Warfarin Sodium Tablets
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Warfarin Sodium Tablets
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Warfarin Sodium Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
[Drug Name]
Generic name: Warfarin Sodium Tablets
English name: Warfarin Sodium Tablets
Pinyin: Huafalinna Pian
[Ingredients]
The active ingredient of this product is warfarin sodium. Its chemical name is: 3-(α-acetophenylbenzyl)-4-hydroxycoumarin sodium salt. Its structural formula is:
Molecular formula: C19H15NaO4 Molecular weight: 330.31
[Properties]
This product is a sugar-coated tablet, appearing white after removal of the coating.
[Indications]
Indicated for patients requiring long-term continuous anticoagulation: ① To prevent the formation and progression of thrombi, for the treatment of thromboembolic diseases; ② For the treatment of venous thrombosis following surgery or trauma, and as adjunctive therapy for myocardial infarction (MI); ③ For prophylactic use in patients with a history of thromboembolic disease or at risk of postoperative thrombotic complications.
[Specification]
2.5mg
[Dosage and Administration]
Oral administration. The usual adult dosage is: 3–4mg for the first 3 days (half dose for elderly, debilitated, or diabetic patients). After 3 days, a maintenance dose of 2.5–5mg daily (1–2 tablets) may be administered (dose adjustment based on clotting time to achieve an INR of 2–3 is permissible). Due to the slow onset of action, a transient hypercoagulable state may occur during the initial 3 days of treatment due to suppression of plasma anticoagulant proteins. If immediate anticoagulation is required, heparin may be co-administered at the start of treatment and discontinued after the drug has fully exerted its anticoagulant effect.
[Adverse Reactions]
Excessive use may lead to various bleeding disorders. Early manifestations include ecchymosis, purpura, gingival bleeding, epistaxis, prolonged wound bleeding, and menorrhagia. Bleeding can occur in any anatomical site, particularly in the urinary and digestive tracts. Intestinal wall hematomas may cause subacute intestinal obstruction, while subdural intracranial hematomas and puncture site hematomas may also be observed. Rare adverse reactions include nausea, vomiting, diarrhea, pruritic rash, allergic reactions, and cutaneous necrosis. Massive oral administration may even result in bilateral mammary gland necrosis, microangiopathy, hemolytic anemia, and extensive skin gangrene; particularly hazardous is an excessively large single dose.
[Contraindications]
Contraindicated in patients with hepatic or renal impairment, severe hypertension, coagulation disorders with bleeding tendency, active ulcers, trauma, threatened abortion, or recent surgery. Contraindicated during pregnancy.
[Matters Need Attention]
(1) Caution should be exercised in elderly individuals or during menstruation.
(2) Strictly adhere to the indications. This product must not be abused in the absence of prothrombin time measurement.
(3) Significant individual variations exist, necessitating close monitoring of the patient's condition during treatment and dosage adjustment based on prothrombin time (PT) and international normalized ratio (INR) values. Close observation should also be maintained for oral mucosal, nasal, and subcutaneous bleeding, as well as occult blood in stool and hematuria. Unnecessary surgical procedures should be avoided during medication. Patients scheduled for elective surgery should discontinue the medication for 7 days, while those requiring emergency surgery must achieve a corrected PT/INR value ≤1.6. Excessive fatigue and activities prone to injury should be avoided.
(4) If mild bleeding occurs, or if the prothrombin time is significantly prolonged to more than 2.5 times the normal range, the dose should be immediately reduced or discontinued. For severe bleeding, intravenous administration of vitamin K1 (10–20 mg) may be given to control the bleeding, and whole blood, plasma, or prothrombin complex may be transfused if necessary.
(5) As this product is an indirect-acting anticoagulant with a long half-life, its therapeutic effect may not stabilize until 5-7 days after administration. Therefore, the adequacy of the maintenance dose must be determined only after 5-7 days of observation.
