Orfarin tablets

Orfarin

  • Active Ingredient: Warfarin
  • 5 mg, 2 mg, 1 mg
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What is Orfarin?

The active ingredient of Orfarin brand is warfarin. Warfarin is an anticoagulant (blood thinner). Warfarin reduces the formation of blood clots. C19H15NaO4 M.W. 330.31 Crystalline Warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg Warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains FD&C yellow no. 5 (tartrazine) aluminum lake and FD&C red no. 40 aluminum lake.

Used for

Orfarin is used to treat diseases such as: Antiphospholipid Syndrome, Chronic Central Venous Catheterization, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis, First Event, Deep Vein Thrombosis, Recurrent Event, Heart Attack, Heart Failure, Prevention of Thromboembolism in Atrial Fibrillation, Prosthetic Heart Valves - Thrombosis Prophylaxis, Prosthetic Heart Valves, Mechanical Valves - Thrombosis Prophylaxis, Prosthetic Heart Valves, Tissue Valves - Thrombosis Prophylaxis, Protein S Deficiency, Pulmonary Embolism, First Event, Pulmonary Embolism, Recurrent Event, Thromboembolic Stroke Prophylaxis.

Side Effect

Possible side effects of Orfarin include: clay-colored stools; red or dark brown urine; confusion; fever; yellow eyes and skin; change in taste, or bad, unusual, or unpleasant (after) taste.

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Surgery and dental work

Because of the risk of bleeding, your dose of Orfarin may need to be lowered or stopped a few days before having an operation or dental work.

Tell the surgeon or dentist that you're taking Orfarin. You should also tell anyone else involved with your care, such as an anticoagulant nurse, if you need an operation so they can make arrangements.

Atrial Fibrillation

In five prospective, randomized, controlled clinical trials involving 3711 patients with non-rheumatic AF, Orfarin significantly reduced the risk of systemic thromboembolism including stroke (see Table 4). The risk reduction ranged from 60% to 86% in all except one trial (CAFA: 45%), which was stopped early due to published positive results from two of these trials. The incidence of major bleeding in these trials ranged from 0.6% to 2.7% (see Table 4).

Table 4: Clinical Studies of Orfarin in Non-Rheumatic AF Patients * Study N Thromboembolism % Major Bleeding Orfarin- Treated Patients Control Patients PT Ratio INR % Risk Reduction p-value Orfarin- Treated Patients Control Patients AFASAK 335 336 1.5-2.0 2.8-4.2 60 0.027 0.6 0.0 SPAF 210 211 1.3-1.8 2.0-4.5 67 0.01 1.9 1.9 BAATAF 212 208 1.2-1.5 1.5-2.7 86

Trials in patients with both AF and mitral stenosis suggest a benefit from anticoagulation with COUMADIN .

Q: My sister is on Coumadin. However, her blood test INR has been around 1.3 for the past few weeks. I am concerned that the doctor is going to raise the dose. Is there any food she can consume to up the INR level?

A: Coumadin (Orfarin) is an anticoagulant or blood thinner. Coumadin works by blocking the formation of clotting factors in the blood. Coumadin is used to treat or prevent blood clots that may form in people with certain medical conditions. This includes atrial fibrillation (an abnormal heart rhythm), heart valve replacements, pulmonary embolism (PE), deep venous thrombosis (DVT), and heart attack. The dosing of Coumadin is very individualized and is based on a laboratory test called the International Normalized Ratio (INR). Some people are very sensitive to the effects of Coumadin and may require only small doses to reach their goal INR. However, other people may require higher doses in order to reach their goal. Regardless, the focus of Coumadin treatment should be on reaching the goal, which may take frequent dose adjustments, not maintaining one dose or trying to prevent a dose adjustment. Patients on Coumadin should not make any changes to their diets without talking to their healthcare provider first, as this could lead to serious or life-threatening effects. Vitamin K is the primary dietary factor that affects Coumadin. Too much vitamin K can lead to the formation of blood clots which can cause heart attack and stroke. However, decreasing the amount of vitamin K in the diet can lead to bleeding, hemorrhages, and stroke. Patients on Coumadin should contact their healthcare provider right away if they experience any signs of bleeding, such as nosebleeds, bleeding gums, easy or unusual bruising, cuts that won't clot or stop, and bloody or dark urine or stool. For more specific information, consult with your doctor or local pharmacist for guidance based on your health status and current medications, particularly before taking any action. Sarah Lewis, PharmD

Q: Should I take Coumadin with my other medications, or should I take by itself?

