Jantoven (Warfarin Sodium Tablets) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Jantoven

Drug Side Effects Explained »

Drug Side Effects: Types

Side effects fall into several categories. Allergic reactions can happen with any drug and can range from itching and rash all the way up to a life-threatening anaphylactic reaction.

Other side effects simply Ã¢â‚¬Å“come with the territory.Ã¢â‚¬Â Some drugs can't help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (also known by the brand name Benadryl). Though it eases allergy symptoms, it also suppresses the activity of the body chemical acetylcholine, and that leads to drowsiness and a host of other side effects, including dry mouth.

Some drugs have barely noticeable side effects when dosed properly. For example, Warfarin (Jantoven, Coumadin) used to prevent blood clots, is usually well tolerated, but serious internal bleeding can occur.

Side effects may only pop up when certain drugs are mixed with certain other things. These might also be...

Read the Drug Side Effects Explained article »

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SIDE EFFECTS

Potential adverse reactions to Jantoven® Tablets (Warfarin Sodium Tablets, USP) 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, difficulty 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, pruritis, 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.

DRUG INTERACTIONS

Drug-Drug and Drug-Disease Interactions

Numerous factors, alone or in combination, including changes in diet and medications, including botanicals, may influence response of the patient to anticoagulants. It is generally good practice to monitor the patient's response with additional PT/INR determinations in the period immediately after discharge from the hospital, and whenever other medications, including botanicals, are initiated, discontinued or taken irregularly. The following factors are listed for reference; however, other factors may also affect the anticoagulant response.

Drugs may interact with Jantoven® Tablets (Warfarin Sodium Tablets, USP) through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with Jantoven® Tablets (warfarin sodium tablets) are synergism (impaired hemostasis, reduced clotting factor synthesis), competitive antagonism (vitamin K), and altered physiologic control loop for vitamin K metabolism (hereditary resistance). Pharmacokinetic mechanisms for drug interactions with Jantoven (warfarin sodium tablets) ® Tablets are mainly enzyme induction, enzyme inhibition, and reduced plasma protein binding. It is important to note that some drugs may interact by more than one mechanism.

The following factors, alone or in combination, may be responsible for INCREASED PT/INR response:

ENDOGENOUS FACTORS:

blood dyscrasias - see
CONTRAINDICATIONS
cancercollagen vascular disease
congestive heart failure

diarrhea
elevated temperature
hepatic disorders
infectious hepatitis
jaundice

hyperthyroidism
poor nutritional state
steatorrhea
vitamin K deficiency

EXOGENOUS FACTORS:

Potential drug interactions with Jantoven® Tablets (warfarin sodium tablets) are listed below by drug class and by specific drugs.

Classes of Drugs
5-lipoxygenase Inhibitor Adrenergic Stimulants, Central Alcohol Abuse Reduction Preparations Analgesics Anesthetics, Inhalation Antiandrogen Antiarrhythmics^† Antibiotics^† Aminoglycosides (oral) Cephalosporins, parenteral Macrolides Miscellaneous Penicillins, intravenous, high dose Quinolones (fluoroquinolones) Sulfonamides, long acting Tetracyclines Anticoagulants Anticonvulsants^† Antidepressants^† Antimalarial Agents Antineoplastics^† Antiparasitic/Antimicrobials	Antiplatelet Drugs/Effects Antithyroid Drugs^† Beta-Adrenergic Blockers Cholelitholytic Agents Diabetes Agents, Oral Diuretics^† Fungal Medications, Intravaginal, Systemic^† Gastric Acidity and Peptic Ulcer Agents^† Gastrointestinal Prokinetic Agents, Ulcerative Colitis Agents Gout Treatment Agents Hemorrheologic Agents Hepatotoxic Drugs Hyperglycemic Agents Hypertensive Emergency Agents Hypnotics^† Hypolipidemics^† Bile Acid-Binding Resins^† Fibric Acid Derivatives HMG-CoA Reductase Inhibitors^†	Leukotriene Receptor Antagonist Monoamine Oxidase Inhibitors Narcotics, prolonged Nonsteroidal Anti- Inflammatory Agents Proton Pump Inhibitors Psychostimulants Pyrazolones Salicylates Selective Serotonin Reuptake Inhibitors Steroids, Adrenocortical^† Steroids, Anabolic (17-Alkyl Testosterone Derivatives) Thrombolytics Thyroid Drugs Tuberculosis Agents^† Uricosuric Agents Vaccines Vitamins^†

