Pregnancy In late pregnancy, as with other NSAIDs, diclofenac sodium should be avoided because it may cause premature closure of the ductus arteriosus. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of diclofenac sodium in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.
Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Diclofenac sodium, like other NSAIDs, can cause GI discomfort and, rarely, more serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death.
Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.
Risk of Ulceration, Bleeding, and Perforation. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and bulers, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms.
Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians. Patients should be informed of the warning signs and symptoms of hepatotoxicity e. If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
Patients should be informed of the signs of an anaphylactoid reaction e. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Gastrointestinal Bleeding, Ulceration, And Perforation NSAIDs, including diclofenac, cause serious gastrointestinal GI adverse events including inflammation, bleeding, ulceration , and perforation of the esophagus , stomach, small intestine , or large intestine , which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. However, even short-term therapy is not without risk. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy, concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors SSRIs ;, smoking, use of alcohol, older age, and poor general health status.
Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Use the lowest effective dosage for the shortest possible duration. Avoid administration of more than one NSAID at a time Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. Hepatotoxicity In clinical trials of diclofenac- containing products, meaningful elevations i. In a large, open-label, controlled trial of 3, patients treated with oral diclofenac sodium for months, patients were monitored first at 8 weeks and 1, patients were monitored again at 24 weeks.
Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis. Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac.
Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis , jaundice , fulminant hepatitis with and without jaundice, and liver failure.
Some of these reported cases resulted in fatalities or liver transplantation. In a European retrospective population-based, case-controlled study, 10 cases of diclofenac associated drug-induced liver injury with current use compared with non-use of diclofenac were associated with a statistically significant 4-fold adjusted odds ratio of liver injury.
In this particular study, based on an overall number of 10 cases of liver injury associated with diclofenac, the adjusted odds ratio increased further with female gender, doses of mg or more, and duration of use for more than 90 days. Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms.
The optimum times for making the first and subsequent transaminase measurements are not known. Do you have any suggestions? Your question regards problems with constipation while using diclofenac Cataflam. Diclofenac is an NSAID nonsteroidal anti-inflammatory drug, and there are many medications available in this class of medications.
Sometimes one medication will work better than a different medication or have fewer side effects. Please talk to your health care provider regarding trying a different medication to treat your arthritis pain. Jen Marsico, RPh Q: Diclofenac is a medication in the NSAID family of drugs that is used to treat pain caused by inflammation. Diclofenac is used to treat a variety of conditions including arthritis, migraines, and joint pain. The prescribing information on diclofenac lists the following as the most common side effects of the medication: Some side effects that you should report to your physician include: Lori Poulin, PharmD Q: Arthrotrec is known for weight gain due to fluid retention and renal difficulties.
Should I consult a doctor for a diuretic to lose excess fluid weight? Arthrotec is a combination of diclofenac and misoprostol. Diclofenac belongs to the group of drugs known as nonsteroidal anti-inflammatory drug NSAIDs and has analgesic and anti-inflammatory effects.
Misoprostol is a gastrointestinal protective agent that is used in combination with NSAIDs to reduce the risk of stomach or intestinal ulcers. Arthrotec is used for the treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients who are at high risk of developing a stomach or intestinal ulcer with NSAID therapy. Patients who have had a stomach ulcer or gastrointestinal bleeding are at 10 times greater risk of having gastrointestinal bleeding when taking a NSAID.
Other factors that increase the risk of gastrointestinal bleeding in patients taking NSAIDs include use of oral corticosteroids or blood thinners, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. The most common side effects of Arthrotec are abdominal pain, diarrhea, upset stomach, nausea, and gas. Patients should be aware of the signs and symptoms of these possible conditions, including chest pain, shortness of breath, weakness, slurring of speech, swelling, unexplained weight gain, nausea, fatigue, itching, yellowing of the skin or eyes, or right upper quadrant tenderness.
If you develop these signs or symptoms, please consult with your health care provider for guidance based on your health status and current medications, particularly before taking any action.
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