Jantoven

DRUG DESCRIPTION

Jantoven® Tablets (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(?-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its empirical formula is C19H15NaO4 , and its structural formula may be represented by the following:

Jantoven (crystalline warfarin sodium) structural formula illustration

Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether.

Jantoven® Tablets (Warfarin Sodium Tablets, USP) for oral use contain: 1 mg, 2 mg, 2? mg, 3 mg, 4 mg, 5 mg, 6 mg, 7?mg or 10 mg of crystalline warfarin sodium, USP. They also contain:

All Strengths: Lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch (corn).

1 mg: FD&C Red #40 Aluminum Lake
2 mg:
FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake 2? mg: D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake
3 mg:
Brown #75 Synthetic Brown Iron Oxide
4 mg:
FD&C Blue #1 Aluminum Lake
5 mg:
FD&C Yellow #6 Aluminum Lake
6 mg:
Yellow #10 Synthetic Yellow Iron Oxide, Black #85 Synthetic Black Iron Oxide and FD&C Blue #1 Aluminum Lake 7? mg: D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake
10 mg:
Dye Free.

What are the possible side effects of warfarin (Coumadin, Jantoven)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • skin changes or discoloration anywhere on your body;
  • purple toes or fingers;
  • pain in your stomach, back, or sides;
  • low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • diarrhea, fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Jantoven »

What are the precautions when taking warfarin sodium tablets (Jantoven)?

Before taking warfarin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as anemia, hemophilia), bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood vessel disorders (such as aneurysms), recent major injury/surgery, liver disease, alcohol use, mental/mood disorders (including memory problems), frequent falls/injuries.

It is important that all your doctors and dentists know that you take warfarin. Before having surgery or any...

Read All Potential Precautions of Jantoven »


Jantoven Consumer (continued)

SIDE EFFECTS: Nausea, loss of appetite, or stomach/abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding if it affects your blood clotting proteins too much (shown by unusually high INR lab results). Even if your doctor stops your medication, this risk of bleeding can continue for up to a week. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, chest pain, shortness of breath, difficulty swallowing.

Tell your doctor right away if any of these unlikely but serious side effects occur: persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin.

This drug rarely has caused very serious (possibly fatal) problems if its effects lead to small blood clots (usually at the beginning of treatment). This can lead to severe skin/tissue damage that may require surgery or amputation if left untreated. Patients with certain blood conditions (protein C or S deficiency) may be at greater risk. Get medical help right away if any of these rare but serious side effects occur: painful/red/purplish patches on the skin (such as on the toe, breast, abdomen), change in the amount of urine, vision changes, confusion, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking warfarin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as anemia, hemophilia), bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood vessel disorders (such as aneurysms), recent major injury/surgery, liver disease, alcohol use, mental/mood disorders (including memory problems), frequent falls/injuries.

It is important that all your doctors and dentists know that you take warfarin. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Avoid getting injections into the muscles. If you must have an injection into a muscle (for example, a flu shot), it should be given in the arm. This way, it will be easier to check for bleeding and/or apply pressure bandages.

This medication may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding and may also affect how this medication works. Limit or avoid alcoholic beverages.

If you have not been eating well, if you have an illness or infection that causes fever, vomiting, or diarrhea for more than 2 days, or if you start using any antibiotic medications, contact your doctor or pharmacist immediately because these conditions can affect how warfarin works.

This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, call your doctor immediately. Your doctor may need to check you.

The Food & Drug Administration has stated that generic warfarin products are interchangeable. However, consult your doctor or pharmacist before switching warfarin products. Be careful not to take more than one medication that contains warfarin unless specifically directed by the doctor or health care provider who is monitoring your warfarin treatment.

Older adults may be at greater risk for bleeding while using this drug.

This medication is not recommended for use during pregnancy because of serious (possibly fatal) harm to an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you are planning pregnancy, discuss a plan for managing your condition with your doctor before you become pregnant. Your doctor may switch the type of medication you use during pregnancy.

Very small amounts of this medication may pass into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Jantoven Patient Information Including Side Effects

Brand Names: Coumadin, Jantoven

Generic Name: warfarin (Pronunciation: WAR far in)

  • What is warfarin (Jantoven)?
  • What are the possible side effects of warfarin (Jantoven)?
  • What is the most important information I should know about warfarin (Jantoven)?
  • What should I discuss with my healthcare provider before taking warfarin (Jantoven)?
  • How should I take warfarin (Jantoven)?
  • What happens if I miss a dose (Jantoven)?
  • What happens if I overdose (Jantoven)?
  • What should I avoid while taking warfarin (Jantoven)?
  • What other drugs will affect warfarin (Jantoven)?
  • Where can I get more information?

What is warfarin (Jantoven)?

Warfarin is an anticoagulant (blood thinner). Warfarin reduces the formation of blood clots.

Warfarin is used to prevent heart attacks, strokes, and blood clots in veins and arteries.

Warfarin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of warfarin (Jantoven)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • skin changes or discoloration anywhere on your body;
  • purple toes or fingers;
  • pain in your stomach, back, or sides;
  • low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • diarrhea, fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding that will not stop;
  • blood in your urine;
  • black, bloody, or tarry stools;
  • nosebleeds, bleeding gums, coughing up blood;
  • feeling weak or light-headed;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • sudden leg or foot pain; or
  • sudden numbness or weakness, especially on one side of the body.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • gas and bloating; or
  • hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about warfarin (Jantoven)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Never take a double dose of this medication.

If you need to have a lumbar puncture (spinal tap) or any type of surgery, you may need to temporarily stop using warfarin. Be sure the surgeon knows ahead of time that you are using this medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking warfarin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking warfarin.

Warfarin interacts with many other drugs, and these interactions can be dangerous, even fatal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

You should not take acetaminophen (Tylenol), aspirin, or NSAIDs (non-steroidal anti-inflammatory drugs) unless your doctor has told you to. NSAIDs include celecoxib (Celebrex), diclofenac (Voltaren), ibuprofen (Motrin, Advil), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.These medicines may affect blood clotting and could cause serious bleeding in your stomach or intestines.

Avoid sudden changes in your diet. Vitamin K decreases the effects of warfarin. Large amounts of vitamin K are found in foods such as liver, broccoli, brussels sprouts, spinach, Swiss chard, coriander, collards, cabbage, and other green leafy vegetables. Do not change the amount of these foods in your diet without first talking to your doctor.

Avoid eating cranberries, drinking cranberry juice, or taking cranberry herbal products.

Avoid drinking alcohol, which can increase some of the side effects of this medication.

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