Arthrotec

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

What is Arthrotec?

Arthrotec is a tablet containing a combination of diclofenac and misoprostol. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain.

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 other than those listed here.

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 can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use Arthrotec just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Arthrotec can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

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

Do not drink alcohol while taking Arthrotec. Alcohol can increase the risk of stomach bleeding caused by diclofenac.

What should I discuss with my healthcare provider before taking Arthrotec?

Taking an NSAID can increase your risk of life- threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use Arthrotec just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

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.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Arthrotec:

• 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.

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 Arthrotec. 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. Do not use Arthrotec without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings in more detail

How should I take Arthrotec?

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

Take Arthrotec 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 Arthrotec with anyone else, even if they have the same symptoms you have. 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much Arthrotec. 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 specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb Arthrotec.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac ( such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking Arthrotec. Alcohol can increase the risk of stomach bleeding caused by diclofenac. Avoid prolonged exposure to sunlight. Diclofenac may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Arthrotec side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Arthrotec and seek medical attention or call your doctor at once if you have any of these serious side effects:

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

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

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

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

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.

Side effects other than those listed here may also 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?

Before taking Arthrotec, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• cyclosporine (Neoral, Sandimmune);

• digoxin (Lanoxin);

• diuretics (water pills) such as furosemide (Lasix);

• insulin or diabetes medicine you take by mouth;

• lithium (Eskalith, Lithobid);

• methotrexate (Rheumatrex, Trexall);

• phenobarbital (Luminal, Solfoton);

• steroids (prednisone and others);

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), meloxicam(Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), and others; or

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril ( Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

If you are using any of these drugs, you may not be able to use Arthrotec, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Arthrotec. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information abou Arthrotec.

What does my medication look like?

Diclofenac and misoprostol is available with a prescription under the brand name Arthrotec. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about Arthrotec, especially if it is new to you.

• Arthrotec 50 mg/200 mcg - round, white tablets

• Arthrotec 75 mg/200 mcg - round, white tablets

• 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 1996-2009 Cerner Multum, Inc. Version: 4.01. Revision Date: 05/27/2009 3:04:41 PM.