Prescription Drug Information: Warfarin Sodium (Page 6 of 6)

15 REFERENCES

OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16 HOW SUPPLIED/STORAGE AND HANDLING

4 mg Tablets: Blue, Round, Flat Beveled edge tablets debossed I on the left side of bisect and G on the right side of bisect on one side and W on the top and 4 on the bottom of other side.

NDC 68071-4384-3 BOTTLES OF 30

NDC 68071-4384-9 BOTTLES OF 90

Storage: Store at 20° to 25°C (68° F to 77° F). [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP.
Special Handling
Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [ see References (15)].
Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [ see Use in Special Populations (8.1)].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instructions for Patients
Advise patients to:
• Strictly adhere to the prescribed dosage schedule [see Dosage and Administration(2.1)].
• If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses [see Dosage and Administration(2.5)].
• Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy [see Dosage and Administration(2.1)].
• Be aware that if therapy with warfarin sodium is discontinued, the anticoagulant effects of warfarin sodium may persist for about 2 to 5 days [see Clinical Pharmacology(12.2)].
• Avoid any activity or sport that may result in traumatic injury [see Use in Special Populations (8.4)]. And to tell their physician if they fall often as this may increase their risk for complications.
• Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables [see Drug Interactions(7.4)].
• Contact their physician to report any serious illness, such as severe diarrhea, infection, or fever [see Warnings and Precautions (5) and Adverse Reactions (6)].
• Carry identification stating that they are taking warfarin sodium.
Bleeding Risks
Advise patients to:
• Notify their physician immediately if any unusual bleeding or symptoms occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Box Warning and Warnings and Precautions (5.1)].
Concomitant Medications and Botanicals (Herbals)
Advise patients to:
• Not take or discontinue any other drug, including salicylates (e.g., aspirin and topical analgesics), other over-the-counter drugs, and botanical (herbal) products except on advice of your physician [see Drug Interactions (7)].
Pregnancy and Nursing
Advise patients to:
• Contact their doctor
– immediately if they think they are pregnant [see Use in Special Populations (8.1)],
– to discuss pregnancy planning [see Use in Special Populations (8.3)],
– if they are considering breastfeeding [see Use in Special Populations (8.2)].

Rev: 09/2016

SPL MEDGUIDE SECTION


Warfarin Sodium Tablets, USP
(war’ far in soe’ dee um)
Read this Medication Guide before you start taking warfarin sodium and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about warfarin sodium when you start taking it and at regular checkups.
What is the most important information I should know about warfarin sodium?
Warfarin sodium can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium is a blood thinner medicine that lowers the chance of blood clots forming in your body.

  • You may have a higher risk of bleeding if you take warfarin sodium and:
    • are 65 years of age or older
    • have a history of stomach or intestinal bleeding
    • have high blood pressure (hypertension)
    • have a history of stroke, or “mini-stroke” (transient ischemic attack or TIA)
    • have serious heart disease
    • have a low blood count or cancer
    • have had trauma, such as an accident or surgery
    • have kidney problems
    • take other medicines that increase your risk of bleeding, including:

      • a medicine that contains heparin
      • other medicines to prevent or treat blood clots
      • nonsteroidal anti-inflammatory drugs (NSAIDs)
    • take warfarin sodium for a long time. Warfarin sodium, USP is the active ingredient in warfarin sodium.

Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above.
Many other medicines can interact with warfarin sodium and affect the dose you need or increase warfarin sodium side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider.
Do not take other medicines that contain warfarin sodium while taking warfarin sodium tablets.

  • Get your regular blood test to check for your response to warfarin sodium. This blood test is called an INR test. The INR test checks to see how fast your blood clots. Your healthcare provider will decide what INR numbers are best for you. Your dose of warfarin sodium will be adjusted to keep your 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)
    • nosebleeds
    • 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
  • Some foods and beverages can interact with warfarin sodium and affect your treatment and dose.
    • Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of warfarin sodium.
    • Always tell all of your healthcare providers that you take warfarin sodium.
    • Wear or carry information that you take warfarin sodium.

See “What are the possible side effects of warfarin sodium?” for more information about side effects.

