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diclofenac and misoprostol (Oral route)

Pronunciation

dye-KLOE-fen-ak SOE-dee-um, mye-soe-PROST-ol

Oral route(Tablet, Enteric Coated)

Administration of misoprostol to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy. Diclofenac sodium/misoprostol should not be taken by pregnant women. Women must have a negative serum pregnancy test within 2 weeks prior to beginning therapy and effective contraceptive measures must be used. Oral and written warnings of the hazards of misoprostol, including the risk of possible contraception failure, must be given to the patient prior to initiating therapy .

Commonly used brand name(s)

In the U.S.

  • Arthrotec

Available Dosage Forms:

  • Tablet, Enteric Coated
  • Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: Diclofenac

Chemical Class: Diclofenac

Uses For diclofenac and misoprostol

Diclofenac and misoprostol combination is used to relieve symptoms of arthritis (e.g., osteoarthritis or rheumatoid arthritis) in patients who may develop stomach ulcers from taking nonsteroidal anti-inflammatory drugs (NSAIDs).

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Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), used to relieve symptoms of arthritis such as inflammation, swelling, stiffness, and joint pain. Misoprostol is used to decrease the chance of having stomach and intestinal ulcers.

diclofenac and misoprostol is available only with your doctor's prescription.

Before Using diclofenac and misoprostol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For diclofenac and misoprostol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to diclofenac and misoprostol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diclofenac and misoprostol combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac and misoprostol combination in the elderly. However, elderly patients may be more sensitive to the effects of diclofenac and misoprostol combination than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving diclofenac and misoprostol.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking diclofenac and misoprostol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using diclofenac and misoprostol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac

Using diclofenac and misoprostol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Apixaban
  • Ardeparin
  • Argatroban
  • Beta Glucan
  • Bivalirudin
  • Ceritinib
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Clovoxamine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Deferiprone
  • Desirudin
  • Dipyridamole
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Femoxetine
  • Feverfew
  • Flesinoxan
  • Fluoxetine
  • Fluvoxamine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Heparin
  • Lepirudin
  • Levomilnacipran
  • Meadowsweet
  • Methotrexate
  • Milnacipran
  • Nadroparin
  • Nefazodone
  • Nitisinone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Pralatrexate
  • Prasugrel
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Sertraline
  • Sibutramine
  • Tacrolimus
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Zimeldine

Using diclofenac and misoprostol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cholestyramine
  • Cilazapril
  • Ciprofloxacin
  • Clopamide
  • Colestipol
  • Cyclopenthiazide
  • Delapril
  • Desvenlafaxine
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Fluconazole
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Lithium
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Spironolactone
  • Talinolol
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamterene
  • Trichlormethiazide
  • Valsartan
  • Verapamil
  • Xipamide
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of diclofenac and misoprostol. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Asthma or
  • Bleeding problems or
  • Congestive heart failure or
  • Edema (fluid retention or body swelling) or
  • Heart attack, history of or
  • Heart disease or
  • Hypertension (high blood pressure) or
  • Kidney disease or
  • Liver disease (including hepatitis) or
  • Porphyria (blood disorder) or
  • Stomach or intestinal ulcers or bleeding, history of or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma or
  • Aspirin sensitivity, history of—diclofenac and misoprostol should not be used in patients with these conditions.
  • Heart surgery (e.g., coronary artery bypass graft [CABG])—diclofenac and misoprostol should not be used to relieve pain right before or after the surgery.
  • Systemic lupus erythematosus (SLE)—May cause side effects to become worse.

Proper Use of diclofenac and misoprostol

For safe and effective use of diclofenac and misoprostol, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of diclofenac and misoprostol may increase the chance of unwanted effects. Do not change the dose or stop using diclofenac and misoprostol without checking first with your doctor.

diclofenac and misoprostol should come with a medication guide and a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Do not take diclofenac and misoprostol combination with magnesium-containing antacids. Antacids may be taken with diclofenac and misoprostol combination, if needed, to help relieve stomach pain, unless you are otherwise directed by your doctor. However, do not take magnesium-containing antacids, since they may cause diarrhea or worsen the diarrhea that is sometimes caused by diclofenac and misoprostol.

