Hydrocodone/paracetamol

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Hydrocodone/paracetamol
Vicodin5mg.jpg
Combination of
Hydrocodone Opioid analgesic
Paracetamol Anilide analgesic
Clinical data
Trade names Lorcet, Norco, Vicodin, others
Other namesHydrocodone/acetaminophen, hydrocodone/APAP
AHFS/Drugs.com Professional Drug Facts
License data
Routes of
administration 		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability >80%
Metabolism Hydrocodone: extensively liver, primarily CYP3A4;
/Paracetamol: liver, CYP2E1
Elimination half-life for hydrocodone: 228–294 mins (3.8–4.9 hrs); for paracetamol: 120–240 mins (2–4 hrs)
Excretion for hydrocodone: urinary; for paracetamol: urinary (10–15% unchanged)
Identifiers
CAS Number
PubChem CID
ChemSpider
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Hydrocodone/paracetamol (also known as hydrocodone/acetaminophen) is the combination of the pain medications hydrocodone and paracetamol (acetaminophen). [1] It is used to treat moderate to severe pain. [1] [3] It is taken by mouth. [1] Recreational use is common in the United States. [4] [5]

Contents

Common side effects include dizziness, sleepiness, constipation, and vomiting. [1] [3] Serious side effects include addiction, decreased rate of breathing, low blood pressure, serotonin syndrome, severe allergic reactions, and liver failure. [1] Use during pregnancy may harm the fetus. [1] Use with alcohol is not recommended. [3] Hydrocodone works by binding to the mu-opioid receptor. [1] How paracetamol works is unclear but may involve blocking the creation of prostaglandins. [1] [6]

Hydrocodone/paracetamol was approved for medical use in the United States in 1982. [1] In the United States, it is a schedule II controlled substance. [1] In 2021, it was the twentieth most commonly prescribed medication in the United States, with more than 26 million prescriptions. [7] [8] It is not available in the United Kingdom, [9] though the combination codeine/paracetamol (co-codamol) is. [10] It is sold under the brand names Vicodin and Norco among others. [1] [2]

Uses

Medical

Hydrocodone/paracetamol is a fixed-dose combination consisting of the opioid hydrocodone and the non-opioid analgesic paracetamol. It is indicated for relief of moderate to severe pain of acute, chronic, or postoperative types. [2] Hydrocodone/paracetamol comes in oral solution and tablet formulations; however strength of each component may vary. [1] In October 2014, the Drug Enforcement Administration rescheduled hydrocodone combination drugs from schedule III to schedule II due to its risk for misuse, abuse, and diversions. [11]

Recreational

Hydrocodone diversion and recreational use has escalated due to its opioid effects. [12] 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 forensic laboratories as reported by the Drug Enforcement Administration's National Forensic Laboratory Information System (NFLIS) and System to Retrieve Information from Drug Evidence (STRIDE). [13]

Pregnancy and breastfeeding

Prolonged use of hydrocodone/paracetamol during pregnancy can result in neonatal opioid withdrawal syndrome. [1] Hydrocodone/paracetamol passes into breast milk and may harm the baby. [1]

Kidney and liver impairment

Use with caution due to possible risk of toxicity. [1]

Side effects

Most common

Less common

Black box warning

"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." [2]

In the US, the label for hydrocodone/paracetamol contains a black box warning about addiction, abuse, and misuse. [2] [1]

Overdose

Hydrocodone: Respiratory depression, extreme somnolence progressing towards coma, muscle limpness, cold and clammy skin, slow heart rate, low blood pressure, abrupt loss of heart function, and death may occur. [2]

Paracetamol: Liver and kidney failure, low blood sugar coma may occur. [2]

Interactions

Hydrocodone may demonstrate an enhanced respiratory depressant effect when combined with other sedatives such as other opioids, benzodiazepines, nonbenzodiazepine sedatives, psychotropics, and anticonvulsants. [14]

Concurrent use of paracetamol with alcohol products may increase the risk of acute liver failure. [2]

Monitoring

Laboratory function tests should be used to monitor therapy in people with severe liver or renal disease. [2]

Pharmacology

Hydrocodone

Paracetamol

Society and culture

On 30 June 2009, a U.S. Food and Drug Administration (FDA) advisory panel voted by a narrow margin to advise the FDA to remove Vicodin and another opioid, Percocet, from the market because of "a high likelihood of overdose from prescription narcotics and acetaminophen products". [22] 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. [22] Each year, paracetamol overdose is linked to about 400 deaths and 42,000 hospitalizations. [23]

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. [24] [25] [26] [27] 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. [24] [25] [27]

On 22 August 2014, the Drug Enforcement Administration (DEA) announced that all hydrocodone combination products (HCPs) will be rescheduled from Schedule III to Schedule II of the Controlled Substances Act (CSA), effective on 6 October 2014. [11] In 2010, more than 16,000 deaths were attributed to abuse of opioid drugs. [11] Even though there are legitimate medical uses for HCPs, data suggest that a significant number of individuals misuse them. [11]

Actor Matthew Perry struggled with his addiction to Vicodin for many years after a jetski accident in 1997. [28]