A: It is recommended that each dose of Coumadin (Orfarin) be taken with a full glass of water at the same time each day or as prescribed by your doctor. Your Coumadin dose can be taken with or without food. The manufacturer of Coumadin makes no warnings that Coumadin should not be taken with other medications, vitamins, or supplements. Talk to your doctor about concerns you have with specific medications you are taking. Do not start or stop any medications or treatments without first talking to your doctor. I believe you will find the following links at everydayhealth.com also very helpful for your current situation. //www.everydayhealth.com/drugs/coumadin (general info). Jennifer Carey, PharmD

Antibiotics and antifungals

Some antibiotics and antifungals can change how Orfarin works in your body. Your doctor may monitor you more closely when you start or stop an antibiotic or antifungal medication. Examples are:

  • Antibiotics such as:
    • macrolides, including:
      • azithromycin
      • clarithromycin
      • erythromycin
    • sulfamethoxazole/trimethoprim
  • fluconazole
  • itraconazole
  • ketoconazole
  • posaconazole
  • voriconazole

Orfarin side effects

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

Orfarin increases your risk of bleeding, which can be severe or life-threatening. Call your doctor at once if you have any signs of bleeding such as:

sudden headache, feeling very weak or dizzy;

swelling, pain, unusual bruising;

bleeding gums, nosebleeds;

bleeding from wounds or needle injections that will not stop;

heavy menstrual periods or abnormal vaginal bleeding;

blood in your urine, bloody or tarry stools; or

coughing up blood or vomit that looks like coffee grounds.

Clots formed by Orfarin may block normal blood flow, which could lead to tissue death or amputation of the affected body part. Get medical help at once if you have:

pain, swelling, hot or cold feeling, skin changes, or discoloration anywhere on your body; or

sudden and severe leg or foot pain, foot ulcer, purple toes or fingers.

Bleeding is the most common side effect of Orfarin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Precautions

Before taking Orfarin, 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, kidney disease, 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 Orfarin. 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 alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.

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 right away because these conditions can affect how Orfarin 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 right away. Your doctor may need to check you.

The Food & Drug Administration has stated that generic Orfarin products are interchangeable. However, consult your doctor or pharmacist before switching Orfarin products. Be careful not to take more than one medication that contains Orfarin unless specifically directed by the doctor or health care provider who is monitoring your Orfarin 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 with your doctor the use of reliable forms of birth control while taking this medication and for 1 month after stopping the medication. If you become pregnant or think you may be pregnant, tell your doctor right away. 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.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

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.

Q: I take Coumadin every day. What herbs and vegetables can I safely eat?

A: Coumadin (Orfarin) is a blood thinner used to prevent heart attack, stroke and (blood clots in veins and arteries, but foods that have vitamin K can keep it from working if eaten in large quantities. However, when a person is being adjusted to a dose of Coumadin (Orfarin), they should try to keep eating the same types of food, and keep the same medications or OTC (over the counter) products, unless these substances have too much of an effect on the drug. Then, the dose of the blood thinner can be adjusted to the lifestyle. Always let the doctor know if new medications have been added or if old medications have been stopped, as there may be a need to adjust the Coumadin (Orfarin) dose at that time. To avoid changing the dose of the blood thinner, you may want to avoid large amounts of liver, cabbage, kale, spinach, brussels sprouts, parsley, collard greens, mustard greens, chard, green leafy vegetables in general, cranberry juice, alcohol, and green tea. If you are unable to eat for days, or have ongoing stomach upset, diarrhea, or fever, you may need and adjustment in dose, so let our doctor know as soon as possible. Coumadin (Orfarin) is not fast acting, so it may take a few days to see the level in the blood. Sometimes, other blood thinners are given during the transition. Patti Brown, PharmD

Summary

Orfarin (Coumadin, Jantoven) is an anticoagulant drug that inhibits the blood from clotting, thus preventing blood clots. It is prescribed for the treatment of patients with deep vein thrombosis, the reduction of pulmonary embolism, and in patients with atrial fibrillation to reduce the risk of strokes and heart attack. Common side effects of Orfarin include:

Drug interactions, and warnings and precautions, and pregnancy and breastfeeding information should be reviewed prior to taking this medication.

Immediate action required: Call 999 or go to A&E if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you're wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of Orfarin.

For a full list, see the leaflet inside your medicines packet.

You can report any suspected side effect to the UK safety scheme.


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