| Revision as of 16:16, 11 October 2011 edit94.193.251.53 (talk) apostrophe← Previous edit |
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{{Short description|Combination pain relief drug}} |
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{{refimprove|date=October 2010}} |
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{{Use dmy dates|date=January 2024}} |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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{{Drugbox |
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{{Drugbox |
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| Verifiedfields = changed |
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| verifiedrevid = 401626179 |
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| Watchedfields = changed |
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| image = Vicodin5mg.jpg |
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| verifiedrevid = 470622128 |
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| drug_name = Hydrocodone / Paracetamol |
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| type = combo |
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| image = Vicodin5mg.jpg |
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| alt = |
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<!--Combo data--> |
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<!-- Combo data --> |
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| component1 = Hydrocodone |
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| type = combo |
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| class1 = ] |
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| component1 = Hydrocodone |
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| component2 = Paracetamol |
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| class1 = ] |
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| class2 = ] |
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| component2 = Paracetamol |
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| class2 = ] |
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| component4 = <!-- Drugname, automatically linked --> |
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| class4 = <!-- Group, manual link using ] --> |
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<!--Clinical data--> |
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<!-- Clinical data --> |
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| tradename = |
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| tradename = Lorcet, Norco, Vicodin, others |
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| Drugs.com = {{drugs.com|parent|hydrocodone/paracetamol}} |
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| Drugs.com = {{drugs.com|ppa|hydrocodone-and-acetaminophen}} |
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| MedlinePlus = |
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| licence_EU = <!-- EMEA requires brand name --> |
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| DailyMedID = Hydrocodone bitartrate and acetaminophen |
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| licence_US = Vicodin |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU_comment = |
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| pregnancy_US = C |
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| pregnancy_category = |
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| pregnancy_category = |
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| dependency_liability = |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> |
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| addiction_liability = |
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| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| routes_of_administration = ] |
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| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> |
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| ATC_prefix = N02 |
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| legal_US = Schedule III |
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| ATC_suffix = AJ22 |
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| routes_of_administration = ] |
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| ATC_supplemental = |
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<!--Identifiers--> |
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<!-- Legal status --> |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> |
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| CAS_number = 330988-71-1 |
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| legal_AU_comment = |
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| PubChem = 11247932 |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> |
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| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} |
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| legal_BR_comment = |
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| ChemSpiderID = 9422965 |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_CA_comment = |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_DE_comment = |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_NZ_comment = |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> |
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| legal_UK_comment = |
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| legal_US = Schedule II |
