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). Alkalinize urine. DMARDS decrease the pain and swelling of inflammatory arthritis and may also prevent damage to joints, which can reduce the risk of long-term loss of function. If anuria is present, restrict fluids and salt, and treat appropriately. If you become pregnant while taking sulfasalazine, call your doctor. Sulfasalazine causes temporary infertility in males. Serious infections, including fatal sepsis and pneumonia, have been reported. Do not take a double dose to make up for a missed one. It is the generic name of a drug that belongs to a class of drugs called sulfa drugs. In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose. It can also cause your urine or skin to turn yellowish-orange; this effect is harmless. It is also important information to carry with you in case of emergencies. What is this drug used for? Sulfasalazine is in a class of medications called anti-inflammatory drugs. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Sulfasalazine and its metabolite are also present in human milk. 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. Elderly patients with rheumatoid arthritis showed a prolonged plasma half-life for SSZ, SP, and their metabolites. 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. Medication indication. • It is used to treat rheumatoid arthritis and ulcerative colitis. 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. Last updated on Mar 1, 2020. Generic Name: Sulfasalazine Drug Class: 5-Aminosalicylic Acid Derivatives; DMARDs, Other Sulfasalazine tablets contain Sulfasalazine, 500 mg, for oral administration. If diarrhea recurs, the dosage should be increased to previously effective levels. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of Sulfasalazine. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose. Side … What side effects can this medication cause? There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking Sulfasalazine. The most common adverse reactions associated with Sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. Used for. For current full prescribing information, please visit www.greenstonellc.com. 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. Monitor human milk fed infants of mothers taking Sulfasalazine for signs and symptoms of diarrhea and/or bloody stools. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. 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. Sulfasalazine is used to treat ulcerative colitis and to maintain remission. Drink plenty of fluids (at least six to eight glasses of water or other beverage per day) while taking sulfasalazine. 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 is a topic covered in the Davis's Drug Guide.. To view the entire topic, please sign in or purchase a subscription.. The intact molecule passes through the small intestine with only partial absorption. It works by reducing inflammation (swelling) inside the body. Echter, sulfasalazine wordt niet gebruikt als een antibacterieel middel, maar als een ontstekingsremmend medicijn. Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome. Sulfasalazine is a milder DMARD in regards to its benefit, but can be useful in mild or early cases of inflammatory arthritis. 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. 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 did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. In case of overdose, call the poison control helpline at 1-800-222-1222. Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. Medically reviewed by Drugs.com. Littleton, MA: Publishing Sciences Group, Inc, 1977: 296–313. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage. For a patient who develops a new infection during treatment with Sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Overview. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. Severe Interactions. Sulfasalazine comes as regular and delayed-release (releases the medication in the intestine to prevent irritation to the stomach and to allow the medication to work in the intestine where its effects are needed) tablets. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. 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). Other reactions: urine discoloration and skin discoloration. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. When endoscopic examination confirms satisfactory improvement, the dosage of Sulfasalazine should be reduced to a maintenance level. 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. http://www.upandaway.org. Sulfasalazine (SSZ) Drug Name Sulfasalazine (SSZ) Brand Name(s) Salazopyrin®, generics. 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. If such signs or symptoms are present, the patient should be evaluated immediately. The dosage of Sulfasalazine tablets should be adjusted to each individual's response and tolerance. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed. Desensitization of patients with inflammatory bowel disease to Sulfasalazine. 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). 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. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. 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. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. 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. Do not stop taking sulfasalazine without talking to your doctor. Sulfasalazine (Azulfidine) has also been prescribed "off label" for Crohn's disease and ankylosing spondylitis. Oligospermia and infertility have been observed in men treated with Sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Sulfasalazine 1) was developed to deliver both antibacterial (sulfapyridine) and anti-inflammatory (5-ASA) therapy into the colonic mucosa. The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Talk to your doctor about the possible risks of using this drug for your condition. 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. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. These medications are not usually taken together. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. D00448 Sulfasalazine (USP/INN); Salazosulfapyridine (JP17) Drugs listed in the Japanese Pharmacopoeia [BR:br08311] Chemicals D00448 Salazosulfapyridine Drug metabolizing enzymes and transporters [br08309.html] Drug transporters D00448 Pharmacogenomic biomarkers [br08341.html] Polymorphisms and mutations affecting drug response D00448 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 sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus. Discontinue treatment with Sulfasalazine while awaiting the results of blood tests. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving Sulfasalazine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. 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). Following intravenous injection, the calculated volume of distribution (Vdss) for SSZ was 7.5 ± 1.6 L. SSZ is highly bound to albumin (>99.3%) while SP is only about 70% bound to albumin. Drugs that are substrates for this transporter, such as sulfasalazine, may exhibit an increase in systemic exposure if coadministered with eltrombopag. Sulfasalazine may make your skin sensitive to sunlight. Do not take more or less of it or take it more often than prescribed by your doctor. Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. 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): Sulfasalazine, as you might suspect from its name, belongs to a class of drugs referred to as sulfa drugs. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Am J Med 1982;73:520–4. 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. 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. 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. 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. Continue to take sulfasalazine even if you feel well. Keep all appointments with your doctor and the laboratory. A case of agranulocytosis has been reported in an infant whose mother was taking both Sulfasalazine and prednisone throughout pregnancy. It works by reducing inflammation (swelling) inside the body. Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. • 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 … Due to limited data, a causal relationship between Sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. It’s a combination of salicilate (the main ingredient in aspirin) and a sulfa antibiotic. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported. The low molecular weight of Sulfasalazine and its metabolites may facilitate their removal by dialysis. 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