Coumadin Sodium 2.5mg 1 Tablet
| Generic Name | WARFARIN SODIUM |
| Strength | WARFARIN SODIUM 2.5mg |
| Indication/Usage | For the treatment of venous thrombosis, atrial fibrillation with embolization, pulmonary embolism and as an adjunct in the treatment of coronary occlusion. |
| Dosage and Administration | Must be individualized for each patient according to the particular patient's sensitivity to the drug. The dosage should be adjusted based upon the results of the 1-stage prothrombin time (PT). Different thromboplastin reagents vary substantially in their responsiveness to sodium warfarin-induced effects on PT. To define the appropriate therapeutic regimen, it is important to be familiar with the sensitivity of the thromboplastin reagent used in the laboratory and its relationship to the International Reference Preparation (IRP), a sensitive thromboplastin reagent prepared from human brain. |
| Warning and Precautions | The most serious risks associated with anticoagulant therapy with warfarin sodium are hemorrhage in any tissue or organ (see BLACK BOX WARNING) and, less frequently (<0.1 %), necrosis and/or gangrene of skin and other tissues. Hemorrhage and necrosis have in some cases been reported to result in death or permanent disability. Necrosis appears to be associated with local thrombosis and usually appears within a few days of the start of anticoagulant therapy. In severe cases of necrosis, treatment through debridement or amputation of the affected tissue, limb, breast or penis has been reported. Careful diagnosis is required to determine whether necrosis is caused by an underlying disease. Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation. Although various treatments have been attempted, no treatment for necrosis has been considered uniformly effective. See below for information on predisposing conditions. These and other risks associated with anticoagulant therapy must be weighed against the risk of thrombosis or embolization in untreated cases. It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. Warfarin Sodium, a narrow therapeutic range (index) drug, may be affected by factors such as other drugs and dietary vitamin K. Dosage should be controlled by periodic determinations of prothrombin time (PT)/International Normalized Ratio (INR) or other suitable coagulation tests. Determinations of whole blood clotting and bleeding times are not effective measures for control of therapy. Heparin prolongs the one-stage PT. When heparin and warfarin are administered concomitantly, refer below to CONVERSION FROM HEPARIN THERAPY for recommendations. Caution should be observed when warfarin is administered in any situation or in the presence of any predisposing condition where added risk of hemorrhage, necrosis, and/or gangrene is present. Anticoagulation therapy with warfarin may enhance the release of atheromatous plaque emboli, thereby increasing the risk of complications from systemic cholesterol microembolization, including the "purple toes syndrome.” Discontinuation of warfarin therapy is recommended when such phenomena are observed. Systemic atheroemboli and cholesterol microemboli can present with a variety of signs and symptoms including purple toes syndrome, livedo reticularis, rash, gangrene, abrupt and intense pain in the leg, foot, or toes, foot ulcers, myalgia, penile gangrene, abdominal pain, flank or back pain, hematuria, renal insufficiency, hypertension, cerebral ischemia, spinal cord infarction, pancreatitis, symptoms simulating polyarteritis, or any other sequelae of vascular compromise due to embolic occlusion. The most commonly involved visceral organs are the kidneys followed by the pancreas, spleen, and liver. Some cases have progressed to necrosis or death. Purple toes syndrome is a complication of oral anticoagulation characterized by a dark, purplish or mottled color of the toes, usually occurring between 3-10 weeks, or later, after the initiation of therapy with warfarin or related compounds. Major features of this syndrome include purple color of plantar surfaces and sides of the toes that blanches on moderate pressure and fades with elevation of the legs; pain and tenderness of the toes; waxing and waning of the color over time. While the purple toes syndrome is reported to be reversible, some cases progress to gangrene or necrosis which may require debridement of the affected area, or may lead to amputation. Heparin-induced thrombocytopenia: Warfarin should be used with caution in patients with heparin-induced thrombocytopenia and deep venous thrombosis. Cases of venous limb ischemia, necrosis, and gangrene have occurred in patients with heparin-induced thrombocytopenia and deep venous thrombosis when heparin treatment was discontinued and warfarin therapy was started or continued. In some patients sequelae have included amputation of the involved area and/or death . A severe elevation (>50 seconds) in activated partial thromboplastin time (aPTT) with a PT/INR in the desired range has been identified as an indication or increased risk of postoperative hemorrhage. The decision to administer anticoagulants in the following conditions must be based upon clinical judgment in which the risks of anticoagulant therapy are weighed against the benefits: Lactation: Based on very limited published data, warfarin has not been detected in the breast milk of mothers treated with warfarin. The same limited published data reports that some breast-fed infants, whose mothers were treated with warfarin, had prolonged prothrombin times, although not as prolonged as those of the mothers. The decision to breast-feed should be undertaken only after careful consideration of the available alternatives. Women who are breast-feeding and anticoagulated with warfarin should be very carefully monitored so that recommended PT/INR values are not exceeded. It is prudent to perform coagulation tests and to evaluate vitamin K status in infants at risk for bleeding tendencies before advising women taking warfarin to breast-feed. Effects in premature infants have not been evaluated. Severe to moderate hepatic or renal insufficiency. Infectious diseases or disturbances of intestinal flora: sprue, antibiotic therapy. Trauma which may result in internal bleeding. Surgery or trauma resulting in large exposed raw surfaces. Indwelling catheters. Severe to moderate hypertension. Known or suspected deficiency in protein C mediated anticoagulant responses: Hereditary or acquired deficiencies of protein C or its cofactor, protein S have been associated with tissue necrosis following warfarin administration. Not all patients with these conditions develop necrosis, and tissue necrosis occurs in patients without these deficiencies. Inherited resistance to activated protein C has been described in many patients with venous thromboembolic disorders but has not yet been evaluated as a risk factor for tissue necrosis. The risk associated with these conditions, both for recurrent thrombosis and for adverse reactions, is difficult to evaluate since it does not appear to be the same for everyone. Decisions about testing and therapy must be made on an individual basis. It has been reported that concomitant anticoagulation therapy with heparin for 5 to 7 days during initiation of therapy with warfarin may minimize the incidence of tissue necrosis. Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation. Miscellaneous: polycythemia vera, vasculitis, and severe diabetes. In patients with acquired or inherited warfarin resistance, decreased therapeutic responses to warfarin have been reported. Exaggerated therapeutic responses have been reported in other patients. Patients with congestive heart failure may exhibit greater than expected PT/INR response to warfarin sodium, thereby requiring more frequent laboratory monitoring, and reduced doses of warfarin sodium. Concomitant use of anticoagulants with streptokinase or urokinase is not recommended and may be hazardous. (Please note recommendations accompanying these preparations.) |
| Adverse Reactions | Potential adverse reactions to warfarin may include: • Fatal or nonfatal hemorrhage from any tissue or organ. This is a consequence of the anticoagulant effect, the signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding. Hemorrhagic complications may present as paralysis; paresthesia; headache, chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath, difficult breathing or swallowing; unexplained swelling; weakness; hypotension; or unexplained shock. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis. Bleeding during anticoagulant therapy does not always correlate with PT/INR. (See OVERDOSAGE: Treatment.) • Bleeding which occurs when the PT/INR is within the therapeutic range warrants diagnostic investigation since it may unmask a previously unsuspected lesion, e.g., tumor, ulcer, etc. • Necrosis of skin and other tissues. (See WARNINGS.) • Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, systemic cholesterol microembolization, purple toes syndrome, hepatitis, cholestatic hepatic injury, jaundice, elevated liver enzymes, hypotension, vasculitis, edema; anemia, pallor, fever, rash, dermatitis, including bullous eruptions, urticaria, angina syndrome, chest pain, abdominal pain including cramping, flatulence/bloating, fatigue, lethargy, malaise, asthenia, nausea, vomiting, diarrhea, pain, headache, dizziness, loss of consciousness, syncope, coma, taste perversion, pruritus, alopecia; cold intolerance, and paresthesia including feeling cold and chills. Rare events of tracheal or tracheobronchial calcification have been reported in association with long-term warfarin therapy. The clinical significance of this event is unknown. Priapism has been associated with anticoagulant administration; however, a causal relationship has not been established. |
| Contraindication | Anticoagulation is contraindicated in any localized or general physical condition or personal circumstance in which the hazard of hemorrhage might be greater than the potential clinical benefits of anticoagulation, such as: Pregnancy: Warfarin sodium tablets, USP are contraindicated in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus in utero. Furthermore, there have been reports of birth malformations in children born to mothers who have been treated with warfarin during pregnancy. Embryopathy characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) has been reported in pregnant women exposed to warfarin during the first trimester. Central nervous system abnormalities also have been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, Dandy-Walker malformation, and midline cerebellar atrophy. Ventral midline dysplasia, characterized by optic atrophy, and eye abnormalities have been observed. Mental retardation, blindness, and other central nervous system abnormalities, have been reported in association with second and third trimester exposure. Although rare, teratogenic reports following in utero exposure to warfarin include urinary tract anomalies such as single kidney, asplenia, anencephaly, spina bifida, cranial nerve palsy, hydrocephalus, cardiac defects and congenital heart disease, polydactyly, deformities of toes, diaphragmatic hernia, corneal leukoma, cleft palate, cleft lip, schizencephaly, and microcephaly. Spontaneous abortion and stillbirth are known to occur and a higher risk of fetal mortality is associated with the use of warfarin. Low birth weight and growth retardation have also been reported. Women of childbearing potential who are candidates for anticoagulant therapy should be carefully evaluated and the indications critically reviewed with the patient. If the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the possibility of termination of the pregnancy should be discussed in light of those risks. Hemorrhagic tendencies or blood dyscrasias. Recent or contemplated surgery of: (1) central nervous system; (2) eye; (3) traumatic surgery resulting in large open surfaces. Bleeding tendencies associated with active ulceration or overt bleeding of: (1) gastrointestinal, genitourinary or respiratory tracts; (2) cerebrovascular hemorrhage; (3) aneurysms-cerebral, dissecting aorta; (4) pericarditis and pericardial effusions; (5) bacterial endocarditis. Threatened abortion, eclampsia and preeclampsia. Inadequate laboratory facilities. Unsupervised patients with senility, alcoholism, or psychosis or other lack of patient cooperation. Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding. Miscellaneous: major regional, lumbar block anesthesia, malignant hypertension and known hypersensitivity to warfarin or to any other components of this product. |
| Drug Interaction | Coumarins may also affect the action of other drugs. Hypoglycemic agents (chlorpropamide and tolbutamide) and anticonvulsants (phenytoin and phenobarbital) may accumulate in the body as a result of interference with either their metabolism or excretion |
| Requires Prescription? (Yes or No) | Yes |
| Overdose and Treatment | Signs and Symptoms: Suspected or overt abnormal bleeding (e.g., appearance of blood in stools or urine, hematuria, excessive menstrual bleeding, melena, petechiae, excessive bruising or persistent oozing from superficial injuries) are early manifestations of anticoagulation beyond a safe and satisfactory level. |
