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diclofenac and misoprostol

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?

Do not use 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 diclofenac and misoprostol. 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 diclofenac and misoprostol.

Slideshow: Is it Safe to Give Human Medicine to Pets?

Always get your pet's drug and dose recommendation from the veterinarian.

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

Diclofenac may increase your risk of fatal 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 using this medicine.

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

You should not use this medicine if you are allergic to diclofenac or misoprostol, or if you have:

  • active bleeding in your stomach or intestines; or

  • a history of allergic reaction to aspirin or other NSAIDs.

Diclofenac may increase your risk of fatal 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 using 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 take heart or blood pressure medicine;

  • if you smoke; or

  • if you 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. 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 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 medicine with anyone else, even if they have the same symptoms you have.

If you use diclofenac and misoprostol 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 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.

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:

  • swelling, rapid weight gain, little or no urinating;

  • shortness of breath (even with mild exertion);

  • worsening of asthma symptoms (wheezing, chest tightness, trouble breathing);

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

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

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

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

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

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

Common side effects may include:

  • heartburn or stomach pain, bloating, 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)

Diclofenac and misoprostol dosing information

Usual Adult Dose for Osteoarthritis:

Diclofenac 50 mg/misoprostol 200 mg: 1 tablet orally 3 times daily.

For patients who experience intolerance, diclofenac 75 mg/misoprostol 200 mg orally 2 times daily or diclofenac 50 mg/misoprostol 200 mg orally 2 times daily can be used, but are less effective in preventing ulcers.

Usual Adult Dose for Rheumatoid Arthritis:

Diclofenac 50 mg/misoprostol 200 mg: 1 tablet orally 3 to 4 times daily.

For patients who experience intolerance, diclofenac 75 mg/misoprostol 200 mg orally 2 times daily or diclofenac 50 mg/misoprostol 200 mg orally 2 times daily can be used, but are less effective in preventing ulcers.

What other drugs will affect diclofenac and misoprostol?

Ask your doctor before using diclofenac and misoprostol 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:

  • 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 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: 9.01. Revision Date: 2014-11-05, 2:57:21 PM.

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