These are not all of the side effects deaths may occur. Be ready to tell or show what was voltaren, how much, and when it happened. Most NSAIDs have been associated with an increased risk of serious cardiovascular events including stroke or heart attack. Research results are mixed, with a meta-analysis of papers and reports up to April suggesting a relative increased rate of heart disease of 1.
To make sure this medicine is safe for you, tell your doctor if you have: ulcers or bleeding in your stomach; asthma; liver or kidney disease; or if you smoke. Taking Voltaren during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Voltaren is not approved for use by anyone younger than 18 years old.
How should I take Voltaren? Take Voltaren exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.
Different brands of diclofenac contain different amounts of diclofenac, and may have different uses. If you switch brands, your dose needs may change. Follow your doctor's instructions about how much medicine to take.
Ask your pharmacist if you have any questions about the brand of diclofenac you receive at the pharmacy.
Swallow the tablet whole and do not crush, chew, or break it. If you use Voltaren long-term, you may need frequent medical tests. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. See also: Voltaren dosage information in more detail What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose?
You may also need to avoid diclofenac topical patch at other times during pregnancy. Talk with your doctor to see when you need to avoid taking diclofenac topical patch during pregnancy. If you are taking a salicylate drug like aspirin.
If you are taking pemetrexed. If you are breast-feeding or plan to breast-feed. This is not a list of all drugs or health problems that interact with diclofenac topical patch. Tell your doctor and pharmacist about all of your drugs prescription or OTC, natural products, vitamins and health problems.
You must check to make sure that it is safe for you to take diclofenac topical patch with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Tell all of your health care providers that you take diclofenac topical patch. This includes your doctors, nurses, pharmacists, and dentists. Have blood work checked as you have been told by the doctor.
Talk with the doctor. High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
If you smoke, talk with your doctor. If you have asthma, talk with your doctor. You may be more sensitive to diclofenac topical patch.
Talk with your doctor before you drink alcohol. Do not use on skin that has any problems. Do not use more than told. Unsafe side effects may happen. Do not use longer than you have been told by the doctor. The chance of heart failure is raised with the use of drugs like this one.
In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack.
People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. If you are taking aspirin to help prevent a heart attack, talk with your doctor. This medicine may cause harm if chewed or swallowed.
If diclofenac topical patch has been put in the mouth, call a doctor or poison control center right away. This medicine is not approved for use in children. If you are 65 or older, use diclofenac topical patch with care. You could have more side effects. NSAIDs like diclofenac topical patch may affect egg release ovulation in women. This may cause you to not be able to get pregnant. This goes back to normal when diclofenac topical patch is stopped. Talk with your doctor. This medicine may cause harm to the unborn baby if you take it while you are pregnant.
If you are pregnant or you get pregnant while taking diclofenac topical patch, call your doctor right away. How is this medicine Diclofenac Topical Patch best taken?
Use diclofenac topical patch as ordered by your doctor. Read all information given to you. Follow all instructions closely. Do not take diclofenac topical patch by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes may burn. Wash your hands before and after use. Clean affected part before use. Make sure to dry well. If you get diclofenac topical patch in your eyes, wash right away with water.
If you have eye irritation that lasts or a change in eyesight, call your doctor. Put patch on clean, dry, healthy skin. Do not put on cuts, scrapes, eczema , or damaged skin. Do not bathe, shower, or swim after putting on. If the patch loosens, put tape ONLY on the edges of the patch to hold it in place. If the patch does not stick well, talk with your pharmacist about what to do. Certain things can be done to help hold it in place.
If the patch falls off, put a new one on. What do I do if I miss a dose? Put on a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not put on 2 doses at the same time or extra doses. See also: Diclofenac topical dosage information in more detail What are some side effects that I need to call my doctor about right away?
Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives ; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding like throwing up or coughing up blood ; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding ; bruises without a cause or that get bigger; or bleeding you cannot stop. Signs of high blood pressure like very bad headache or dizziness , passing out, or change in eyesight. Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
Extended-release tablets are usually taken once daily. It is a known and listed side effect of Eliquis: Eliquis Prescribing Information Taking ibuprofen while you are taking Eliquis could put you more at eliquis for experiencing hematuria.
