Nabumetone precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
List of precautions
Renal Effects
Hepatic Function
Fluid Retention and Edema
Photosensitivity
Renal Effects
As a class, NSAIDs have been associated with renal papillary necrosis and
other abnormal renal pathology during long-term administration to animals.
A second form of renal toxicity often associated with NSAIDs is seen in patients with
conditions leading to a reduction in renal blood flow or blood volume, where renal prostaglandins have
a supportive role in the maintenance of renal perfusion. In these patients, administration of an NSAID
results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in a reduction of renal
blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction
are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the
elderly. Discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state.
Hepatic Function
As with other NSAIDs, borderline elevations of 1 or more liver function
tests may occur in up to 15% of patients. These abnormalities may progress, may remain essentially
unchanged, or may return to normal with continued therapy. The ALT (SGPT) test is probably the
most sensitive indicator of liver dysfunction. Meaningful (3 times the upper limit of normal) elevations
of ALT (SGPT) or AST (SGOT) have occurred in controlled clinical trials of RELAFEN in less than
1% of patients. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an
abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe
hepatic reaction while on therapy with RELAFEN. Severe hepatic reactions, including jaundice and
fatal hepatitis, have been reported with RELAFEN and other NSAIDs. Although such reactions are
rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver
disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), RELAFEN should
be discontinued.
Fluid Retention and Edema
Fluid retention and edema have been observed in some
patients taking RELAFEN; therefore, as with other NSAIDs, RELAFEN should be used cautiously in patients with a history of congestive heart failure, hypertension, or other conditions predisposing to
fluid retention
Photosensitivity
Based on ultraviolet (U.V.) light photosensitivity testing, RELAFEN may
be associated with more reactions to sun exposure than might be expected based on skin tanning types.
Adapted from the FDA Package Insert.