Diclofenac and Misoprostol (Oral Route)

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ARTICLE SECTIONS

US Brand Names

Arthrotec

Description

Diclofenac and misoprostol combination is used for patients with arthritis who may develop stomach ulcers from taking nonsteroidal anti-inflammatory drugs (NSAIDs) alone.

Diclofenac is a NSAID used in this combination medicine to help relieve some symptoms of arthritis, such as inflammation, swelling, stiffness, and joint pain.

Misoprostol is used in this combination medicine to prevent stomach ulcers.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet
Tablet, Enteric Coated

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of diclofenac and misoprostol combination in children with use in other age groups.

Geriatric

Certain side effects, such as confusion, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of nonsteroidal anti-inflammatory drugs. Also, elderly people are more likely than younger adults to get sick if this medicine causes stomach problems.

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.

Breastfeeding

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.

Drug Interactions

Using this medicine 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

Other Interactions

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse or
Bleeding problems or
Hepatitis or other liver disease or
Kidney disease (or history of) or
Tobacco use (or recent history of) or
Stomach ulcer, or other stomach or intestinal problems or
Systemic lupus erythematosus—The chance of side effects may be increased

Anemia or
Asthma or
Dehydration or
Fluid retention (swelling of feet or lower legs) or
Heart disease or
High blood pressure or
Low platelet count or
Low white blood cell count or
Porphyria (liver) or
Volume depletion—Diclofenac and misoprostol combination may make these conditions worse

Proper Use

For safe and effective use of this medicine, 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 health care professional. Taking too much of this medicine may increase the chance of unwanted effects.

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 the diclofenac and misoprostol combination.

Do not chew, crush, or dissolve tablets.

Do not give this medication to another person.

Diclofenac and misoprostol combination should be taken with meals.

Dosing

The dose of this medicine 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 this medicine. 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—1 tablet of Arthrotec 50 three times a day.
  - Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
  - Adults—1 tablet of Arthrotec 50 three or four times a day.
  - 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—1 tablet of Arthrotec 50 two times a day or 1 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 this medicine, 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.

Precautions

Misoprostol may cause miscarriage if taken during pregnancy. Therefore, if you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

This medicine 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 and/or does not stop after a week.

If you will be taking this medicine for a long time, your doctor should check your progress at regular visits. Your doctor may want to do certain tests to find out if unwanted effects are occurring. The tests are very important because serious side effects, including ulcers, bleeding, blood, or liver problems, can occur without any warning.

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

Taking nonsteroidal anti-inflammatory drugs together with this medicine on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g.,Toradol) regularly while you are taking a diclofenac and misoprostol combination may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicine together. If your health care professional 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 this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

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 as soon as possible if any of the following side effects occur:

Less common

Black, tarry stools
Bleeding or crusting sores on lips
Blood in urine or stools
Bruises and/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 and/or indigestion
Increased blood pressure
Increased heart rate
Increased weight gain
Itching of the skin
Irregular heartbeat
Large, flat, blue or purplish patches on the skin
Light-headedness 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 hepatic reactions
Severe stomach pain, cramping or burning
Shortness of breath, troubled breathing, tightness in chest, and/or wheezing
Skin rash
Sores, ulcers, or white spots on lips or in mouth
Sore throat
Stiff neck and/or back
Sudden decrease in the amount of urine
Swelling and/or tenderness in upper stomach
Swelling of face, fingers, feet, and/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

Symptoms of overdose

Confusion
Diarrhea
Drowsiness
Fever
Nausea and/or vomiting
Pounding heartbeat
Convulsions (seizures)
Shortness of breath
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