MedPath

Tranexamic acid

Generic Name
Tranexamic acid
Brand Names
Cyklokapron, Lysteda
Drug Type
Small Molecule
Chemical Formula
C8H15NO2
CAS Number
1197-18-8
Unique Ingredient Identifier
6T84R30KC1

Overview

Tranexamic acid is a synthetic derivative of lysine used as an antifibrinolytic in the treatment and prevention of major bleeding. It possesses a similar mechanism of action to aminocaproic acid but is approximately 10-fold more potent. It was first patented in 1957 and received its initial US approval in 1986.

Background

Tranexamic acid is a synthetic derivative of lysine used as an antifibrinolytic in the treatment and prevention of major bleeding. It possesses a similar mechanism of action to aminocaproic acid but is approximately 10-fold more potent. It was first patented in 1957 and received its initial US approval in 1986.

Indication

Taken orally, tranexamic acid is indicated for the treatment of hereditary angioedema, cyclic heavy menstrual bleeding in premenopausal females, and other instances of significant bleeding in the context of hyperfibrinolysis. Given intravenously, tranexamic acid is indicated for short-term use (2-8 days) in patients with hemophilia to prevent or reduce bleeding following tooth extraction.

Associated Conditions

  • Bleeding
  • Heavy Menstrual Bleeding
  • Hereditary Angioedema (HAE)

FDA Approved Products

Tranexamic acid
Manufacturer:Gland Pharma Limited
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2021/06/25
NDC:68083-160
Tranexamic Acid
Manufacturer:Methapharm, Inc.
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2021/02/25
NDC:67850-041
Tranexamic Acid
Manufacturer:American Regent, Inc.
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2021/03/01
NDC:0517-0960
Tranexamic Acid
Manufacturer:Caplin Steriles Limited
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2021/02/28
NDC:65145-106
Tranexamic Acid
Manufacturer:Zydus Lifesciences Limited
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2022/11/05
NDC:70771-1085

Singapore Approved Products

HAEMOSTOP INJECTION 100MG/ML
Manufacturer:PT. Novell Pharmaceutical Laboratories
Form:INJECTION, SOLUTION
Strength:100mg/ml
Online:Yes
Approved: 2016/07/21
Approval:SIN15052P
CYKLOKAPRON TABLET 500 mg
Manufacturer:Pfizer Italia S.r.l.
Form:TABLET, FILM COATED
Strength:500 mg
Online:Yes
Approved: 1989/03/09
Approval:SIN02487P
MEDSAMIC SOLUTION FOR INJECTION 100MG/ML
Manufacturer:Medochemie Ltd. – Ampoule Injectable Facility
Form:INJECTION, SOLUTION
Strength:100mg/ml
Online:Yes
Approved: 2017/01/26
Approval:SIN15167P
TAFIXYL SOLUTION FOR INJECTION 100 MG/ML
Manufacturer:Industria Farmaceutica Galenica Senese s.r.l.
Form:INJECTION, SOLUTION
Strength:100 mg/mL
Online:Yes
Approved: 2022/07/14
Approval:SIN16551P
XAMILUX INJECTION 100MG/ML
Manufacturer:Gland Pharma Limited
Form:INJECTION, SOLUTION
Strength:100mg/ml
Online:Yes
Approved: 2019/06/12
Approval:SIN15715P

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