Arthrotec
Generic Name: diclofenac and misoprostol (Oral route)
dye-KLOE-fen-ak SOE-dee-um, mye-soe-PROST-ol
Administration of misoprostol to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported 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.
Patients must be advised of the abortifacient property and warned not to give the drug to others.
Diclofenac sodium/misoprostol should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, diclofenac sodium/misoprostol may be prescribed if the patient:
- has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
- is capable of complying with effective contraceptive measures.
- has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
- will begin diclofenac sodium/misoprostol only on the third day of the next normal menstrual period .
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
- Tablet, Enteric Coated
Therapeutic Class: Analgesic
Pharmacologic Class: Diclofenac
Chemical Class: Diclofenac
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Uses For Arthrotec
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.
Before Using Arthrotec
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. |
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
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
Using this medicine 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.
- Ardeparin
- Beta Glucan
- Certoparin
- Dalteparin
- Danaparoid
- Enoxaparin
- Ginkgo
- Methotrexate
- Nadroparin
- Parnaparin
- Pemetrexed
- Reviparin
- Tacrolimus
- Tinzaparin
Using this medicine 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.
- Acetohexamide
- Alacepril
- Amiloride
- Azosemide
- Bemetizide
- Benazepril
- Bendroflumethiazide
- Benzthiazide
- Bumetanide
- Buthiazide
- Candesartan Cilexetil
- Canrenoate
- Captopril
- Chlorothiazide
- Chlorpropamide
- Chlorthalidone
- Cholestyramine
- Cilazapril
- Ciprofloxacin
- Citalopram
- Clopamide
- Clopidogrel
- Clovoxamine
- Colestipol
- Cyclopenthiazide
- Cyclosporine
- Cyclothiazide
- Delapril
- Desvenlafaxine
- Duloxetine
- Enalaprilat
- Enalapril Maleate
- Eprosartan
- Escitalopram
- Ethacrynic Acid
- Femoxetine
- Flesinoxan
- Fluoxetine
- Fluvoxamine
- Fosinopril
- Furosemide
- Gliclazide
- Glimepiride
- Glipizide
- Gliquidone
- Glyburide
- Hydrochlorothiazide
- Hydroflumethiazide
- Imidapril
- Indapamide
- Irbesartan
- Lisinopril
- Lithium
- Losartan
- Methyclothiazide
- Metolazone
- Milnacipran
- Moexipril
- Nefazodone
- Olmesartan Medoxomil
- Paroxetine
- Pentopril
- Perindopril
- Phenylbutazone
- Piretanide
- Polythiazide
- Quinapril
- Quinethazone
- Ramipril
- Sertraline
- Spirapril
- Spironolactone
- Tasosartan
- Telmisartan
- Temocapril
- Tolazamide
- Tolbutamide
- Torsemide
- Trandolapril
- Triamterene
- Trichlormethiazide
- Valsartan
- Venlafaxine
- Xipamide
- Zimeldine
- 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 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 of Arthrotec
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.
- For osteoarthritis:
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 While Using Arthrotec
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.
Arthrotec 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
- Changes in facial skin color
- fast or irregular breathing
- puffiness or swelling of the eyelids or around the eyes
- 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- Diarrhea
- gas
- heartburn
- Abnormal vision
- acne
- change in sense of taste
- decreased appetite
- dry mouth
- irritability or nervousness
- loss of hair
- muscle pain
- decrease in sexual ability
- tingling, burning, or prickling sensations
- trembling or shaking
- trouble 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.
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