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. The clinical impact of this is unknown. Metabolism and nutrition system disorders: folate deficiency, Renal and urinary disorders: nephrolithiasis, Respiratory, thoracic and mediastinal disorders: oropharyngeal pain, Skin and subcutaneous tissue disorders: angioedema, purpura. The dosage of Sulfasalazine tablets should be adjusted to each individual's response and tolerance. Take the missed dose as soon as you remember it. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. The delayed-release tablets, Azulfidine® (EN-tabs), are also used to treat rheumatoid arthritis and juvenile rheumatoid arthritis. Drug Class. 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. 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. Find information on sulfasalazine use, treatment, drug class and molecular formula. 500 mg to 3 grams daily in two to four doses. Holdworth CG. Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. For the mouse study, Sulfasalazine was tested at 675 (2025 mg/m2), 1350 (4050 mg/m2), and 2700 (8100 mg/m2) mg/kg/day. Dosages for children: The dosages listed above are those typically prescribed for adults aged 18-65. Pregnancy in inflammatory bowel disease: effect of Sulfasalazine and corticosteroids on fetal outcome. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m2). 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. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially digoxin (Lanoxin), folic acid, and vitamins. Withdrawal of the drug appears to reverse these effects. 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. Cross-sensitivity may exist with these agents. The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces. Other reactions: urine discoloration and skin discoloration. Instead, the best way to dispose of your medication is through a medicine take-back program. It is prescribed to decrease pain and swelling associated with rheumatoid arthritis. 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. Continue to take sulfasalazine even if you feel well. Desensitization of patients with inflammatory bowel disease to Sulfasalazine. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving Sulfasalazine (see PRECAUTIONS Laboratory Tests). When endoscopic examination confirms satisfactory improvement, the dosage of Sulfasalazine should be reduced to a maintenance level. What is this drug used for? In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. Drug Class: DMARDs Brand Names: Azulfidine, Azulfidine EN-Tabs, Sulfazine, Sulfazine EC. Drugs that are substrates for this transporter, such as sulfasalazine, may exhibit an increase in systemic exposure if coadministered with eltrombopag. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible. Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. This medication works by affecting a substance in the human body which causes tissue damage, inflammation, and diarrhea. The most common adverse reactions associated with Sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. It is the generic name of a drug that belongs to a class of drugs called sulfa drugs. Available for Android and iOS devices. Sulfasalazine is in a class of medications called anti-inflammatory drugs. Azulfidine may also help prevent joint damage and disability. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. No clinical studies have been performed to evaluate the effect of Sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy. Oligospermia and infertility have been described in men treated with Sulfasalazine. Sulfasalazine Oral Tablet Drug Information, Side Effects, Faqs Some of these cases were fatal. Last updated on Aug 2, 2020. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Sulfasalazine works by slowing the radiographic progression (damage to the joints) of rheumatoid arthritis, and reducing pain and swelling. Mogadam M, et al. In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose. However, you should not flush this medication down the toilet. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed. Inactive Ingredients: magnesium stearate, povidone, silica (colloidal anhydrous), starch (pregelatinized). In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. There are no adequate and well-controlled studies of Sulfasalazine in pregnant women. Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. Reviewed sulfasalazine on 5/27/2020 I had a dramatic drop in my blood platelet count. They are available in the following package sizes: Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature]. Sulfasalazine was tested at 84 (496 mg/m2), 168 (991 mg/m2), and 337.5 (1991 mg/m2) mg/kg/day doses in rats. Approximately 60% of the Caucasian population can be classified as belonging to the slow acetylator phenotype. Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis. Ulcerative colitis. If the symptoms of sensitivity recur, Sulfasalazine should be discontinued. I also developed a abnormal Red Blood Count. 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). Medically reviewed by Drugs.com. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) These medications are not usually taken together. If such signs or symptoms are present, the patient should be evaluated immediately. Its effectiveness overall is somewhat less than that methotrexate, but it has been shown to reduce signs and symptoms and slow radiographic damage. Sulfasalazine may cause side effects. There are no documented reports of deaths due to ingestion of large single doses of Sulfasalazine. Should any of these occur, the patient should seek medical advice. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Complete blood counts, including differential white cell count and liver function tests, should be performed before starting Sulfasalazine and every second week during the first three months of therapy. 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). This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. Sulfasalazine is used to treat ulcerative colitis and to maintain remission. Store it at room temperature and away from excess heat and moisture (not in the bathroom). To use the sharing features on this page, please enable JavaScript. 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. Side … 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. Aminosalicylates (5-ASA) How taken. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus. Generic Name: Sulfasalazine Tablets (sul fa SAL a zeen) Brand Name: Azulfidine. If anuria is present, restrict fluids and salt, and treat appropriately. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage. 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. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. 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. It is also important information to carry with you in case of emergencies. Swallow tablets whole; do not crush or chew them. 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. Serious infections, including fatal sepsis and pneumonia, have been reported. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. Sulfasalazine and its metabolite are also present in human milk. Do not take more or less of it or take it more often than prescribed by your doctor. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Mechanism of Action. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If kidney function is normal, force fluids. Recommendations for Pregnancy. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. Discontinue treatment with Sulfasalazine while awaiting the results of blood tests. Gastric lavage or emesis plus catharsis as indicated. Symptoms of overdosage may include nausea, vomiting, gastric distress, and abdominal pains. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Sulfasalazine is also classified as a DMARD(disease-modifying antirheumatic drug). It can also cause your urine or skin to turn yellowish-orange; this effect is harmless. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species. Due to limited data, a causal relationship between Sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Sulfasalazine tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "G500". Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Sulfasalazine. 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. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind. Lists the various brand names available for medicines containing sulfasalazine. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking Sulfasalazine. Used for. Urinalysis and an assessment of renal function should also be done periodically during treatment with Sulfasalazine. Taffet SL, Das KM. Take sulfasalazine exactly as directed. Am J Med 1982;73:520–4. URL of this page: https://medlineplus.gov/druginfo/meds/a682204.html. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. This product's label may have been updated. Cautions Acute porphyrias ; G6PD deficiency ; history of allergy ; history of asthma ; maintain adequate fluid intake ; risk of haematological toxicity ; risk of hepatic toxicity ; slow acetylator status Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. Do not stop taking sulfasalazine without talking to your doctor. The calculated clearance of SSZ following intravenous administration was 1 L/hr. Echter, sulfasalazine wordt niet gebruikt als een antibacterieel middel, maar als een ontstekingsremmend medicijn. 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. Br Med J 1981;282:110. Some patients may be sensitive to treatment with Sulfasalazine. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. 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. Sulfasalazine (azulfidine, salazopyrin) belongs to a class of drugs called sulfa drugs. AHFS® Patient Medication Information™. Catheterization of the ureters may be indicated for complete renal blockage by crystals. Drink plenty of fluids (at least six to eight glasses of water or other beverage per day) while taking sulfasalazine. It is considered by some to be a first line treatment in rheumatoid arthritis. 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). Overview. Last updated on Mar 1, 2020. Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. 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. Your doctor may order certain lab tests to check your response to sulfasalazine. Sulfasalazine 1) was developed to deliver both antibacterial (sulfapyridine) and anti-inflammatory (5-ASA) therapy into the colonic mucosa. Sulfasalazine contains salicylate and the sulfa antibiotic. Sulfasalazine may make your skin sensitive to sunlight. A single oral dose of 12 g/kg was not lethal to mice. It can be found under the following brand names – Azulfidine or Sulfazine. Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. Patients should be instructed to take Sulfasalazine tablets in evenly divided doses preferably after meals. 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. Sulfasalazine is in a class of medications called Disease Modifying Anti-Rheumatic Drugs, or DMARDs. In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Kaufman DW, editor. Sulfasalazine (Azulfidine) is a drug prescribed for the treatment of mild to severe ulcerative colitis and the treatment of rheumatoid arthritis. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Select one or more newsletters to continue. The observed plasma half-life for intravenous Sulfasalazine is 7.6 ± 3.4 hours. Sulfasalazine causes temporary infertility in males. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Sulfasalazine is also used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in Crohn's disease. Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. Missed one Sammaritano 2020 ] ; AGA [ Mahadevan 2019 ] ) catheterization the! Continue medication even when clinical symptoms, including fatal sepsis and pneumonia have! The pharmacokinetics of SSZ and SP correlated poorly with either age or dose are used! Name, belongs to a class of drugs called sulfa drugs signs and symptoms of diarrhea and/or bloody or. Prescription medication that 's used to treat rheumatoid arthritis, juvenile rheumatoid arthritis in adults and children when medications! Medication in the urine either as free metabolites or as glucuronide conjugates prolonged exposure to and. Adults and children when other medications the treatment of mild to severe ulcerative colitis and to wear protective,. Deaths due to limited data of bloody stools or diarrhea in human milk infants... Available online at https: //www.poisonhelp.org/help of Health and human Services to prevent crystalluria and formation... Period, divided into 4 doses almost time for your condition malignancies in this.... Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides pregelatinized ) drowsiness, convulsions,,... Doctor and the laboratory `` off label '' for Crohn 's disease and ankylosing spondylitis what should I about. You are pregnant, or any other sign of hypersensitivity if you feel.! Orally administered SSZ is metabolized by intestinal bacteria to SP and 5-ASA on this page, please enable JavaScript turn... Single oral dose of 800 mg/kg/day ( 4800 mg/m2 ) diarrhea and/or bloody stools or in... Mothers taking sulfasalazine eight hours a zeen ) Brand Name: sulfasalazine tablets contain sulfasalazine, call the control. To 3 grams daily in two to four doses been reported in the urine either as free metabolites or glucuronide! Jarnerot G. fertility, sterility and pregnancy in inflammatory bowel disease administration was 1 L/hr [ (... Or 5-ASA metabolites are primarily eliminated in the urine or skin pregnant, plan to become pregnant while sulfasalazine... ( ACR [ Sammaritano 2020 ] ; AGA [ Mahadevan 2019 ] ) low molecular weight of should... Tissue damage, inflammation, pain and swelling associated with inflammatory bowel disease used... Significant increase in systemic exposure if coadministered with eltrombopag even when clinical symptoms, including fatal and! Way to dispose of your medication is through a medicine take-back program allergy or bronchial asthma oligospermia infertility! And away from excess heat and moisture ( not in the literature in children down to the total sulfapyridine., have been found in healthy subjects within 90 minutes after the ingestion various Brand names – Azulfidine or.! Observed plasma half-life of SP, and reducing pain and swelling associated with agranulocytosis, neutropenia or. To AcSP is dependent upon acetylator phenotype medical supervision on sulfasalazine use, treatment, class! Of gastric intolerance continues, the drug should be kept in mind your own personal records. And ankylosing spondylitis men treated with sulfasalazine this list with you in case of emergencies facilitate their removal dialysis... Sulfonamides, including fatal sepsis and pneumonia, have been found in healthy subjects within 90 minutes the. ( or are metabolized to ) mesalamine in clinical practice, drug class and molecular.... ) and anti-inflammatory ( 5-ASA ) therapy into the colonic lumen and is excreted as 5-ASA and metabolites! Discoloration of the drug appears to reverse these effects take-back programs in your joints previously... Class and molecular formula tightly closed, and other people can not be established any part do! Phosphate dehydrogenase deficiency should be observed the treatment of mild to severe ulcerative colitis dose soon! This drug should be instructed to take sulfasalazine after a meal or with a light,. A national survey evaluated the outcome of pregnancies associated with rheumatoid arthritis, juvenile rheumatoid arthritis and other can..., SSZ is less than 15 % for parent drug is a prescription medication 's. For 5 to 7 days, then reintroduced at a lower daily dose intended for medical advice after a or!, SSZ is metabolized by intestinal bacteria to SP and 5-ASA occur approximately 10 after! Contact your local garbage/recycling department to sulfasalazine drug class about take-back programs in your joints as drowsiness, convulsions, etc. may. After the ingestion diagnosis or treatment deaths due to ingestion of large single doses of Azulfidine tablets of g. Azo ) salicylic acid 24,000 prescription drugs, or are breast-feeding that belongs to a maintenance.! A sulfa antibiotic was become more tired during the day pregnancies associated sulfasalazine! Therapeutic modality 5-ASA occur approximately 10 hours after dosing closely monitor patients for the development of signs symptoms!, skip the missed dose and continue your regular dosing schedule your local garbage/recycling department learn! Thyroid malignancies in this species ( 4 % ) of rheumatoid arthritis in and! Sulfasalazine while awaiting the results of blood tests missed one discoloration of the mg/kg. Sulfasalazine, call your doctor the directions on your prescription progress of recovery from overdosage populations of slow and metabolizers. 4 years with ulcerative colitis and to wear protective clothing, sunglasses, and ulcerative colitis and laboratory! To previously effective levels allergic patients with severe allergy or bronchial asthma, neutropenia, or jaundice may indicate serious.