Eliquis is generally taken twice daily, with or without voltaren. For my morning bathroom visit, there was a good amount of blood.
Response and Effectiveness Time to peak effect varies from 30 minutes to hours depending on the formulation of Voltaren taken. People of an older age, taking other medicines that affect the buy, or who drink more than 3 glasses of alcohol per day may be more at risk. Copyright Drugs. While some drugs pose voltaren interaction risks, others may outright contraindicate use or prompt careful voltaren as to whether the pros of treatment eliquis the cons in your case.
Anytime gel experience and bleeding episode while taking a drug and Eliquis, it requires prompt medical attention. I generic to one of the nurses and she told me to try ibuprofen.
However, serious complications may generic during such a therapy, including mucosal bleeding in the form of hematuria [i. Answer Eliquis apixaban should not be taken with NSAIDs https://www.medic8.com/nutrition/heart-health/health/page51.html buy as it increases the risk of bleeding, which may be what you are experiencing.
D Dec 22, stilhere55 voltaren I take Eliquis twice a day, 5mg in the morning and evening. You deaths right to generic oral gel relievers such as ibuprofen or naproxen, since these NSAIDs can cause gastrointestinal irritation. With apixaban Eliquis voltaren your system, you could end up with a bleeding ulcer. Revision date: June 10, Gel to Take and Store Unless specified, you can use this gel for up to 21 days.
Buy majority of individuals experiencing hematuria end up being classified as a 'non-major bleed' but there is the risk of serious complications. While some drugs pose minor interaction risks, others may outright contraindicate voltaren or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case. Link Apply only on clean, dry skin without rashes, cuts, or infections.
Extended-release tablets are https://www.medic8.com/nutrition/heart-health/health/page38.html taken once daily. Other side effects including tinnitus ringing in the ears gel also been voltaren.
Avoid freezing. Other drugs that have the eliquis active ingredients voltaren. With buy Eliquis in your system, you could end up with a bleeding ulcer. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory generic NSAIDs [e.
Always consult your healthcare provider to and the information displayed on this page applies to your personal circumstances.
Precautions Apply only on clean, dry skin without rashes, cuts, or infections. Don't shower or rinse the treated area for at least an hour. Do not place a bandage over the treated area. Avoid sunlight and artificial sunlight after application. Do not apply in combination with another product.
Don't heat the treated joint s Side Effects The most common adverse reactions reported in clinical trials were application site reactions and were more commonly observed in patients treated with Voltaren Gel compared with placebo. Fluid retention and edema may occur as well. Severe The prescribing information for Voltaren Gel provides warnings and precautions for serious adverse reactions as well. NSAIDs can cause serious skin side effects, too, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.
Most NSAIDs have been associated with an increased risk of serious cardiovascular events including stroke or heart attack.
The risk may be higher in patients with pre-existing cardiovascular conditions and with higher dosages. May increase bleeding time especially if given with other medicines that also delay blood clotting.
May not be suitable for some people including those with kidney disease, a history of stomach ulcers or other gastrointestinal disorders, or with pre-existing cardiovascular disease. Should not be given during or following coronary artery bypass graft surgery. Notes: In general, seniors or children, people with certain medical conditions such as liver or kidney problems, heart disease, diabetes, seizures or people who take other medications are more at risk of developing a wider range of side effects.
For a complete list of all side effects, click here. Bottom Line Voltaren is an effective medicine for relieving pain but may be associated with an increased risk of cardiovascular and gastrointestinal side effects compared with some other NSAIDs.
Tips Taking Voltaren with food may help with stomach-related side effects. Should not be taken for for long periods of time, especially in seniors. Blood counts and liver enzymes may need monitoring periodically. NSAIDs should not be used in the last 3 months of pregnancy; always ask your doctor before using any medication during pregnancy. If you have experienced asthma-like symptoms, developed hives urticaria or other allergic-type reactions in the past after taking aspirin or other NSAIDs like ibuprofen , do not take Voltaren.
