Warfarin Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Warfarin Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING: BLEEDING RISK
PRECAUTIONSPRECAUTIONSInformation for Patients

WARFARIN SODIUM DESCRIPTION




Warfarin Sodium




CLINICAL PHARMACOLOGY



Mechanism of Action


Pharmacokinetics




WARNINGSLactation


Table 1






Pharmacogenomics



Elderly

Asians

Renal Dysfunction

Hepatic Dysfunction


CLINICAL TRIALS
Atrial Fibrillation (AF)

Table 2Table 2


Myocardial Infarction
DOSAGE AND ADMINISTRATION










Mechanical and Bioprosthetic Heart Valves




INDICATIONS & USAGE





WARFARIN SODIUM CONTRAINDICATIONS


Pregnancy


Hemorrhagic tendencies or blood dyscrasias.
Recent or contemplated surgery of:
Bleeding tendencies associated with active ulceration or overt bleeding of:
Threatened abortion,
Inadequate laboratory facilities.
Unsupervised patients with senility,
Spinal puncture
Miscellaneous:

WARNINGS

BLACK BOX WARNING
Conversion fromHeparin Therapy






Lactation:
Severe to moderate hepatic or renal insufficiency.
Infectious diseases or disturbances of intestinal flora:
Trauma
Surgery or trauma
Indwelling catheters.
Severe to moderate hypertension.

Known or suspected deficiency in protein C mediated anticoagulant response:
Miscellaneous:

PRECAUTIONS

Periodic determination of PT/INR is essentialDOSAGE AND ADMINISTRATIONLaboratory ControlCLINICAL PHARMACOLOGY:Pharmacogenomics
Drug-Drug and Drug-Disease Interactions
It is generally good practice to monitor the patient
Drugs may interact with warfarin sodium through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with warfarin sodium 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 warfarin sodium 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:
















Botanical (Herbal) Medicines


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

Effect on Other Drugs

Considerations for Increased Bleeding Risk
PRECAUTIONSCLINICAL PHARMACOLOGYPharmacokinetics:DOSAGE AND ADMINISTRATION


INFORMATION FOR PATIENTS

CONTRAINDICATIONSPatients should be informed that all warfarin sodium, USP, products represent the same medication, and should not be taken concomitantly, as overdosage may result.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

CONTRAINDICATIONS

PREGNANCY


CONTRAINDICATIONS

PEDIATRIC USE



GERIATRIC USE

CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION

WARFARIN SODIUM ADVERSE REACTIONS


  • ●     Bleeding during anticoagulant therapy does not always correlate with PT/INR (seeOVERDOSAGE: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 (seeWARNINGS).
  • ●     Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, including anaphylactic 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.



OVERDOSAGE

Signs and Symptoms


Treatment





DOSAGE & ADMINISTRATION

The best available information supports the following recommendations for dosing of warfarin sodium tablets.
Venous Thromboembolism (including deep venous thrombosis [DVT] and pulmonary embolism [PE])

Atrial Fibrillation

Post-Myocardial Infarction

Mechanical and Bioprosthetic Heart Valves

Recurrent Systemic Embolism and Other Indications

An INR of greater than 4.0 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding.
Initial Dosage



  • ●     Clinical factors including age, race, body weight, sex, concomitant medications, and comorbidities and
  • ●     Genetic factors (CYP2C9 and VKORC1 genotypes).

CLINICAL PHARMACOLOGYPRECAUTIONS


Maintenance
PRECAUTIONS
Duration of Therapy

Missed Dose

Intravenous Route of Administration


Laboratory Control
PRECAUTIONS
Treatment during Dentistry and Surgery

Conversion from Heparin Therapy


  • ●     5 hours after the last IV bolus dose of heparin, or
  • ●     4 hours after cessation of a continuous IV infusion of heparin, or
  • ●     24 hours after the last subcutaneous heparin injection.

HOW SUPPLIED





REFERENCES



























SPL MEDGUIDE

WARFARIN SODIUM TABLETS, USP
(CRYSTALLINE)


What is the most important information I should know about warfarin?
Take your warfarin exactly as prescribed to lower the chance of blood clots forming in your body (seeWhat is warfarin?).