Specific Drugs Reported
acetaminophen alcohol^† allopurinol aminosalicyclic acid amiodarone HCl argatroban aspirin atenolol atorvastatin^† azithromycin bivalirudin capecitabine cefamandole cefazolin cefoperazone cefotetan cefoxitin ceftriaxone celecoxib cerivastatin chenodiol chloramphenicol chloral hydrate^† chlorpropamide cholestyramine^† cimetidine ciprofloxacin cisapride clarithromycin clofibrate cyclophosphamide^† danazol dextran dextrothyroxine diazoxide diclofenac	dicumarol diflunisal disulfiram doxycycline erythromycin esomeprazole ethacrynic acid ezetimibe fenofibrate fenoprofen fluconazole fluorouracil fluoxetine flutamide fluvastatin fluvoxamine gefitinib gemfibrozil glucagon halothane heparin ibuprofen ifosfamide indomethacin influenza virus vaccine itraconazole Jantoven® Tablets (warfarin sodium tablets) overdose ketoprofen ketorolac lansoprazole lepirudin levamisole levofloxacin levothyroxine	liothyronine lovastatin mefenamic acid methimazole^† methyldopa methylphenidate methylsalicylate ointment (topical) metronidazole miconazole, (intravaginal, oral, systemic) moricizine hydrochloride^† nalidixic acid naproxen neomycin norfloxacin ofloxacin olsalazine omeprazole oxandrolone oxaprozin oxymetholone pantoprazole paroxetine penicillin G, intravenous pentoxifylline phenylbutazone phenytoin^† piperacillin piroxicam pravastatin^† prednisone^† propafenone propoxyphene	propranolol propylthiouracil^† quinidine quinine rabeprazole ranitidine^† rofecoxib sertraline simvastatin stanozolol streptokinase sulfamethizole sulfamethoxazole sulfinpyrazone sulfisoxazole sulindac tamoxifen tetracycline thyroid ticarcillin ticlopidine tissue plasminogen activator (t-PA) tolbutamide tramadol trimethoprim/ sulfamethoxazole urokinase valdecoxib valproate vitamin E zafirlukast zileuton
also: other medications affecting blood elements which may modify hemostasis dietary deficiencies prolonged hot weather unreliable PT/INR determinations ^†Increased and decreased PT/INR responses have been reported.

The following factors, alone or in combination, may be responsible for DECREASED PT/INR response:

ENDOGENOUS FACTORS:

edema
hereditary coumarin resistance
hyperlipemia

hypothyroidism
nephrotic syndrome

EXOGENOUS FACTORS:

Potential drug interactions with Jantoven® Tablets (Warfarin Sodium Tablets, USP) are listed below by drug class and by specific drugs.

Classes of Drugs
Adrenal Cortical Steroid Inhibitors Antaids Antianxiety Agents Antiarrhythmics^† Antibiotics^† Anticonvulsantst Antidepressants^† Antihistamines Antineoplastics^† Antipsychotic Medications	Antithyroid Drugs^† Barbiturates Diuretics^† Enteral NutritionaSupplements Fungal Medications,Systemic^† Gastric Acidity and PepticUlcer Ajents^† Hypnotics^†	Hypolipidemics^† Bile Acid-Binding Resins^† HMG-CoA Reductase Inhibitors^† Immunosuppressives Oral Contraceptives, Estrojen Containing Selective Estrogen Receptor Modulators Steroids, Adrenocortical^† Tuberculosis Agents^† Vitamins^†

Specific Drugs Reported
alcohol^† aminoglutethimide amobarbital atorvastatin^† azathioprine butabarbital butalbitalcar bamazepine chloral hydrate^† chlordiazepoxide chlorthalidone cholestyramine^† clozapine corticotropin cortisone	cyclophosphamide^† dicloxacillin ethchlorvynol glutethimide griseofulvin haloperidol Jantoven® Tablets (warfarin sodium tablets) underdosage meprobamate 6-mercaptopurine methimazole^† moricizine hydrochloride^† nafcillin paraldehyde pentobarbital phenobarbital	phenytoin ^† pravastatin ^† prednisone primidone propylthiouracil^† raloxifeneranitidine^† rifampin secobarbita spironolactone sucralfate vitamin C (high dose) vitamin K
also: diet high in vitamin K unreliable PT/INR determinations ^†Increased and decreased PT/INR responses have been reported.

Because a patient may be exposed to a combination of the above factors, the net effect of Jantoven® Tablets (warfarin sodium tablets) on PT/INR response may be unpredictable. More frequent PT/INR monitoring is therefore advisable. Medications of unknown interaction with coumarins are best regarded with caution. When these medications are started or stopped, more frequent PT/INR monitoring is advisable. It has been reported that concomitant administration of warfarin and ticlopidine may be associated with cholestatic hepatitis.

