Diclofenac + Misoprostol
(dye kloe' fen ak) + (mye soe prost' ole)
Diclofenac: P - Contraindicated in pregnancy L - Caution when used during lactation
Misoprostol: P - Contraindicated in pregnancy L - Contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
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 (see also PRECAUTIONS). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.
Diclofenac & misoprostol combination 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, This Combination may be prescribed if the patient:
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
This Combination is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events.
This is indicated for patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol.
The diclofenac component is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostol component is indicated for patients with a special need for the prophylaxis of NSAID-induced gastric and duodenal ulceration.
Oral - Tablets, Oral diclofenac sodium 50 mg/misoprostol 200 mcg- Tablets, Oral diclofenac sodium 75 mg/misoprostol 200 mcg.
Treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
PO 50 mg/200 mcg three times daily. For patients experiencing intolerance, 50 mg/200 mcg or 75 mg/200 mcg twice daily can be used, but is less effective at preventing ulcers. Dosages of diclofenac higher than 150 mg/day and misoprostol 800 mcg/day in osteoarthritis are not recommended.
Rheumatoid Arthritis, Adults
PO 50 mg/200 mcg three or four times daily. For patients experiencing intolerance, 50 mg/200 mcg or 75 mg/200 mcg twice daily can be used, but is less effective at preventing ulcers. Dosages of diclofenac higher than 225 mg/day and misoprostol 800 mcg/day in RA are not recommended.
Diclofenac, an NSAID, decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis. Misoprostol, a prostaglandin E1 analogue, provides gastric antisecretory and mucosal protective properties.
Diclofenac: Aspiration pneumonitis, confusion, death, drowsiness, general hypotonia, GI complaints, increased intracranial pressure, loss of consciousness, vomiting.
Misoprostol: Abdominal pain, bradycardia, convulsions, diarrhea, dyspnea, fever, GI discomfort, hypotension, palpitations, sedation, tremor.
Pregnancy; sensitivity to aspirin or any NSAID; sensitivity to misoprostol or other prostaglandins; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; treatment of perioperative pain in the setting of coronary artery bypass graft surgery.
Cardiovascular: Arrhythmia, atrial fibrillation, CHF, hypertension, hypotension, MI, palpitations, phlebitis, premature ventricular contractions, syncope, tachycardia, vasculitis.
CNS: Coma, convulsions, depression, hallucinations, meningitis, psychotic reaction.
Dermatologic: Erythema multiforme, exfoliative dermatitis, pemphigoid reaction, photosensitivity, skin ulceration, Stevens-Johnson syndrome, TEN.
GI: Esophageal ulceration, GI bleeding, GI neoplasm benign, hematemesis, intestinal perforation, peptic ulcer, rectal bleeding.
Genitourinary: Hematuria, interstitial nephritis, nephrotic syndrome, papillary necrosis, proteinuria, renal failure, vaginal hemorrhage.
Hematologic-Lymphatic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocythemia, thrombocytopenia.
Hepatic: Abnormal hepatic function, hepatitis, jaundice, liver failure, pancreatitis.
Hypersensitivity: Angioedema, laryngeal/pharyngeal edema, urticaria.
Respiratory: Pneumonia, pulmonary embolism, respiratory depression.
Miscellaneous: Death, infection, sepsis.
Antihypertensive effect may be decreased by diclofenac. In addition, the risk of nephrotoxicity may be increased. Closely monitor BP. If BP control deteriorates, consider stopping diclofenac/misoprostol. Periodic measurement of renal function and potassium concentrations is warranted.
Alcohol, corticosteroids, smoking
The risk of GI bleeding may be increased. Monitor for signs of GI bleeding.
Aminoglycoside plasma concentrations may be elevated in premature infants because diclofenac may reduce the glomerular filtration rate. If this combination cannot be avoided, reduce the aminoglycoside dose prior to starting diclofenac/misoprostol or stop diclofenac/misoprostol before starting aminoglycoside therapy. Monitor aminoglycoside concentrations and renal function.
Bioavailability of misoprostol may be reduced and absorption of diclofenac may be delayed. Magnesium-containing antacids increase risk of misoprostol-associated diarrhea.
Risk of serious GI complications, including bleeding, may be increased. In addition, the cardioprotective effect of aspirin may be reduced. Concurrent use of diclofenac and aspirin is not generally recommended.
Diclofenac plasma concentrations may be elevated, increasing the pharmacologic effects and risk of adverse reactions. Monitor the clinical response and adjust the dose of diclofenac/misoprostol as needed.
