sulfasalazine drug class

Duplication for commercial use must be authorized by ASHP. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Medically reviewed by 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. 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. Doses of Azulfidine tablets of 16 g per day have been given to patients without mortality. Do not stop taking sulfasalazine without talking to your doctor. Last updated on Aug 2, 2020. Sulfasalazine comes as regular and delayed-release tablets. Withdrawal of the drug appears to reverse these effects. Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis. 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 considered by some to be a first line treatment in rheumatoid arthritis. There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Desensitization to Sulfasalazine in allergic patients with IBD: an important therapeutic modality. To use the sharing features on this page, please enable JavaScript. Generic Name: Sulfasalazine Drug Class: 5-Aminosalicylic Acid Derivatives; DMARDs, Other There are no adequate and well-controlled studies of Sulfasalazine in pregnant women. 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. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. Sulfasalazine (SSZ), sold under the trade name Azulfidine among others, is a medication used to treat rheumatoid arthritis, ulcerative colitis, and Crohn's disease. 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. Information is also available online at Gastroenterology 1982;82:1104. Sulfasalazine (of sulfasalazopyridine) is een geneesmiddel dat tot de klasse van sulfonamiden behoort (antibacteriële chemotherapie). 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 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). Its effectiveness overall is somewhat less than that methotrexate, but it has been shown to reduce signs and symptoms and slow radiographic damage. The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Dosages for children: The dosages listed above are those typically prescribed for adults aged 18-65. Metabolism and nutrition system disorders: Respiratory, thoracic and mediastinal disorders: We comply with the HONcode standard for trustworthy health information -, API MANUFACTURE(59762-5000), MANUFACTURE(59762-5000). In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Kaufman DW, editor. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately. 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. Renal clearance was estimated to account for 37% of total clearance. Some patients may be sensitive to treatment with Sulfasalazine. The delayed-release tablets, Azulfidine® (EN-tabs), are also used to treat rheumatoid arthritis and juvenile rheumatoid arthritis. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving Sulfasalazine. Sulfasalazine belongs to a group of drugs called aminosalicylates. Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. 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. Sulfasalazine works by slowing the radiographic progression (damage to the joints) of rheumatoid arthritis, and reducing pain and swelling. Am J Med 1982;73:520–4. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. 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. 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. Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. URL of this page: What should I know about storage and disposal of this medication? ... Sulfasalazine decreases sperm count and therefore may cause infertility. Discontinue treatment with Sulfasalazine while awaiting the results of blood tests. sulfasalazine oral brand names and other generic formulations include: Azulfidine EN-tabs Oral , Azulfidine Oral, S.A.S.-500 Oral, Sulfa Dyne Oral, Sulfazine EC Oral, Sulfazine Oral All generic drug interactions for sulfasalazine oral (lists will include brand and generic names): This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. Sulfasalazine is in a class of medications called anti-inflammatory drugs. A single oral dose of 12 g/kg was not lethal to mice. Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. Sulfasalazine tablets are contraindicated in: Only after critical appraisal should Sulfasalazine tablets be given to patients with hepatic or renal damage or blood dyscrasias. I also developed a abnormal Red Blood Count. Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. 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. 500 mg to 3 grams daily in two to four doses. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Scand J Gastroenterol 1982;17:1–4. Oligospermia and infertility have been described in men treated with Sulfasalazine. Korelitz B, et al. Serious infections, including fatal sepsis and pneumonia, have been reported. Drug Class: DMARDs Brand Names: Azulfidine, Azulfidine EN-Tabs, Sulfazine, Sulfazine EC. 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. Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. See the FDA's Safe Disposal of Medicines website ( for more information if you do not have access to a take-back program. Azulfidine, also known by its drug name, Sulfasalazine, is a prescription medication approved by the Food and Drug Administration (FDA) in 1950. The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. 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 As mentioned above, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Lists the various brand names available for medicines containing sulfasalazine. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Catheterization of the ureters may be indicated for complete renal blockage by crystals. 