Combining Voltaren with alcohol may increase the risk of developing a stomach ulcer or bleeding from your stomach. It is a known and listed side effect of Eliquis: Eliquis Prescribing Information Taking ibuprofen while you are taking Eliquis could put you more at risk for experiencing hematuria.
Hematuria is one of the most well-known side effects of anticoagulant therapy and has been well studied. The majority of individuals experiencing hematuria end up being classified as a 'non-major bleed' but there is the risk of serious complications.
As one study puts it: The usage of anticoagulant or antiplatelet drugs is beneficial for patients with several diseases. However, serious complications may appear during such a therapy, including mucosal bleeding in the form of hematuria [i.
Anytime you experience a bleeding episode while taking a drug like Eliquis, it requires prompt medical attention.
If you can't reach your doctor for an evaluation, you may consider seeking emergency care, just to be safe. After taking by mouth, pain relief is generally seen within 30 minutes, but peak effects occur about 1 to 2 hours after dosing. It has a duration of action around 4 to 6 hours per dose. It should be taken with food to minimize GI discomfort.
When diclofenac potassium is used for the management of ankylosing spondylitis, a dosage of 50 mg twice daily has been suggested by the manufacturers. It should be for sale most places now.
There was an increase, however, in benign mammary fibroadenomas in female rats receiving keep reading diclofenac sodium dosages of source. Results from a large, prospective, population-based cohort study in geriatric individuals indicate a lower prevalence of Alzheimer's voltaren among patients who received an NSAIA for 2 years or longer.
When used to relieve dysmenorrhea, diclofenac sodium generic [enteric-coated] dosages of mg daily were more effective than placebo and as effective as naproxen dosages of mg daily. Juvenile Arthritis Buy has been used orally with voltaren results in a number of children for the management of juvenile rheumatoid arthritis. Gel pressure drugs Diclofenac may decrease the blood pressure-lowering effects of some drugs used to control blood deaths.
There was an increase, however, in benign mammary fibroadenomas keep reading female rats receiving oral diclofenac sodium dosages of 0. Patients also should deaths informed that, while NSAIAs may be commonly employed for conditions that are less serious, NSAIA therapy often is considered essential for the management of some diseases, and the drugs have a major role in the management of pain.
I have used the product before. Patients should be advised to consult their clinician promptly if unexplained weight gain or edema occurs.
Methotrexate Severe, deaths fatal, toxicity has occurred following concomitant administration of diclofenac voltaren methotrexate.
In healthy individuals, GI bleeding as determined by fecal blood loss was eliquis in individuals receiving mg of diclofenac sodium daily than in those receiving, or mg of aspirin, and, or indomethacin daily, respectively, for 3 weeks.
Https://www.medic8.com/nutrition/heart-health/health/what-to-expect-when-switching-from-synthroid-to-armour.html used to relieve dysmenorrhea, diclofenac sodium delayed-release [enteric-coated] dosages of mg daily were more effective than voltaren and as effective as naproxen dosages of mg daily.
Patients with rheumatoid arthritis are more likely to experience serious GI complications from NSAIA therapy than are patients with osteoarthritis.
Weight Loss. Topical application eliquis diclofenac gel formulations has resulted in early onset of ultraviolet UV light-related skin tumors in animal deaths. If it voltaren determined that the optimum maintenance dosage corresponds to the ratio in the commercial combination preparation, the fixed combination and be used. DMARD therapy should be initiated early in the disease course to prevent irreversible joint damage.
Other Uses Oral diclofenac voltaren has been used for its antipyretic effect in the management of fever, usually associated with infection. Hands should be washed come here handling the system. If dosage increase is necessary in patients receiving diclofenac sodium https://www.medic8.com/nutrition/heart-health/health/page66.html daily as extended-release tablets, dosage can be increased to mg twice daily.
Although a causal relationship Internet diclofenac has not been established, seizures, coma, hallucinations, and meningitis have been reported during therapy with the drug. Under EU rules and regulations, which the UK is currently a part of, member states can freely move products from one state to another. Dosage and Administration Administration The potential benefits and risks of diclofenac therapy deaths well as alternative therapies should be considered prior to initiating diclofenac therapy.
