WARFARIN is a brand name for Warfarin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Transient attack of cerebral ischaemia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and elderly patients:
Elective and sub-acute prophylactic loading dose: 10 mg once a day for two days, tailored to individual requirements. 0 mg once a day.
Monitoring:
Baseline prothrombin (PT) or INR measurements should be made before beginning therapy with warfarin tablets. A therapeutic range of acceptable coagulation test measurements should be individually established which are then monitored at regular intervals to guide treatment and subsequent dosing.
A maintenance dose can be omitted if the prothrombin time is excessively prolonged.
Emergency anticoagulant therapy:
Emergency anticoagulation should be initiated with heparin and warfarin together. Where there is less urgency, as in patients predisposed to or at special risk of thromboembolism, anticoagulant therapy may be initiated with warfarin alone.
Paediatric population:
No data are available. Method of administration Oral Warfarin tablets should be taken at the same time each day, preferably on an empty stomach
4) (Frequency: not known) Respiratory, thoracic and mediastinal disorders Haemothorax, epistaxis Skin and subcutaneous disorders Rash; alopecia; purpura; ‘purple toes’ syndrome; erythematous swollen skin patches leading to ecchymosis, infarction and skin necrosis; calciphylaxis Vascular disorders Haemorrhage Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Most adverse events reported with warfarin are a result of over anticoagulation therefore it is important that the need for therapy is reviewed on a regular basis and therapy discontinued when no longer required. Patients should be given a patient-held information booklet (‘warfarin card’) and informed of symptoms for which they should seek medical attention.
Commencement of therapy Monitoring When warfarin is started using a standard dosing regimen the INR should be determined daily or on alternate days in the early days of treatment. Once the INR has stabilised in the target range the INR can be determined at longer intervals.
g. patients with severe hypertension, liver or renal disease. Patients for whom adherence may be difficult should be monitored more frequently. Thrombophilia Patients with protein C deficiency are at risk of developing skin necrosis when starting warfarin treatment.
In patients with protein C deficiency therapy should be introduced without a loading dose of warfarin even if heparin is given. Patients with protein S deficiency may also be at risk and it is advisable to introduce warfarin therapy slowly in these circumstances.
Risk of haemorrhage The most frequently reported adverse effect of all oral anticoagulants is haemorrhage. g. concomitant NSAID use, recent ischaemic stroke, bacterial endocarditis, previous gastrointestinal bleeding). 5). All patients treated with warfarin should have INR monitored regularly.
Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shorter duration of therapy. Patients should be instructed on measures to minimise risk of bleeding and to report immediately to physician’s signs and symptoms of bleeding.
Checking the INR and reducing or omitting doses depending on INR level is essential, following consultation with anticoagulation services if necessary. If the INR is found to be too high, reduce dose or stop warfarin treatment; sometimes it will be necessary to reverse anticoagulation.
4 for further details). 4). - Within 48 hours postpartum. 6). 5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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INR should be checked within 2-3 days to ensure that it is falling. Any concomitant anti-platelet drugs should be used with caution due to an increased risk of bleeding. Haemorrhage Haemorrhage can indicate an overdose of warfarin has been taken.
9. Unexpected bleeding at therapeutic levels should always be investigated and INR monitored. Anticoagulant-related nephropathy In patients with altered glomerular integrity or with a history of kidney disease, acute kidney injury may occur, possibly in relation to episodes of excessive anticoagulation and haematuria.
A few cases have been reported in patients with no pre-existing kidney disease. Close monitoring including renal function evaluation is advised in patients with a supratherapeutic INR and haematuria (including microscopic). Ischaemic stroke Anticoagulation following an ischaemic stroke increases the risk of secondary haemorrhage into the infarcted brain.
In patients with atrial fibrillation long term treatment with warfarin is beneficial, but the risk of early recurrent embolism is low and therefore a break in treatment after ischaemic stroke is justified. Warfarin treatment should be re-started 2-14 days following ischaemic stroke, depending on the size of the infarct and blood pressure.
In patients with large embolic strokes, or uncontrolled hypertension, warfarin treatment should be stopped for 14 days. 5. For surgery where there is a risk of severe bleeding, warfarin should be stopped 3 days prior to surgery. g. 5 and heparin therapy should be started.
If surgery is required and warfarin cannot be stopped 3 days beforehand, anticoagulation should be reversed with low-dose vitamin K. The timing for re-instating warfarin therapy depends on the risk of post operative haemorrhage. In most instances warfarin treatment can be re-started as soon as the patient has an oral intake.
Dental Surgery Warfarin need not be stopped before routine dental surgery eg, tooth extraction. Active peptic ulceration Due to a high risk of bleeding, patients with active peptic ulcers should be treated with caution. Such patients should be reviewed regularly and informed of how to recognise bleeding and what to do in the event of bleeding occurring.
5). Any change to medication, including self-medication with OTC products, warrants increased monitoring of the INR. Patients should be instructed to inform their doctor before they start to take any additional medications including over the counter medicines, herbal remedies or vitamin preparations.
Calciphylaxis Calciphylaxis is a rare syndrome of vascular calcification with cutaneous necrosis, associated with high mortality. The condition is mainly observed in patients with end- stage renal disease on dialysis or in patients with known risk factors such as protein C or S deficiency, hyperphosphataemia, hypercalcaemia or hypoalbuminaemia.
Rare cases of calciphylaxis have been reported in patients taking warfarin, also in the absence of renal disease. In case calciphylaxis is diagnosed, appropriate treatment […]