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| legal_US_comment = <ref name="Norco FDA label">{{cite web | title=Norco (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) CII Revised: March 2021 | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=566bd196-3c0c-4f05-9e2e-4803ad3126d4 | access-date=23 November 2022}}</ref><ref name="Vicodin FDA label">{{cite web | title=Vicodin Vicodin ES Vicodin HP (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) Rx only CS-II | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=365698 | access-date=23 November 2022}}</ref> |
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| legal_EU = |
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| legal_EU_comment = |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
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| legal_UN_comment = |
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| legal_status = <!-- For countries not listed above --> |
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<!--Chemical data--> |
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<!-- Pharmacokinetic data --> |
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| bioavailability = >80% |
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| smiles = O=C(Nc1ccc(O)cc1)C.O=C45Oc1c2c(ccc1OC)C3N(CC253CC4)C |
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| metabolism = Hydrocodone: extensively ], primarily ];<br /> /Paracetamol: liver, ] |
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| InChI = 1/C18H21NO3.C8H9NO2/c1-19-8-7-18-11-4-5-13(20)17(18)22-16-14(21-2)6-3-10(15(16)18)9-12(11)19;1-6(10)9-7-2-4-8(11)5-3-7/h3,6,11-12,17H,4-5,7-9H2,1-2H3;2-5,11H,1H3,(H,9,10)/t11-,12+,17-,18-;/m0./s1 |
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| elimination_half-life = for hydrocodone: 228–294 mins (3.8–4.9 hrs); for paracetamol: 120–240 mins (2–4 hrs) |
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| InChIKey = DQGPYIDMOHQZSY-RNWHKREABN |
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| excretion = for hydrocodone: urinary; for paracetamol: urinary (10–15% unchanged) |
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| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChI = 1S/C18H21NO3.C8H9NO2/c1-19-8-7-18-11-4-5-13(20)17(18)22-16-14(21-2)6-3-10(15(16)18)9-12(11)19;1-6(10)9-7-2-4-8(11)5-3-7/h3,6,11-12,17H,4-5,7-9H2,1-2H3;2-5,11H,1H3,(H,9,10)/t11-,12+,17-,18-;/m0./s1 |
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<!-- Identifiers --> |
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| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
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| CAS_number_Ref = {{cascite|changed|??}} |
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| StdInChIKey = DQGPYIDMOHQZSY-RNWHKREASA-N |
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| CAS_number = 330988-71-1 |
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| PubChem = 11247932 |
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| IUPHAR_ligand = |
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| DrugBank = |
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| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} |
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| ChemSpiderID = 9422965 |
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| UNII = |
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| KEGG = |
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| ChEBI = |
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| ChEMBL = |
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| synonyms = Hydrocodone/acetaminophen, hydrocodone/APAP |
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}} |
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}} |
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'''Hydrocodone/paracetamol''' (also known as '''hydrocodone/acetaminophen''') is a combination of two ] products ] and ] (acetaminophen) used to relieve moderate to severe ].<ref></ref> It is usually found in tablet form, produced and marketed under the ]s ''Vicodin'', ''Vicodin ES'', ''Vicodin HP'', ''Anexsia'', ''Anolor DH5'', ''Bancap HC'', ''Zydone'', ''Dolacet'', ''Lorcet'', ''Lortab'', and ''Norco'', as well as ]. Hydrocodone also comes in a combination with ], available under the trade name ]. |
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<!-- Definition and medical uses --> |
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==Medical uses== |
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'''Hydrocodone/paracetamol''' (also known as '''hydrocodone/acetaminophen''') is the combination of the ]s ] and ] (acetaminophen).<ref name="Norco FDA label" /> It is used to treat moderate to severe ].<ref name="Norco FDA label" /><ref name=Man2010>{{cite book | vauthors = Mancano M, Gallagher J |title=Frequently Prescribed Medications |date=2010 |publisher=Jones & Bartlett Learning |isbn=9780763781170 |page=7 |url=https://books.google.com/books?id=EUV5CjvH9B4C&pg=PA7 }}</ref> It is taken ].<ref name="Norco FDA label" /> ] is common in the United States.<ref>{{cite book | vauthors = Parrillo VN |title=Encyclopedia of Social Problems |date=2008 |publisher=SAGE |isbn=9781412941655 |page=262 |url=https://books.google.com/books?id=mRGr_B4Y1CEC&pg=PT306 }}</ref><ref>{{cite journal | vauthors = Singla A, Sloan P | title = Pharmacokinetic evaluation of hydrocodone/acetaminophen for pain management | journal = Journal of Opioid Management | volume = 9 | issue = 1 | pages = 71–80 | date = 2013 | pmid = 23709306 | doi = 10.5055/jom.2013.0149 }}</ref> |
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Hydrocodone/paracetamol, like other ] analgesics, is used to manage pain. It is most commonly prescribed for relief of moderate to moderately severe pain of acute, chronic, or post-operative types. |
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<!-- Side effects and mechanism --> |
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===Formulations=== |
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Common side effects include dizziness, sleepiness, ], and vomiting.<ref name="Norco FDA label" /><ref name=Man2010/> Serious side effects include ], ], ], ], and ].<ref name="Norco FDA label" /> Use during ] may harm the fetus.<ref name="Norco FDA label" /> Use with ] is not recommended.<ref name=Man2010/> Hydrocodone works by binding to the ].<ref name="Norco FDA label" /> How paracetamol works is unclear but may involve blocking the creation of ].<ref name="Norco FDA label" /><!-- quote = The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. --><ref name="Mechanism of action of paracetamol">{{cite journal | vauthors = Graham GG, Scott KF | title = Mechanism of action of paracetamol | journal = American Journal of Therapeutics | volume = 12 | issue = 1 | pages = 46–55 | date = 1 February 2005 | pmid = 15662292 | doi = 10.1097/00045391-200501000-00008 | s2cid = 38261222 }}</ref> |
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<!-- Society and culture --> |
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Hydrocodone/paracetamol is made as a mixture of hydrocodone and paracetamol. Paracetamol acts as an ]/]. Hydrocodone is a semi-synthetic ] analgesic. |
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Hydrocodone/paracetamol was approved for medical use in the United States in 1982.<ref name="Norco FDA label" /> In the United States, it is a ].<ref name="Norco FDA label" /> In 2022, it was the 23rd most commonly prescribed medication in the United States, with more than 23{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Acetaminophen; Hydrocodone Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/AcetaminophenHydrocodone | access-date = 30 August 2024 }}</ref> It is not available in the United Kingdom,<ref>{{cite news | vauthors = Atkins L |title=Know what a Vike is? |url=https://www.theguardian.com/lifeandstyle/2001/aug/16/healthandwellbeing.health1 |access-date=23 December 2018 |work=] |date=16 August 2001}}</ref> though the combination ] (co-codamol) is.<ref>{{cite web |title=Co-codamol 30/500 Tablets - Summary of Product Characteristics (SmPC) |url=https://www.medicines.org.uk/emc/product/4457/smpc |website=eMC |access-date=7 August 2019}}</ref> It is sold under the brand names '''Vicodin''' and '''Norco''' among others.<ref name="Norco FDA label" /><ref name="Vicodin FDA label" /> |
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===Pregnancy=== |
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==Uses== |
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===Medical=== |
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This drug is classified under pregnancy category C. Although not enough research has been done to deem this drug safe for pregnant women, if the positive effects outweigh the possible negatives, then it can be taken. If taken in the time before delivery, it may give rise to respiratory depression in the baby. Mothers using any opioids regularly during pregnancy run the risk of their babies being substance-dependent and, therefore, going through withdrawal symptoms after birth. Withdrawal symptoms include excessive crying, vomiting, irritability, tremors, and fever. Nursing mothers should not use this drug, as ] is transferred through breast milk; it is unknown whether ] is.<ref> HP Official FDA information, side effects and uses. - Drugs.com</ref> |
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Hydrocodone/paracetamol is a ] consisting of the ] hydrocodone and the non-opioid analgesic paracetamol. It is indicated for relief of moderate to severe pain of acute, chronic, or postoperative types.<ref name="Vicodin FDA label" /> Hydrocodone/paracetamol comes in oral solution and tablet formulations; however strength of each component may vary.<ref name="Norco FDA label" /> In October 2014, the ] rescheduled hydrocodone combination drugs from ], to schedule II due to its risk for misuse, abuse, and diversions.<ref name="Federal Register">{{cite web | title=Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II | website=Federal Register | date=22 August 2014 | url=https://www.federalregister.gov/documents/2014/08/22/2014-19922/schedules-of-controlled-substances-rescheduling-of-hydrocodone-combination-products-from-schedule | access-date=23 November 2022}} {{PD-notice}}</ref> |
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==Adverse effects== |
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===Recreational=== |
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Hydrocodone diversion and recreational use have escalated due to its opioid effects.<ref>{{Cite web|title= Norco Addiction |url= https://www.thefix.com/content/norco-addiction|website= The Fix|access-date= 4 November 2015|date= 21 January 2015}}</ref> In 2009 and 2010, hydrocodone was the second most frequently encountered opioid in the pharmaceutical industry. In-drug evidence was submitted to U.S. federal state and local ] laboratories as reported by the ]'s National Forensic Laboratory Information System (NFLIS) and ] (STRIDE).<ref name=April2013DEA>{{cite web |url=https://www.deadiversion.usdoj.gov/drug_chem_info/hydrocodone.pdf |title=Hydrocodone (Trade Names: Vicodin, Lortab, Lorcet-HD, Hycodan, Vicoprofen) |date=April 2013 |publisher=] |access-date=21 May 2013 |archive-date=18 April 2013 |archive-url=https://web.archive.org/web/20130418010504/http://www.deadiversion.usdoj.gov/drug_chem_info/hydrocodone.pdf |url-status=live }}</ref> |
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] |
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Side-effects of hydrocodone/paracetamol are most commonly upset stomach, nausea, and altered mental status (e.g., dizziness, light headedness). Other rarer side-effects include ], ]s, clammy skin, paranoia, hallucinations, severe weakness, ], ], ], ] (yellowing of eyes or skin), unusual ], ], ], stomach pain,<ref>{{cite web |
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| author=Drugs.com | date=March 24, 2008 |
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| url=http://www.drugs.com/vicodin.html | title=Vicodin |
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| publisher=Cerner Multum, Inc. | accessdate=2008-06-09 }}</ref> ], ], ], ], ], ]es, ]ing, ], ], decreased ], and altered ]. Vicodin also has ] effects on the ]. However, some of the less mundane effects can be desirable effects that are sought after by some. Those effects include ] and ], as well as slowing of the pulse. |
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===Pregnancy and breastfeeding=== |
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Unlike ], ] does not cause ulcers. However, paracetamol can cause liver damage, and, thus, dosages should never exceed 4000 mg a day; this is especially important and will be a smaller number of doses when using mixed drugs like Vicodin. It is imperative that users of this drug follow physician-prescribed dosages. Liver damage can manifest, ranging from abdominal pain to outright liver failure, and can necessitate a liver transplant to avoid death. |
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Prolonged use of hydrocodone/paracetamol during pregnancy can result in neonatal opioid withdrawal syndrome.<ref name="Norco FDA label" /> Hydrocodone/paracetamol passes into breast milk and may harm the baby.<ref name="Norco FDA label" /> |
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===Kidney and liver impairment=== |
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==Pharmacodynamics== |
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There is a possible risk of toxicity.<ref name="Norco FDA label" /> |
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Besides the activity of hydrocodone and acetaminophen on their own, there is observed a factor of ] related to the two substances in tandem{{cn}} that is not altogether understood, but this independent synergy has been observed to be related to the inhibition of ]. The pharmacodynamics of a mixed drug such as Vicodin depends on the kinetics of the drugs that comprise it. |
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==Side effects== |
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Hydrocodone: Acts at ].<ref name=Zacny>{{cite journal |author=Zacny JP, Gutierrez S, Bolbolan SA |title=Profiling the subjective, psychomotor, and physiological effects of a hydrocodone/acetaminophen product in recreational drug users |journal=Drug Alcohol Depend |volume=78 |issue=3 |pages=243–52 |year=2005 |month=June |pmid=15893155 |doi=10.1016/j.drugalcdep.2004.11.009}}</ref> Hydrocodone is metabolized to ] by the activity of ] 2D6. Cytochrome 3A4 forms the substrate norhydrocodone. Note that this conversion is only somewhat responsible for the effects of hydrocodone.<ref></ref> Hydrocodone passes through the blood-brain barrier (BBB) because of its modifications. The brain is typically where the analgesic effects are being carried out. Many of the side-effects of this drug are caused by the fact that it so readily crosses the ]. The half-life of hydrocodone is approximately 3.8 hrs. |
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===Most common=== |
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Paracetamol: The major active metabolites are sulphates and glucuronide conjugates. Its main mode of action is to inhibit the activity of the enzyme cyclooxygenase (COX). COX enzymes are necessary for the production of prostaglandins. Prostaglandins are a form of hormone (although rarely classified as such) that are indicated to be mediators of pain, fever, and inflammation. The half-life of paracetamol may be measured either by salivary or by plasma counts. Both measurements give a varying half-life between 1 and 4 hours.<ref>{{cite journal | last1 = Lee |
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* Lightheadedness<ref name="Vicodin FDA label" /> |
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| first1 = HS |
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* Dizziness<ref name="Vicodin FDA label" /> |
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| last2 = Ti |
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* Euphoria {{Citation needed|date=January 2017}} |
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| first2 = TY |
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* Sedation<ref name="Vicodin FDA label" /> |
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| last3 = Lye |
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* Nausea and vomiting<ref name="Vicodin FDA label" /> |
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| first3 = WC |
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* Headaches |
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| last4 = Khoo |
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| first4 = YM |
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| last5 = Tan |
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| first5 = CC |
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|title=Paracetamol and its metabolites in saliva and plasma in chronic dialysis patients |journal=Br J Clin Pharmacol |volume=41 |issue=1 |pages=41–7 |year=1996 |month=January |pmid=8824692 |doi=10.1111/j.1365-2125.1996.tb00157.x}}</ref> Peak levels are reached between 40–60 minutes after ingestion. It has been proposed that paracetamol aids in the reduction of pain by increasing serotonergic neurotransmissions.<ref>{{cite journal |
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| author = Garrone, B., Polenzani L., De Santi, S., Moreci, W., and Guglielmotti, A. |
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| title = Paracetamol reduces neuropathic pain-like behaviour in rats by potentiating serotonergic neurotransmission |
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| journal = Int J Integ Biol |
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| volume = 1 |
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| issue = 3 |
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| pages = 196–205 |
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| year = 2007 |
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| issn = 0973-8363 |
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| url = http://ijib.classicrus.com/IJIB/Arch/2007/1027.pdf |
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}}</ref> Paracetamol is a peripherally acting drug, and hence does not cross the BBB as readily as hydrocodone.{{Citation needed|date=May 2009}} |
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==Society and culture== |
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===Less common=== |
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* Central nervous system: drowsiness, confusion, lethargy, anxiety, fear, unease, dependence, mood changes, impairment of mental and physical performance<ref name="Vicodin FDA label" /> |
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===Manufacture=== |
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* Gastrointestinal system: constipation<ref name="Vicodin FDA label" /> |
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The principal constituent of Vicodin, hydrocodone, has the same basic structure as morphine but is metabolized by different enzymes. There are three variations of Vicodin, with different amounts of hydrocodone in each. Hydrocodone, like oxycodone, is an intermediate-strength analgesic that has similar effects as morphine; hydrocodone is approximately twice as potent as morphine by mouth for acute use. The tablets are made with less hydrocodone than paracetamol. The theory of using the mix comes from the idea that these drugs alleviate pain using different mechanisms and also that the adverse side-effects of each separate drug are reduced by using reduced dosages of both drugs in order to get the same analgesic effect.<ref>{{cite journal |author=Beaver WT, McMillan D |title=Methodological considerations in the evaluation of analgesic combinations: acetaminophen (paracetamol) and hydrocodone in postpartum pain |journal=Br J Clin Pharmacol |volume=10 Suppl 2 |issue= |pages=215S–223S |year=1980 |month=October |pmid=7192153 |pmc=1430165}}</ref> |
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* Genitourinary system: inability to urinate, bladder spasms<ref name="Vicodin FDA label" /> |
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* Respiratory depression: decreased rate and effort of breathing<ref name="Vicodin FDA label" /> |
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* Hearing impairment, permanent hearing loss<ref name="Vicodin FDA label" /> |
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* Dermatological: rash, itching<ref name="Vicodin FDA label" /> |
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===Boxed warning=== |
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Both hydrocodone and acetaminophen are white crystalline powders, which are then manufactured into tablet form. Manufacturers of hydrocodone (generic or otherwise) include Abbott Laboratories (makers of trademark Vicodin), Amerisource Health Services Corp, Cardinal Health, Drx Pharmaceutical Consultants Inc, Eckerd Corp, Hospira Inc, Mallinckrodt Pharm. Quality Care, Pdrx Pharmaceuticals Inc, Physicians Total Care Inc, Rx Papoo |
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"Paracetamol has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of paracetamol at doses that exceed 4000 milligrams per day, and often involve more than one paracetamol-containing product."<ref name="Vicodin FDA label" /> |
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s Packaging Inc, and Watson Pharmaceuticals. |
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In the US, the label for hydrocodone/paracetamol contains a ] about addiction, abuse, and misuse.<ref name="Vicodin FDA label" /><ref name="Norco FDA label" /> |
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On January 13, 2011, FDA announced that it is asking manufacturers of prescription acetaminophen combination products to limit the maximum amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit. FDA believes that limiting the amount of acetaminophen per tablet, capsule, or other dosage unit in prescription products will reduce the risk of severe liver injury from acetaminophen overdosing, an adverse event that can lead to liver failure, liver transplant, and death.<ref>, United States Food and Drug Administration</ref> |
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===Legal status=== |
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==Overdose== |
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Hydrocodone: ], extreme ] progressing towards coma, muscle limpness, cold and clammy skin, slow heart rate, low blood pressure, abrupt loss of heart function, and death may occur.<ref name="Vicodin FDA label" /> |
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In the United States, Vicodin production is regulated in part by the ] of 1970. This guarantees that all manufacturing, importing, possession, and distribution of drugs are to be overseen and regulated by the ]. |
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Paracetamol: Liver and kidney failure, low blood sugar, and coma may occur.<ref name="Vicodin FDA label" /> |
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In the U.S. Vicodin is a ]. Pure ] and ] are Schedule II drugs, but, when compounded with ] or with an ], they can become a Schedule III drug. Schedule III drugs are classified by the U.S. government as having the potential to cause moderate or low physical dependence, or a high psychological dependence if misused. |
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== Interactions == |
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====United States==== |
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To qualify for treatment as a ] medication in the ], hydrocodone must be combined with a non-] ingredient in a recognized ] amount. There are four dosage forms recognized by the U.S. authorities: |
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*per 100 ml (i.e., a liquid), which must have no more than 300 mg of (dissolved) hydrocodone in addition to the therapeutic amount of a non-narcotic ingredient |
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*per dosage unit (i.e., a solid, pill or capsule), which must have no more than 15 mg of hydrocodone in addition to the therapeutic amount of a non-narcotic ingredient |
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Hydrocodone may demonstrate an enhanced respiratory depressant effect when combined with other ]s such as other ]s, ]s, ], ], and ]s.<ref>{{cite journal | vauthors = Becker DE | title = Adverse drug interactions | journal = Anesthesia Progress | volume = 58 | issue = 1 | pages = 31–41 | date = 1 January 2011 | pmid = 21410363 | pmc = 3265267 | doi = 10.2344/0003-3006-58.1.31 }}</ref> |
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=== Proposed U.S. ban === |
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On June 30, 2009, a ] (FDA) advisory panel voted by a narrow margin to advise the FDA to remove Vicodin and another painkiller, ], from the market because of "a high likelihood of overdose from prescription narcotics and acetaminophen products". |
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The panel cited concerns of liver damage from their acetaminophen component, which is also the main ingredient in commonly-used nonprescription drugs such as Tylenol.<ref>, ]</ref> |
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Each year, ] is linked to about 400 deaths and 42,000 hospitalizations.<ref name="NYTreasons">, '']''</ref> |
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Concurrent use of paracetamol with alcohol products may increase the risk of ].<ref name="Vicodin FDA label" /> |
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The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.<ref name=FDA_20110113>{{Cite press release |
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| url = http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239894.htm |
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| date = January 13, 2011 |
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| title = FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings |
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| publisher = ] (FDA) |
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| accessdate = January 13, 2011 |
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}}</ref><ref name=FDA_CDER>{{cite web |
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| url = http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm |
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| title = FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure |
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| date = January 13, 2011 |
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| publisher = ] (FDA) |
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| accessdate = January 13, 2011 |
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}}</ref><ref>{{cite news |
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| url = http://www.boston.com/lifestyle/health/articles/2011/01/13/fda_orders_lowering_pain_reliever_in_vicodin/ |
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| title = FDA orders lowering pain reliever in Vicodin |
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| author = Matthew Perrone |
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| agency = Associated Press |
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| date = January 13, 2011 |
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| work = ] |
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| accessdate = January 13, 2011 |
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}}</ref><ref name=NYT_Harris>{{cite news |
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| url = http://www.nytimes.com/2011/01/14/health/policy/14fda.html |
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| title = F.D.A. Plans New Limits on Prescription Painkillers |
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| author = Gardiner Harris |
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| work = ] |
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| date = January 13, 2011 |
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| accessdate = January 13, 2011 |
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}}</ref> Manufacturers will have three years to limit the amount of acetaminophen in their prescription drug products to 325 mg per dosage unit.<ref name=FDA_CDER /><ref name=NYT_Harris /> The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.<ref name=FDA_20110113 /><ref name=FDA_CDER /><ref name=NYT_Harris /> |
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==Pharmacology== |
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Hydrocodone, the narcotic component of Vicodin, is still available in Canada as a single drug and marketed under the trade name Hycodan in syrup and tablet forms by Bristol-Myers-Squibb.<ref></ref> |
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===Popular media=== |
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===Hydrocodone=== |
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* Mechanism of action: Hydrocodone acts primarily as an agonist at the ], but is also a weak agonist against the ] and ] receptors.<ref name=":0">{{cite journal |vauthors = Vallejo R, Barkin RL, Wang VC |title = Pharmacology of opioids in the treatment of chronic pain syndromes |journal = Pain Physician |volume = 14 |issue = 4 |pages = E343-60 |date = 1 August 2011 |doi = 10.36076/ppj.2011/14/E343 |pmid = 21785485 |doi-access = free }}</ref> |
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The popular American ] ], '']'''s plot centers on the ] habitual use (and abuse) of Vicodin to manage pain stemming from an ] in his ] incurred some years earlier. |
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* Absorption/distribution: The oral formulation can be absorbed from the gastrointestinal tract and remain 20–50% bound to plasma proteins.<ref name=":0"/> The onset of analgesia is about 20 to 30 minutes with a duration of 4 to 8 hours and t<sub>1/2</sub> of 3 to 4 hours.<ref name=":0"/> Maximum serum levels are achieved at 1.3 hours.<ref name="Norco FDA label" /> |
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* Metabolism/excretion: It is metabolized to ] by ] and to ], also biologically active, by ].<ref>{{cite journal |vauthors = Cone EJ, Darwin WD, Gorodetzky CW, Tan T |title = Comparative metabolism of hydrocodone in man, rat, guinea pig, rabbit, and dog |journal = Drug Metabolism and Disposition |volume = 6 |issue = 4 | pages = 488–93 |date = 1 August 1978 |pmid = 28931 }}</ref><ref name=":2">{{Cite book |title= Essentials of Pharmacology for Anesthesia, Pain Medicine, and Critical Care | vauthors = Kaye AD |publisher= Springer |year= 2015 |isbn= 9781461489481 |pages= 134–13}}</ref> For individuals who have a defect in the gene encoding CYP2D6, the clearance of the drug will be lower and less metabolite such as hydromorphone will be formed; however, the effect on analgesia remains unknown.<ref name=":2"/> |
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* Metabolites: Hydromorphone, the major active metabolite, has a 10-33-fold higher binding affinity for the mu-opioid receptor than hydrocodone. It may be up to >100-fold higher in some patients.<ref>{{Cite book |title=Hydrocodone and acetaminophen (paracetamol): Drug information |publisher=Lexicomp |year=2024 |edition=Version 390.0}}</ref> |
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===Paracetamol=== |
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Vicodin is referenced in multiple songs by rapper ] such as "Kill You", "Under the Influence", "Deja Vu", "Old Time's Sake", "Underground", "Going Through Changes", "Oh No", and "Cocaine". He also featured a Vicodin pill on the CD of his debut album '']''. The rapper has admitted to an addiction to the painkiller (along with other substances), the hiatus in rapping that it caused, and the subsequent rehabilitation required to return to his career.<ref>, Access Hollywood, May 4, 2009</ref> |
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* Mechanism of action: Paracetamol acts to inhibit ] enzyme, which is responsible for prostaglandin synthesis.<ref name="Mechanism of action of paracetamol"/> ]s increase the perception of pain. Inhibition of prostaglandin production helps to alleviate pain.<ref>{{cite book |title=Principles of Pharmacology: The Pathophysiologic Basis of Drug Therapy | vauthors = Golan DE |publisher= Lippincott Williams & Wilkins |year=2008 |isbn=978-0-7817-8355-2 |pages=275–276}}</ref> |
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* Absorption/distribution: The half-life of oral paracetamol is 1.25 to 3 hours and peak level is reached by 10–60 minutes after ingestion.<ref name=":3">{{cite book |title=The Essence of Analgesia and Analgesics | vauthors = Sinatra RS |publisher=Cambridge University Press |year=2011 |isbn=978-0-521-14450-6 |pages=256}}</ref> |
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* Metabolism/excretion: Paracetamol is metabolized primarily in the liver via ] and ] to mostly non-toxic metabolites and some highly reactive metabolites, which is inactivated by ].<ref name=":3"/> 85% of the oral dose is excreted via the ]s.<ref name="Vicodin FDA label" /> At high doses, the supply of glutathione cannot meet its demand, thus resulting in the accumulation of highly reactive compounds leading to liver damage.<ref name=":3"/> |
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==Society and culture== |
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==References== |
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{{Reflist|30em}} |
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==External links== |
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===Legal status=== |
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In June 2009, a US ] (FDA) advisory panel voted by a narrow margin to advise the FDA to remove Vicodin and another opioid, ], from the market because of "a high likelihood of overdose from prescription narcotics and acetaminophen products".<ref name=":5"/> The panel also cited concerns of liver damage from their paracetamol component, which is also the main ingredient in commonly used nonprescription drugs such as Tylenol.<ref name=":5">{{cite web|url=http://www.cnn.com/2009/HEALTH/06/30/acetaminophen.fda.hearing/index.html|title=FDA advisers vote to take Vicodin, Percocet off market |publisher=CNN}}</ref> Each year, ] is linked to about 400 deaths and 42,000 hospitalizations.<ref>{{Cite news|title= F.D.A. Plans New Limits on Prescription Painkillers|url= https://www.nytimes.com/2011/01/14/health/policy/14fda.html|newspaper= The New York Times|date= 13 January 2011|access-date= 4 November 2015|issn= 0362-4331| vauthors = Harris G }}</ref> |
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In January 2011, the FDA asked manufacturers of prescription combination products that contain paracetamol to limit the amount of paracetamol to no more than 325 mg in each tablet or capsule within three years.<ref name="FDA_20110113">{{Cite press release | url= https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239894.htm | date= 13 January 2011 | title= FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings | publisher= U.S. ] (FDA) | access-date= 13 January 2011 }}</ref><ref name="FDA_CDER">{{cite web | url= https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-prescription-acetaminophen-products-be-limited-325-mg-dosage-unit | title= FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure | date= 13 January 2011 | publisher= U.S. ] (FDA) | access-date= 13 January 2011 }}</ref><ref>{{cite news | url= http://archive.boston.com/lifestyle/health/articles/2011/01/13/fda_orders_lowering_pain_reliever_in_vicodin/ | title= FDA orders lowering pain reliever in Vicodin | vauthors = Perrone M | agency= Associated Press | date= 13 January 2011 | work= ] | access-date= 13 January 2011 }}</ref><ref name="NYT_Harris">{{cite news | url= https://www.nytimes.com/2011/01/14/health/policy/14fda.html | title= F.D.A. Plans New Limits on Prescription Painkillers | vauthors = Harris G | work= ] | date= 13 January 2011 | access-date= 13 January 2011 }}</ref> The FDA also required manufacturers on all paracetamol-containing products to issue a black box warning indicating the potential risk for severe liver injury and a warning highlighting potential for allergic reactions.<ref name="FDA_20110113"/><ref name="FDA_CDER"/><ref name="NYT_Harris"/> |
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In August 2014, the Drug Enforcement Administration (DEA) announced that all hydrocodone combination products (HCPs) would be rescheduled from schedule III to schedule II of the ] (CSA), effective in October 2014.<ref name="Federal Register" /> In 2010, more than 16,000 deaths were attributed to abuse of opioid drugs.<ref name="Federal Register" /> Even though there are legitimate medical uses for hydrocodone combination products, data suggest that a significant number of individuals misuse them.<ref name="Federal Register" /> |
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===Popular culture=== |
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Actor ] struggled with his addiction to Vicodin for many years after a ] ] in 1997.<ref>{{Cite news |last=Diver |first=Tony |date=29 October 2023 |title='No one would be surprised if I died': How Matthew Perry opened up about his addiction |language=en-GB |work=] |url=https://www.telegraph.co.uk/world-news/2023/10/29/matthew-perry-friends-dead-addiction-painkillers-memoir/ |access-date=17 December 2023 |issn=0307-1235}}</ref> |
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In May 2017, ] ] was arrested by the police for ]. Woods said that this was due to four ] that he was taking for a back operation, one of which was Vicodin.<ref>{{cite news|title=Police release dashcam footage of Tiger Woods' DUI arrest|url=https://www.theguardian.com/sport/2017/may/31/tiger-woods-dui-arrest-dashcam-footage|access-date=1 June 2017|agency=Associated press|publisher=Guardian|date=1 June 2017}}</ref><ref>{{cite news| vauthors = Murray E |title=Tiger Woods says medication, not alcohol led to Florida DUI arrest|url=https://www.theguardian.com/sport/2017/may/29/tiger-woods-dui-charges-florida-golf|access-date=1 June 2017|work=]|date=29 May 2017}}</ref> |
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], the main protagonist of '']'', constantly carries Vicodin with him and often takes it to relieve his leg pain, something that plays a major role throughout the series.<ref name="pilot">{{cite episode| title = Pilot| episode-link = Pilot (House)| series = House, M.D.|airdate = 16 November 2004| season = 1| number = 1}}</ref><ref name="vicodin">{{cite episode| title = Twenty Vicodin| episode-link = Twenty Vicodin| series = House, M.D.|airdate = 3 October 2011| season = 8| number = 1}}</ref> |
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===Brand names=== |
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Brand names include Adol, Hycet, Lortab, Lorcet, Norco, and Vicodin among others.<ref>{{cite web|title=Adol (Hydrocodone-Acetaminoph) Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing – WebMD|url=http://www.webmd.com/drugs/2/drug-163640/adol-hydrocodone-acetaminoph-oral/details|website=WebMD|access-date=26 July 2017}}</ref> |
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== References == |
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{{Reflist}} |
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{{Analgesics}} |
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{{Anti-inflammatory products}} |
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{{Opioid receptor modulators}} |
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{{Portal bar | Medicine}} |
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{{Authority control}} |
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{{DEFAULTSORT:Hydrocodone Paracetamol}} |
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