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

Logo TRANIC

SCHEDULING STATUS:
S4

PROPRIETARY NAME (AND DOSAGE FORM):
TRANIC

COMPOSITION:
Each tablet contains 500 mg
tranexamic acid.

PHARMACOLOGICAL CLASSIFICATION:
A 8.1 Coagulants, haemostatics

PHARMACOLOGICAL ACTION:
Tranexamic acid is an antifibrinolytic compound which is a competitive inhibitor of the conversion of plasminogen to plasmin. At high concentrations it is a non-competitive inhibitor of plasmin.
Pharmacokinetics:
Tranexamic acid is excreted unchanged in the urine.
Following oral administration, 1,13% and 39% of the administered dose were recovered after 3 and 24 hours respectively, in the urine. Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women. Tranexamic acid crosses the blood brain barrier.

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:
Hypersensitivity to tranexamic acid.
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 TRANIC.
Thrombophlebitis, impaired liver function and subarachnoid bleeding.

WARNINGS:
For patients in renal failure, TRANIC should be given with caution because of the risk of accumulation.
Pregnancy and lactation : See Pregnancy and lactation.

INTERACTIONS:
Medicines with actions on haemostasis should be given with caution to patients on TRANIC. 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.

PREGNANCY AND LACTATION:
TRANIC is contra-indicated in pregnancy. The safety of TRANIC has not been established in pregnancy.
Tranexamic acid passes into breast milk at a concentration of a hundredth of the corresponding serum levels. Mothers breastfeeding their babies should not use tranexamic acid.

DOSAGE AND DIRECTIONS FOR USE:
Traumatic hyphaema:
1,0 to 1,5 g every 8 hours for six to seven days.
Patients with established coagulopathies undergoing minor surgery:
Conisation 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 tablets (1 –1,5 g) three to four times daily, given at the onset of heavy bleeding for the duration of the period.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Gastro-intestinal disorders: less frequent
Gastro-intestinal disorders (nausea, vomiting, diarrhoea) may occur.
Eye disorders: less frequent
Transient disturbance of colour vision may occur. Patients who experience disturbances of colour vision should be withdrawn from treatment.
Cardiovascular disorders: less frequent
Thrombotic complications have been reported in patients receiving tranexamic acid, but these are usually a consequence of its inappropriate use.
Special precautions:
Dosage 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
120 –250 15 mg/kg body weight twice daily
250 –500 15 mg/kg body weight daily
>500 7,5 mg/kg body weight daily
Patients with a previous history of thromboembolic disease should not be given TRANIC unless simultaneous treatment with anticoagulants can be given. For patients who are to receive continuous treatment with TRANIC 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. Liver function tests should also be performed.

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).

IDENTIFICATION:
White, film coated, capsule shaped tablets, 18 mm long and 8 mm wide. The tablets are marked “FW291” on one face and have a central division line on the reverse.

PRESENTATION
30 Tablets packed into 3 opaque blister strips (PVC sealed with aluminium foil) of 10 tablets each.

STORAGE INSTRUCTIONS:
Store below 25ºC in the original container.
Protect from light.
Keep out of reach of children.
Keep the blisters in the carton until required for use.

REGISTRATION NUMBER:
41/8.1/0223

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Pharmafrica (Pty) Ltd
33 Hulbert Road
New Centre
JOHANNESBURG

DATE OF PUBLICATION OF THE PACKAGE INSERT:
04 JUNE 2010

New addition to this site: May 2014
Source: Pharmaceutical Industry

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