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Sulfasalazine (Sulfasalazine) - Summary

 
 



SULFASALAZINE SUMMARY

Sulfasalazine
Tablets USP
Rev: December 2003
Rx only

Sulfasalazine Tablets USP, 500 mg for Oral Administration Therapeutic classification: Anti-inflammatory agent. Chemical designation: 5-[[ p -(2-Pyridylsulfamoyl)phenyl]azo]salicylic acid. Chemical Structure:

Sulfasalazine 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.


See all Sulfasalazine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to 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. [2011]
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.

more studies >>

Clinical Trials Related to 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 methotrexate-sulfasalazine-HCQ.

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.

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 artery disease.

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.

more trials >>

Reports of Suspected Sulfasalazine Side Effects

Drug Rash With Eosinophilia and Systemic Symptoms (39)Diarrhoea (38)Pyrexia (33)Rash (31)Abdominal Pain (30)Thrombocytopenia (30)Haematemesis (28)Contusion (25)Headache (25)Full Blood Count Abnormal (25)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Sulfasalazine has an overall score of 7.25. The effectiveness score is 7.50 and the side effect score is 8.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Sulfasalazine review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   ulcerative colitis
Dosage & duration:   8 tablets per day taken daily for the period of since 2001
Other conditions:   abcessed colon
Other drugs taken:   none
  
Reported Results
Benefits:   CLEARED UP ULCERATIVE COLITIS AND HAVE NOT HAD RELAPSE SINCE. I WAS DIAGNOSED WITH THIS ILLNESS WHEN I WAS 18. I LOATHED THE INVESTIGATIONS SO MUCH THAT I ONLY KEPT APPOINTMENTS TIL I WAS ABOUT 21. I STOPPED TAKING THE SALAZOPYRIN WHEN I WAS ABOUT 22. I HAD OCCASIONAL PROBLEMS BUT NOTHING THAT DIDN'T CLEAR ITSELF UP. I WENT ON TO HAVE 3 HEALTHY CHILDREN. HOWEVER IN 2001 THE PROB CAME BACK WITH A VENGEANCE AND I NEEDED SURGERY AND WAS VERY ILL - IT WOULD HAVE HELPED IF THE MEDICAL PROFESSION HAD TAKEN SOME INTEREST IN ME AND HADN'T SIMPLY TOLD MW I WAS TRESSED AND TO GO AWAY. PRIVATE CONSULTATIONS FINALLY MEANT THAT I WAS REFERRED TO A CONSULTATN AND HAD THE SURGERY
Side effects:   THE SURGERY MEANT I HAD NO MORE PAIN. AND IN FACT THE TABLETS ARE THE VERY OLD STYLE SULFASALZINE. THEY ARE NOT THE ENTERIC COATED ONES.I DO NOT NOTICE ANY SIDE EFFECTS APART FROM OCCASIONAL YELLOW STAINS. i AM CAREFUL NOT TO DRINK TOO MUCH AS THIS SEEMS TO BE A PROBLEM. ALSO IF MY LIVER HAS TO WORK HARD BECAUSE OF THE TABLETS, THEN THE LEAST I CAN DO IS NOT OVERSTRAIN IT. OTHERWISE THERE ARE NO SIDE EFFECTS AS FAR AS I CAN TELL. NEED LIVER FUNCTION BLOOD TESTS DONE REGULARLY IE ABOUT EVERY THREE MONTHS OR WHEN I REMEMBER. THEY HAVE ALL BEEN CLEAR TO DATE.
Comments:   HAD SURGERY TO REMOVE ABCESS AND PART OF COLON AND NOW TAKE TABLETS DAILY AND AM REVIEWED ANNUALLY BY COLONOSCOPY

 

Sulfasalazine review by 54 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Crohn's Disease
Dosage & duration:   500 mg taken 4 times daily, with food for the period of 6 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   None (see next entry).
Side effects:   Before I started using the drug I had none of the classic symptoms of Crohn's Disease (loose bowel movements, abdominal pain, etc.), but these side effects started when I started taking the drug, and subsided when I stopped. Also, I developed other side effects while using the drug, including low-level nausea, loss of appetite and headaches.
Comments:   I started off on a dose of 1 x 500 mg enteric-coated tabs four times daily (the doctor's recommended test dose to see if I responded negatively to the drug), but when I tried to increase this to 2x 500 mg tabs four times daily after one week, the side effects I had been experiencing increased, so I dropped back. I tried one more time to increase the dose more gradually (2 x 500 mg in the morning; then 1 x 500 mg at lunch, dinner and bedtime), but even this became too unpleasant to put up with (especially since I didn't have these symptoms before I started!). I perservered for 6 weeks, before deciding to taper the dose to zero over a couple of weeks, after which the symptoms disappeared.

 

Sulfasalazine review by 54 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Crohn's Disease
Dosage & duration:   500 mg taken 4 times daily, with food for the period of 6 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   None (see next entry).
Side effects:   Before I started using the drug I had none of the classic symptoms of Crohn's Disease (loose bowel movements, abdominal pain, etc.), but these side effects started when I started taking the drug, and subsided when I stopped. Also, I developed other side effects while using the drug, including low-level nausea, loss of appetite and headaches.
Comments:   I started off on a dose of 1 x 500 mg enteric-coated tabs four times daily (the doctor's recommended test dose to see if I responded negatively to the drug), but when I tried to increase this to 2x 500 mg tabs four times daily after one week, the side effects I had been experiencing increased, so I dropped back. I tried one more time to increase the dose more gradually (2 x 500 mg in the morning; then 1 x 500 mg at lunch, dinner and bedtime), but even this became too unpleasant to put up with (especially since I didn't have these symptoms before I started!). I perservered for 6 weeks, before deciding to taper the dose to zero over a couple of weeks, after which the symptoms disappeared.

See all Sulfasalazine reviews / ratings >>

Page last updated: 2013-02-10

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