Morfarin

Morfarin

warfarin

Manufacturer:

Charoon Bhesaj

Distributor:

Charoon Bhesaj
Full Prescribing Info
Contents
Warfarin sodium.
Description
MORFARIN TABLET 3 mg: Each tablet contains: Warfarin sodium 3 mg.
MORFARIN TABLET 5 mg: Each tablet contains: Warfarin sodium 5 mg.
Indications/Uses
Prophylaxis and treatment of venous thrombosis, pulmonary embolism and thrombotic disorders.
Prophylaxis of thromboembolic complication associated with atrial fibrillation.
Adjunct in the prophylaxis of systemic embolism after myocardial infarction.
Dosage/Direction for Use
Initial: Oral, 2 to 5 mg per day, the dosage being adjusted according to PT/ INR determinations.
Maintenance: Oral 2 to 10 mg per day, as indicated by PT/INR determinations.
Duration of therapy: Individualize the duration of therapy. Continue anticoagulant therapy until the danger of thrombosis and embolism has passed.
Contraindications
Woman who are pregnant or may become pregnant, hemorrhagic tendencies or blood dyscrasias, recent or contemplated surgery of the CNS or eyes or traumatic surgery resulting in large, open surfaces, bleeding of the GI, respiratory or GU tracts, aneurysm, pericarditis and pericarditis effusion, bacterial endocarditis, spinal puncture, lumbar block anesthesia, hypersensitivity to warfarin or any other components of the products.
Warnings
1. The most serious risks associated with anticoagulant therapy with warfarin are hemorrhage in any tissue or organ and less frequently, necrosis and gangrene of skin and other tissues.
2. Deficiencies of protein C, protein S have been associated with tissue necrosis following warfarin administration.
3. Observe caution when warfarin is administered concomitantly with NSAIDs, including aspirin to be certain that no change in anticoagulation dosage is required.
4. Lower initiation and maintenance doses of warfarin are recommended for elderly patients.
Special Precautions
Use in Children: Safety and efficacy in children under 18 years of age have not been established.
Use In Pregnancy & Lactation
Pregnancy: Category X. Warfarin is contraindicated in woman who are or may become pregnant because the drug passes through the central barrier and may cause fatal hemorrhage to the fetus. There have been reports of birth malformations in children born to mothers who have been treated with warfarin during pregnant.
Lactation: Warfarin has not been detected in the breast milk of mothers treated with warfarin.
Adverse Reactions
Potential adverse events: Hematologic: Fatal or nonfatal hemorrhage from any organ or tissue, paralysis; paresthesia; headache; chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath; difficult breathing or swallowing; unexplained swelling; weakness; hypotension; unexplained shock.
Dermatologic: Necrosis of skin and other tissues.
Infrequent adverse events: Dermatologic: Rash; dermatitis, including bullous eruptions; urticaria; pruritus; alopecia.
GI: Abdominal pain, including cramping; flatulence/bloating; nausea; vomiting; diarrhea.
Hepatic: Hepatitis; cholestatic hepatic injury; jaundice; elevated liver enzymes.
Miscellaneous: Hypersensitivity/allergic reactions; systemic cholesterol microembolization; purple toes syndrome; vasculitis; edema; fever; fatigue; lethargy; malaise; asthenia; pain; headache; dizziness; taste perversion; cold intolerance; paresthesia, including feeling of cold and chills.
Rare adverse events: Miscellaneous: Tracheal or tracheobronchial calcification (in association with long-term therapy); priapism (causal relationship not established).
Drug Interactions
Increased effect: Acetaminophen, androgens, capecitabine, cephalosporins, disulfiram, fibric acids, glucagon, NSAIDs, COX-2 selective, propoxyphene, quinolones, SSRIs, sulfonamides, thyroid hormones, zafirlukast, zileuton, allopurinol, amiodarone, anti-fungals, cimetidine, HMG-Co A reductase inhibitors, metronidazole, omeprazole, propafenone, quinidine, macrolide antibiotics, tetracyclines, vitamin E.
Decreased effect: Contraceptive oral, estrogens, griseofulvin, aminoglutethimide, barbiturates, carbamazepine, glutethimide.
Storage
Store below 30°C and protected from light.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AA03 - warfarin ; Belongs to the class of vitamin K antagonists. Used in the treatment of thrombosis.
Presentation/Packing
Form
Morfarin tab 3 mg
Packing/Price
(foil) 50 × 10's
Form
Morfarin tab 5 mg
Packing/Price
(foil) 50 × 10's
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