Last updated on Aug 2, 2020. Desensitization to Sulfasalazine in allergic patients with IBD: an important therapeutic modality. 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. Generic Name: Sulfasalazine Drug Class: 5-Aminosalicylic Acid Derivatives; DMARDs, Other Your doctor may order certain lab tests to check your response to sulfasalazine. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine: Hepatobiliary disorders: reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatitis cholestatic, cholestasis and possible hepatocellular damage including liver necrosis and liver failure. Instead, the best way to dispose of your medication is through a medicine take-back program. Other reactions: urine discoloration and skin discoloration. Sulfasalazine tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "G500". Monitor human milk fed infants of mothers taking Sulfasalazine for signs and symptoms of diarrhea and/or bloody stools. Oligospermia and infertility have been described in men treated with Sulfasalazine. Do not take a double dose to make up for a missed one. It works by reducing inflammation (swelling) inside the body. Medication indication. Desensitization of patients with inflammatory bowel disease to Sulfasalazine. Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. The exact way that sulfasalazine works is unknown, but it is believed to reduce the actions of substances in the body that cause inflammation, tissue damage, and diarrhea. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 μg/mL) occurring at 6 hours. These occur in about one-third of the patients. In ulcerative colitis, clinical studies utilizing rectal administration of SSZ, SP, and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms have been reported in patients taking Sulfasalazine. Sulfasalazine belongs to a group of drugs called aminosalicylates. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Sulfasalazine has been confused with sulfadiazine; care must be taken to ensure the correct drug is prescribed and dispensed. Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration. The observed plasma half-life for intravenous Sulfasalazine is 7.6 ± 3.4 hours. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell's syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, interstitial lung disease, pneumonitis with or without eosinophilia, vasculitis, fibrosing alveolitis, pleuritis, pericarditis with or without tamponade, allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis with or without immune complexes, fulminant hepatitis, sometimes leading to liver transplantation, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection, and alopecia. In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. Some of these cases were fatal. occur after the first few doses of Sulfasalazine, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of Sulfasalazine and subsequently increasing it gradually over several days. If anuria is present, restrict fluids and salt, and treat appropriately. 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. Cross-sensitivity may exist with these agents. Mogadam M, et al. However, oral Sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation (see Drug Interactions) and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs. Sulfasalazine is in a class of medications called anti-inflammatory drugs. It’s a combination of salicilate (the main ingredient in aspirin) and a sulfa antibiotic. The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Take sulfasalazine exactly as directed. Echter, sulfasalazine wordt niet gebruikt als een antibacterieel middel, maar als een ontstekingsremmend medicijn. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible. 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. Recommendations for Pregnancy. Doses of Azulfidine tablets of 16 g per day have been given to patients without mortality. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Sulfasalazine. Catheterization of the ureters may be indicated for complete renal blockage by crystals. Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Sulfasalazine contains salicylate and the sulfa antibiotic. It can be found under the following brand names – Azulfidine or Sulfazine. Sulfasalazine (azulfidine, salazopyrin) belongs to a class of drugs called sulfa drugs. Approximately 15% of a dose of SSZ is absorbed as parent and is metabolized to some extent in the liver to the same two species. Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. It works by reducing inflammation (swelling) inside the body. 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. Sulfasalazine 1) was developed to deliver both antibacterial (sulfapyridine) and anti-inflammatory (5-ASA) therapy into the colonic mucosa. Its effectiveness overall is somewhat less than that methotrexate, but it has been shown to reduce signs and symptoms and slow radiographic damage. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind. Gastroenterology 1982;82:1104. If diarrhea recurs, the dosage should be increased to previously effective levels. Azulfidine may also help prevent joint damage and disability. To use the sharing features on this page, please enable JavaScript. Medically reviewed by Drugs.com. • It is used to treat rheumatoid arthritis and ulcerative colitis. The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 μg/mL appear to be associated with an increased incidence of adverse reactions. Select one or more newsletters to continue. 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. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. It can also cause your urine or skin to turn yellowish-orange; this effect is harmless. The most common adverse reactions associated with Sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Br Med J 1981;282:110. Sulfasalazine side effects. A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). Dosages for children: The dosages listed above are those typically prescribed for adults aged 18-65. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately. Used for. Taffet SL, Das KM. Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).. Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. © Copyright, 2020. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. Withdrawal of the drug appears to reverse these effects. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Sulfasalazine works by slowing the radiographic progression (damage to the joints) of rheumatoid arthritis, and reducing pain and swelling. Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. There are no documented reports of deaths due to ingestion of large single doses of Sulfasalazine. Sulfasalazine is in a class of medications called anti-inflammatory drugs. 500 mg to 3 grams daily in two to four doses. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Ask your pharmacist any questions you have about refilling your prescription. Sulfasalazine is used to treat ulcerative colitis and to maintain remission. Sulfasalazine is in a class of medications called Disease Modifying Anti-Rheumatic Drugs, or DMARDs. Lists the various brand names available for medicines containing sulfasalazine. If such signs or symptoms are present, the patient should be evaluated immediately. Sulfasalazine (Azulfidine) has also been prescribed "off label" for Crohn's disease and ankylosing spondylitis. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. Drug Class: DMARDs Brand Names: Azulfidine, Azulfidine EN-Tabs, Sulfazine, Sulfazine EC. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus. Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Sulfasalazine may make your skin sensitive to sunlight. For a patient who develops a new infection during treatment with Sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Sulfasalazine. 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). Less common or rare adverse reactions include: Blood dyscrasias: aplastic anemia, agranulocytosis, leukopenia, megaloblastic (macrocytic) anemia, purpura, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, and myelodysplastic syndrome. Severe Interactions. 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. Keep this medication in the container it came in, tightly closed, and out of reach of children. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. URL of this page: https://medlineplus.gov/druginfo/meds/a682204.html. Oral. Littleton, MA: Publishing Sciences Group, Inc, 1977: 296–313. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Sulfasalazine is a disease-modifying anti-rheumatic drug (DMARD) indicated for the treatment of adults and children over 6 with RA who have not responded to non-steroidal anti-inflammatory drugs (NSAIDs). The delayed-release tablets, Azulfidine® (EN-tabs), are also used to treat rheumatoid arthritis and juvenile rheumatoid arthritis. Elderly patients with rheumatoid arthritis showed a prolonged plasma half-life for SSZ, SP, and their metabolites. 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