In addition, NSAIAs may interfere with the natriuretic response to diuretics voltaren activity that depends in part on prostaglandin-mediated alterations in renal blood flow e. Diclofenac voltaren not a substitute for corticosteroid therapy, and the drug is not eliquis in the management of adrenal deaths. Voltaren Diclofenac is prescription medication used to treat pain and inflammation and stiffness and swelling associated with osteoarthritis or rheumatoid arthritis as well as pain after eye surgery.
Cautions Adverse reactions to voltaren diclofenac are usually mild and transient and mainly involve the upper GI tract; however, adverse effects may be severe enough to require discontinuance of the drug in about 1. Examples of these blood pressure drugs include: angiotensin-converting enzyme ACE inhibitors, such as benazepril, captopril, enalapril, and lisinopril angiotensin II receptor blockers, such as candesartan, irbesartan, losartan, and olmesartan beta-blockers, such as acebutolol, atenolol, metoprolol, and propranolol diuretics water pillssuch as furosemide and hydrochlorothiazide Cancer drug Using the cancer drug pemetrexed with diclofenac may and the effects of pemetrexed.
When the gel is used for the management of upper extremity i. Therefore, clinicians should remain alert to the possible development of serious GI effects e. Juvenile Arthritis Diclofenac has been used orally with good visit web page in a number of children for the management of juvenile rheumatoid arthritis.
Skin infection developed in one individual after the diclofenac system that had been voltaren to the foot was subjected to prolonged voltaren to wetness. Diclofenac and deaths should be used concomitantly with caution. Lactation Because of the potential for serious adverse reactions to diclofenac in nursing infants, a decision should and made whether to discontinue nursing or the drug, taking into account the importance of the drug html the woman.
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Sep 14, · Voltaren Gel Patient Information at www.medic8.com Voltaren Gel Information for Consumers; Voltaren Gel Information for Healthcare Professionals (includes dosage details) Side Effects of Voltaren Gel (detailed) Search this Group.
Search. Latest News. ACP, AAFP Issue Guidelines for Acute Musculoskeletal Injuries.
Diclofenac epolamine is administered by topical application of a transdermal system. Patients receiving diclofenac epolamine transdermal system Flector should be instructed in the use of the system and given a copy of the patient information provided by the manufacturer.
The transdermal system should be applied to the most painful area twice daily. The system should be applied to intact skin only; application to damaged skin e.
Hands should be washed after handling the system. Contact with the eyes and mucous membranes should be avoided. The transdermal system should not be worn while bathing or showering. If a system should begin to peel off during the period of use, the edges of the system may be taped to the skin.
Dosage The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed. Dosage of diclofenac must be carefully adjusted according to individual requirements and response, using the lowest possible effective dosage.
Based on safety reviews conducted to evaluate available data on cardiovascular risk of diclofenac, some authorities e. See Cautions: Cardiovascular Effects. Commercially available diclofenac sodium enteric-coated tablets Voltaren , diclofenac sodium extended-release tablets Voltaren-XR , and diclofenac potassium conventional tablets Cataflam are not necessarily bioequivalent on a mg per mg basis.
Inflammatory Diseases Based on safety reviews conducted to evaluate cardiovascular risk of diclofenac, some authorities e. Rheumatoid Arthritis and Osteoarthritis For the symptomatic treatment of acute or chronic rheumatoid arthritis, the usual initial adult dosage of diclofenac sodium delayed-release enteric-coated tablets or diclofenac potassium conventional tablets is mg daily, administered in divided doses of 75 mg diclofenac sodium delayed-release [enteric-coated] tablets only twice daily or 50 mg diclofenac sodium delayed-release [enteric-coated] tablets or diclofenac potassium conventional tablets 3 or 4 times daily.
For the management of rheumatoid arthritis, the usual initial adult dosage of diclofenac sodium extended-release tablets is mg daily. If dosage increase is necessary in patients receiving diclofenac sodium mg daily as extended-release tablets, dosage can be increased to mg twice daily.
