Generic Name: diclofenac/misoprostol (dye-KLOE-fen-ak/MYE-soe-PROST-ol)
Brand Name: Arthrotec
Diclofenac/misoprostol is contraindicated in pregnant women because the misoprostol component can cause abortion. Misoprostol has been shown to cause the uterus to tear in pregnant women if it is used to induce labor or to cause an abortion after the first trimester of pregnancy. Diclofenac/misoprostol should only be given to women of childbearing age when nonsteroidal anti-inflammatory drug (NSAID) therapy is required and the patient is at high risk of developing stomach ulcers or complications from stomach ulcers. Diclofenac/misoprostol may be prescribed only if the patient has had a negative pregnancy test within 2 weeks before beginning therapy; is capable of using hormonal birth control (eg, birth control pills); has received oral and written warnings of the serious side effects associated with misoprostol, the risk of failed birth control, and the danger to women of childbearing age who take diclofenac/misoprostol by mistake; and will begin taking diclofenac/misoprostol only the second or third day of the next normal menstrual period. Diclofenac/misoprostol is to be used only by the patient for whom it is prescribed. Do not share it with others.
Diclofenac/misoprostol contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious, and sometimes fatal, heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take diclofenac/misoprostol for a long time. Do not use diclofenac/misoprostol right before or after bypass heart surgery.
Diclofenac/misoprostol may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Diclofenac/misoprostol is used for:
Treating joint swelling, pain, and stiffness caused by osteoarthritis or rheumatoid arthritis in patients who are at a high risk of developing NSAID-induced ulcers or their complications. It may also be used for other conditions as determined by your doctor.
Diclofenac/misoprostol is an NSAID and prostaglandin analog combination. The prostaglandin maintains prostaglandin activity needed to protect the lining of the stomach and reduce acid secretion, reducing the risk of ulcers. The NSAID decreases prostaglandins that cause pain and inflammation, relieving joint pain.
Do NOT use diclofenac/misoprostol if:
- you are allergic to any ingredient in diclofenac/misoprostol or other prostaglandins
- you are pregnant
- you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, naproxen, celecoxib)
- you have recently had or will be having bypass heart surgery
- you have liver problems (eg, hepatic porphyria)
Contact your doctor or health care provider right away if any of these apply to you.
Before using diclofenac/misoprostol:
Some medical conditions may interact with diclofenac/misoprostol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
- if you have a history of swelling or fluid buildup, seizures, lupus, asthma, or growths in the nose (nasal polyps)
- if you have high blood pressure, blood problems (eg, anemia, porphyria, low blood platelets), bleeding or clotting problems, heart problems (eg, heart failure), blood vessel disease, inflammatory bowel disease, seizures, or if you are at risk of any of these diseases
- if you are dehydrated, if you drink alcohol or have a history of alcohol abuse, or if you smoke
Some MEDICINES MAY INTERACT with diclofenac/misoprostol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), direct factor Xa inhibitors (eg, rivaroxaban), heparin, prasugrel, or selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, paroxetine) because the risk of bleeding may be increased
- Oral diabetic medicines (eg, glipizide) or insulin because the risk of high or low blood sugar may be increased
- Azole antifungals (eg, itraconazole, voriconazole), bisphosphonates (eg, risedronate), or probenecid because they may increase the risk of diclofenac/misoprostol's side effects
- Rifamycins (eg, rifampin) because they may decrease diclofenac/misoprostol's effectiveness
- Cyclosporine, digoxin, lithium, methotrexate, other NSAIDs (eg, ibuprofen), quinolones (eg, ciprofloxacin), or tenofovir because the risk of their side effects may be increased by diclofenac/misoprostol
- Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by diclofenac/misoprostol
- Medicines that may harm the liver (eg, acetaminophen, ketoconazole, isoniazid, certain medicines for HIV infection, certain antibiotics or seizure medicines) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if diclofenac/misoprostol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use diclofenac/misoprostol:
Use diclofenac/misoprostol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Diclofenac/misoprostol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get diclofenac/misoprostol refilled.
- Take diclofenac/misoprostol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Do not take magnesium-containing antacids while taking diclofenac/misoprostol. If an antacid is needed, use one with calcium or aluminum.
- If you miss a dose of diclofenac/misoprostol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use diclofenac/misoprostol.
Important safety information:
- Diclofenac/misoprostol may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use diclofenac/misoprostol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Diclofenac/misoprostol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to diclofenac/misoprostol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Diabetes patients - Diclofenac/misoprostol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Women who are able to become pregnant should use effective birth control while they are taking diclofenac/misoprostol. Talk with your doctor if you are unsure of effective birth control methods.
- Lab tests, including complete blood cell counts, blood electrolyte levels, and liver function, may be performed while you use diclofenac/misoprostol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Diclofenac/misoprostol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not take diclofenac/misoprostol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Diclofenac/misoprostol is found in breast milk. Do not breast-feed while taking diclofenac/misoprostol.
Possible side effects of diclofenac/misoprostol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; drowsiness; gas; headache; indigestion; nausea; stomach pain or upset; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; bleeding and ulcers in the stomach and intestines; chest pain; change in the amount of urine produced; dark urine; dizziness or blurred vision; fast or irregular heartbeat; loss of appetite; mental or mood changes; one-sided weakness; pale stools; persistent loss of appetite; red, swollen, blistered, or peeling skin; seizures; severe diarrhea or stomach pain; severe headache and stiff neck; severe nausea and vomiting; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of infection (eg, chills, fever, sore throat); trouble breathing or shortness of breath; unusual bleeding or bruising; vaginal bleeding after menopause; vision, hearing, or speech problems; vomit that looks like coffee grounds; weakness, fatigue, or fainting; weight loss; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; convulsions; diarrhea; difficulty breathing; dizziness; drowsiness; fever; light-headedness; nausea; sleepiness; stomach pain; tremor; unusually fast or slow heartbeat.Proper storage of diclofenac/misoprostol:
Store diclofenac/misoprostol at 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep diclofenac/misoprostol out of the reach of children and away from pets.
- If you have any questions about diclofenac/misoprostol, please talk with your doctor, pharmacist, or other health care provider.
- Diclofenac/misoprostol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take diclofenac/misoprostol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about diclofenac/misoprostol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to diclofenac/misoprostol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using diclofenac/misoprostol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.