  •      Warfarin is very important for your health, but it can cause serious and life-threatening bleeding problems.To benefit from warfarin and also lower your chance for bleeding problems, you must:
  •      Get your regular blood test to check for your response to warfarin.This blood test is called a PT/INR test. The PT/INR test checks to see how fast your blood clots. Your healthcare provider will decide what PT/INR numbers are best for you. Your dose of warfarin will be adjusted to keep your PT/INR in a target range for you.
  •      Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:
  • ●     pain, swelling or discomfort
  • ●     headaches, dizziness, or weakness
  • ●     unusual bruising (bruises that develop without known cause or grow in size)
  • ●     nose bleeds
  • ●     bleeding gums
  • ●     bleeding from cuts takes a long time to stop
  • ●     menstrual bleeding or vaginal bleeding that is heavier than normal
  • ●     pink or brown urine
  • ●     red or black stools
  • ●     coughing up blood
  • ●     vomiting blood or material that looks like coffee grounds
  •      Many other medicines, including prescription and non- prescription medicines, vitamins and herbal supplements can interact with warfarin and:
  • ●     affect the dose you need, or
  • ●     increase warfarin side effects.
Tell your healthcare provider about all the medicines, vitamins and herbal supplements you take. Do not stop medicines or take anything new unless you have talked to your healthcare provider. Keep a list of your medicines with you at all times to show your healthcare provider and pharmacist.
  • ●     Do not take other medicines that contain warfarin.Warfarin is the active ingredient in warfarin sodium tablets.
  • ●     Somefoods can interact with warfarin and affect your treatment and dose.
  •      Eat a normal, balanced diet.Talk to your doctor before you make any diet changes.
Do not eat large amounts of leafy green vegetables.
  •      Avoid drinking cranberry juice or eating cranberry products.
  • ●     Avoid drinking alcohol.
  • ●     Always tell all of your healthcare providers that you take warfarin.
  • ●     Wear or carry information that you take warfarin.
What is warfarin?

Who should not take warfarin?
Do not take warfarin if:

  •      your chance of having bleeding problems is higher than the possible benefit of treatment.Your healthcare provider will decide if warfarin is right for you. Talk to your healthcare provider about all of your health conditions.
  • ●     you are pregnant or plan to become pregnant.

  •      you are allergic to warfarin or to anything else in warfarin sodium tablets.


  • ●     have bleeding problems
  • ●     fall often
  • ●     have liver or kidney problems
  • ●     have high blood pressure
  • ●     have a heart problem called congestive heart failure
  • ●     have diabetes
  • ●     drink alcohol or have problems with alcohol abuse. Alcohol can affect your warfarin dose and should be avoided.
  •      are pregnant or planning to become pregnant. SeeWho should not take warfarin?
  •      are breastfeeding. Warfarin may increase bleeding in your baby. Talk to your doctor about the best way to feed your baby. If you choose to breastfeed while taking warfarin, both you and your baby should be carefully monitored for bleeding problems.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. SeeWhat is the most important information I should know about warfarin?
How should I take warfarin?

  •      Take warfarin exactly as prescribed.Your healthcare provider will adjust your dose from time to time depending on your response to warfarin.
  •      You must have regular blood tests and visits with your healthcare provider to monitor your condition.
  •      Take warfarin at the same time every day.You can take warfarin either with food or on an empty stomach.
  •      If you miss a dose of warfarin, call your healthcare provider.Take the dose as soon as possible on the same day. Do not take a double dose of warfarin the next day to make up for a missed dose.
  •      Call your healthcare provider right away if you take too much warfarin.
  • ●     Call your healthcare provider if you are sick with diarrhea, an infection, or have a fever.
  • ●     Tell your healthcare provider about any planned surgeries, medical or dental procedures. Your warfarin may have to be stopped for a short time or you may need your dose adjusted.
  •      Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head.Your healthcare provider may need to check you.
What should I avoid while taking warfarin?
  • ●     Do not start, stop, or change any medicine without talking with your healthcare provider.
  • ●     Do not make changes in your diet, such as eating large amounts of green, leafy vegetables.
  • ●     Do not change your weight by dieting, without first checking with your healthcare provider.
  • ●     Avoid drinking alcohol.
  • ●     Do not do any activity or sport that may cause a serious injury.
What are the possible side effects of warfarin?
  • ●     Warfarin is very important for your health, but it can cause serious and life threatening bleeding problems. SeeWhat is the most important information I should know about warfarin?
  •      Serious side effects of warfarin also include:
  •      death of skin tissue (skin necrosis or gangrene).This can happen soon after starting warfarin. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
  •      purple toes syndrome.Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.
Other side effects with warfarin include

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store warfarin sodium tablets?
  •      Store at 20to 25(68to 77[See USP Controlled Room Temperature.] Protect from light.
  • ●     Keep warfarin and all medicines out of reach of children.


Rx only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-861(NDC:31722-333)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
WARFARIN SODIUM WARFARIN 6 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
STARCH, CORN
hydroxypropyl cellulose
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
turquoise 8 mm 333;IG ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-861-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 2011-12-19


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