When diclofenac is used in fixed combination with misoprostol for the symptomatic treatment of chronic rheumatoid arthritis, the usual dosage is 50 mg of diclofenac sodium 3 or 4 times daily. Dosage may be changed to 50 or 75 mg of diclofenac sodium twice daily in patients who do not tolerate the usual dosage; however, these dosages may be less effective in preventing NSAIA-induced ulcers.
When therapy with diclofenac and misoprostol is required for the treatment of chronic rheumatoid arthritis, the commercially available combination of diclofenac in fixed combination with misoprostol should not be used for initial therapy. Instead, dosage should first be adjusted by administering each drug separately. If it is determined that the optimum maintenance dosage corresponds to the ratio in the commercial combination preparation, the fixed combination may be used. If clinically indicated, supplemental doses of misoprostol or diclofenac as the individual component can be administered with the fixed combination.
For the symptomatic treatment of osteoarthritis, the usual adult dosage of diclofenac sodium delayed-release enteric-coated tablets or diclofenac potassium conventional tablets is mg daily, administered in divided doses of 75 mg diclofenac sodium delayed-release [enteric-coated] tablets only twice daily or 50 mg diclofenac sodium delayed-release [enteric-coated] tablets or diclofenac potassium conventional tablets 2 or 3 times daily.
For the management of osteoarthritis, the recommended adult dosage of diclofenac sodium extended-release tablets is mg daily. When diclofenac is used in fixed combination with misoprostol for the symptomatic treatment of osteoarthritis, the usual dosage is 50 mg of diclofenac sodium 3 times daily. When therapy with diclofenac and misoprostol is required for the treatment of osteoarthritis, the commercially available combination of diclofenac in fixed combination with misoprostol should not be used for initial therapy.
When the gel is used for the management of upper extremity i. The total daily dose applied to all affected joints should not exceed 32 g of gel, with no more than 16 g of gel applied daily to any single lower extremity joint and no more than 8 g of gel applied daily to any single upper extremity joint. Ankylosing Spondylitis For the symptomatic treatment of ankylosing spondylitis, the usual adult dosage of diclofenac sodium delayed-release enteric-coated tablets is mg daily, administered in divided doses of 25 mg 4 or 5 times daily.
When diclofenac potassium is used for the management of ankylosing spondylitis, a dosage of 50 mg twice daily has been suggested by the manufacturers.
Pain and Dysmenorrhea When diclofenac potassium conventional tablets are used for relief of pain or primary dysmenorrhea, an initial dose of 50 mg is recommended, followed by 50 mg every 8 hours as needed; some patients may benefit from an initial dose of mg, followed by 50 mg every 8 hours as needed. When diclofenac epolamine transdermal system Flector is used for relief of acute pain due to strains, sprains, and contusions, one system is applied to the most painful area twice daily.
Dosage in Renal or Hepatic Impairment Diclofenac dosage reductions do not appear to be necessary in patients with renal impairment. However, patients with substantially impaired renal function should be monitored closely during diclofenac therapy, because of potential risks of NSAIA therapy in such patients. Reduction of oral diclofenac dosage may be necessary in patients with hepatic impairment. Cautions Adverse reactions to oral diclofenac are usually mild and transient and mainly involve the upper GI tract; however, adverse effects may be severe enough to require discontinuance of the drug in about 1.
Most diclofenac-induced adverse effects occur during the first months of treatment. The relationship of the frequency of adverse effects to dosage remains to be established. Overall, the frequency and nature of adverse effects produced by diclofenac sodium delayed-release enteric-coated tablets, diclofenac potassium conventional tablets, and ibuprofen appear to be similar.
Adverse cardiovascular effects reported occasionally in diclofenac-treated patients include congestive heart failure, hypertension, tachycardia, and syncope. Arrhythmia, myocardial infarction, chest pain, palpitations, vasculitis, thrombophlebitis, hypotension, angina-like attack, and circulatory shock or distress have occurred rarely.
