Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Azulfidine EN-tabs have been approved for the treatment of
rheumatoid arthritis (RA) in patients who have responded
inadequately to or are intolerant of analgesics or other
non-steroidal anti-inflammatory drugs (NSAIDs). Azulfidine EN-tabs
are enteric-coated to reduce stomach absorption and minimize
Available by prescription only, Azulfidine EN-tabs are
administered daily in evenly divided doses (2-3) totaling two grams
and are recommended for use in concurrent treatment with analgesics
and/or other NSAIDs, at least until effects are apparent.
In clinical trials, the effects of Azulfidine EN-tabs were
measured by the degree of improvement in the number and extent of
actively inflamed joints. Subject response to Azulfidine EN-tabs in
clinical trials were observed in some subjects as early as four
weeks after starting treatment, but 12 weeks may be required in
some subjects before clinical benefit is noted.
The most common adverse reactions associated with Azulfidine
EN-tabs are anorexia, headache, nausea, vomiting, gastric distress,
and reversible low sperm count. These side effects occur in
one-third of subjects. Additionally, skin rash was reported by 13%
of subjects in RA trials. The medication is contraindicated in
pediatric subjects under two years of age, subjects with intestinal
or urinary obstruction, subjects with porphyria (group of disorders
associated with a lack of porphyins) and subjects hypersensitive to
sulfasalazine, its metabolites, sulfonamides or salicylates.
Complete blood counts and urinalysis should be done frequently in
subjects taking Azulfidine EN-tabs.
Rheumatoid arthritis, one of the more common forms of arthritis
is a chronic, systemic, inflammatory autoimmune disorder of unknown
etiology. RA causes inflammation in the lining of the joints and
other internal organs; destruction of cartilage, bone, tendons, and
ligaments can follow. It affects approximately 1% of the U.S.
population (2.5 million).
Disease onset occurs most often between the ages of 40 and 60
with 91% of patients older than 40. More than 60% of RA patients
are women. With Americans living longer, RA is an important medical
condition that is growing in magnitude.
According to 1996 clinical guidelines issued by the American
College of Rheumatology (ACR), subjects with active RA have a 70%
probability of developing joint damage or erosions within two years
of disease onset. While NSAIDs are a common first step in
alleviating symptoms of RA, joint damage may occur and progress.
Therefore, many subjects will require second-line therapy if
response to salicylates and other non-steroidal anti-inflammatory
drugs is inadequate.