[Medication Use in Pregnant and Lactating Women]
(1) The drug readily crosses the placenta and may cause fetal malformations. Use during pregnancy may lead to "fetal warfarin syndrome," with an incidence rate of 5% to 30%. Clinical manifestations include osteogenesis imperfecta, nasal hypoplasia, optic atrophy, intellectual disability, and malformations of the heart, liver, spleen, gastrointestinal tract, and head. Administration in the third trimester may result in hemorrhage and stillbirth. Therefore, this product is contraindicated during the first trimester (first 3 months) and the third trimester (last 3 months). For pregnant women with hereditary thrombophilia, low-dose heparin may be administered under close laboratory monitoring.
(2) A small amount of warfarin can be excreted in breast milk. For lactating women, the recommended daily dose is 5–10mg (2–4 tablets), with a plasma concentration typically ranging from 0.48–1.8 μg/ml. The drug concentration in breast milk and infant plasma is extremely low, resulting in minimal impact on infants.
[Pediatric Dosage]
The dosage should be adjusted according to individual needs.
[Geriatric Medication]
Elderly patients should use with caution, and the dosage should be appropriately reduced and individualized.
[Drug Interaction]
1. Drugs that enhance the anticoagulant effect of this product include: aspirin, sodium salicylate, glucagon, quinidine, indomethacin, phenylbutazone, quinine, uricoside, metformin, metronidazole, allopurinol, erythromycin, chloramphenicol, certain aminoglycoside antibiotics, cephalosporins, phenytoin, cimetidine, clofibrate, levothyroxine, paracetamol, etc.
2. Drugs that reduce the anticoagulant effect of this product: phenytoin sodium, barbiturates, oral contraceptives, estrogens, cholestyramine, rifampin, vitamin K analogs, clopidogrel, spironolactone, propranolol, corticosteroids, etc.
3. Contraindications: This product should not be used concomitantly with the following medications: epinephrine hydrochloride, amikacin, vitamin B12, metaraminol, oxytocin, chlorpromazine hydrochloride, vancomycin hydrochloride, etc.
4. When used concomitantly with chloral hydrate, the efficacy and toxicity of this product are enhanced, and the dosage should be reduced with caution. Impaired absorption or decreased synthesis of vitamin K also affects the anticoagulant effect of this product.
[Drug Overdose]
This experiment was not conducted and there is no reliable reference literature.
[Pharmacology and Toxicology]
Pharmacological action: This product is a medium-strength anticoagulant of the dicoumarol class. Its mechanism of action involves competitive antagonism of vitamin K, inhibition of coagulation factor synthesis in hepatocytes, and reduction of thrombin-induced platelet aggregation, thereby exhibiting anticoagulant and antiplatelet aggregation effects.
[Toxicology Study]
Not performed and no reliable references available.
[Pharmacokinetics]
The drug is rapidly and completely absorbed through the oral gastrointestinal tract, with a bioavailability of up to 100%. After absorption, it binds to plasma proteins at a rate of 98%–99%, crosses the placenta, and is present in minimal amounts in breast milk. It is primarily stored in the lungs, liver, spleen, and kidneys. The drug is metabolized in the liver, and its metabolites are excreted by the kidneys. The drug begins to act 12–18 hours after administration, reaches its peak anticoagulant effect within 36–48 hours, and maintains this effect for 3–6 days, with a half-life (t1/2) of approximately 37 hours.
[Storage]
Protect from light and store in a tightly sealed container.
[Packaging]
Medical aluminum foil/Polyvinyl chloride (PVC) solid medical hard sheet packaging, 20 sheets per plate × 2 plates per box.
[Validity]
24 months
[Implementation Standard]
China Pharmacopoeia 2020 Edition Part II
[Approval Number]
National Drug Approval Number H19993692
[Marketing Authorization Holder/Manufacturer]
Company Name: Henan Zhongjie Pharmaceutical Co., Ltd.
Registered address: South Railway Station, Xinxiang City, Henan Province
Production address: South Railway Station, Xinxiang City, Henan Province
Postal Code: 453003
Phone Number: +86-373-5071333
Fax: +86-373-5071222
Website: http://www.xxzjyy.com.cn
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