Nonsteroidal anti-inflammatory agents NSAIAs , including selective cyclooxygenase-2 COX-2 inhibitors and prototypical NSAIAs, increase the risk of serious adverse cardiovascular thrombotic events, including myocardial infarction and stroke which can be fatal , in patients with or without cardiovascular disease or risk factors for cardiovascular disease. The association between cardiovascular complications and use of NSAIAs is an area of ongoing concern and study. Available data suggest that the increase in risk may occur early within the first weeks following initiation of therapy and may increase with higher dosages and longer durations of use.
Although the relative increase in cardiovascular risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk. Results from observational studies utilizing Danish national registry data indicated that patients receiving NSAIAs following a myocardial infarction were at increased risk of reinfarction, cardiovascular-related death, and all-cause mortality beginning in the first week of treatment.
Although the absolute mortality rate declined somewhat after the first year following the myocardial infarction, the increased relative risk of death in patients who received NSAIAs persisted over at least the next 4 years of follow-up. In 2 large controlled clinical trials of a selective COX-2 inhibitor for the management of pain in the first days following coronary artery bypass graft CABG surgery, the incidence of myocardial infarction and stroke was increased.
Findings from some systematic reviews of controlled observational studies and meta-analyses of data from randomized studies of NSAIAs suggest that naproxen may be associated with a lower risk of cardiovascular thrombotic events compared with other NSAIAs. However, limitations of these observational studies and the indirect comparisons used to assess cardiovascular risk of the prototypical NSAIAs e. Findings from some of these meta-analyses and systematic reviews also suggest that the cardiovascular risk associated with diclofenac, particularly at higher dosages e.
Some authorities e. See Dosage and Administration: Dosage. Data from observational studies also indicate that use of NSAIAs in patients with heart failure is associated with increased morbidity and mortality. Results from a retrospective study utilizing Danish national registry data indicated that use of selective COX-2 inhibitors or prototypical NSAIAs in patients with chronic heart failure was associated with a dose-dependent increase in the risk of death and an increased risk of hospitalization for myocardial infarction or heart failure.
In addition, findings from a meta-analysis of published and unpublished data from randomized controlled trials of NSAIAs indicated that use of selective COX-2 inhibitors or prototypical NSAIAs was associated with an approximate twofold increase in the risk of hospitalization for heart failure.
There is no consistent evidence that use of low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs. There is some evidence that the incidence of diclofenac-induced peptic ulcers and gastric lesions may be reduced with concomitant use of an appropriate ulcer preventive regimen.
Esophagitis, gastritis, glossitis, stomatitis, aphthous stomatitis, changes in appetite, dry mouth and mucous membranes, pancreatitis with or without hepatitis , thirst, colitis, ulceration of the colon, and distress have occurred during diclofenac therapy. The incidence of abdominal pain, diarrhea, and other GI symptoms may be higher in patients receiving diclofenac in fixed combination with misoprostol than in patients receiving diclofenac without misoprostol.
Usual oral dosages of diclofenac sodium reportedly produce fewer adverse GI effects than usual anti-inflammatory dosages of aspirin or naproxen. In healthy individuals, GI bleeding as determined by fecal blood loss was less in individuals receiving mg of diclofenac sodium daily than in those receiving , , or mg of aspirin, naproxen, or indomethacin daily, respectively, for 3 weeks. In healthy adults, the frequency of GI mucosal lesions observed with endoscopic examination was lower with diclofenac than with naproxen.
However, the clinical importance of these findings is not known since currently there is no evidence to indicate that diclofenac is less likely to produce serious GI lesions during chronic therapy than other prototypical NSAIAs.
Serious adverse GI effects e. Minor upper GI effects e. Therefore, clinicians should remain alert to the possible development of serious GI effects e. In addition, patients should be advised about the signs and symptoms of serious NSAIA-induced GI toxicity and what action to take if they occur.
If signs and symptoms of a serious GI event develop, additional evaluation and treatment should be initiated promptly; the NSAIA should be discontinued until appropriate diagnostic studies have ruled out a serious GI event. However, short-term therapy is not without risk.
Therefore, whenever use of relatively high dosages within the recommended dosage range is considered, sufficient benefit to offset the potential increased risk of GI toxicity should be anticipated. In addition to a history of ulcer disease, pharmacoepidemiologic studies have identified several comorbid conditions and concomitant therapies that may increase the risk for GI bleeding, including concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIA therapy, smoking, alcoholism, older age, and poor general health status.
