Bula do remedy Coumadin

the package insert of the medicine Coumadin. Therapeutic class of Anticoagulant. Active principles warfarin sodium.

what For?

Coumadin is indicated for: the prevention and/or treatment of venous thrombosis and its extension, and pulmonary embolism; prevention and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or heart valve replacements, and a reduction in the risk of death, recurrence of myocardial infarction and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

adult Use – Use oral

Pharmacokinetics

How it works?

Coumadin is an anticoagulant that acts on the inhibition of coagulation factors dependent on vitamin K.

The goal of therapy with anticoagulants is to reduce the ability of blood clotting to prevent thrombosis, and at the same time prevent the occurrence of spontaneous bleeding.

Coumadin is absorbed completely after oral administration, being that the medicine reaches the blood circulation in the first 4 hours.

Dosage

How to use?

your doctor will indicate the ideal dose for you, as well as the diet being followed.

The dosage of Coumadin for each patient should be determined through constant monitoring of the response of the INR (ratio of regulated international) and consideration of the indication being treated. The routine use of high doses of attack is not recommended, as it can increase the incidence of bleeding complications and other complications and does not offer a protection more quick against the formation of thrombus.

patients with increased risk of bleeding (such as, for example, elderly or debilitated patients, patients with liver failure or heart failure congestive, patients on concomitant treatment with other medications known to increase sensitivity to warfarin, patients of specific ethnic groups, and patients with increased risk of bleeding complications due to other factors) should receive lower doses of initial and maintenance. (see Warning and Caution).

it Is recommended that therapy with Coumadin is begun with a dose of 2 to 5 mg daily with adjustments posológicos based on the results of the determinations of the INR.

In the majority of patients are satisfactorily maintained at a dose of 2 to 10 mg a day. The flexibility of dosage is obtained from the compressed creased in the middle. The individual dose and the intervals should be adjusted according to the response of the prothrombin time of the patient. The duration of therapy for each patient should be individualized. In general, therapy with anticoagulant should be continued until the risk of thrombosis and embolism is eliminated.

do Not stop treatment without the knowledge of your doctor. If therapy is interrupted, the effects anticoagulants Coumadin may persist for about 2 to 5 days.

Side Effects

What are the evils that can cause me?

Tell your doctor the appearance of side effects such as diarrhea, infection, fever, hypersensitivity reactions / allergic, micro-embolization and systemic cholesterol (micro-obstruction of a vessel), inflammation of the liver, liver damage, elevated liver enzymes,
vasculitis (inflammation in vessels), skin rash, dermatitis, including rash with blisters, hives, abdominal pain, gas/bloat, nausea, vomiting, diarrhea, altered taste, itching, hair loss, calcification of tracheal or tracheobronchial and chills.

immediately Inform the doctor if you experience any bleeding or the symptom is not usual. The signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding due to cuts, increased menstrual flow, vaginal bleeding that does not coincide with the menstrual cycle, bleeding in the nose, presence of blood in the phlegm, vomiting of blood, bleeding from gums when brushing teeth, bleeding or appearance unusual bruising urine with red color or dark brown, tarry stools red or darkened, headache, dizziness or weakness.

The following serious side effects to Coumadin are discussed in greater detail in other sections of this package insert: Bleeding (see Warnings and Overdosage), and necrosis of the skin and other tissues. (see Warnings).

Contraindications

When should I not use?

Coumadin in pregnancy and lactation: you should not use this medicine if you are pregnant, except if you have mechanical heart valves at high risk of thrombosis.

Tell your doctor the occurrence of pregnancy during treatment or after its completion. Tell your doctor if you are breast-feeding.

This medicine should not be used by women who are pregnant or who may become pregnant during treatment.

If you are allergic to any component of the formulation, should not use Coumadin.

treatment with drugs of this class should not be used in any physical condition localized or general, or personal circumstances in which the risk of hemorrhage is greater than the clinical benefits of the treatment, such as:

    the

  • Tendencies to hemorrhage or blood disorders;
  • the

  • recent Surgery or the possibility of surgery-related: central nervous system; eyes; surgery trauma resulting in large open surfaces;
  • the

  • Patients with a tendency to bleeding associated with the ulceration, the active systems are the gastrointestinal, genital, urinary, or respiratory; hemorrhage stroke; cerebral aneurysms, dissecting aorta; pericarditis and efusões pericárdicas; bacterial endocarditis;
  • the

  • threatened abortion, eclampsia (spasms muscle with or without loss of the senses) and pre-eclampsia;
  • the

  • Patients inadequately controlled with an INR (ratio regulated international) above the therapeutic range, and/or with high risk of non-adherence to the correct treatment;
  • the

  • Puncture spine and other diagnostic procedures or therapeutic with potential for bleeding not controllable;
  • the

  • regional Anesthesia of large, anesthesia blocking lumbar, malignant hypertension and known hypersensitivity to warfarin or to any of the components of this product (for example: anaphylaxis).

Warnings and Precautions

what should I know before using?

The more serious business risks associated with the therapy of anti-coagulation using warfarin sodium are hemorrhage in any tissue or organ and, less frequently, necrosis and/or gangrene of skin and other tissues.