Do not give diclofenac and misoprostol to another person.

Diclofenac and misoprostol combination should be taken with meals. Swallow the tablets whole. Do not chew, crush, or dissolve it.

Dosing

The dose of diclofenac and misoprostol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of diclofenac and misoprostol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For osteoarthritis:
      • Adults—One tablet of Arthrotec 50 three times a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For rheumatoid arthritis:
      • Adults—One tablet of Arthrotec 50 three or four times a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For osteoarthritis or rheumatoid arthritis (for patients who are unable to tolerate other doses):
      • Adults—One tablet of Arthrotec 50 two times a day or One tablet of Arthrotec 75 two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of diclofenac and misoprostol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using diclofenac and misoprostol

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using diclofenac and misoprostol while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using diclofenac and misoprostol and after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. Also, you must have a negative pregnancy test within 2 weeks before you will be allowed to take diclofenac and misoprostol. If you think you have become pregnant while using diclofenac and misoprostol, stop taking diclofenac and misoprostol and tell your doctor right away.

diclofenac and misoprostol may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use diclofenac and misoprostol for a long time might also have a higher risk.

diclofenac and misoprostol may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain medicines (such as a steroid medicine or a blood thinner).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.

diclofenac and misoprostol may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using diclofenac and misoprostol.

Serious skin reactions can occur during treatment with diclofenac and misoprostol. Check with your doctor right away if you have any of the following symptoms while taking diclofenac and misoprostol: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of meningitis.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with diclofenac and misoprostol.

diclofenac and misoprostol may cause diarrhea in some people. The diarrhea will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor if the diarrhea is severe or does not stop after a week.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with diclofenac and misoprostol. Therefore, do not regularly drink alcoholic beverages while taking diclofenac and misoprostol, unless otherwise directed by your doctor.

Taking nonsteroidal anti-inflammatory drugs (e.g., acetaminophen, aspirin or other salicylates, or ketorolac, Toradol®) together with diclofenac and misoprostol on a regular basis may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take everyday, and on how long you take the medicine together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with diclofenac and misoprostol for more than a few days, and do not take any ketorolac (e.g., Toradol®) while you are taking diclofenac and misoprostol, unless your doctor has directed you to do so and is following your progress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

diclofenac and misoprostol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Black, tarry stools
  • bleeding or crusting sores on the lips
  • blood in the urine or stools
  • bruises or red spots on the skin
  • chest pain
  • chills
  • confusion
  • continuing thirst
  • convulsions (seizures)
  • cough or hoarseness
  • disorientation
  • drowsiness
  • fainting
  • fever with or without chills
  • fluid retention
  • general feeling of illness
  • heartburn or indigestion
  • increased blood pressure
  • increased heart rate
  • increased weight gain
  • irregular heartbeat
  • itching of the skin
  • large, flat, blue or purplish patches on the skin
  • lightheadedness or dizziness
  • lower back or side pain
  • mental depression
  • muscle cramps
  • nausea
  • painful or difficult urination
  • pounding heartbeat
  • psychotic reaction
  • rectal bleeding
  • seeing, hearing, or feeling things that are not there
  • severe headache
  • severe liver reactions
  • severe stomach pain, cramping, or burning
  • shortness of breath, troubled breathing, tightness in the chest, or wheezing
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiff neck or back
  • sudden decrease in the amount of urine
  • swelling or tenderness in the upper stomach
  • swelling of the face, fingers, feet, or lower legs
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of material that looks like coffee grounds
  • yellow eyes or skin
Rare
  • Changes in facial skin color
  • fast or irregular breathing
  • puffiness or swelling of the eyelids or around the eyes

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Diarrhea
  • fever
  • slow heartbeat
  • stomach pain
  • trembling or shaking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Gas
Less common
  • Abnormal vision
  • acne
  • change in sense of taste
  • decreased appetite
  • decrease in sexual ability
  • dry mouth
  • irritability or nervousness
  • loss of hair
  • muscle pain
  • tingling, burning, or prickling sensations
  • trouble with swallowing
  • vaginal bleeding

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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