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Diclofenac and misoprostol (Oral route)

Pronunciation:

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

Brand Names:

  • Arthrotec

Dosage Forms:

  • Tablet, Enteric Coated
  • Tablet

Warnings:

Oral route(Tablet, Enteric Coated)

Diclofenac sodium/misoprostol should not be administered during pregnancy as abortion, premature birth, or birth defects can occur. Avoid use in women of childbearing potential unless the patient requires NSAID therapy and is at high risk of developing complications from gastric or duodenal ulcers and meets the following criteria: has a negative serum pregnancy test within 2 weeks of treatment initiation, uses effective contraception, receives oral and written warnings of the hazards of misoprostol, and initiates therapy only on the second or third day of her next normal menstrual period. NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac sodium/misoprostol is contraindicated in the setting of CABG surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Diclofenac

Chemical—

Diclofenac

Uses of This Medicine:

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

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.

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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 this medicine.

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.

Other 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 this medicine, 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 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.

  • Abciximab
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Balsalazide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bismuth Subsalicylate
  • Bivalirudin
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Bumetanide
  • Cangrelor
  • Celecoxib
  • Ceritinib
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Choline Magnesium Trisalicylate
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deferiprone
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diazoxide
  • Dibenzepin
  • Diclofenac
  • Diflunisal
  • Digoxin
  • Dipyridamole
  • Dipyrone
  • Dothiepin
  • Doxepin
  • Droxicam
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Feverfew
  • Floctafenine
  • Flufenamic Acid
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Ibuprofen
  • Iloprost
  • Imipramine
  • Indapamide
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Magnesium Salicylate
  • Meadowsweet
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • Mesalamine
  • Methotrexate
  • Methyclothiazide
  • Methylprednisolone
  • Metolazone
  • Milnacipran
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Nortriptyline
  • Olsalazine
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paramethasone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Phenyl Salicylate
  • Piketoprofen
  • Piroxicam
  • Polythiazide
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylamide
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • Spironolactone
  • Sulfasalazine
  • Sulindac
  • Tacrolimus
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Trolamine Salicylate
  • Valdecoxib
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

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.

  • Acebutolol
  • Alacepril
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cholestyramine
  • Cilazapril
  • Ciprofloxacin
  • Colestipol
  • Delapril
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Imidapril
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Pindolol
  • Practolol
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Telmisartan
  • Temocapril
  • Timolol
  • Trandolapril
  • Valsartan
  • Zofenopril

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:

  • 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 or
  • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma or
  • Aspirin sensitivity, history of or
  • Stomach or intestinal bleeding—Should not be used in patients with these conditions.
  • Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of This Medicine:

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 doctor. Taking too much of this medicine may increase the chance of unwanted effects. Do not change the dose or stop using this medicine without checking first with your doctor.

This medicine 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 this medicine.

Do not give this medicine 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 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—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 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.

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

Precautions While Using This Medicine:

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 this medicine 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 this medicine and after treatment ends. 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 this medicine. If you think you have become pregnant while using this medicine, stop taking this medicine and tell your doctor right away.

This medicine 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 this medicine for a long time might also have a higher risk.

This medicine 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.

This medicine 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 this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: 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 aseptic meningitis.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

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 or does not stop after a week.

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 (eg, acetaminophen, aspirin or other salicylates, or ketorolac, Toradol®) together with this medicine 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 this medicine for more than a few days, and do not take any ketorolac (eg, Toradol®) while you are taking this medicine, 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.

Side Effects of This Medicine:

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 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
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
troubled breathing, tightness in the chest
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.


Last Updated: 8/4/2017
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