[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-216937-en":3,"doc-seo-216937-105":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},216937,962084931830,"Jacob","https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd",7,"Healthcare","Tramadol Hydrochloride and Acetaminophen Tablets, USP - Clinical Pharmacology Overview","Tramadol hydrochloride and acetaminophen tablets combine a centrally acting synthetic opioid analgesic with a non-opiate analgesic and antipyretic agent. Clinical pharmacology describes tramadol’s analgesic mechanisms through µ-opioid receptor binding of parent drug and the M1 metabolite, plus weak inhibition of norepinephrine and serotonin reuptake. Pharmacokinetics outlines absorption, enantiomer-specific parameters, and food effects, including delayed time to peak without changing overall absorption extent. Volunteer studies report no single-dose interaction, while steady-state dosing shows reduced tramadol and M1 bioavailability for combination tablets versus tramadol alone, without significant acetaminophen changes.","TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN-tramadol hydrochloride and acetaminophen tablet  \nAvPAK  \n----------  \nTramadol Hydrochloride and Acetaminophen Tablets, USP CIV  \nDESCRIPTION  \nTramadol hydrochloride and acetaminophen tablets , USP combine two analgesics , tramadol, USP 37.5 mg and acetaminophen, USP 325 mg.  \nThe chemical name for tramadol hydrochloride, USP is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:  \nThe molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter , crystalline and odorless powder .  \nThe chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is:  \nThe molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless , crystalline powder , possessing a slightly bitter taste.  \nTramadol hydrochloride and acetaminophen tablets , USP contain 37.5 mg tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color . Inactive ingredients in the tablets are carnauba wax , crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide.  \nDissolution Method: Test 2  \nCLINICAL PHARMACOLOGY  \nThe following information is based on studies of tramadol alone or acetaminophen alone, except where otherwise noted:  \nPharmacodynamics  \nTramadol hydrochloride and acetaminophen tablets contain tramadol hydrochloride and acetaminophen. Tramadol is a centrally acting synthetic opioid analgesic . Although its mode of action is not completely understood, from animal tests , at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.  \nOpioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to µ-opioid receptors . In animal models , M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests . The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY, Pharmacokinetics) .  \nTramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro , as have some other opioid analgesics . These mechanisms may contribute independently to the overall analgesic profile of tramadol.  \nApart from analgesia, tramadol administration may produce a constellation of symptoms (including dizziness , somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids .  \nAcetaminophen is a non-opiate, non-salicylate analgesic .  \nPharmacokinetics  \nTramadol is administered as a racemate and both the [-] and [+] forms of both tramadoland M1 are detected in the circulation. The pharmacokinetics of plasma tramadol and acetaminophen following oral administration of one tramadol hydrochloride and acetaminophen tablet are shown in Table 1. Tramadol has a slower absorption and longer half-life when compared to acetaminophen.  \nTable 1: Summary of Mean (±SD) Pharmacokinetic Parameters of the (+) -and (-) Enantiomers of Tramadol and M1 and Acetaminophen Following A Single Oral Dose Of One Tramadol Hydrochloride and Acetaminophen Combination Tablet  \n(37 .5 mg/325 mg) in Volunteers .  \n Parameter a (+)-Tramadol (-)-Tramadol (+)-M1 (-)-M1 acetaminophen  C max (ng/mL) 64.3 (9 . 3) 55.5 (8 . 1) 10.9 (5 . 7) 12.8 (4 . 2) 4.2 (0 . 8)  \nt max (h) 1.8 (0 . 6) 1.8 (0 . 7) 2.1 (0 . 7) 2.2 (0 . 7) 0.9 (0 . 