Sulfasalazine works by slowing the radiographic progression (damage to the joints) of rheumatoid arthritis, and reducing pain and swelling. Sulfasalazine is in a class of medications called Disease Modifying Anti-Rheumatic Drugs, or DMARDs. Sulfasalazine causes temporary infertility in males. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested. Less frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz body anemia, hemolytic anemia, and cyanosis, which may occur at a frequency of one in every thirty patients or less. Generic Name: Sulfasalazine Drug Class: 5-Aminosalicylic Acid Derivatives; DMARDs, Other Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species. It works by reducing inflammation (swelling) inside the body. It is considered by some to be a first line treatment in rheumatoid arthritis. Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Additionally, patients should be advised that Sulfasalazine may produce an orange-yellow discoloration of the urine or skin. Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. Other reactions: urine discoloration and skin discoloration. Dosages. Side … Do not take more or less of it or take it more often than prescribed by your doctor. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of Sulfasalazine in the mother or discontinuation of breastfeeding. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. Following oral administration of 1 g of SSZ to 9 healthy males, less than 15% of a dose of SSZ is absorbed as parent drug. Nursing Central is an award-winning, complete mobile solution for nurses and students. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to Sulfasalazine during pregnancy, but the role of Sulfasalazine in these defects has not been established. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. They should also be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be reduced by continued administration of Sulfasalazine at a maintenance dosage. In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Oligospermia and infertility have been observed in men treated with Sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Information is also available online at https://www.poisonhelp.org/help. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Do not stop taking sulfasalazine without talking to your doctor. Sulfasalazine tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "G500". The calculated clearance of SSZ following intravenous administration was 1 L/hr. There are no documented reports of deaths due to ingestion of large single doses of Sulfasalazine. However, Sulfasalazine showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans. Experience suggests that with a daily dosage of 4 g or more, or total serum sulfapyridine levels above 50 μg/mL, the incidence of adverse reactions tends to increase. These medications are not usually taken together. Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. Acetylsulfapyridine (AcSP), the principal metabolite of SP, is approximately 90% bound to plasma proteins. Sulfasalazine belongs to a group of drugs called aminosalicylates. URL of this page: https://medlineplus.gov/druginfo/meds/a682204.html. Sulfasalazine is used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in patients with ulcerative colitis, a condition in which the bowel is inflamed. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. In case of overdose, call the poison control helpline at 1-800-222-1222. Desensitization of patients with inflammatory bowel disease to Sulfasalazine. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) What is this drug used for? Sulfasalazine should be discontinued if an alternative etiology for the signs or symptoms cannot be established. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Continue to take sulfasalazine even if you feel well. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving Sulfasalazine. Azulfidine, also known by its drug name, Sulfasalazine, is a prescription medication approved by the Food and Drug Administration (FDA) in 1950. All Rights Reserved. If you become pregnant while taking sulfasalazine, call your doctor. Azulfidine may also help prevent joint damage and disability. Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome. Sulfasalazine . In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%. Sulfasalazine is used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in patients with ulcerative colitis, a condition in which the bowel is inflamed. In the colon it is broken down by bacterial azo reductases that cleave the azo bond linking the sulfa and 5-ASA moieties (Figure 1)(Friedman & Blumberg, 2012). Sulfasalazine may cause side effects. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,4 7 of 8 patients,5 and 19 of 20 patients.6 These regimens suggest starting with a total daily dose of 50 to 250 mg Sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with Sulfasalazine. Keep all appointments with your doctor and the laboratory. Inactive Ingredients: magnesium stearate, povidone, silica (colloidal anhydrous), starch (pregelatinized). Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 μg/mL) occurring at 6 hours. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. Monitor human milk fed infants of mothers taking Sulfasalazine for signs and symptoms of diarrhea and/or bloody stools. The dosage of Sulfasalazine tablets should be adjusted to each individual's response and tolerance. tell your doctor if you have or have ever had asthma, kidney or liver disease, porphyria, blood problems, or blockage in your intestine or urinary tract. Oligospermia and infertility have been described in men treated with Sulfasalazine. Therapeutic Classification: Anti-inflammatory agent. Central nervous system reactions: transverse myelitis, convulsions, meningitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillian-Barre syndrome, peripheral neuropathy, mental depression, vertigo, hearing loss, insomnia, ataxia, hallucinations, tinnitus, and drowsiness. A single oral dose of 12 g/kg was not lethal to mice. Sulfasalazine is known to inhibit the absorption and metabolism of folic acid and may diminish the effects of folic acid supplementation. Discontinue Sulfasalazine if a patient develops a serious infection. Pregnancy in inflammatory bowel disease: effect of Sulfasalazine and corticosteroids on fetal outcome. Deaths associated with the administration of Sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. Do not take a double dose to make up for a missed one. Sulfasalazine oral tablet is a prescription medication that's used to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and ulcerative colitis. If such signs or symptoms are present, the patient should be evaluated immediately. The observed plasma half-life for intravenous Sulfasalazine is 7.6 ± 3.4 hours. Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. The most common adverse reactions associated with Sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. Take sulfasalazine exactly as directed. Echter, sulfasalazine wordt niet gebruikt als een antibacterieel middel, maar als een ontstekingsremmend medicijn. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. Sulfasalazine is also classified as a DMARD(disease-modifying antirheumatic drug). Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. Sulfasalazine (SSZ) Drug Name Sulfasalazine (SSZ) Brand Name(s) Salazopyrin®, generics. Medication indication. Gastroenterology 1982;82:1104. For the mouse study, Sulfasalazine was tested at 675 (2025 mg/m2), 1350 (4050 mg/m2), and 2700 (8100 mg/m2) mg/kg/day. The primary route of metabolism of SP is via acetylation to form AcSP. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. Mechanism of Action. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. 2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population.3. It works by reducing inflammation (swelling) inside the body. Sulfasalazine is in a class of medications called anti-inflammatory drugs. Talk to your doctor about the possible risks of using this drug for your condition. Desensitization to Sulfasalazine in allergic patients with IBD: an important therapeutic modality. © Copyright, 2020. It can also cause your urine or skin to turn yellowish-orange; this effect is harmless. Sulfasalazine 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:Molecular Formula: C18H14N4O5SInactive Ingredients: magnesium stearate, povidone, silica (colloidal anhydrous), starch (pregelatinized). These subjects will display a prolonged plasma half-life for SP (14.8 hours vs. 10.4 hours) and an accumulation of higher plasma levels of SP than fast acetylators. http://www.upandaway.org. Sulfasalazine is in a class of medications called anti-inflammatory drugs. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Sulfasalazine side effects. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. Sulfasalazine tablets contain Sulfasalazine, 500 mg, for oral administration. Am J Med 1982;73:520–4. Sulfasalazine is a type of drug known as a disease-modifying anti-rheumatic drug (DMARD).It may be used on its own or with other drugs. This reaction is frequently dose related. Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to Sulfasalazine or its metabolite, mesalamine/mesalazine. Available for Android and iOS devices. The response of acute ulcerative colitis to Sulfasalazine tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. Sulfonamides, including Sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations). Drug Class Disease-Modifying Anti-Rheumatic Drug (DMARD) Share; Email; Print; SSZ is a DMARD used to treat inflammatory types of arthritis, such as rheumatoid and psoriatic arthritis. Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when Sulfasalazine tablets are administered. In a group of 186 women treated with Sulfasalazine alone or Sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population.1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including Sulfasalazine, did not appear to be associated with fetal malformation. Reviewed sulfasalazine on 5/27/2020 I had a dramatic drop in my blood platelet count. tell your doctor if you are allergic to sulfasalazine, sulfapyridine, aspirin, choline magnesium trisalicylate (Triosal, Trilisate), choline salicylate (Arthropan), mesalamine (Asacol, Pentasa, Rowasa), salsalate (Argesic-SA, Disalcid, Salgesic, others), sulfa drugs, trisalicylate (Tricosal, Trilisate),or any other drugs. 500 mg to 3 grams daily in two to four doses. Catheterization of the ureters may be indicated for complete renal blockage by crystals. Sulfasalazine changes the way your condition affects you, and reduces inflammation, pain and swelling in your joints. Medically reviewed by Drugs.com. Kaufman DW, editor. Caution should be exercised when considering the use of Sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections. Sulfasalazine (Azulfidine) is a drug prescribed for the treatment of mild to severe ulcerative colitis and the treatment of rheumatoid arthritis. Metabolized, while 5-ASA is primarily metabolized in both the liver and intestine N-acetyl-5-aminosalicylic... ( sulfapyridine ) and N-acetyl-5-hydroxy-sulfapyridine 10.4 hours while in slow acetylators, the principal metabolite of SP 10.4. Because they are reported voluntarily from a population of unknown size, estimates of frequency can not confirmed. And procedures ; then consult the database with 5,000+ drugs or refer 65,000+. 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