Skip to Content

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 substances in the body that cause pain and inflammation.

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

Do not use Arthrotec if you are pregnant. Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus. You must have a negative pregnancy test within 2 weeks before you start taking Arthrotec. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period. Use effective birth control while you are using Arthrotec.

Slideshow: Top 11 Truths About Narcotic Painkiller Meds

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Arthrotec just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

You should not use Arthrotec if you have active bleeding in your stomach or intestines.

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac, especially in older adults. You should not use Arthrotec if you have active bleeding in your stomach or intestines.

Before taking this medicine

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking Arthrotec.

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 using diclofenac, especially in older adults.

You should not use Arthrotec if you are allergic to diclofenac or misoprostol, or:

  • if you have active bleeding in your stomach or intestines;

  • if you are pregnant; or

  • if you have a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Arthrotec is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

  • a history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • asthma;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • liver or kidney disease; or

  • fluid retention.

Do not use Arthrotec 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 with Arthrotec.

You will need to have a pregnancy test within 2 weeks before you start taking Arthrotec. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period.

It is not known whether diclofenac and misoprostol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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 amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

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 Arthrotec long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat.

Arthrotec dosing information

Usual Adult Dose of Arthrotec for Osteoarthritis:

Diclofenac 50 mg-misoprostol 200 mcg: 1 tablet orally 3 times daily.
Maximum doses: diclofenac 150 mg/day; misoprostol 200 mcg/dose and 800 mcg/day

Comments:
-Monitor response to initial therapy and adjust dose and frequency to fit individual needs; consider titration of individual components if appropriate.
-For gastric ulcer prevention, misoprostol 200 mcg 3 times a day is therapeutically equivalent to 200 mcg 4 times a day and both are more protective than 200 mcg 2 times a day.
-For duodenal ulcer prevention, misoprostol 200 mcg 4 times a day is more protective than 200 mcg 2 or 3 times a day, but may not be well tolerated.
-For patients who experience intolerance: Diclofenac 75 mg-misoprostol 200 mcg or diclofenac 50 mg-misoprostol 200 mcg orally twice a day may be used, however these regimens are less effective in preventing ulcers.

Use: Relief of osteoarthritis in patients who need protection against gastric and duodenal ulcers.

Usual Adult Dose of Arthrotec for Rheumatoid Arthritis:

Diclofenac 50 mg-misoprostol 200 mcg orally 3 to 4 times a day
Maximum doses: diclofenac 225 mg/day; misoprostol 200 mcg/dose and 800 mcg/day

Comments:
-Monitor response to initial therapy and adjust dose and frequency to fit individual needs; consider titration of individual components if appropriate.
-For gastric ulcer prevention, misoprostol 200 mcg 3 times a day is therapeutically equivalent to 200 mcg 4 times a day and both are more protective than 200 mcg 2 times a day.
-For duodenal ulcer prevention, misoprostol 200 mcg 4 times a day is more protective than 200 mcg 2 or 3 times a day, but may not be well tolerated.
-For patients who experience intolerance: Diclofenac 75 mg-misoprostol 200 mcg or diclofenac 50 mg-misoprostol 200 mcg orally twice a day may be used, however these regimens are less effective in preventing ulcers.

Use: Relief of rheumatoid arthritis in patients who need protection against gastric and duodenal ulcers

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 Arthrotec?

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.

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.

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

Avoid taking aspirin or other NSAIDs.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. 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.

Arthrotec side effects

Get emergency medical help if you have signs of an allergic reaction to Arthrotec: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

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

  • the first sign of any skin rash, no matter how mild;

  • shortness of breath (even with mild exertion);

  • swelling or rapid weight gain;

  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; 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:

  • abnormal vaginal bleeding;

  • heartburn, indigestion stomach pain, gas;

  • nausea, vomiting;

  • diarrhea, constipation; or

  • dizziness.

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 Arthrotec if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine (Paxil), 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, especially:

  • cyclosporine;

  • lithium;

  • methotrexate;

  • heart or blood pressure medication, including a diuretic or "water pill";

  • oral diabetes medicine;

  • a blood thinner - warfarin (Coumadin, Jantoven);

  • other forms of diclofenac - Cambia, Cataflam, Flector, Voltaren, Zipsor, Zorvolex;

  • other NSAIDs - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam, and others; or

  • steroid medicine - prednisone, dexamethasone, and others.

This list is not complete. Other drugs may interact with diclofenac and misoprostol, 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. 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 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 1996-2016 Cerner Multum, Inc. Version: 9.02. Revision Date: 2015-09-02, 12:16:26 PM.

Hide