[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-217270-en":3,"doc-seo-217270-105":30,"detail-sidebar-cat-0-en-105":92},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":20,"is_deleted":4,"is_public":20,"is_downloadable":20,"audit_status":20,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":14,"update_tm":28,"read_time":29},217270,2336475104736,"วิน","https://ap-avatar.wpscdn.com/avatar/22000c4c5e0e5b17e70?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786591360781797222",7,"Healthcare","SULFASALAZINE - Sulfasalazine Tablet - Description, Clinical Pharmacology, Indications","Sulfasalazine tablets (500 mg) deliver sulfasalazine for oral administration as an anti-inflammatory therapeutic agent. The document details its chemical designation and composition, then summarizes clinical pharmacology: metabolites 5-ASA and sulfapyridine, proposed anti-inflammatory/immunomodulatory mechanisms, and key pharmacokinetic findings for absorption, distribution, metabolism, and excretion. It also covers special populations, including elderly and pediatric patients, and describes variations by acetylator phenotype and gender, plus core indications and contraindications.","SULFASALAZINE-sulfasalazine tablet  \nSunrise Pharmaceutical, Inc .  \n----------  \nSulfasalazine Tablets, USP  \nDESCRIPTION  \nSulfasalazine tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent.  \nChemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.  \nChemical Structure:  \nMolecular Formula: C 18H 14N4O 5S Molecular Weight: 398.39  \nInactive ingredients: Corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, talc , and purified water USP.  \nCLINICAL PHARMACOLOGY  \nPharmacodynamics  \nThe mode of action of sulfasalazine (SSZ) or its metabolites , 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), 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 . 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.  \nPharmacokinetics  \nIn vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. In the intestine, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Of the two species , SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed.  \nAbsorption:  \nFollowing oral administration of 1 g of SSZ to 9 healthy males , less than 15% of a dose of SSZ is absorbed as parent drug. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 µg/mL) occurring at 6 hours .  \nIn comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs . SP apparently is well absorbed from the colon with an estimated bioavailability of 60% . In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30% .  \nDistribution:  \nFollowing 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. Acetylsulfapyridine (AcSP), the principal metabolite of SP , is approximately 90% bound to plasma proteins .  \nMetabolism:  \nAs mentioned above, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. 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 . The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours . The primary route of metabolism of SP is via acetylationto form AcSP. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. In fast acetylators , the mean plasma half-life of SP is 10.4 hours while in slow acetylators , it is 14.8 hours . SP can also be metabolized to 5-hydroxy-sulfapyridine (SPOH) and N-acetyl-5-hydroxy-sulfapyridine. 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.  \nExcretion:  \nAbsorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates . The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces","cbCainEbFuQia8Gd","https://ap.wps.com/l/cbCainEbFuQia8Gd","pdf",518368,1,14,"English","en",105,"# Description\n## Chemical designation and composition\n# Clinical pharmacology\n## Pharmacodynamics\n## Pharmacokinetics\n### Absorption and distribution\n### Metabolism and excretion\n## Special populations\n### Elderly, pediatric, acetylator status, gender\n# Indications and usage\n# Contraindications\n# Warning","[{\"question\":\"What is sulfasalazine and how is it used in ulcerative colitis?\",\"answer\":\"Sulfasalazine tablets contain sulfasalazine for oral administration. They are indicated for treating mild to moderate ulcerative colitis, as adjunctive therapy in severe ulcerative colitis, and for prolonging remission between acute attacks.\"},{\"question\":\"How does sulfasalazine work according to the document’s pharmacodynamics?\",\"answer\":\"The action of sulfasalazine or its metabolites (5-ASA and sulfapyridine) may involve anti-inflammatory and/or immunomodulatory properties. In ulcerative colitis, major therapeutic action may reside in the 5-ASA portion.\"},{\"question\":\"What pharmacokinetic factors influence sulfasalazine metabolites, especially acetylator status?\",\"answer\":\"Sulfasalazine is metabolized in the intestine to sulfapyridine (SP) and 5-ASA. The metabolism of SP to its main metabolite is dependent on acetylator phenotype, leading to different plasma half-lives in fast versus slow acetylators, and slow acetylators may show a higher incidence of adverse events in a small trial.\"}]","SULFASALAZINE - Sulfasalazine Tablet - Description, Clinical Pharmacology, Indications | PDF",1788831854,35,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":13,"keywords":34,"description":14,"schema_data":35,"social_meta":87,"head_meta":89,"extra_data":91,"updated_unix":28},"sulfasalazine-sulfasalazine-tablet-description-clinical-pharmacology-indications","",{"@graph":36,"@context":86},[37,54,69],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":20},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/document/","Document",2,{"item":49,"name":12,"@type":43,"position":50},"https://docshare.wps.com/document/healthcare/",3,{"item":52,"name":13,"@type":43,"position":53},"https://docshare.wps.com/document/sulfasalazine-sulfasalazine-tablet-description-clinical-pharmacology-indications/217270/",4,{"url":52,"name":13,"@type":55,"author":56,"headline":13,"publisher":58,"fileFormat":61,"inLanguage":23,"description":14,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/pdf","2026-09-11","2026-09-08",true,{"@type":66,"interactionType":67,"userInteractionCount":20},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"What is sulfasalazine and how is it used in ulcerative colitis?","Question",{"text":76,"@type":77},"Sulfasalazine tablets contain sulfasalazine for oral administration. They are indicated for treating mild to moderate ulcerative colitis, as adjunctive therapy in severe ulcerative colitis, and for prolonging remission between acute attacks.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"How does sulfasalazine work according to the document’s pharmacodynamics?",{"text":81,"@type":77},"The action of sulfasalazine or its metabolites (5-ASA and sulfapyridine) may involve anti-inflammatory and/or immunomodulatory properties. In ulcerative colitis, major therapeutic action may reside in the 5-ASA portion.",{"name":83,"@type":74,"acceptedAnswer":84},"What pharmacokinetic factors influence sulfasalazine metabolites, especially acetylator status?",{"text":85,"@type":77},"Sulfasalazine is metabolized in the intestine to sulfapyridine (SP) and 5-ASA. The metabolism of SP to its main metabolite is dependent on acetylator phenotype, leading to different plasma half-lives in fast versus slow acetylators, and slow acetylators may show a higher incidence of adverse events in a small trial.","https://schema.org",{"og:url":52,"og:type":88,"og:title":13,"og:site_name":59,"og:description":14},"article",{"robots":90,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":93},[94,98,102,106,111,116,119,124,129,132,136],{"id":20,"doc_module":4,"doc_module_name":46,"category_name":95,"show_sort_weight":96,"slug":97},"Story & Novel",90,"story-novel",{"id":47,"doc_module":4,"doc_module_name":46,"category_name":99,"show_sort_weight":100,"slug":101},"Literature",80,"literature",{"id":53,"doc_module":4,"doc_module_name":46,"category_name":103,"show_sort_weight":104,"slug":105},"Exam",70,"exam",{"id":107,"doc_module":4,"doc_module_name":46,"category_name":108,"show_sort_weight":109,"slug":110},5,"Comic",60,"comic",{"id":112,"doc_module":4,"doc_module_name":46,"category_name":113,"show_sort_weight":114,"slug":115},6,"Technology",50,"technology",{"id":11,"doc_module":4,"doc_module_name":46,"category_name":12,"show_sort_weight":117,"slug":118},40,"healthcare",{"id":120,"doc_module":4,"doc_module_name":46,"category_name":121,"show_sort_weight":122,"slug":123},8,"Research & Report",30,"research-report",{"id":125,"doc_module":4,"doc_module_name":46,"category_name":126,"show_sort_weight":127,"slug":128},9,"Religion & Spirituality",20,"religion-spirituality",{"id":127,"doc_module":4,"doc_module_name":46,"category_name":130,"show_sort_weight":127,"slug":131},"World Cup","world-cup",{"id":133,"doc_module":4,"doc_module_name":46,"category_name":134,"show_sort_weight":133,"slug":135},10,"Lifestyle","lifestyle",{"id":137,"doc_module":4,"doc_module_name":46,"category_name":138,"show_sort_weight":107,"slug":139},19,"General","general"]