Patients with rheumatoid arthritis are more likely to experience serious GI complications from NSAIA therapy than are patients with osteoarthritis. In addition, geriatric or debilitated patients appear to tolerate GI ulceration and bleeding less well than other individuals, and most spontaneous reports of fatal GI effects have been in such patients. Alternatively, some clinicians suggest that a proton-pump inhibitor e. In one study, therapy with high dosages of famotidine 40 mg twice daily was more effective than placebo in preventing peptic ulcers in NSAIA-treated patients; however, the effect of the drug was modest.
In addition, efficacy of usual dosages of H2-receptor antagonists for the prevention of NSAIA-induced gastric and duodenal ulcers has not been established. Therefore, most clinicians do not recommend use of H2-receptor antagonists for the prevention of NSAIA-associated ulcers.
However, while celecoxib mg twice daily was comparably effective to diclofenac sodium 75 mg twice daily plus omeprazole 20 mg daily in preventing recurrent ulcer bleeding recurrent ulcer bleeding probabilities of 4. Additional study is necessary to elucidate optimal therapy for preventing GI complications associated with NSAIA therapy in high-risk patients. Anxiety, asthenia, confusion, depression, abnormal dreams, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, irritability, and vertigo have occurred occasionally in patients receiving the drug.
Tingling sensation, dreams, myoclonus, and migraine have occurred rarely. Although a causal relationship to diclofenac has not been established, seizures, coma, hallucinations, and meningitis have been reported during therapy with the drug. Renal, Electrolyte, and Genitourinary Effects Diclofenac has caused impairment of renal function, resulting in acute renal failure, interstitial nephritis, nephrotic syndrome, increased BUN and serum creatinine concentrations, and renal papillary necrosis in patients receiving the drug.
In at least one patient receiving oral diclofenac, acute renal failure became chronic. Urinary tract infection, renal calculi, and hyponatremia have occurred rarely. Hepatic Effects Severe, sometimes fatal, hepatic reactions, including jaundice and fulminant hepatitis, liver necrosis, cholestasis, hepatic failure, asymptomatic hepatitis, acute hepatitis, and chronic active hepatitis, have been reported rarely in patients receiving diclofenac. Borderline 1.
Liver function abnormalities associated with NSAIA therapy may progress, may remain essentially unchanged, or may be transient with continued therapy. Increased serum concentrations of bilirubin have been reported rarely in patients receiving diclofenac therapy. Misoprostol does not appear to exacerbate hepatic effects e. Diclofenac should be discontinued if signs or symptoms of a severe hepatic reaction occur. Other adverse dermatologic reactions, including alopecia, photosensitivity, and excessive perspiration, have occurred occasionally.
Bullous eruption, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, urticaria, and angioedema, have occurred rarely. Sensitivity reactions, including anaphylaxis; swelling of the eyelids, tongue, lips, pharynx, or larynx; urticaria; asthma; bronchospasm; laryngeal edema; dyspnea; chest tightness; wheezing; anaphylactoid reactions; eosinophilic pneumonitis and angioedema, sometimes with concomitant, potentially severe hypotension, have been reported in patients receiving diclofenac.
Application site pruritus, erythema, paresthesia, dryness, vesicles, irritation, or papules also have occurred in patients receiving diclofenac gel. Application site reactions i. Rash also has been reported in patients receiving diclofenac epolamine transdermal system.
Skin infection developed in one individual after the diclofenac system that had been applied to the foot was subjected to prolonged exposure to wetness. Edema and abnormal sensation at the treated site and allergic skin reactions also have been reported.
Adverse ocular effects including blurred vision and conjunctivitis and hearing impairment have occurred in diclofenac-treated patients. Leukopenia, thrombocytopenia, purpura, ecchymosis, eosinophilia, melena, and rectal bleeding have occurred occasionally in patients receiving diclofenac.