Bile acid sequestrants
The effects of diclofenac may be decreased. If an interaction is suspected, consider increasing the diclofenac/misoprostol dose during administration of cholestyramine.
Risk of gastric ulceration may be increased. Use with caution. Monitor for signs of GI adverse reactions, especially gastric ulceration.
Risk of cyclosporine toxicity, including nephrotoxicity, may be increased. Closely monitor renal function and cyclosporine concentrations. If an interaction is suspected, consider decreasing the cyclosporine dosage or stopping diclofenac/misoprostol.
Diclofenac may elevate digoxin levels, increasing risk of toxicity. Monitor for possible digoxin toxicity.
The natriuretic effect of furosemide and thiazide diuretics may be reduced. Coadministration of potassium-sparing diuretics may increase serum potassium levels.
The risk of hemorrhagic adverse reactions may be increased. If concurrent use cannot be avoided, close clinical and laboratory monitoring are warranted.
Hypoglycemic agents, Oral
Both hypo- and hyperglycemia may occur, necessitating a change in the hypoglycemic agent dosage. Monitor blood glucose and adjust the Oral hypoglycemic dose as needed.
Lithium levels may be elevated, increasing risk of toxicity. Monitor for signs of lithium toxicity. Additional lithium plasma concentration monitoring is warranted. Adjust the lithium dose as needed.
May increase methotrexate levels and risk of toxicity. If coadministration cannot be avoided, use with caution. Monitor for signs of methotrexate toxicity. Monitoring methotrexate concentrations may be useful in managing treatment.
Phenobarbital toxicity has been reported following the initiation of diclofenac therapy. Monitor for phenobarbital toxicity.
Diclofenac plasma concentrations may be elevated, increasing the risk of toxicity. Monitor for signs of diclofenac toxicity and adjust treatment as needed.
Quinolone plasma concentrations may be elevated. The risk of CNS stimulation and seizures from quinolones may be increased. Use with caution.
Serotonin reuptake inhibitors
The risk of upper GI bleeding may be increased. If coadministration cannot be avoided, close clinical monitoring for signs of GI bleeding is warranted. Consider shortening diclofenac/misoprostol treatment duration, decreasing the diclofenac/misoprostol dose, or using alternative therapy.
The effects of diclofenac may be decreased, possibly because of decreased absorption. Monitor the clinical response and adjust treatment as needed.
May increase risk of gastric erosion and bleeding. Closely monitor coagulation status and adjust the anticoagulant dose as needed. Monitor for signs of GI bleeding.
|Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Also not recommended in breast-feeding mothers.
Diclofenac: Excreted in breast milk.
Misoprostol: The active metabolite, misoprostol acid, is excreted in breast milk.
M01AB05 - diclofenac; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|APAIN MS||Kemiko Pharmaceuticals Ltd||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 330.00 MRP|
|ARTHROFEN 50mg||Healthcare Pharmacuticals Ltd.||Diclofenac Sodium BP 50mg + Misoprostol INN 200mcg||Tablet||30's MRP 300 Tk|
|ARTHROFEN 75mg||Healthcare Pharmacuticals Ltd.||Diclofenac Sodium BP 75mg + Misoprostol INN 200mcg||Tablet||30's MRP 360 Tk|
|CLOFINA||R A K Pharmaceuticals Pvt. Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 300.00 MRP|
|DIMIS||Everest Pharmaceuticals Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 300.00 MRP|
|ERDON SUPER-50||Aristopharma Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 300.00 MRP|
|ERDON SUPER-75||Aristopharma Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 330.00 MRP|
|MICLOFENAC 50||Square Pharmaceuticals Ltd.||Diclofenac Sodium 50mg + Misoprostol 200mcg||Tablet||3x10's: 302.10 MRP|
|MICLOFENAC 75||Square Pharmaceuticals Ltd.||Diclofenac Sodium 75mg + Misoprostol 200mcg||Tablet||3x10's: 332.10 MRP|
|MISOCLO||General Pharmaceuticals Ltd||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||20's: 200.80 MRP|
|MISOCLO-75||General Pharmaceuticals Ltd||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||20's: 220.80 MRP|
|MISOFEN||Somatec Pharmaceuticals Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 331.20 MRP|
|MISOFENAC 50||The Acme Laboratories Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 301.20 MRP|
|PANFRE Plus 50||Pacific Pharmaceuticals Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||30's: 230.00 MRP|
|PROFENAC Plus||Popular Pharmaceuticals Ltd.||Diclofenac Sodium BP 75mg+ Misoprostol INN 200mg||Tablet||20's: 200.80 MRP|
|ULTRAFEN Plus 50||Beximco Pharmaceuticals Ltd||Diclofenac Sodium BP 50mg (core) + Misoprostol INN 200mcg (outer mantle), enteric coated||Tablet||50's:500.00 MRP|
|ULTRAFEN Plus 75||Beximco Pharmaceuticals Ltd||Diclofenac Sodium BP 75mg (core) + Misoprostol INN 200mcg (outer mantle), enteric coated||Tablet||30's: 330.00 MRP|
For female patients:
Do not take diclofenac and misoprostol if you are pregnant or plan to become pregnant. If you become pregnant while taking diclofenac and misoprostol, stop taking the medication and call your doctor immediately. Diclofenac and misoprostol may cause miscarriage (pregnancy loss), serious bleeding, or premature birth (baby is born too early) if taken during pregnancy.
