about 30% to 50%, bioavailability is not affected by food. The peak plasma level 3 hour after 1g orally is 8mg/l. The biological half-life in the joint fluid is about 3 hours.
Pregnancy and lactation:
Pregnancy: Use only if clearly needed.
Lactation: Excercise caution when administering to nuring women.
