CYKLOKAPRON TABLET 500 mg

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

TRANEXAMIC ACID

Disponibil de la:

PFIZER PRIVATE LIMITED

Codul ATC:

B02AA02

Dozare:

500 mg

Forma farmaceutică:

TABLET, FILM COATED

Compoziție:

TRANEXAMIC ACID 500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

Pfizer Italia S.r.l.

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1989-03-09

Prospect

CYK-SIN-0213/0 
Date of Last Revision: February 2013 
Page 1 of 8 

1. NAME OF THE MEDICINAL PRODUCT 
CYKLOKAPRON TABLETS 
CYKLOKAPRON INJECTION 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active Ingredient: tranexamic acid 

3. PHARMACEUTICAL FORM 
Film-coated tablets 
Injection  

Chemical Name: trans-4-(aminomethyl) cyclohexanecarboxylic acid.  

Structural Formula:

Empirical Formula: C
8
H
15
NO
2

 Molecular Weight: 157.2 

Tranexamic acid is a white crystalline powder.  

4. CLINICAL PARTICULARS 
4.1. THERAPEUTIC INDICATIONS 
• 
Haemorrhage or risk of haemorrhage in increased fibrinolysis or
fibrinogenolysis.   

Local fibrinolysis may occur in the following conditions:
menorrhagia, prostatectomy 
and bladder surgery, haematuria, gastro-intestinal haemorrhage,
epistaxis, ulcerative 
colitis, conisation of the cervix, and dental extraction in
patients with coagulopathies. 

General fibrinolysis may occur in the following conditions and
situations: 
Dosage Form 
Strength 
Film-Coated Tablets 
500 mg 
Injection  
100 mg/mL 
CYK-SIN-0213/0 
Date of Last Revision: February 2013 
Page 2 of 8 
Prostatic and
pancreatic cancer, after thoracic and other major surgery, in
obstetrical 
complications such as ablatio placentae and
post partum haemorrhage, leukemia, liver 
diseases, in connection with thrombolytic therapy with
streptokinase. 

• 
Hereditary angioneurotic oedema  

4.2. POSOLOGY AND METHOD OF ADMINISTRATION 
The recommended standard dose is 5 to 10 mL by slow intravenous
injection at a rate of 1 
ml/minute or 2 to 3 tablets of 0.5 g two to three times daily. 

For the indications listed below the following doses are
recommended: 

General fibrinolysis: 1.0 g (2 ampoules of 5 mL) by slow
intravenous injection every six to 
eight hours. 

Prostatectomy: 0.5 to 1.0 g orally (1 to 2 ampoules of 5 mL)
by slow intravenous

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
CYKLOKAPRON TABLETS
CYKLOKAPRON INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: tranexamic acid
3.
PHARMACEUTICAL FORM
Film-coated tablets
Injection
Chemical name: trans-4-(aminomethyl) cyclohexanecarboxylic acid.
Structural formula:
Empirical formula: C
8
H
15
NO
2
Molecular weight: 157.2
Tranexamic acid is a white crystalline powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Haemorrhage or risk of haemorrhage in increased fibrinolysis or
fibrinogenolysis.
Local fibrinolysis may occur in the following conditions: Menorrhagia,
prostatectomy
and bladder surgery, haematuria, gastrointestinal haemorrhage,
epistaxis, ulcerative
colitis, conisation of the cervix, and dental extraction in patients
with coagulopathies.
General fibrinolysis may occur in the following conditions and
situations: Prostatic
and pancreatic cancer, after thoracic and other major surgery, in
obstetrical
complications such as ablatio placentae and postpartum haemorrhage,
leukemia, liver
diseases, in connection with thrombolytic therapy with streptokinase.
•
Hereditary angioneurotic oedema.
DOSAGE FORM
STRENGTH
Film-coated tablets
500 mg
Injection
100 mg/mL
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL
ADMINISTRATION.
The recommended standard dose is 5 mL to 10 mL by slow intravenous
injection at a rate of
1 mL/minute or 2 to 3 tablets of 0.5 g 2 to 3 times daily.
For the indications listed below, the following doses are recommended:
_General fibrinolysis_
: 1.0 g (2 ampoules of 5 mL) by slow intravenous injection every 6 to
8 hours.
_Prostatectomy_
: 0.5 g to 1.0 g (1 to 2 ampoules of 5 mL) by slow intravenous
injection every 6
to 8 hours (the first injection being given during the operation) for
the first 3 days after
surgery, thereafter 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times
daily until macroscopic
haematuria is no longer present.
_Haematuria_
: 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily u