𝔖 Bobbio Scriptorium
✦   LIBER   ✦

Call for abstracts 1990 scientific forum of American College of Emergency Physicians


Book ID
104310939
Publisher
Elsevier Science
Year
1990
Tongue
English
Weight
148 KB
Volume
19
Category
Article
ISSN
1097-6760

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✦ Synopsis


7.5 m g hydrocodone bitartrate a n d 650 m g acetaminophen (May be habit forming.)

BRIEF SUMMARY OF PRESCRIBING INFORMATION CLINICAL PHARMACOLOGY

Uydmcadone is a semisynthetic narcotic analgesic and antitexsive with multiple actthex q~,lBa tively similar to tl~se of codeine Most of these involve the esetml nervous system and smooth muscle. The precise mebeaeism el action of hydracnBane and other npthbs is nat knOWer although it is believed to rethte to the existe~e ot opiate receptors in the copeat nervous system, th additthn to analgesia, narcotics may produce drowsiness, changex in mood and mental clouding

INBICAE[ONS AHB USAGE

Fnr the relntf of moderate te mndmathly severe pain. CBUTBAIRBICATIOBS Hypersensitivity to acntam[nbeBafl nr hydrncodexe.

WARNINGS Respiratory Oepression:

At the high doses er th sensitive patients, hydrocodnne may produce dnsemelnted respiratory depression by acting dlrecUy on the brain stem respiratory cee~ee Bydre copose also affects the center that contrels respiratory rhythm, ned may pmpoce dregular and periodic breathing. Head Injury and Increased Intraeranial Pressure: Fbe respiratory depressant effects of narcotics and their capacity to elevate eerebmapthal fluid pressure may be markedly exaggerated in the presence of bend injoly, other irdracrantal lesions or a pro existing increase ie intracraethl ressere Furthermore, narcotics produce adverse rexct]ese which may obscure the clinical course of patients w h head injuries Acnte Abdominal Conditions: The administration of exmntica may obscure the diagnosis nr clinical course of patients with acnte abdominal cnnditiexs PRECAUTIONS Special Risk Patients: As with any narcotic ann]Basic agent, Hythncodsee gibrtrate and gcentponophnn [ablate sbeuld be nsbe with caution in elderly or dethDtnted patients and these with severe impairment of hepatic nr re~[ function, bypothyrthdism, Addison's disease, prostatic hypertrophy or orethraL strthtara. The usoal precexlises should be observed and the posaibiDty of repa]retery depression sbenld be kept in mind. Information for Patients: ~rncndone Bitartrate and Acetaminophea Tablets, like aD serentics, may impair the mental and/or physical abilities required far the performance nt potentially bezarpoue tasks snch as driving a car or oberntthg machthery; patients should be cantinned accordthgty CouRh Reflex= Bydrecbeexa suppresses the cough reflex; as with all narcotics, caution sbould be exercised when Hydrec~exe gitartrate and Acatabenepben fableth are used beetpaeratisely ned in patients with puBaonary diseexe Bran Interactions: Patients receiving other narcotic ase]gesica, antipggcbeties, anfianxthty agents, or ether CNS depressants (including alcohol) cnncapotmlUy with hydrncednne and acstapono phen tablets may exhibit an additive CNS depmseion. When combined therapy is sontemplnted, [he dose of one or both agents should be reduced

The use nf MAO inhth]fers or tricpolic antidepressants with hydrecpoene prepnrnt ions may increase the nlfect nl either the antidepressant or hythecodnne

The concurrent usa of antinbelieergcs with hythosedsee may produce paralytic flees UsaGe in Pregnancy: Terutogenic Effects: Pregnancy Category C Hydrecodene has been shown to be terntegenic in bemsthrs when given in doses POe times the human dose. There are no abeqoate and weDseontreHed studies in preGnant woman. Hydrecadnne Bitartrata and Acntmaieopbee Tablets sbenLd be u~d during pregnancy nnty if the potential benefit iustilths the potential risk to the fetus Hnateratogeoic Effects: Babies born tn mothers who bexe been taking paBads regularly prior to delivery will be phythcally dependent. "ale withdrawal signs include iritabi[ity and excessive crying, tremors, Pyperadive reUexex, increased respffathry [aLe, increased stools, sneezing, yawning, vnmitthg, and thser. The intensity nf the aybemme does not abeays correlate with the duration el maternal npthid use Dr dose There is eo cnnsensus on the best method ef managing withdrawn[ Chlerpromazine O.7 to I m~kg q6h, and paregoric 2 to d drnps/kg q4h, have been used to treat witbthawaL symptoms in infants The domlion of therapy is 4 to 28 days, with the dosage decreased as thieraPed. LePer and Delivery: As with aD narcotics, edmienttrntion th DyPnosoBaoe Bithrtrnte and Acetaponpabee Tablets to the mother sbertly before Ba]ivery may reseU in some degree el respiratory depression in the newborn, especintly if bi~e[ doses are used Nursing Mothers: B is not knnwn whether tats drug is excreted in human milk, Because many drugs are excreted in human nBIk ned because of the pnteetthl for serious adverse reactions ie nursing talents from Hythecndnnn gBartrath and Acethmieephen Tablets, a decision sbeuld be made wbethar tn diecnntthun nursing nr to dthsentinue the drug, taking into aecoset the impnrntnee nt the drug tn the mntbeE Pediatric Use: Safety and eilectiseeesa in children have net been exntblishbe

ADVERSE REACTIONS

The moat frequently obsenabe adverse re~nLthns gmlude DghtheaBapoess, dizzntess, sedation, causen and vomiting these effects seem to be more prorthennt in ambethtory than in nmlnmbntntory palgmta and some of the adverse reactions may be aPevntted it the pntthnt lies down Uther adverse reactions include: Central Nervous System: Drowsiness, mental clouding, lethargy, impailment of mental and physical peflormance, anxiety, fear, dyspbeda, psychic dependence, mood changes Gastrointestinal System: Tile antthrentΒ’ phenathiazines are useful in suppressing the nausea and vomiting which may ~cur (see above); bnwevm, some phenn~iazine derivatives seem to be anti analgesic and to increase the amocat nt ear.tic required to preduce pain relthl, while otber phenothiazines rednce the am~nt el na[setic reqLgre~ to produce a given level of anaLGe, sia. ?relonged ~mintatratian of HythocoBase Bitartrnte and Acntamthnpben Tablets may produce cexstipntion. Genitourinary System: Ureteral spasm, spasm of vexical sphntnte, s and nrinary rntenl[nn have Baen reported Respiratory Depression: flydrnsednno bintntrate may produce Rose related respPntory Bapresstha by acting directly on the taahl stem respiratory eentee HydrocoBaen also affecta the centel that em/truls respiratory thytPm, abe may produce irregular and periodic breathing If significant respiratory depression occurs, it may be antagonized by Um use of nalnxmro hythnbeloride Apoly tither supportive measares when d~icated URBG ABUSE AUB DEPEHBEHCE gyntocadnnn Bitartrnte ar~ Aentamthopbeo ~athets are subject to the tepornt DnnlroDed Substance


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