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Arthrotec

Pronunciation

Generic Name: diclofenac and misoprostol (dye KLOE fen ak and mye so PROST ole)
Brand Name: Arthrotec

What is diclofenac and misoprostol?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.

Diclofenac and misoprostol is a combination medicine used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Diclofenac and misoprostol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about diclofenac and misoprostol?

You should not use this medication if you have a history of allergic reaction to aspirin or other NSAID (non-steroidal anti-inflammatory drug).

Do not use diclofenac and misoprostol if you are pregnant. This medication can cause birth defects, miscarriage, premature labor, or rupture of the uterus. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant.

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Diclofenac may increase your risk of heart attack or stroke, especially if you use it long term or have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking this medicine.

What should I discuss with my healthcare provider before taking diclofenac and misoprostol?

You should not use this medication if you are allergic to diclofenac (Cataflam) or misoprostol (Cytotec), or if you have a history of allergic reaction to aspirin or other NSAIDs.

Diclofenac may increase your risk of heart attack or stroke, especially if you use it long term or have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking this medicine.

To make sure diclofenac and misoprostol is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, or history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • liver or kidney disease;

  • asthma;

  • polyps in your nose;

  • porphyria;

  • a bleeding or blood clotting disorder;

  • if you smoke; or

  • drink more than three alcoholic beverages a day.

FDA pregnancy category X. Do not use this medicine if you are pregnant. Diclofenac and misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus. Use an effective form of birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant during treatment.

You will need to have a pregnancy test within 2 weeks before you start taking diclofenac and misoprostol.

Diclofenac and misoprostol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medication.

How should I take diclofenac and misoprostol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take diclofenac and misoprostol with food or milk to lessen stomach upset.

Swallow the tablet whole. Do not crush, break, or chew the pill.

Do not share this medication with anyone else, even if they have the same symptoms you have.

If you use this medication long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking diclofenac and misoprostol?

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb diclofenac and misoprostol.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

Avoid exposure to sunlight or tanning beds. Diclofenac and misoprostol can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Diclofenac and misoprostol side effects

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

Stop using this medicine and call your doctor at once if you have:

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • chest pain, sudden cough, wheezing, shortness of breath;

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • little or no urinating;

  • swelling, rapid weight gain;

  • nausea, upper stomach pain, itching, diarrhea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • bruising, severe tingling, numbness, pain, muscle weakness;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • fever, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • upset stomach, mild heartburn or stomach pain, bloating, gas;

  • mild diarrhea, constipation;

  • dizziness, mild headache;

  • unusual vaginal bleeding;

  • mild skin rash; or

  • ringing in your ears.

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.

See also: Side effects (in more detail)

What other drugs will affect diclofenac and misoprostol?

Ask your doctor before using diclofenac if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with diclofenac and misoprostol, especially:

  • cyclosporine;

  • digoxin;

  • lithium;

  • methotrexate;

  • rifampin;

  • antifungal medication--fluconazole, voriconazole;

  • a blood thinner (warfarin, Coumadin);

  • a diuretic or "water pill";

  • heart or blood pressure medication--amiodarone, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril;

  • insulin or oral diabetes medication; or

  • other NSAIDs--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with diclofenac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about diclofenac and misoprostol.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.01. Revision Date: 2013-05-03, 3:23:18 PM.

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