1. We will deliver orders in the following areas (except in island barangays).
| a) Pangasinan ✔ Dagupan City |
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| b) La Union ✔ Agoo |
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| c) Ilocos Sur ✔ Tagudin |
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| d) Ilocos Norte ✔ Laoag City |
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| e) Bataan ✔ Orion |
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| f) Abra ✔ Bangued |
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| g) Pampanga ✔ Angeles City |
2. There are two (2) ways to receive your order:
a) via Home Delivery
b) via Store Pickup in any of the following St. Joseph Drug (pick-up point)i> branches:
✔ Perez Blvd., Dagupan City
✔ Mabini St., Poblacion West, Calasiao, Pangasinan
✔ Rizal St. corner Biagtan St., Poblacion, Mangaldan, Pangasinan
✔ Rizal St., Poblacion, San Fabian, Pangasinan
✔ Charms Bldg., Poblacion, Pozzorubio, Pangasinan
✔ CB Mall, Mc Arthur Highway, Nancayasan, Urdaneta, Pangasinan
✔ Zone 1 Market Road corner McArthur Highway, Villasis, Pangasinan
✔ Roxas corner Malong St., San Carlos, Pangasinan
✔ Calvo St., Mangatarem, Pangasinan
✔ Poblacion, Basista, Pangasinan
✔ Poblacion, Binmaley, Pangasinan
✔ Solis St., Brgy. Poblacion, Lingayen, Pangasinan
✔ Poblacion, Quezon Avenue, Alaminos, Pangasinan
✔ Concordia (Pob.), Bolinao, Pangasinan
✔ National Road, Poblacion, Bani, Pangasinan
✔ Mother Goose Bldg., Tapuac District, Dagupan City, Pangasinan
✔ Joleco Bldg., I, A.B. Fernandez Ave., Dagupan City, Pangasinan
✔ E&J Bldg., Milo Street, Manaoag, Pangasinan
✔ Panda Ave., Poblacion, Mapandan, Pangasinan
✔ San Guillermo, San Jacinto, Pangasinan
✔ Blue Horizon Bldg., Quezon Blvd., Poblacion, Alaminos City, Pangasinan
✔ CentroMart, Rizal St., Lingayen, Pangasinan
✔ Poblacion, Aguilar, Pangasinan
✔ Romulo Highway, Poblacion, Bugallon ,Pangasinan
✔ Gen. Luna St., Poblacion, Rosales, Pangasinan
✔ Quezon Blvd., Tayug, Pangasinan
✔ National Road, Umingan, Pangasinan
✔ Poblacion East, Alcala, Pangasinan
✔ M.H. Del Pilar St., Bayambang, Pangasinan
✔ CSI, Malasiqui, Pangasinan
✔ P. Tavera St., Poblacion, Binalonan, Pangasinan
✔ Guiset Sur, San Manuel, Pangasinan
✔ Poblacion West, Asingan, Pangasinan
✔ G/F Magic Mall, Alexander St., Urdaneta City, Pangasinan
✔ Poblacion, Infanta, Pangasinan
✔ Agbayani St., Poblacion, Sual, Pangasinan
✔ Poblacion, Urbiztondo, Pangasinan
✔ Poblacion, Sta.Barbara, Pangasinan
✔ Victoria Rd., San Nicolas Norte, Agoo, La Union
✔ CSI City Mall, Biday, San Fernando City, La Union
✔ Osmeña Street, San Fernando City, La Union
✔ Poblacion East, Rosario, La Union
✔ Brgy. Lacong, Tagudin, Ilocos Sur
✔ Hennady Bldg. McArthur Poblacion, Brgy. V, Bantay, Ilocos Sur
✔ National Highway, San Antonio, Candon City, Ilocos Sur
✔ Quezon Avenue, Vigan City, Ilocos Sur
✔ City Galore Square, J.P. Rizal cor. Ligo St., Laoag City, Ilocos Norte
✔ Trece Grande Bldg., 187 JP Rizal St. Cor. Dr. Damaso Samonte St. Brgy 19, Laoag City, Ilocos Norte
✔ National Road, San Vicente, Orion, Bataan
✔ Taft St., Zone 5, Bangued, Abra
✔ Washington St., Brgy 2 Abian, Batac, Ilocos Norte
✔ Middle Session, Baguio City, Benguet
✔ G/F Senvik Loy Bldg., La Trinindad, Benguet
✔ CSI Warehouse, Purok I Palanginan, Iba, Zambales
✔ Magic Mall, Poblacion, Sta. Cruz, Zambales
✔ Sto. Rosario St., Sto. Domingo, Angeles City, Pampanga
3. We charge the following delivery fee:
| Mode of Delivery | Delivery Fee |
|---|---|
| Home Delivery | Delivery fee starts at P60.00 for the first four (4) kilometers. Additional amount will be charged depending on the distance of the shipping address you specified (please refer to the Shipping Fee Directory). |
| Store Pickup | Free of Charge |
4. We will deliver your order as follows:
a) for Home Delivery
| Orders Received | Delivery Schedule |
|---|---|
| Before 1:00pm | Same day delivery within 2:00pm to 6:00pm |
| After 1:00pm | Next day delivery within 2:00pm to 6:00pm |
b) for Store Pick-up
You may expect your order to be ready within 2 hours to a day (depending on the availability of ordered item) upon placement of order. You will be notified via call/SMS once your order is ready for pick-up. We encourage you to claim your order within 3 days (during store hours) upon receipt of advice that your order is ready for pick-up, otherwise, such shall deemed as cancelled.
