Arthrotec

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 about Arthrotec

Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy. Do not use Arthrotec if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using Arthrotec.

Arthrotec may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use Arthrotec just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Arthrotec, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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

Before taking Arthrotec

Do not use Arthrotec just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Arthrotec, especially in older adults.

Do 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.

To make sure you can safely take Arthrotec, tell your doctor if you have any of these other conditions:

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

• heart disease, congestive heart failure, high blood pressure;

• 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.

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

FDA pregnancy category X. Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy. Do not use Arthrotec if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. You will need to have a pregnancy test within 2 weeks before you start taking Arthrotec.

See also: Arthrotec pregnancy and breastfeeding warnings (in more detail)

How should I take Arthrotec?

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

Take this medicine with a full glass of water. Swallow the Arthrotec tablet whole. Do not crush, break, or chew the pill. Take Arthrotec with food or milk to lessen stomach upset. Do not share this medication with anyone else, even if they have the same symptoms you have.

If you use this medication long-term, your liver function may need to be checked with frequent blood tests. Visit your doctor regularly.

Store Arthrotec 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.

Overdose symptoms may include drowsiness, confusion, muscle weakness, nausea, vomiting, stomach pain, shallow breathing, feeling light-headed, or fainting.

What should I avoid while taking Arthrotec?

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 other cold, allergy, or pain medicine. NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain type of drug. Check the label to see if a medicine contains asprin, 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.

See also: Arthrotec and alcohol (in more detail)

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 Arthrotec and call your doctor at once if you have a serious side effect such as:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

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

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

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

• neck stiffness, chills, 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.

Less serious Arthrotec side effects may include:

• mild stomach pain, nausea, diarrhea, bloating, gas;

• dizziness, drowsiness, headache;

• blurred vision, ringing in your ears; or

• unusual vaginal bleeding.

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: Arthrotec side effects (in more detail)

What other drugs will affect Arthrotec?

Tell your doctor about all other medicines you use, especially:

• a blood thinner such as warfarin (Coumadin, Jantoven);

• cyclosporine (Neoral, Gengraf, Sandimmune);

• digoxin (Lanoxin);

• a diuretic (water pill);

• insulin or diabetes medicine you take by mouth;

• lithium (Eskalith, Lithobid);

• methotrexate (Rheumatrex, Trexall);

• phenobarbital (Luminal, Solfoton);

• steroids (prednisone and others);

• voriconazole (Vfend);

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

• an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

This list is not complete and other drugs may interact with Arthrotec. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Arthrotec.