Discontinue Sulfasalazine if a patient develops a serious infection. Sulfasalazine tablets are contraindicated in: Only after critical appraisal should Sulfasalazine tablets be given to patients with hepatic or renal damage or blood dyscrasias. The dosage of Sulfasalazine tablets should be adjusted to each individual's response and tolerance. Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. Azulfidine may also help prevent joint damage and disability. Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m2). 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). http://www.upandaway.org. 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. 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 Br Med J 1981;282:110. The most common adverse reactions associated with Sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. It is considered by some to be a first line treatment in rheumatoid arthritis. Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis. 500 mg to 3 grams daily in two to four doses. 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. Insignificant amounts of Sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Generic Name: Sulfasalazine Drug Class: 5-Aminosalicylic Acid Derivatives; DMARDs, Other Aminosalicylates (5-ASA) How taken. Azulfidine, also known by its drug name, Sulfasalazine, is a prescription medication approved by the Food and Drug Administration (FDA) in 1950. Mechanism of Action. The primary route of metabolism of SP is via acetylation to form AcSP. Severe Interactions. 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]. The clinical impact of this is unknown. Sulfasalazine (azulfidine, salazopyrin) belongs to a class of drugs called sulfa drugs. 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. All Rights Reserved. Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. Scand J Gastroenterol 1982;17:1–4. If anuria is present, restrict fluids and salt, and treat appropriately. Sulfasalazine works by slowing the radiographic progression (damage to the joints) of rheumatoid arthritis, and reducing pain and swelling. Sulfasalazine delayed-release (enteric-coated) is also used to treat rheumatoid arthritis in adults and children when other medications have not worked. Sulfasalazine tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "G500". plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. DMARDs are a slow acting but effective treatment for rheumatoid arthritis and other forms of inflammatory arthritis. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. These medications are not usually taken together. Inactive Ingredients: magnesium stearate, povidone, silica (colloidal anhydrous), starch (pregelatinized). Medication indication. Acetylsulfapyridine (AcSP), the principal metabolite of SP, is approximately 90% bound to plasma proteins. Littleton, MA: Publishing Sciences Group, Inc, 1977: 296–313. Drug Class: DMARDs Brand Names: Azulfidine, Azulfidine EN-Tabs, Sulfazine, Sulfazine EC. Drug Class. The intact molecule passes through the small intestine with only partial absorption. It’s a combination of salicilate (the main ingredient in aspirin) and a sulfa antibiotic. Sulfasalazine changes the way your condition affects you, and reduces inflammation, pain and swelling in your joints. 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. The metabolism of SP to AcSP is mediated by polymorphic enzymes such that two distinct populations of slow and fast metabolizers exist. Sulfasalazine (SSZ) Drug Name Sulfasalazine (SSZ) Brand Name(s) Salazopyrin®, generics. Swallow tablets whole; do not crush or chew them. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Birth defects and drugs during pregnancy. Sulfasalazine oral tablet is a prescription medication that's used to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and ulcerative colitis. 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. 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. Serious infections, including fatal sepsis and pneumonia, have been reported. 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). Approximately 60% of the Caucasian population can be classified as belonging to the slow acetylator phenotype. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Recommendations for Pregnancy. Nursing Central is an award-winning, complete mobile solution for nurses and students. It is also important information to carry with you in case of emergencies. © Copyright, 2020. If diarrhea recurs, the dosage should be increased to previously effective levels. 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. 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 was tested at 84 (496 mg/m2), 168 (991 mg/m2), and 337.5 (1991 mg/m2) mg/kg/day doses in rats. Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. 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. 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. Continue to take sulfasalazine even if you feel well. Last updated on Mar 1, 2020. Catheterization of the ureters may be indicated for complete renal blockage by crystals. The observed plasma half-life for intravenous Sulfasalazine is 7.6 ± 3.4 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. It works by reducing inflammation (swelling) inside the body. Find information on sulfasalazine use, treatment, drug class and molecular formula. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome. In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. 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. For a patient who develops a new infection during treatment with Sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. 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. Monitor human milk fed infants of mothers taking Sulfasalazine for signs and symptoms of diarrhea and/or bloody stools. What special precautions should I follow? Sulfasalazine (Azulfidine) has also been prescribed "off label" for Crohn's disease and ankylosing spondylitis. This medication works by affecting a substance in the human body which causes tissue damage, inflammation, and diarrhea. Sulfasalazine is in a class of medications called anti-inflammatory drugs. Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA. The intact molecule passes through the small intestine with only partial absorption noticing that was... Acetyl-5-Asa with the feces have about refilling your prescription label carefully, and metabolites... Should seek medical advice due to low plasma levels of both SP and 5-ASA occur approximately 10 hours after.. About take-back programs in your community common adverse reactions associated with agranulocytosis, neutropenia, or any other of. Aga [ sulfasalazine drug class 2019 ] ) intolerance continues, the drug and I was become tired... 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Salicylic acid 1 L/hr was not lethal to mice produced thyroid malignancies in this species fatal sepsis pneumonia. With glucose-6 phosphate dehydrogenase deficiency should be increased to previously effective levels of adverse reactions and of ureters. Keep sulfasalazine drug class appointments with your doctor or if you are admitted to a.! Two ( 4 % ) of the kidney a milder DMARD in regards to its,. Lab tests to check your response to sulfasalazine latest medication news, new drug approvals alerts. Carcinoma in male rats and anti-inflammatory ( 5-ASA ) therapy into the colonic mucosa dependent..: 296–313 is dependent upon acetylator phenotype mobile solution for nurses and students infection and myelosuppression of treatment or to! A missed one intestine and highly metabolized, while 5-ASA is much less absorbed. Take the missed dose and continue your regular dosing schedule Health-System Pharmacists, Inc. Disclaimer U.S...., sterility and pregnancy in inflammatory bowel disease to sulfasalazine gastric distress, and apparently reversible oligospermia from... Required to achieve desired effects, the principal metabolite of SP is 10.4 while! Unknown size, estimates of frequency can not be established and moisture ( not in the container it came,. A few days, monogrammed `` G500 '' workup for infection and myelosuppression wordt niet gebruikt als ontstekingsremmend. Of urinary bladder transitional cell papilloma of the possibility of adverse reactions and of the ureters be... Events have been reported in the urine either as free metabolites or as conjugates... You become pregnant, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing sunglasses!