sulfasalazine tablets, USP
AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure:
AZULFIDINE Tablets are indicated:
- a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
- b)for the prolongation of the remission period between acute attacks of ulcerative colitis.
Published Studies Related to Azulfidine (Sulfasalazine)
Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. [2011.06]
OBJECTIVE: Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an effective treatment in patients with ankylosing spondylitis (AS). Sulfasalazine is frequently used for the treatment of both axial symptoms and peripheral symptoms of AS, and it has been the recommended therapy before the use of an anti-TNF agent when peripheral arthritis is present. Until now, no clinical trial has compared the efficacy and safety of a TNF blocker with that of sulfasalazine. This study was undertaken to compare the efficacy and safety of etanercept with that of sulfasalazine after 16 weeks of treatment in patients with axial and peripheral manifestations of AS... CONCLUSION: In this population of patients with AS, etanercept was significantly more effective than sulfasalazine in improving the signs and symptoms of AS in the axial skeleton and peripheral joints. Copyright (c) 2011 by the American College of Rheumatology.
Effects of etanercept versus sulfasalazine in early axial spondyloarthritis on active inflammatory lesions as detected by whole-body MRI (ESTHER): a 48-week randomised controlled trial. [2011.04]
PURPOSE: To evaluate the potential of etanercept versus sulfasalazine to reduce active inflammatory lesions on whole-body MRI in active axial spondyloarthritis with a symptom duration of less than 5 years... CONCLUSION: In patients with early axial spondyloarthritis active inflammatory lesions detected by whole-body MRI improved significantly more in etanercept versus sulfasalazine-treated patients. This effect correlated with a good clinical response in the etanercept group.
Sulfasalazine and pentoxifylline in psoriasis: a possible safe alternative. [2011.02]
BACKGROUND: Conventional therapy of extensive psoriasis is effective but has complications. Biologics are safer but expensive. OBJECTIVE: To assess the efficacy of sulfasalazine and pentoxifylline, which have TNF antagonizing and anti-proliferative action in the treatment of psoriasis... CONCLUSION: Although incomparable to methotrexate, combined sulfasalazine and pentoxifylline produced a good response in cases of extensive psoriasis. Multicentre studies are needed to validate these results.
Clinical efficacy and safety of etanercept versus sulfasalazine in patients with
ankylosing spondylitis: a randomized, double-blind trial. 
peripheral manifestations of AS... CONCLUSION: In this population of patients with AS, etanercept was significantly
[Ozone therapy combined with sulfasalazine delivered via a colon therapy system for treatment of ulcerative colitis]. [2010.12]
OBJECTIVE: To assess the therapeutic effect of ozone therapy combined with sulfasalazine sulfasalazine delivered via a colon therapy system in the treatment of distal ulcerative colitis... CONCLUSION: Ozone therapy combined with sulfasalazine delivered via a colon therapy system is feasible and effective for treatment of ulcerative colitis.
Clinical Trials Related to Azulfidine (Sulfasalazine)
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis [Active, not recruiting]
The study has been designed as a 48-week, double-blind, randomized, controlled study
comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis [Recruiting]
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed
release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study
will fulfill the post approval commitment to the FDA.
Effects of Sulfasalazine on BOLD Response to Alcohol Cues [Recruiting]
The overarching objective of this pilot study is to apply both neuroimaging and
pharmacogenetic tools to the study of alcohol dependence. This proposed research will
provide a mechanistic test of the function of the genetic variation. The specific aims and
hypotheses are to test whether Sulfasalazine, as compared to placebo, diminishes
blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal
cortex (PFC). To test the hypothesis, we will compare Sulfasalazine treatment with placebo
treatment on BOLD difference maps for the contrast alcohol minus control. We will also
explore whether specific genetic variations influence this effect. A double-blind,
placebo-controlled 2 (Medication: Sulfasalazine 1500 mg vs. placebo control) x 2 (Cue:
Alcohol Cue vs. Control cue) within-subjects, crossover design will be used to test the
hypothesis that Sulfasalazine reduces the BOLD response in the striatum and prefrontal
cortex after exposure to alcohol cues. Twenty alcohol-dependent participants will complete
two rounds of the study medication followed by an fMRI scan, during which they will complete
an alcohol cue-exposure task. The order of the medication condition will be counterbalanced
such that subjects will be randomly assigned to receive either Sulfasalazine (1500 mg) in
the first session and placebo in the second session one week later (or vice versa). This
pilot study will help to determine whether NMDA receptors play a role in cue-elicited
activation of key areas of the brain implicated in the development and maintenance of
substance use disorders. Furthermore, if Sulfasalazine reduces cue-elicited activation of
these brain regions, as hypothesized; this study will lay the groundwork for a larger trial
on the efficacy of Sulfasalazine as a treatment for substance use disorders.
