Adverse effects can be minimized by using the lowest effective dose for the shortest time necessary to control symptoms and gastrointestinal and cardiovascular risks.
Aceclofenac should be avoided when used with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Respiratory Disorders: Caution should be exercised when administering to patients with respiratory diseases or a history of bronchial asthma, as NSAIDs have been reported to reduce bronchial constriction in these patients.
Cardiovascular, Renal, and Hepatic Impairment: The use of NSAIDs may cause dose-dependent reductions in prostaglandin formation and lead to renal failure. Patients at the highest risk for this reaction include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics, those recovering from major surgery, and the elderly. The importance of prostaglandins in maintaining renal blood flow should be considered in these patients. Renal function should be monitored in these patients.
Renal Impairment: Patients with mild to moderate renal impairment should be monitored, as NSAID use can lead to further decline in kidney function. The lowest effective dose should be used, and renal function should be monitored regularly. Renal function impairment is usually reversible upon withdrawal of Aceclofenac.
Hepatic Impairment: If abnormal liver function test results persist or worsen, clinical signs or symptoms consistent with liver disease develop, or other manifestations occur (such as eosinophilia or rash), Aceclofenac should be discontinued. Close medical monitoring is necessary for patients with mild to moderate liver impairment. Hepatitis may occur without prodromal symptoms.
The use of Aceclofenac in patients with hepatic metabolic disorders may trigger certain attacks.
Cardiovascular Thrombotic Risk: Non-steroidal anti-inflammatory drugs (NSAIDs), other than aspirin, when taken systemically, can increase the risk of cardiovascular thrombotic events, including heart attack and stroke, which can be fatal. This risk may occur early, within the first few weeks of use, and may increase with prolonged use. The cardiovascular thrombotic risk is primarily associated with high doses.
Doctors should periodically assess for cardiovascular events, even if the patient has no prior cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and should seek medical attention immediately if these symptoms occur.
To minimize the risk of adverse events, LEFGEN should be used at the lowest effective daily dose for the shortest duration necessary.
Careful consideration should be given when using diclofenac in patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes, or smoking).
Gastrointestinal Bleeding, Ulceration, and Perforation: Caution is needed when using the medication in patients with gastrointestinal diseases, such as ulcerative colitis, Crohn's disease, blood abnormalities, or liver porphyria.
Skin Reactions: Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely with NSAID use. Patients appear to be at the highest risk for these reactions early in treatment, with the majority of these reactions occurring within the first month of treatment. Aceclofenac should be discontinued if a rash, mucosal lesions, or signs of hypersensitivity occur.
Caution should be exercised when using Aceclofenac in breastfeeding women, as it may be present in breast milk at very low concentrations.
Side effects such as dizziness, drowsiness, fatigue, or visual disturbances may occur.
Effect of the Drug on the Ability to Drive and Operate Machinery: Caution should be exercised when driving or operating machinery.
Use in the Elderly: Elderly individuals are at higher risk of increased adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.