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Warfarin is indicated for the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.
Warfarin is indicated for the prophylaxis after insertion of prosthetic heart valves.
Warfarin is indicated for the prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Warfarin is indicated for transient cerebral ischaemic attacks.
Adults and elderly patients: The typical induction dose of warfarin is 10 mg daily for 2 days, but this should be tailored to individual requirements. Baseline prothrombin measurements (PT) should be taken before beginning therapy with warfarin.
The daily maintenance dose of warfarin is usually 3 to 9 mg taken at the same time each day. The exact maintenance dose for an individual is dependent on the prothrombin time or other appropriate coagulation tests. 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.
In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together. Where there is less urgency, as in patients disposed to or at special risk of thromboembolism, anticoagulant therapy may be initiated with warfarin alone.
Concomitant heparin therapy affects the results of control tests and should be discontinued at least six hours before the first test is carried out.
Control is established with INR monitoring at regular intervals and subsequent warfarin maintenance dosage further adjusted according to the results obtained.
Paediatric population: No data are available.
Infections and infestations
Fever
Immune system disorders
Hypersensitivity
Nervous system disorders
Cerebral haemorrhage; Cerebral subdural haematoma
Vascular disorders
Haemorrhage
Respiratory, thoracic and mediastinal disorders
Haemothorax, epistaxis
Gastrointestinal disorders
Gastroinestinal haemorrhage, rectal haemorrhage, haematemesis; pancreatitis; diarrhoea; nausea; vomiting; melaena
Hepatobiliary disorders
Jaundice; hepatic dysfunction
Skin and subcutaneous disorders
Rash; alopecia; purpura; ‘purple toes’ syndrome; erythematous swollen skin patches leading to ecchymosis, infarction and skin necrosis; calciphylaxis
Renal and Urinary disorders
Haematuria; anticoagulant-related nephropathy
If a rapid antithrombotic effect is needed, heparin treatment must be initiated first. After this, heparin treatment is continued along with the initiated warfarin treatment for at least 5 to 7 days until the INR has been at target level for at least two days.
Interactions
There is a large risk for interactions when warfarin is used concomitantly with other drugs. An intensified monitoring of the therapeutic response to warfarin is therefore recommended when treatment with other drugs is initiated or withdrawn during warfarin treatment.
Genetic variations
Elimination of warfarin is slower in patients with certain mutations in the gene for the enzyme CYP2C9 metabolising (S)-warfarin. These patients only require a low maintenance dose and have a risk of excessive bleeding if a high initial dose is given. In addition, it will take longer to achieve the new efficacy level after adjusting the dose. Also patients with genetic variations of the enzyme VKOR may require lower doses due to increased sensitivity to warfarin.
Resistance
Resistance to warfarin is a very rare phenomenon. Only case reports have been published on that. These patients need 5 to 20 fold warfarin doses to achieve therapeutic response. If the response of the patient to warfarin treatment is poor, other more plausible causes should be ruled out: patient incompliance, interaction with other medicaments or food, and also laboratory errors.
Coumarin necrosis
To avoid coumarin necrosis patients with a hereditary deficiency of antithrombotic protein C or S must first be treated with heparin. Concomitantly initiating warfarin loading doses must not exceed 5 mg. Heparin treatment must be continued for 5 to 7 days as described above.
Store below 30°C and protect from light and moisture.
Keep out of reach of children.
1 x10 Alu/PVC blister
Warfarin Tablets BP 5 mg are available in an Alu/PVC blister of 10 tablets. Such 01 blister in a carton with pack insert.
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