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
Do not Arthrotec 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 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.
You should not use Arthrotec 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 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 using this medicine.
Before taking this medicine
You should not use Arthrotec if you are allergic to diclofenac or misoprostol, or if you have:
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 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 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. 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. 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 while taking Arthrotec.
How should I take Arthrotec?
ake 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 this medicine 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 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 of Arthrotec 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 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 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 into your bloodstream.
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. 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 Arthrotec 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 Arthrotec 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)
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:
-
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.