Women who can become pregnant generally should not take diclofenac and misoprostol. However, you and your doctor may decide that diclofenac and misoprostol combination is needed to treat your condition. In that case you must:
For all patients:
People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as diclofenac and misoprostol combination may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take diclofenac and misoprostol right before or right after the surgery.
NSAIDs such as diclofenac may cause ulcers, bleeding, or holes in the stomach or intestine. Misoprostol is taken in combination with diclofenac to protect the stomach and intestine, but may not prevent all damage to these parts of the body. Problems with the stomach and intestine may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking diclofenac and misoprostol. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking diclofenac and misoprostol and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to diclofenac and misoprostol. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.
Do not give this medication to anyone else, especially a woman who is or could become pregnant.
Your doctor or pharmacist will give you the manufacturer's patient information sheet for diclofenac and misoprostol and the general Medication Guide for NSAIDs when you begin your treatment and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the patient information sheet and Medication Guide.
Why is this medication prescribed?
The combination of diclofenac and misoprostol is used to relieve the pain, tenderness, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis in patients who have a high risk of developing stomach ulcers. Diclofenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain and inflammation. Misoprostol is in a class of medications called prostaglandins. It prevents ulcers caused by diclofenac by protecting the stomach lining and decreasing stomach acid production.
How should this medicine be used?
The combination of diclofenac and misoprostol comes as a tablet to take by mouth. It is usually taken with food two to four times a day. To help you remember to take diclofenac and misoprostol, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your Doctor to explain any part you do not understand. Take diclofenac and misoprostol combination exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Other uses for this medicine
This medication may be prescribed for other uses; ask your Doctor for more information.
What special precautions should I follow?
Before taking diclofenac and misoprostol,
- tell your Doctor if you are allergic to diclofenac, misoprostol, aspirin or other NSAIDs such as ibuprofen and naproxen; prostaglandins such as alprostadil, carboprost, dinoprostone and mifepristone; any other medications, or any of the inactive ingredients in diclofenac and misoprostol tablets. Ask your Doctor for a list of the inactive ingredients.
- tell your Doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme inhibitors such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, and trandolapril; antacids containing magnesium; cyclosporine; digoxin; diuretics; insulin and Oral medications for diabetes; methotrexate; lithium; and phenobarbital. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or inflammatory bowel disease; asthma, especially if you also have frequent stuffed or runny nose or nasal polyps; lupus; hepatic porphyria; liver or kidney disease; or swelling of the hands, feet, ankles, or lower legs.
- tell your doctor if you are breast-feeding. You should not breast-feed while you are taking this medication.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking diclofenac and misoprostol.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Diclofenac and misoprostol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- gas or bloating
- unexplained weight gain
- excessive tiredness
- lack of energy
- upset stomach
- loss of appetite
- pain in the upper right part of the stomach
- yellowing of the skin or eyes
- flu-like symptoms
- pale skin
- fast heartbeat
- stiff neck
- sore throat
- muscle pain
- sensitivity to light
- swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- unusual vaginal bleeding
- cloudy, discolored, or bloody urine
- back pain
- difficult or painful urination
Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, consult your doctor immediately. Do not take any more diclofenac and misoprostol until you speak to your doctor.
Diclofenac and misoprostol may cause other side effects. Consult your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Office of Directorate General, Drugs Administration.
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture. Throw away any medication that is outdated or no longer needed.
In case of emergency/overdose
In case of overdose, consult your Doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
- stomach pain
- low muscle tone
- shaking of a part of the body that you cannot control
- shortness of breath
- fast, pounding, or slow heartbeat
What other information should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking diclofenac and misoprostol.
Do not let anyone else take your medication.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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