Melox Special Precautions





Full Prescribing Info
Special Precautions
Before initiating therapy with meloxicam in patients with a history of oesophagitis, gastritis or peptic ulcer, freedom from these conditions must be established. Routine attention should be given to the possibility of recurrence of these conditions in meloxicam-treated patients with a history of these conditions.
Monitoring for digestive disturbances, particularly gastrointestinal bleeding, should be done in patients with gastrointestinal symptoms, or a history of gastrointestinal disease.
In common with other NSAIDs, gastrointestinal bleeding, or ulceration and/or perforation, has been reported with meloxicam at any stage of treatment, in rare instances resulting in fatalities. These events can occur with or without any warning symptoms, and in patients with or without a previous history of serious gastrointestinal events. The elderly generally experience more serious consequences of gastrointestinal bleeding or ulceration and/or perforation.
In the rare instances where gastrointestinal bleeding or ulceration occurs in patients on meloxicam therapy, the drug should be withdrawn promptly.
In the event of severe cutaneous or mucosal adverse effects occurring, meloxicam withdrawal must be considered. The possible occurrence of severe skin reactions and hypersensitivity reaction that are severe and life-threatening is known to occur with NSAIDs, including oxicams.
NSAIDs may cause glomerulonephritis, interstitial nephritis, nephritic syndrome or renal medullary necrosis in rare cases.
In common with the majority of NSAIDs, there are occasional reports of increases in serum transaminase levels, serum bilirubin, other liver function parameters, serum creatinine and blood urea nitrogen, and other laboratory test disturbances. In most cases, these have been transitory and minor abnormalities. However, if such an abnormality be significant or persist, meloxicam should be withdrawn and appropriate clinical investigation performed.
NSAIDs may cause the retention of sodium, potassium and water, and may interfere with the natriuretic effects of diuretics. This may result in consequential exacerbation of the condition of patients with cardiac insufficiency or hypertension.
In patients with decreased renal blood flow and blood volume, synthesis of renal prostaglandins responsible for maintenance of renal perfusion may be inhibited by NSAIDs. Administration of NSAIDs in such patients may cause the decompensation of latent renal failure, although renal function reverts to original status following therapy withdrawal. This risk affects all elderly patients, patients with congestive heart failure, cirrhosis, nephritic syndrome or renal failure. Patients who have undergone major surgery resulting in hypovolaemia, or on diuretic therapy are similarly affected. Diuresis and renal function should be carefully monitored during meloxicam therapy (see Dosage & Administration).
Daily dosage recommendations should not be exceeded if there is inadequate therapeutic efficacy.
Additional NSAIDs should not be added to the dosage regimen as toxicity may be increased, and therapeutic efficacy has not been demonstrated.
Effects on the Ability to Drive or Operate Machinery: Patients may experience drowsiness, vertigo, visual disturbances and other central nervous system disturbances during meloxicam therapy (see Adverse Reactions). Patients should be cautioned as to the possibility of such effects and advised not to drive or operate machinery if such disturbances occur.
Use in pregnancy: Lethal effects on the foetus have been reported in animal studies using doses higher than those administered clinically. It is recommended that the use of meloxicam be avoided during pregnancy. In the final trimester of pregnancy, the use of any prostaglandin synthesis inhibitor may result in foetal cardiopulmonary toxicity, pulmonary hypertension and premature closure of the ductus arteriosus, and renal toxicity. Uterine contraction may also be inhibited and in animals, this has been associated with dystocia incidence elevation and delayed parturition. Meloxicam, in common with all NSAIDs, is absolutely contraindicated during the final trimester of pregnancy.
Use in lactation: NSAIDs are excreted in maternal breast milk, therefore, administration should be avoided in women who are breastfeeding as a precaution.
Use in children: The safety and efficacy of meloxicam have not been established in children <15 years.
Use in the elderly: Elderly, fragile or weakened patients are often less tolerant of adverse effects and therefore, require careful monitoring during therapy. In common with other NSAIDs, particular caution should be exercised with the elderly, who frequently have impairment of cardiac, hepatic and renal functions.
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