Agranulocytosis, lymphadenopathy, hemolytic anemia, aplastic anemia, and pancytopenia have been reported rarely in diclofenac-treated patients. Bruising in the extremities and abdomen, spontaneous bleeding, and hematoma formation also have been reported rarely in patients receiving the drug.
Diclofenac may inhibit platelet aggregation and prolong bleeding time. Diclofenac usually does not affect platelet count, prothrombin time, partial thromboplastin time, or thrombin time. Respiratory Effects Asthma or dyspnea has been reported occasionally in patients receiving diclofenac.
Respiratory tract infection e. Other Adverse Effects Fever, infection, and sepsis have occurred in patients receiving diclofenac.
Back, leg, or joint pain and hyperglycemia have occurred rarely. Although a causal relationship to diclofenac has not been established, weight changes have occurred in patients receiving the drug. Precautions and Contraindications Multiple diclofenac-containing preparations should not be used concomitantly.
When diclofenac sodium is used in fixed combination with misoprostol, the cautions, precautions, and contraindications associated with misoprostol must be considered in addition to those associated with diclofenac. Patients should be advised that diclofenac, like other NSAIAs, is not free of potential adverse effects, including some that can cause discomfort, and that more serious effects e.
Patients also should be informed that, while NSAIAs may be commonly employed for conditions that are less serious, NSAIA therapy often is considered essential for the management of some diseases, and the drugs have a major role in the management of pain. Clinicians may wish to discuss with their patients the potential risks and likely benefits of NSAIA therapy, particularly when consideration is being given to use of these drugs in less serious conditions for which therapy without an NSAIA may represent an acceptable alternative to both the patient and clinician.
Patients should be advised to read the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed. NSAIAs increase the risk of serious adverse cardiovascular thrombotic events. To minimize the potential risk of adverse cardiovascular events, the lowest effective dosage and shortest possible duration of therapy should be employed.
Some clinicians suggest that it may be prudent to avoid use of NSAIAs whenever possible in patients with cardiovascular disease. Patients receiving NSAIAs including those without previous symptoms of cardiovascular disease should be monitored for the possible development of cardiovascular events throughout therapy. Patients should be informed about the signs and symptoms of serious cardiovascular toxicity chest pain, dyspnea, weakness, slurring of speech and instructed to seek immediate medical attention if such toxicity occurs.
Diclofenac should be avoided in patients with recent myocardial infarction unless the benefits of therapy are expected to outweigh the risk of recurrent cardiovascular thrombotic events; if diclofenac is used in such patients, the patient should be monitored for cardiac ischemia. There is no consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs. Because of the potential for increased adverse effects, patients receiving diclofenac should be advised not to take aspirin.
Use of NSAIAs can result in the onset of hypertension or worsening of preexisting hypertension; either of these occurrences may contribute to the increased incidence of cardiovascular events. NSAIAs should be used with caution in patients with hypertension.
Blood pressure should be monitored closely during initiation of NSAIA therapy and throughout therapy. Because NSAIAs increase morbidity and mortality in patients with heart failure, the manufacturer states that diclofenac should be avoided in patients with severe heart failure unless the benefits of therapy are expected to outweigh the risk of worsening heart failure; if diclofenac is used in such patients, the patient should be monitored for worsening heart failure.
Some experts state that use of NSAIAs should be avoided whenever possible in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure. Patients receiving NSAIAs should be advised to inform their clinician if they experience symptoms of heart failure, including dyspnea, unexplained weight gain, and edema.
Use of NSAIAs may diminish the cardiovascular effects of certain drugs used to treat heart failure and edema e. See Drug Interactions. The risk of potentially serious adverse GI effects should be considered in patients receiving diclofenac, particularly in patients receiving chronic therapy with the drug. See Cautions: GI Effects. Diclofenac should be used with caution and under close supervision in patients with a history of GI disease.
Diclofenac should be used with extreme caution and under close supervision in patients with a history of GI bleeding or peptic ulceration, and such patients should receive an appropriate ulcer preventive regimen. All patients considered at increased risk of potentially serious adverse GI effects e. To minimize the potential risk of adverse GI effects, the lowest effective dosage and shortest possible duration of therapy should be employed.
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