The risk of hemorrhage is related to the level of intensity and the duration of therapy with drugs of this class. In some cases, it was reported that the hemorrhage and necrosis have resulted in death or permanent disability. The necrosis appears to be associated with the thrombosis site, and generally occurs a few days after beginning therapy with an anticoagulant.

in Patients that have severe cases of necrosis may require treatment through debridement or amputation of the affected tissue, limb, breast or penis. A careful diagnosis is required to determine whether necrosis is caused by an underlying disease. Therapy should be discontinued when there is suspicion that the warfarin is the cause of the development of the necrosis; in this case, the therapy using heparin may be considered a form of anti-coagulation.

treatment with Coumadin can be influenced by factors such as other medications, dietary intake of vitamin K in the diet, nutritional status and strength hereditary warfarin. The dosage should be controlled by laboratory tests journals to determine the INR (ratio of regulated international), or other adequate tests of coagulation.

You must be cautious when Coumadin is administered in the presence of any condition or of a predisposition in which there is a risk of hemorrhage, necrosis and/or gangrene, or any other situation.

The therapy of anti-coagulation with Coumadin may enhance the release of clots of plaque atheromatous, thus increasing the risk of complications, including the syndrome of the fingers purple. If you notice these phenomena, the therapy with Coumadin should be stopped.

You should be aware of also to the following pre-dispositions and conditions, the risks associated with therapy with anticoagulants: thrombocytopenia induced by heparin, pregnancy, lactation, severe hepatic impairment to moderate, infectious diseases, or intestinal disorders catheter bladder of long duration, increase in blood pressure, severe to moderate deficiency of response to anticoagulant mediated by the C protein, eye surgery, increase in the number of red blood cells, vasculitis, and diabetes.

You should avoid any activity or sports that may result in injury traumatic, dramatic changes in eating habits, for example, large variations in the intake of green vegetables.

Factors, either isolated or in combination, including travel, changes in diet, environment, physical state and medications, including herbal products, may influence the response of the patient to anticoagulants.

Women of childbearing age and are candidates to receive treatment with drugs of this class should be carefully evaluated and the indications critically reviewed with the doctor. If the patient becomes pregnant while making use of the drug, the potential risks to the fetus should be assessed and, depending on the potential of these risks, the possibility of disruption of gpregnancy should be discussed.

The safety and effectiveness in pediatric patients have not been established in clinical studies adequate and well-controlled. The paediatric use of Coumadin is based on the data and recommendations for adult and paediatric data the limited available observational studies and patient registry. In pediatric patients it may be difficult to achieve and maintain tracks therapeutic INR. Determinations of INR are most often recommended due to possible needs for changes in the warfarin.

No difference overall in safety or efficacy were observed between these elderly patients and younger in controlled clinical studies, but greater sensitivity of some older individuals cannot be ruled out. Patients from 60 years of age seem to present a response to an INR greater than expected to the effects of anticoagulants of the warfarin.

Coumadin is contraindicated in any elderly patient who is not receiving medical follow-up.

elderly Patients who are taking Coumadin should be careful in any situation or physical condition in which there is additional risk of bleeding.

patients of asian origin may require lower doses of initial and maintenance warfarin. The age was the determining factor more important to justify the need for warfarin of chinese patients, and this need progressively smaller with advancing age.

it is Not necessary dose adjustment in cases of renal dysfunction.

The functional change of the liver can potentiate the response to warfarin. Care should be taken when using Coumadin in these patients.

Drug Interactions

Factors endogenous that affect the response to anticoagulation:

the following factors are responsible for increasing the response of the INR: diarrhea, disorders of the liver, nutritional status, poor, esteatorreia, or deficiency of vitamin K.

the following factors are responsible for slow response of the INR: increase in intake of vitamin K or resistance hereditary warfarin.

Some medicines or habits may increase or decrease the effect of warfarin as in the following examples:

Increase the effect of warfarin: fluconazole, fluvastatin, metronidazole, miconazole, cimetidine, ciprofloxacin, norfloxacino, oral contraceptives, propranolol, alprazolam, amlodipine were reported, atorvastatin, itraconazole, ketoconazole, lopinavir / ritonavir, quinidine, propafenone, amiodarone, metildopa, atenolol, prasugrel, ticlopidine, abciximabe, tirofibana, heparin, estreptoquinase, alteplase, pentoxifylline, bezafibrato, clofibrate, ciprofibrato, fenofibrate, genfibrozila, lovastatin, pravastatin, rosuvastatin, simvastatin, ezetimibe, ranitidine, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, allopurinol, acid valproico, valproate, fosfenitoína, phenytoin, ginkgo biloba, memantine, chloral hydrate, glutetimida, noscapina, oxolamina, dexamethasone, methylprednisolone, prednisone, exenatida, clorpropamida, tolbutamide, amoxicillin, benzylpenicillin, penicillin G, piperacillin, ticarcillin, cefaclor, cefamandol, cefazolin, cefixime, cefotetana, cefonicida, cefotiam, cefoxitin, ceftriaxana, cefuroxime, doxycycline, tetracycline, tigeciclina, azithromycin, clarithromycin, erythromycin, roxithromycin, telithromycin, neomycin, kanamycin, nalidixic acid, moxifloxacino, pefloxacino, ofloxacino, sulfadoxine, sulfafurazol, sulfametizol, sulfamethoxazole/ trimethoprim, sulfisoxazol, acid aminosalicylic, isoniazid, chloramphenicol, vancomycin, econazole, voriconazole, proguanil, nimorazol, tinidazole, quinine, delavirdine, efavirenz, etravirine, nevirapine, atazanavir, acetaminofem (paracetamol), aspirin (acetylsalicylic acid), diflunisal, propoxyphene, tramadol, diclofenac, indomethacin, ketorolac, sulindac, fenoprofeno, ibuprofen, ketoprofen, naproxen, oxaprozina, celecoxibe, etoricoxibe, lumiracoxibe, rofecoxibe, mefenamic acid, acid meclofenâmico, lornoxicam, piroxicam, glucosamine, and paclitaxel. – decrease the effect of warfarin: carbamazepine, phenobarbital, rifampin, phenytoin, omeprazole, smoking, efavirenz, prednisone, espirolactona, chlorthalidone, cholestyramine, colesevelam, atorvastatin, pravastatin, ranitidine, sucralfate, aprepitanto, fosaprepitanto, ubiquinone (ubidecarenona), primidone, haloperidol, clozapine, clordiazepóxido, meprobamato, chloral hydrate, butobarbital, pentobarbital, secobarbital, cortisone, dicloxacilina, nafcilina, rifapentine, and griseofulvin, ribavirin, efavirenz, nevirapine, darunavir, ritonavir, glucosamine, cyclophosphamide, vitamin C, vitamin K and alcohol, etretinato, isotretinoin.

it is Recommended to get in touch with the doctor before you start, stop, or change the dosage of any medication used or prescribed during your therapy with Coumadin.

Drugs that increase the risk of bleeding: some classes of drugs, such as anticoagulants (argatrobana, dabigatran, bivalirudina, desirudina, heparin, lepirudina, rivaroxabana, apixabana), agents-platelet therapy (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine), anti-inflammatory agents non steroidal (celecoxibe, diclofenac, diflunisal, fenoprofeno, ibuprofen, indomethacin, cetoprofeon, ketorolac, mefenamic acid, naproxen, oxaprozina, piroxicam, sulindac), reuptake inhibitors of serotonin (citalopram, desvenlafaxina, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnaciprano, paroxetine, sertraline, venlafaxine, vilazodone), and thrombolytic agents are known to increase the risk of bleeding. It is recommended that a careful monitoring of patients treated with Coumadin, and any other medicine at the same time.

The antibiotics or antifungal agents may alter the response to anticoagulant. Therefore, the patients in treatment with warfarin should be monitored for the INR when initiating or interrupting the administration of antibiotics or antifungals.

You should exercise caution when administering herbal medicines (therapy that uses plants or plant substances) concomitantly with Coumadin. Due to the lack of standardization in the manufacture of preparations herbal, the amount of active ingredients can vary and this can further compromise the capability to assess the interactions and potential effects on anti-coagulation.

Some herbal remedies may cause bleeding episodes when administered in isolation (for example, garlic and Ginkgo biloba) and may decrease coagulation. It is expected that these effects are additive to the effects anticoagulants Coumadin. On the other hand, other herbal remedies can reduce the effects of Coumadin (for example: coenzyme Q10, St. John’s wort and ginseng).

Some herbal remedies and foods may interact with Coumadin through interactions with enzymes, metabolic (for example: echinacea, grapefruit juice, ginkgo, goldenseal, St. John’s wort). Monitor the response of the patient with determination additional of their INR when starting or stopping the administration of any herbal remedies.

Some herbal remedies that could affect clotting include: agrimônia, celery, licorice, wild lettuce, alfalfa, garlic, aspen, aloe gel, agrimônia, angelica (Dong Quai), arnica, aspen, asafedita, black haw, bromelaínas, bodelha (Fucus vesiculosus), bogbean, boldo, buchu, chamomile (German and Roman), cápsico, horse chestnut, cassia, onion, carrot wild, cimicífuga, danshen (Salvia miltiorrhiza), dandelion, broad beans-the smell, fenugreek, hay-decheiro, feverfew, passion flower, gualtéria, ginger, ginkgo biloba, ginseng (Panax), goldenseal hidraste, yarrow, nicotinate inositol, pau d’arco, prickly ash (Northern), policosanol, quássia,horseradish-rustic, salsa, sarsaparilla German, willow, seed of anise, sênega, tamarind, clover, red clover, clover-smell, ulmária, nettle, mistletoe.

Overdose

what to do if someone use a larger amount than is recommended?

If a person unexpectedly take a large amount of this medicine at once should seek medical help immediately, as this may be a situation of serious risk to life.

The main symptom of poisoning by Coumadin is bleeding; as for example, appearance of blood in the stool or in the urine, menstrual bleeding that is excessive petéquia (patches on the skin), bruises, excessive or exudation, persistent superficial lesions and crashed without explanation in the haemoglobin concentration.