Arthrotec

Pronunciation

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

What is Arthrotec?

Arthrotec contains a combination of 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.

Arthrotec is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Arthrotec may also be used for purposes not listed in this medication guide.

Important information

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

Do not use Arthrotec 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 Arthrotec. 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 Arthrotec 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 Arthrotec.

Before taking this medicine

You should not use Arthrotec 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 Arthrotec 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 Arthrotec.

To make sure Arthrotec 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. Arthrotec 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 Arthrotec. Tell your doctor right away if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

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 Arthrotec?

Take Arthrotec exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Arthrotec with food or milk to lessen stomach upset.

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

Do not share Arthrotec 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?

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 Arthrotec.

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. Arthrotec can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Arthrotec side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Arthrotec: 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 Arthrotec 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 Arthrotec?

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 Arthrotec, 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 Arthrotec.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Arthrotec only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 8.01. Revision Date: 2013-05-03, 3:23:18 PM.

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