7)  \nCL/F (mL/min) 588 (226) 736 (244) - - - - 365 (84) ","cbCaiaRmzZWnj2fO","https://ap.wps.com/l/cbCaiaRmzZWnj2fO","pdf",174318,1,21,"English","en",105,"# Description\n## Drug composition and inactive ingredients\n# Clinical Pharmacology\n## Pharmacodynamics\n## Pharmacokinetics\n## Food effects","[{\"question\":\"What are the main components and strengths of the tablets?\",\"answer\":\"The tablets combine tramadol hydrochloride (37.5 mg) and acetaminophen (325 mg).\"},{\"question\":\"How does tramadol produce analgesia according to the pharmacodynamics section?\",\"answer\":\"Analgesia is linked to binding of tramadol and its M1 metabolite to µ-opioid receptors, plus weak inhibition of norepinephrine and serotonin reuptake.\"},{\"question\":\"Are there drug interactions between tramadol and acetaminophen?\",\"answer\":\"A single-dose pharmacokinetic study in volunteers showed no drug interactions. With multiple dosing to steady state, bioavailability of tramadol and M1 was lower for the combination tablets compared with tramadol alone.\"}]","Tramadol Hydrochloride and Acetaminophen Tablets, USP - Clinical Pharmacology Overview | PDF",1788828472,53,{"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},"tramadol-hydrochloride-and-acetaminophen-tablets-usp-clinical-pharmacology-overview","",{"@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/tramadol-hydrochloride-and-acetaminophen-tablets-usp-clinical-pharmacology-overview/216937/",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/tramadol-hydrochloride-and-acetaminophen-tablets-usp-clinical-pharmacology-overview/216937.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 are the main components and strengths of the tablets?","Question",{"text":81,"@type":82},"The tablets combine tramadol hydrochloride (37.5 mg) and acetaminophen (325 mg).","Answer",{"name":84,"@type":79,"acceptedAnswer":85},"How does tramadol produce analgesia according to the pharmacodynamics section?",{"text":86,"@type":82},"Analgesia is linked to binding of tramadol and its M1 metabolite to µ-opioid receptors, plus weak inhibition of norepinephrine and serotonin reuptake.",{"name":88,"@type":79,"acceptedAnswer":89},"Are there drug interactions between tramadol and acetaminophen?",{"text":90,"@type":82},"A single-dose pharmacokinetic study in volunteers showed no drug interactions. With multiple dosing to steady state, bioavailability of tramadol and M1 was lower for the combination tablets compared with tramadol alone.","https://schema.org",{"og:url":52,"og:type":93,"og:title":13,"og:site_name":64,"og:description":14},"article",{"robots":95,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":98},[99,103,107,111,116,121,124,129,134,137,141],{"id":20,"doc_module":4,"doc_module_name":46,"category_name":100,"show_sort_weight":101,"slug":102},"Story & Novel",90,"story-novel",{"id":47,"doc_module":4,"doc_module_name":46,"category_name":104,"show_sort_weight":105,"slug":106},"Literature",80,"literature",{"id":53,"doc_module":4,"doc_module_name":46,"category_name":108,"show_sort_weight":109,"slug":110},"Exam",70,"exam",{"id":112,"doc_module":4,"doc_module_name":46,"category_name":113,"show_sort_weight":114,"slug":115},5,"Comic",60,"comic",{"id":117,"doc_module":4,"doc_module_name":46,"category_name":118,"show_sort_weight":119,"slug":120},6,"Technology",50,"technology",{"id":11,"doc_module":4,"doc_module_name":46,"category_name":12,"show_sort_weight":122,"slug":123},40,"healthcare",{"id":125,"doc_module":4,"doc_module_name":46,"category_name":126,"show_sort_weight":127,"slug":128},8,"Research & Report",30,"research-report",{"id":130,"doc_module":4,"doc_module_name":46,"category_name":131,"show_sort_weight":132,"slug":133},9,"Religion & Spirituality",20,"religion-spirituality",{"id":132,"doc_module":4,"doc_module_name":46,"category_name":135,"show_sort_weight":132,"slug":136},"World Cup","world-cup",{"id":138,"doc_module":4,"doc_module_name":46,"category_name":139,"show_sort_weight":138,"slug":140},10,"Lifestyle","lifestyle",{"id":142,"doc_module":4,"doc_module_name":46,"category_name":143,"show_sort_weight":112,"slug":144},19,"General","general"]