INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CYKLOKAPRON®
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CYKLOKAPRON®

CYKLOKAPRON® T 500 (Tablets)
CYKLOKAPRON® IV 500 (Injection)
CYKLOKAPRON® 1 g (Effervescent Tablets)

COMPOSITION:
Each tablet contains 500 mg tranexamic acid
Each 5 mL ampoule contains 500 mg tranexamic acid.
Each effervescent tablet contains 1 g tranexamic acid.

PHARMACOLOGICAL CLASSIFICATION:
A. 8.1 Coagulants, haemostatics

PHARMACOLOGICAL ACTION:
CYKLOKAPRON contains tranexamic acid (AMCA), which exerts an inhibitory effect on the activation of plasminogen in the fibrinolytic system, i.e. on the conversion of plasminogen to plasmin.
CYKLOKAPRON is used in fibrinolytic bleeding conditions, which may occur in a number of different clinical conditions in which there is abnormal stimulation of the activation mechanism.
CYKLOKAPRON is absorbed very well by mouth.
CYKLOKAPRON is excreted unchanged through the kidneys.

INDICATIONS:
1. Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery.
2. Management of dental extraction in haemophiliacs.
3. Hereditary angioneurotic oedema.
4. Menorrhagia

CONTRA-INDICATIONS:
In cases of massive upper urinary tract haemorrhage, antifibrinolytics should be avoided to reduce the risk of ureteric obstruction.
Patients with a pronounced thrombotic tendency or colour vision disorder should not be given CYKLOKAPRON.
Thrombophlebitis, impaired liver function and subarachnoid bleeding.

WARNINGS:
For patients in renal failure, CYKLOKAPRON should be given with caution because of the risk of accumulation.
The safety of CYKLOKAPRON has not been established in pregnancy.
Tranexamic acid passes into breast milk at a concentration of a hundredth of the corresponding serum levels. Caution should be exercised when CYKLOKAPRON is given to nursing women.

DOSAGE AND DIRECTIONS FOR USE:
Tranexamic acid is given orally or by slow intravenous infusion/injection. Administration by injection is usually changed to oral administration after a few days. The effervescent tablets should be dissolved in half a glass of water.
Traumatic hyphaema:
1,0 to 1,5 g every 8 hours for six to seven days.
Patients with established coagulopathies undergoing minor surgery:
Conization of the cervix: 1,0 to 1,5 g (2 to 3 tablets) every 8 to 12 hours for 12 days post-operatively.
Dental operations/extractions:
25 mg/kg orally two hours before the operation. Factor VIII and Factor IX should be given as well as tranexamic acid. After the operation, 25 mg/kg of tranexamic acid is given 3 to 4 times a day for 6 to 8 days.
Hereditary angioneurotic oedema:
Some patients are aware of the onset of illness; a suitable treatment for these patients is 1,0-1,5 g two to three times daily for some days. Other patients are treated continually at this dosage.
Menorrhagia:
Two to three coated tablets (1-1,5 g) or one effervescent tablet (1 g) three to four times daily, given at the onset of heavy bleeding for the duration of the period.

For the injection:
CYKLOKAPRON solution for injection is administered intravenously by slow injection over a period of at least five minutes. For intravenous infusion, CYKLOKAPRON solution for injection may be mixed with electrolyte solutions, carbohydrate solutions, Aminosol and dextran solutions.
Heparin solutions may be added to CYKLOKAPRON solution for injection. CYKLOKAPRON solution for injection should not be mixed with blood and infusion solutions containing penicillin.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disorders (nausea, vomiting, diarrhoea) may occur. Cases of giddiness have been reported. Transient disturbance of colour vision may occur. Patients who experience disturbances of colour vision should be withdrawn from treatment.
Rapid intravenous injection may cause dizziness and/or hypotension.
Special precautions:
Dosages should be reduced in patients with renal impairment. For patients with moderate to severe impaired renal function, the following dosages are recommended.
Serum creatinine
(micromol/L)		         Oral Dose         Intravenous Dose
120-250 15 mg/kg body weight twice daily 10 mg/kg body weight twice daily
250-500 15 mg/kg body weight daily 10 mg/kg body weight daily
> 500 7,5 mg/kg body weight daily 5 mg/kg body weight daily
Patients with a previous history of thromboembolic disease should not be given CYKLOKAPRON unless simultaneous treatment with anticoagulants can be given.
For patients who are to receive continuous treatment with CYKLOKAPRON for longer than several days, an ophthalmological examination is advisable (including visual acuity, colour vision, eye-grounds, field of vision), before commencing treatment, and at regular intervals during treatment.
Medicines with actions on haemostasis should be given with caution to patients on antifibrinolytic therapy. The potential for thrombus formation may be increased by oestrogens, for example, or the action of the antifibrinolytic antagonised by compounds such as the thrombolytics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage: Dizziness, headache, nausea and vomiting, diarrhoea.
Faintness and hypotension may occur.
Treatment would consist of procedures to remove unabsorbed drug from the stomach (initiating vomiting, institution of gastric lavage, charcoal therapy) and symptomatic treatment.
Maintain adequate diuresis (with fluids plus diuretics).
The only symptoms of overdosage might be nausea and vomiting and perhaps faintness and hypotension. Treatment would consist of initiating vomiting (to remove unabsorbed drug from the stomach) and enhancing diuresis (with fluids plus diuretics).

IDENTIFICATION:
CYKLOKAPRON Tablets: White, capsular, film coated tablets, with arcs above and below the letters 'CY' engraved on one side and scored on the other.
CYKLOKAPRON Ampoules: Clear, colourless solution.
CYKLOKAPRON Effervescent Tablets: A flat white round effervescent tablet with an orange flavour.

PRESENTATION:
CYKLOKAPRON Tablets in plastic containers of 24 and 100.
CYKLOKAPRON Ampoules of 5 mL in packs of 5.
CYKLOKAPRON Effervescent tablets in aluminium tubes of 16, and cartons containing 3 x 16 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
Keep out of reach of children.
Effervescent tablets: Keep tubes tightly closed in a dry place below 25°C.

REGISTRATION NUMBER:
CYKLOKAPRON® T 500 Tablets:         H/8.1/807
CYKLOKAPRON® I V 500 Injection:         H/8.1/806
CYKLOKAPRON® 1 g EFFERVESCENT TABLETS:         31/8.1/0024

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd.,
Alphen West G,
George St,
MIDRAND 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 December 1999

Updated on this site: January 2005
Source: Pharmaceutical Industry

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