WARFINE 2
-
Chemical Name:
Warfarin Sodium -
Therapeutic Category:
Cardiovascular drugs -
Pharmacologic Category:
Anticoagulant, Coumarin Derivative - Vitamin K Antagonist -
Pharmaceutical Form:
Tablets -
Composition:
Warfarin Sodium 2mg
WARFINE
Tablets
Warfarin Sodium
1. PHARMACOLOGY:
Warfarin is a synthetic coumarin drug which depresses synthesis of prothrombin (factor II) in the liver, and interferes with the production of factors VII, IX and X, thereby minimizing intravascular clotting.
The inhibition of prothrombin involves interference with the action of vitamin K, and it has been postulated that warfarin, like bishydroxycoumarin, competes with vitamin K for an enzyme essential for prothrombin synthesis.
Warfarin is readily absorbed from the gastointestinal tract. Maximal plasma levels are achieved within 2-8 hours, peak effect in 36 to 72 hours, with effects on prothrombin time persisting for about 4 to 5 days following a single therapeutic dose.
2. INDICATIONS:
For the prophylaxis and treatment of:
- Venous thrombosis and its extension.
- Pulmonary embolism.
- Thromboembolism associated with atrial fibrillation.
- Used concomitantly in the prophylaxis of systemic embolism after myocardial infarction.
3. CONTRAINDICATIONS:
Anticoagulation is contraindicated in any localized or general physical condition in which hazard of hemorrhage might be greater than the potential clinical benefits of anticoagulation such as:
- Pregnancy and threatened abortion.
- Hemorrhagic tendencies or blood dyscrasias.
- Recent or contemplated surgery of central nervous system, eye, traumatic surgery resulting in large open surfaces.
- Severe hypertension, hepatic or renal insufficiency.
- Active ulcerations.
- Pericarditis.
- Vitamin K deficiency.
- Miscellaneous: as continuous tubal drainage of the gastrointestinal and urinary tracts.
4. PRECAUTIONS:
Periodic determination of PT or/and other suitable coagulation test.
5. SIDE EFFECTS:
Excessive doses may cause:
- Hemorrhage from a wound or an ulcerative lesion or mucous membranes or any internal organ.
- Necrosis (bleeding into the skin and subcutaneous tissue).
- Skin rash, nausea, vomiting.
6. DRUG INTERACTIONS:
- Drugs generally recognized as diminishing the effects of oral anticoagulants are: Acetomenaphthone, alcohol (chronic ingestion without liver impairment), aminoglutethimide, barbiturates, carbamazepine, dichloralphenazone, griseofulvin, phytomenadione, rifampicin.
- Drugs recognized or generally reported as enhancing oral anticoagulants are: Alcohol (acute ingestion or chronic ingestion with liver impairment), allopurinol, amiodarone, aspirin, cephamandole, chloral hydrate, chloramphenicol, cimetidine, clofibrate, co-trimoxazole, denazole, dextropropoxyphene, dextrothyroxine, dipyridamole, disulfiram, erythromycin, ethacrynic acid, ethyloestrenol, fluconazole, glucagon, itraconazole, ketoconazole, metronidazole, miconazole, norethandrolone, NSAIDs, oymentholone, quinidine, stanozol sulphinphrazone, tamoxifen, thyroid agents, tienilic acid, triclofos sodium.
7. DOSAGE & ADMINISTRATION:
The dosage must be individualized for each patient according to the prothrombin time results used as a guide until establishment of the maintenance dose.
Initial Dosage: (10-20 mg) (2-4 tablets) or as directed by the physician.
Dose should be reduced in elderly patients or in patients with increased sensitivity to Warfarin.
Maintenance Dosage: (2.5-5 mg) (½ - 1 tablet).
The total dose may be administrated once a day at the same time each day.
It should be born in mind that the onset of therapeutic effect occurs only after about 30 hours.
Duration of Therapy:
The duration of therapy should be individualized in each patient.
In general, anticoagulant therapy should be continued until the danger of thrombosis and embolism has passed.
8. PACKAGING & COMPOSITION:
- WARFINE 2 – Tablets: A pack of 100 tablets in blisters. Each tablet contains 2 mg Warfarin Soidum.
- WARFINE 5 – Tablets: A pack of 100 tablets in a container. Each tablet contains 5 mg Warfarin Soidum.
9. STORAGE CONDITIONS:
Store WARFINE – Tablets at temperature between (15-30)°C. Protect from light.
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