Botanical (Herbal) Medicines

Caution should be exercised when botanical medicines (botanicals) are taken concomitantly with Jantoven® Tablets (warfarin sodium tablets) . Few adequate, well-controlled studies exist evaluating the potential for metabolic and/or pharmacologic interactions between botanicals and Jantoven® Tablets (warfarin sodium tablets) . Due to a lack of manufacturing standardization with botanical medicinal preparations, the amount of active ingredients may vary. This could further confound the ability to assess potential interactions and effects on anticoagulation. It is good practice to monitor the patient's response with additional PT/INR determinations when initiating or discontinuing botanicals. Specific botanicals reported to affect Jantoven® Tablets (warfarin sodium tablets) therapy include the following:

Bromelains, danshen, dong quai (Angelica sinensis), garlic, Ginkgo biloba, ginseng and cranberry products are associated most often with an INCREASE in the effects of Jantoven® Tablets (warfarin sodium tablets) .
Coenzyme Q₁₀ (ubidecarenone) and St. John's wort are associated most often with a DECREASE in the effects of Jantoven® Tablets (warfarin sodium tablets)

Some botanicals may cause bleeding events when taken alone (e.g., garlic and Ginkgo biloba) and may have anticoagulant, antiplatelet, and/or fibrinolytic properties. These effects would be expected to be additive to the anticoagulant effects of Jantoven® Tablets (warfarin sodium tablets) . Conversely, other botanicals may have coagulant properties when taken alone or may decrease the effects of Jantoven® Tablets (warfarin sodium tablets) . Some botanicals that may affect coagulation are listed below for reference; however, this list should not be considered all- inclusive. Many botanicals have several common names and scientific names. The most widely recognized common botanical names are listed.

Botanicals that contain coumarins with potential anticoagulant effects:
Alfalfa Angelica (Dong Quai) Aniseed Arnica Asa Foetida Bogbean¹ Boldo Buchu	Capsicum² Cassia³ Celery Chamomile (German and Roman) Dandelion³ Fenugreek Horse Chestnut	Horseradish Licorice³Meadowsweet¹ Nettle Parsley Passion Flower Prickly Ash (Northern) Quassia	Red Clover Sweet Clover Sweet Woodruff Tonka Beans Wild Carrot Wild Lettuce

Miscellaneous botanicals with anticoagulant properties:
Bladder Wrack (Fucus)	Pau d'arco

Botanicals that contain salicylate and/or have antiplatelet properties:
Agrimony⁴ Aloe Gel Aspen Black Cohosh Black Haw Bogbean¹ Cassia³ Clove	Dandelion³ Feverfew Garlic⁵ German Sarsaparilla Ginger Ginkgo Biloba Ginseng (Panax)⁵ Licorice³	Meadowsweet¹ Onion⁵ Policosanol Poplar Senega Tamarind Willow Wintergreen

Botanicals with fibrinolytic properties:
Bromelains Capsicum²	Garlic⁵ Ginseng (Panax)⁵	Inositol Nicotinate Onion⁵

Botanicals with coagulant properties:
Agrimony⁴ Goldenseal	Mistletoe Yarrow
¹Contains coumarins and salicylate. ²Contains coumarins and has fibrinolytic properties. ³Contains coumarins and has antiplatelet properties. ⁴Contains salicylate and has coagulant properties. ⁵Has antiplatelet and fibrinolytic properties.

Effect on Other Drugs

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.

Special Risk Patients

Jantoven® Tablets (warfarin sodium tablets) is a narrow therapeutic range (index) drug, and caution should be observed when warfarin sodium is administered to certain patients such as the elderly or debilitated or when administered in any situation or physical condition where added risk of hemorrhage is present.

Intramuscular (I.M.) injections of concomitant medications should be confined to the upper extremities which permits easy access for manual compression, inspections for bleeding and use of pressure bandages. Caution should be observed when Jantoven® Tablets (warfarin sodium tablets) (or warfarin) are administered concomitantly with nonsteroidal anti- inflammatory drugs (NSAIDs), including aspirin, to be certain that no change in anticoagulation dosage is required. In addition to specific drug interactions that might affect PT/INR, NSAIDs, including aspirin, can inhibit platelet aggregation, and can cause gastrointestinal bleeding, peptic ulceration and/or perforation. Acquired or inherited warfarin resistance should be suspected if large daily doses of Jantoven® Tablets (warfarin sodium tablets) are required to maintain a patient's PT/INR within a normal therapeutic range.

Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.