What is warfarin sodium?
Warfarin sodium is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs.
Who should not take warfarin sodium?
Do not take warfarin sodium if:

  • your chance of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if warfarin sodium is right for you. Talk to your healthcare provider about all of your health conditions.
  • you are pregnant unless you have a mechanical heart valve. Warfarin sodium may cause birth defects, miscarriage, or death of your unborn baby.
  • you are allergic to warfarin or any of the other ingredients in warfarin sodium. See the end of this leaflet for a complete list of ingredients in warfarin sodium tablets.

What should I tell my healthcare provider before taking warfarin sodium?

Before you take warfarin sodium, tell your healthcare provider if you:

  • have bleeding problems
  • fall often
  • have liver problems
  • have kidney problems or are undergoing dialysis
  • have high blood pressure
  • have a heart problem called congestive heart failure
  • have diabetes
  • plan to have any surgery or a dental procedure
  • have any other medical conditions
  • are pregnant or plan to become pregnant. See “ Who should not take warfarin sodium ?” Your health care provider will do a pregnancy test before you start treatment with warfarin sodium. Females who can become pregnant should use effective birth control during treatment, and for at least 1 month after the last dose of warfarin sodium.
  • are breast feeding. You and your health care provider should decide if you will take warfarin sodium and breast feed. Check your baby for bruising or bleeding if you take warfarin sodium and breast feed.

Tell all of your healthcare providers and dentists that you are taking warfarin sodium. They should talk to the healthcare provider who prescribed warfarin sodium for you before you have any surgery or dental procedure. Your warfarin sodium may need to be stopped for a short time or your may need your dose adjusted.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way warfarin sodium works. Certain medicines may increase your risk of bleeding. See ” What is the most important information I should know about warfarin sodium ?”
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take warfarin sodium?

  • Take warfarin sodium exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to warfarin sodium.
  • You must have regular blood tests and visits with your healthcare provider to monitor your condition.
  • If you miss a dose of warfarin sodium, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of warfarin sodium the next day to make up for a missed dose.
  • Call your healthcare provider right away if you:
    • take too much warfarin sodium
    • are sick with diarrhea, an infection, or have a fever
    • 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 sodium?

  • Do not do any activity or sport that may cause a serious injury.

What are the possible side effects of warfarin sodium?

Warfarin sodium may cause serious side effects including:

  • See ” What is the most important information I should know about warfarin sodium?

    • Death of skin tissue (skin necrosis or gangrene). This can happen soon after starting warfarin sodium. 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.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the side effects of warfarin sodium. For more information, ask your healthcare provider or pharmacist.
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 warfarin sodium tablets at 20°C to 25°C (68°F to 77°F).
  • Keep warfarin sodium tablets in a tightly closed container, and keep warfarin sodium tablets out of the light and moisture.
  • Follow your healthcare provider or pharmacist instructions about the right way to throw away outdated or unused warfarin sodium tablets.
  • Females who are pregnant should not handle crushed or broken warfarin sodium tablets.

Keep warfarin sodium and all medicines out of the reach of children.

General information about warfarin sodium.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use warfarin sodium for a condition for which it was not prescribed. Do not give warfarin sodium to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about warfarin sodium. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about warfarin sodium that is written for health professionals.
If you would like more information, talk to your healthcare provider or call Citron Pharma LLC., at 1-855-5-CITRON (1-855-524-8766).
What are the ingredients in warfarin sodium tablets, USP?
Active ingredient: Warfarin Sodium, USP
Inactive ingredients: lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each:
1 mg tablet contains: D&C Red #30 aluminum lake
2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#2
2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#2
3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake
4 mg tablet contains: FD&C Blue#2
5 mg tablet contains: FD&C Yellow # 6 aluminum lake
6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #2
7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake
10 mg tablet is dye free.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Citron Pharma LLC.
East Brunswick, NJ 08816
Revised: 09/2016 Rx Only

PDP
(click image for full-size original)

WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4384(NDC:57237-123)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
FD&C BLUE NO. 2
Product Characteristics
Color blue (BLUE) Score 2 pieces
Shape ROUND (Flat Beveled edge) Size 8mm
Flavor Imprint Code I;G;W;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4384-3 30 TABLET in 1 BOTTLE None
2 NDC:68071-4384-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 11/01/2011
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4384)

Revised: 10/2020 NuCare Pharmaceuticals,Inc.

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