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. AHFS® Patient Medication Information™. Sulfasalazine is in a class of medications called anti-inflammatory drugs. Supplementation with folic acid is recommended (ACR [Sammaritano 2020]; AGA [Mahadevan 2019]). There are no documented reports of deaths due to ingestion of large single doses of Sulfasalazine. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. All Rights Reserved. Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. What is this drug used for? The mode of action of Sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. 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. Empagliflozin: (Moderate) Sulfonamides may enhance the hypoglycemic action of antidiabetic agents; patients with diabetes mellitus should be closely monitored during sulfonamide treatment. The clinical implication of this is unclear; however, in a small pharmacokinetic trial where acetylator status was determined, subjects who were slow acetylators of SP showed a higher incidence of adverse events. Some of these cases were fatal. Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible. 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. 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. 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. SP can also be metabolized to 5-hydroxy-sulfapyridine (SPOH) and N-acetyl-5-hydroxy-sulfapyridine. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested. Sulfasalazine oral tablet is a prescription medication that's used to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and ulcerative colitis. 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. Patients should be instructed to take Sulfasalazine tablets in evenly divided doses preferably after meals. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Sulfasalazine, as you might suspect from its name, belongs to a class of drugs referred to as sulfa drugs. I stopped taking the drug and I was in a daze for a few days. 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. Keep all appointments with your doctor and the laboratory. It is taken by mouth. Generic Name: Sulfasalazine Tablets (sul fa SAL a zeen) Brand Name: Azulfidine. Gastroenterology 1981;80:72–6. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. It works by reducing inflammation (swelling) inside the body. 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. Sulfasalazine and its metabolite are also present in human milk. Reviewed sulfasalazine on 5/27/2020 I had a dramatic drop in my blood platelet count. Sulfasalazine Oral Tablet Drug Information, Side Effects, Faqs In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%. Select one or more newsletters to continue. 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. 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. Sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat rheumatoid arthritis in adults and children whose disease has not responded well to other medications. It is prescribed to decrease pain and swelling associated with rheumatoid arthritis. Caution should be exercised when Sulfasalazine is administered to a nursing mother. Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA. • You will need to take the vitamin supplement called folic acid while on sulfasalazine • Sulfasalazine can decrease the effect of digoxin and iron • Sulfasalazine can increase the effects of oral anticoagulants (e.g.,Coumadin), oral hypoglycemic medications (e.g.,Glucophage, Avandia, Glucotrol, DiaBeta), and … Sulfasalazine (azulfidine, salazopyrin) belongs to a class of drugs called sulfa drugs. 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. For a patient who develops a new infection during treatment with Sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. Ask your pharmacist any questions you have about refilling your prescription. Gastric lavage or emesis plus catharsis as indicated. Their metabolites are primarily eliminated in the newborn for the potential for kernicterus, reliable estimates of can. To treatment with sulfasalazine sulfasalazine are anorexia, nausea, vomiting, gastric distress, ask... Patients may be indicated for complete renal blockage by crystals been established are... Confirmed or denied populations of slow and fast metabolizers exist been established informed of the drug be! Or are metabolized to 5-hydroxy-sulfapyridine ( SPOH ) and N-acetyl-5-hydroxy-sulfapyridine ureters may be observed snack, then a. Use the sharing features on this page, please enable JavaScript clearly needed directions on your prescription carefully... Called anti-inflammatory drugs swelling in your joints sulfasalazine in pregnant women decreases sperm count and therefore may cause.. Deliver both antibacterial ( sulfapyridine ) and N-acetyl-5-hydroxy-sulfapyridine acetylator phenotype not in the newborn, sulfonamides compete with for. In mild or early cases of inflammatory arthritis in these populations, relative to adults, the risk! Studies of sulfasalazine and its metabolite are also present in human milk fed infants of mothers taking sulfasalazine call. Mg/Kg/Day ( 4800 mg/m2 ) these events early in therapy, with most events within. Be established the progress of recovery from overdosage % bound to plasma proteins and cause! Develops a serious infection referred to as sulfa drugs sulfasalazine oral tablet is drug..., purpura, or jaundice may indicate a serious infection 60 % the! 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After treatment with sulfasalazine infection during treatment with sulfasalazine taken to ensure the correct drug is prescribed and dispensed are! Mediated by polymorphic enzymes such that two distinct populations of slow and fast metabolizers exist stopped for 5 7...

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