5. We will deliver your order from Monday to Sunday (including holidays) from 2:00pm to 6:00pm.
6. There are two (2) ways to track your order:
a) For every change in the order status, an email will be sent to you.
b) You can also check your order status by signing-in to your account. Just go to “My Account” and click “Orders” to display the order status.
7. In case you are not home when your order arrives, you may have a representative receive and pay the package for you. However, if payment was made via bank transfer, your representative shall be required to present the following:
a) Authorization Letter; and
b) Your Valid ID (with picture and signature) and that of your representative.
8. If nobody is available to receive your order, our Rider will bring your package back to St. Joseph Drug pick-up point branch nearest/ covering the shipping address you specified, for pick-up within the 3-day claiming period or you can have it redelivered but with a corresponding redelivery fee.
ITEM RETURN/ EXCHANGE/ REFUND1. All products ordered from St. Joseph Drug are subject to quality checking by our designated personnel prior to delivery to/ pick-up by customers.
a) Upon delivery to / pick-up by customer:
✔ Please inspect your package in the presence of our Rider/Pharmacy Assistant. Your signature on the Acknowledgement Receipt signifies that you have received the products completely, correctly, and in good condition (not damaged / defective and / or expiring / expired).
✔ You may refuse to accept the product if such is incorrect, incomplete, or not in good condition. For home delivery, we will redeliver the replacement or additional item/quantity free of delivery charge.
b) After delivery to / pick-up by customer:
✔ We will still accommodate request for item return / exchange / refund under the following conditions:
- Promptly returned within 7 days upon receipt of the product
- Duly supported by St. Joseph Drug official receipt
Note : We may require additional documents (e.g. photo of the affected product) to support your request.
✔ The following items will be acceptable:
- items in good condition provided such are:
- not in a vial
- not loose tablets/capsules
Note : The product must be in its original box/packaging (unused) and complete with gift/promo item (if any).
- products with explicit manufacturing defect
Note : Damaged / defective items due to customer's mishandling or improper use will not be accepted.
✔ Once your request is approved, we will redeliver the replacement or additional item/quantity but with a corresponding redelivery fee (except for products with explicit manufacturing defect which we will redeliver free of delivery charge).
✔ Requests for refund will be reviewed and handled on a case-by-case basis and subject to management's approval.
2. To request for item return/ exchange/ refund, perform any of the following:
a) contact 0917-565-3700 or 0998-530-3700; or
b) report via our live chat/ messaging; or
c) proceed to St. Joseph Drug Perez Blvd., Dagupan City branch.
Note : Request for return/ exchange/ refund of items ordered via our Online Store will not be accepted in any other St. Joseph Drug branches.
3. Requests for item return/ exchange/ refund will be processed within 2-3 working days upon receipt of the required supporting documents. You shall be notified via call/ SMS once the request has been approved.
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