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In all patients: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.
Sodium: 275 mg tablet of naproxen contains approximately 25.06 mg of sodium. This should be considered in patients whose overall intake of sodium should be markedly restricted.
Fertility: The use of naproxen, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation of infertility, withdrawal of naproxen should be considered.
Antipyretic effects: The antipyretic and anti-inflammatory activities of naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.
Respiratory disorder: Caution is required if administered to patients suffering from or with a previous history of bronchial asthma or allergic disease, since NSAIDs have been reported to precipitate bronchospasm in such patients.
Renal failure linked to reduced prostaglandin production: Caution should be observed in patients with conditions leading to a reduction in blood volume and/or renal blood flow as renal prostaglandins have a supportive role in the maintenance of renal perfusion. The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and the elderly. Discontinuation of naproxen is usually followed by recovery to the pretreatment state. Naproxen should be used with great caution in such patients and the monitoring of serum creatinine and/or creatinine clearance is advised and patients should be adequately hydrated. A reduction in the daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in patients. Renal function should also be assessed before and during naproxen therapy.
Use in patients with impaired renal function: Naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, therefore, it should be used with great caution in patients with significantly impaired renal function because naproxen is an inhibitor of prostaglandin synthesis. Naproxen is not recommended in patients with baseline creatinine less than 30 ml/min because accumulation has been seen in such patients. Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding.
Renal Effects: There have been reports of impaired renal function, renal failure, acute interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen.
Use in patients with impaired liver function: Chronic alcoholic liver disease and probably other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. It is prudent to use the lowest effective dose. As with other NSAIDs, elevations of one or more liver function tests may occur. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis (some cases of hepatitis have been fatal), have been reported with this drug as with other NSAIDs. Cross reactivity has been reported.
Use in patients with cardiovascular impairment: Caution should be exercised in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking naproxen. Peripheral oedema has been observed in some patients taking naproxen or other NSAIDs.
SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis.
Haematological: Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen-containing products are administered. Patients at high risk of bleeding or those on full anticoagulation therapies (e.g. dicoumarol derivatives) may be at increased risk of bleeding if given naproxen-containing products concurrently. Naproxen decreases platelet aggression and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Anaphylactic (anaphylactoid) reactions: Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other NSAIDs or naproxen-containing products. They may also occur in individuals with a history of angio-oedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome. Bronchospasm may be precipitated in patients suffering from, or with a history of asthma or allergic disease or aspirin sensitivity.
Steroids: If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
Combination with other NSAIDs: The combination of naproxen-containing products and other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided because of the cumulative risks of inducing serious NSAID-related adverse events.
Contains lactose: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Cardiovascular and cerebrovascular events: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. The use of coxibs and some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke). Although data suggest that the use of naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking).
Hypertension: NSAIDs may lead to the onset of new hypertension or worsening pre-existing hypertension and patients taking antihypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.
Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Debilitated patients seem to tolerate ulceration or bleeding less well than others. Most of the fatal gastrointestinal events associated with NSAIDs occurred in the elderly and/or debilitated patients. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. Naproxen has been found to be well tolerated by patients exhibiting dyspepsia with other similar agents. Nonetheless, episodes of gastrointestinal bleeding have been reported in patients with naproxen therapy. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications, which could increase the risk of ulceration or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. When GI bleeding or ulceration occurs in patients receiving naproxen, the treatment should be withdrawn. Naproxen should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. In patients with a history of gastrointestinal disease, naproxen should be given under close supervision. As with other NSAIDs, the incidence and severity of gastrointestinal complications may increase with increasing dose and duration of treatment with naproxen.
Severe Skin Reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reactions occurring in the majority of cases within the first month of treatment. Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Effects on Ability to Drive and Use Machines: Some patients may experience dizziness, drowsiness, vertigo, insomnia, fatigue and visual disturbances or depression with the use of naproxen sodium. If patients experience these or similar undesirable effects, they should not drive or operate machinery and exercise caution in carrying out activities that require alertness.
Use in the Elderly: The elderly and/or debilitated patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Prolonged use of NSAIDs in these patients is not recommended. Where prolonged therapy is required, patients should be reviewed regularly. In elderly patients, the clearance is reduced. Use of lower end of the dosage range is recommended.
