WARFANT Tablet Ref.[49765] Active ingredients: Warfarin

Posology

Adults

An initial daily dose of 10mg on the first two days. Subsequent daily doses should be adjusted according to the results of the prothrombin time or other appropriate coagulation tests. The single daily maintenance requirement is usually between 5mg and 12mg, but can vary between 2mg and 30mg.

The maintenance dose is omitted if the prothrombin time is excessively prolonged. Once the maintenance dose is stabilised in the therapeutic range it is rarely necessary to alter it.

Doses of warfarin should be given at the same time each day.

Use in elderly patients

The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight for weight basis than younger patients.

Paediatric population

Safety and efficacy of warfarin in children have not been established.

Method of administration

Warfant tablets are for oral administration.

The benefit of gastric decontamination is uncertain. If the patient presents within 1 hour of ingestion of more than 0.25 mg/kg or more than the patient’s therapeutic dose, consider activated charcoal.

In cases of life-threatening haemorrhage

Stop warfarin treatment, give prothrombin complex concentrate (factors II, VII, IX, and X) or (if no concentrate available) fresh frozen plasma. Discuss with local haematologist or National Poisons Information Service, or both.

Non-life threatening haemorrhage

Where anticoagulation can be suspended, give slow intravenous injection of phytomenadione (vitamin K1)

Where rapid re-anticoagulation is desirable (eg, valve replacements) give prothrombin complex concentrate (factors II, VII, IX, and X) or (if no concentrate available) fresh frozen plasma.

Monitor INR to determine when to restart normal therapy. Monitor INR for at least 48 hours post overdose.

For patients on long-term warfarin therapy without major haemorrhage

• INR >8·0, no bleeding or minor bleeding—stop warfarin, and give phytomenadione (vitamin K1)

For patients NOT on long-term anticoagulants without major haemorrhage

Measure the INR (prothrombin time) at presentation and sequentially every 24–48 hours after ingestion depending on the initial dose and initial INR.

• If the INR remains normal for 24–48 hours and there is no evidence of bleeding, there should be no further monitoring necessary.

• Give vitamin K1 (phytomenadione) if:

a) there is no active bleeding and the patient has ingested more than 0·25 mg/kg;

OR

b) the prothrombin time is already significantly prolonged (INR >4·0).

Delay oral vitamin K1 at least 4 hours after any activated charcoal has been given. Repeat INR at 24 hours and consider further vitamin K1.

Polypropylene container: 5 years.

Do not store above 25°C.

Polypropylene container: keep the tablets in the original container in order to protect from light and moisture.

Polypropylene securitainer with tamper evident lid.

Pack size: 100 tablets, 500 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.