Combination Disease-Modifying Antirheumatic Drugs (DMARDs) Versus Sulfasalazine in Inflammatory Back Pain [Recruiting]
Till now no drug has been conclusively shown to affect the natural course of the
inflammatory back ache in seronegative spondylarthropathies. Non-steroidal anti-inflammatory
drugs (NSAIDS) have been the main stay of treatment for these diseases for long. Despite
providing good pain relief, they are largely ineffective in altering the natural course of
these diseases. However, very often, in spite of therapy, pain and discomfort continues in
these patients with recurrent exacerbations. Other drugs have been tried in these patients.
The DMARDS (Disease Modifying Anti Rheumatic Drugs) are a group of drugs which have come
into prominence following their remarkable efficacy in the management of Rheumatoid
Arthritis, another chronic inflammatory autoimmune arthritis. The major drugs which come in
this group are Methotrexate, Sulfasalazine, Hydroxychloroquine and Leflunomide. Of these
drugs, the most well studied drug in Spondylarthropathy is Sulfasalazine. Trials have shown
variable results of response of spondyloarthropathy to sulfasalazine. The other major DMARD
tried is methotrexate. Though large well controlled trials are lacking, the available data
on its efficacy in spondyloarthropathy has not been favorable. Leflunomide, the other major
DMARD has also fared poorly in a controlled trial in ankylosing spondylitis. There is at
present inadequate data regarding the efficacy of Hydroxychloroquine.
The discovery of anti TNF-α have been the major breakthrough in the management of ankylosing
spondylitis (AS) and Spondyloarthropathies (SpA). These drugs, besides providing symptomatic
improvement, also produce improvement in the indices of disease activity as Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI) and the Assessment of Spondylo-Arthritis
International Society (ASAS). Besides, the enormous cost, incurred at a rate of about Rs
700,000/- per annum, put it out of reach of the majority of affected population. Add to
these is the increased risk of tuberculosis and fungal infections, a major problem in India.
In this background there is severe and pressing need for alternate safe and effective drugs
in the management of these diseases. It is here that the combination DMARD therapy assumes
importance as a potential safe and cheaper alternative.
We aim to assess the efficacy of combination DMARD therapy in patients with early
inflammatory chronic backache in patients with sero negative spondyloarthropathies.
Sulfasalazine and Endothelial Function [Completed]
Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and
atherosclerosis. This study will examine the effects of the anti-inflammatory drug
sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will
be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period,
subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated
dilation of the brachial artery will be studied before and after each drug. We hypothesize
that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary
Reports of Suspected Azulfidine (Sulfasalazine) Side Effects
Drug Eruption (12),
Drug Rash With Eosinophilia and Systemic Symptoms (11),
Hepatic Function Abnormal (10),
Liver Disorder (10),
Histiocytosis Haematophagic (10),
Interstitial Lung Disease (9),
Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis (9), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Azulfidine has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Azulfidine review by 49 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || colitis|
|Dosage & duration:|| || 1000 mg taken 3 times a day for the period of oral (tablets)|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || reduced bleeding and inflamation initially, then less bloating, diareaha and nausea.|
|Side effects:|| || some sunlight sensitivity (sunburn more easily) and reduced sperm count.|
|Comments:|| || began with two 500mg tablets three times a day by mouth. reduced to twice a day after six months. symptoms gradually subsided in the first three months. on maintenance dose currently.|
Page last updated: 2013-02-10