[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-216933-en":3,"doc-seo-216933-105":30,"detail-sidebar-cat-0-en-105":97},{"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},216933,687207024478,"Mia  ","https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd",7,"Healthcare","RIFATER Rx Only - Warnings, Description, and Clinical Pharmacology","RIFATER (rifampin, isoniazid, pyrazinamide USP) tablets provide a triple-drug antibacterial regimen presented with Rx-only safety guidance. The warning highlights the risk of severe and sometimes fatal hepatitis linked to isoniazid, including age- and alcohol-related risk patterns, monitoring of symptoms, and management guidance for liver enzyme elevations or suspected hepatic damage. The document also describes tablet composition, inactive ingredients, and the pharmacologic profile, including bioavailability and pharmacokinetic comparisons with separate-dose regimens.","RIFATER® Rx Only  \n(rifampin, isoniazid and pyrazinamide USP)  \nTablets  \nWARNING  \nSevere and sometimes fatal hepatitis associated with isoniazid, a component of RIFATER, therapy may occur and may develop even after many months of treatment. The risk of developing hepatitis is age related. Approximate case rates by age are: 0 per 1,000 for persons under 20 years of age, 3 per 1,000 for persons in the 20 to 34 year age group, 12 per 1,000 for persons in the 35 to 49 year age group, 23 per 1,000 for persons in the 50 to 64 year age group, and 8 per 1,000 for persons over 65 years of age. The risk of hepatitis is increased with daily consumption of alcohol. Precise data to provide a fatality rate for isoniazid-related hepatitis is not  \navailable; however, in a U.S. Public Health Service Surveillance Study of 13,838 persons taking isoniazid, there were 8 deaths among 174 cases of hepatitis. Therefore, patients given RIFATER, which contains isoniazid, should be carefully monitored and interviewed at monthly intervals. Serum transaminase concentration becomes elevated in about 10% to 20% of patients, usually during the first few months of therapy, but it can occur at any time. Usually enzyme levels return to normal despite continuance of drug, but in some cases progressive liver dysfunction occurs. Patients should be instructed to report immediately any of the prodromal symptoms of hepatitis, such as fatigue, weakness, malaise, anorexia, nausea, or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, RIFATER, should be discontinued promptly since continued use of the drug in these cases has been reported to cause a more severe form of liver damage. Patients with tuberculosis should be given appropriate treatment with alternative drugs. If isoniazid, a component of RIFATER, must be reinstituted, it should be reinstituted only after symptoms and laboratory abnormalities have cleared. RIFATER should not be restarted and instead, isoniazid should be restarted in very small and gradually increasing doses and should be withdrawn immediately if thereis any indication of recurrent liver involvement. Treatment should be deferred in persons with acute hepatic diseases.  \nDESCRIPTION  \nRIFATER (rifampin/isoniazid/pyrazinamide USP) tablets are combination tablets containing 120 mg rifampin, 50 mg isoniazid, and 300 mg pyrazinamide for use in antibacterial therapy. The tablets also contain as inactive ingredients: povidone, carboxymethyl cellulose sodium, calcium stearate, sodium lauryl sulfate, sucrose, talc, acacia, titanium dioxide, kaolin, magnesium carbonate, colloidal silicon dioxide, dried aluminum hydroxide gel, ferric oxide, black iron oxide, carnauba wax, white beeswax, colophony, hard paraffin, lecithin, shellac, and propylene glycol. The RIFATER triple therapy combination was developed for dosing convenience.  \nRifampin  \nRifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:  \n3-[[(4-methyl-1-piperazinyl)imino]methyl]-rifamycinor  \n5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl- 1-piperazinyl) formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan- 1,11(2H)-dione 21-acetate.  \nIts structural formula is:  \nIsoniazid  \nIsoniazid is the hydrazide of isonicotinic acid. It is a colorless or white crystalline powder or white crystals. It is odorless and slowly affected by exposure to air and light. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Its molecular weight is 137.14 and its chemical formula is C6H7N3O.  \nThe chemical name for isoniazid is 4-pyridinecarboxylic acid, hydrazide and its structural formu","cbCaisxlSFx3bqRY","https://ap.wps.com/l/cbCaisxlSFx3bqRY","pdf",119357,1,8,"English","en",105,"# WARNING\n## Risk of hepatitis and monitoring instructions\n# DESCRIPTION\n## Tablet composition and inactive ingredients\n## Triple-therapy dosing convenience\n# RIFAMPIN\n## Properties and chemical information\n# ISONIAZID\n## Properties and chemical information\n# PYRAZINAMIDE\n## Properties and chemical information\n# CLINICAL PHARMACOLOGY\n## General bioavailability and pharmacokinetics","[{\"question\":\"What warning is included for RIFATER regarding hepatitis?\",\"answer\":\"RIFATER therapy carries a risk of severe and sometimes fatal hepatitis associated with isoniazid, and the condition may develop even after months of treatment.\"},{\"question\":\"How does age and alcohol use affect hepatitis risk?\",\"answer\":\"Hepatitis risk is age related and increases with daily alcohol consumption, with approximate case rates provided across age groups.\"},{\"question\":\"What monitoring and discontinuation guidance is provided if hepatitis symptoms appear?\",\"answer\":\"Patients should be instructed to report early hepatitis prodromal symptoms immediately; if symptoms or signs suggest hepatic damage occur, RIFATER should be discontinued promptly and alternative management used for tuberculosis patients.\"}]","RIFATER Rx Only - Warnings, Description, and Clinical Pharmacology | PDF",1788828410,20,{"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":92,"head_meta":94,"extra_data":96,"updated_unix":28},"rifater-rx-only-warnings-description-and-clinical-pharmacology","",{"@graph":36,"@context":91},[37,54,74],{"@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/rifater-rx-only-warnings-description-and-clinical-pharmacology/216933/",4,{"url":52,"name":13,"@type":55,"image":56,"author":61,"headline":13,"publisher":63,"fileFormat":66,"inLanguage":23,"description":14,"dateModified":67,"datePublished":68,"encodingFormat":66,"isAccessibleForFree":69,"interactionStatistic":70},"DigitalDocument",{"url":57,"@type":58,"width":59,"height":60},"https://docshare.wps.com/thumbnails/rifater-rx-only-warnings-description-and-clinical-pharmacology/216933.png","ImageObject",300,407,{"name":9,"@type":62},"Person",{"url":41,"name":64,"@type":65},"DocShare","Organization","application/pdf","2026-09-11","2026-09-08",true,{"@type":71,"interactionType":72,"userInteractionCount":20},"InteractionCounter",{"@type":73},"ViewAction",{"@type":75,"mainEntity":76},"FAQPage",[77,83,87],{"name":78,"@type":79,"acceptedAnswer":80},"What warning is included for RIFATER regarding hepatitis?","Question",{"text":81,"@type":82},"RIFATER therapy carries a risk of severe and sometimes fatal hepatitis associated with isoniazid, and the condition may develop even after months of treatment.","Answer",{"name":84,"@type":79,"acceptedAnswer":85},"How does age and alcohol use affect hepatitis risk?",{"text":86,"@type":82},"Hepatitis risk is age related and increases with daily alcohol consumption, with approximate case rates provided across age groups.",{"name":88,"@type":79,"acceptedAnswer":89},"What monitoring and discontinuation guidance is provided if hepatitis symptoms appear?",{"text":90,"@type":82},"Patients should be instructed to report early hepatitis prodromal symptoms immediately; 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