In May 2017, professional golfer Tiger Woods was arrested by the police for driving under the influence. Woods said that this was due to four prescription drugs that he was taking for a back operation, one of which was Vicodin. [29] [30]

Dr. Gregory House, the main protagonist of House, carries Vicodin with himself and often takes it to relieve his leg pain, something that plays a major role throughout the series. [31] [32]

Brand names

Brand names include Adol, Hycet, Lortab, Lorcet, Norco, and Vicodin among others. [33]

Related Research Articles

<span class="mw-page-title-main">Hydrocodone</span> Opioid drug used in pain relief

Hydrocodone, also known as dihydrocodeinone, is a semisynthetic opioid used to treat pain and as a cough suppressant. It is taken by mouth. Typically it is dispensed as the combination acetaminophen/hydrocodone or ibuprofen/hydrocodone for pain severe enough to require an opioid and in combination with homatropine methylbromide to relieve cough. It is also available by itself in a long-acting form under the brand name Zohydro ER, among others, to treat severe pain of a prolonged duration. Hydrocodone is a controlled drug: in the United States a Schedule II Controlled Substance.

<span class="mw-page-title-main">Oxycodone</span> Opioid medication

Oxycodone, sold under various brand names such as Roxicodone and OxyContin, is a semi-synthetic opioid used medically for treatment of moderate to severe pain. It is highly addictive and is a commonly abused drug. It is usually taken by mouth, and is available in immediate-release and controlled-release formulations. Onset of pain relief typically begins within fifteen minutes and lasts for up to six hours with the immediate-release formulation. In the United Kingdom, it is available by injection. Combination products are also available with paracetamol (acetaminophen), ibuprofen, naloxone, naltrexone, and aspirin.

<span class="mw-page-title-main">Paracetamol</span> Common medication for pain and fever

Paracetamol is a non-opioid analgesic and antipyretic agent used to treat fever and mild to moderate pain. It is a widely used over the counter medication. Common brand names include Tylenol and Panadol.

<span class="mw-page-title-main">Hydromorphone</span> Opioid medication used for pain relief

Hydromorphone, also known as dihydromorphinone, and sold under the brand name Dilaudid among others, is a morphinan opioid used to treat moderate to severe pain. Typically, long-term use is only recommended for pain due to cancer. It may be used by mouth or by injection into a vein, muscle, or under the skin. Effects generally begin within half an hour and last for up to five hours. A 2016 Cochrane review found little difference in benefit between hydromorphone and other opioids for cancer pain.

Oxycodone/aspirin is a combination drug marketed by Endo Pharmaceuticals. It is a tablet containing a mixture of 325 mg of aspirin and 4.8355 mg of oxycodone HCl ; it is an opioid/non-opioid combination used to treat moderate to moderately severe pain. The safety of the combination during pregnancy has not been established, although aspirin is generally contraindicated during pregnancy, and the drug has been placed in pregnancy category D. Inactive ingredients include D&C Yellow 10, FD&C Yellow 6, microcrystalline cellulose, and corn starch. Percodan was first marketed by DuPont Pharmaceuticals and prescribed in the United States in 1950. Once a widely prescribed painkiller, it has largely been replaced by alternative oxycodone compounds containing paracetamol (acetaminophen) instead of aspirin, such as Percocet.

Oxycodone/paracetamol, sold under the brand name Percocet among others, is a fixed-dose combination of the opioid oxycodone with paracetamol (acetaminophen), used to treat moderate to severe pain.

<span class="mw-page-title-main">Carisoprodol</span> Muscle relaxant medication

Carisoprodol, sold under the brand name Soma among others, is a medication used for musculoskeletal pain. Use is only approved for up to three weeks. Effects generally begin within half an hour and last for up to six hours. It is taken orally.

<span class="mw-page-title-main">Oxymorphone</span> Opioid analgesic drug

Oxymorphone is a highly potent opioid analgesic indicated for treatment of severe pain. Pain relief after injection begins after about 5–10 minutes, after oral administration it begins after about 30 minutes, and lasts about 3–4 hours for immediate-release tablets and 12 hours for extended-release tablets. The elimination half-life of oxymorphone is much faster intravenously, and as such, the drug is most commonly used orally. Like oxycodone, which metabolizes to oxymorphone, oxymorphone has a high potential to be abused.

<span class="mw-page-title-main">Dihydrocodeine</span> Opioid

Dihydrocodeine is a semi-synthetic opioid analgesic prescribed for pain or severe dyspnea, or as an antitussive, either alone or compounded with paracetamol (acetaminophen) or aspirin. It was developed in Germany in 1908 and first marketed in 1911.

<span class="mw-page-title-main">Dextropropoxyphene</span> Withdrawn opioid medication

Dextropropoxyphene is an analgesic in the opioid category, patented in 1955 and manufactured by Eli Lilly and Company. It is an optical isomer of levopropoxyphene. It is intended to treat mild pain and also has antitussive and local anaesthetic effects. The drug has been taken off the market in Europe and the US due to concerns of fatal overdoses and heart arrhythmias. It is still available in Australia, albeit with restrictions after an application by its manufacturer to review its proposed banning. Its onset of analgesia is said to be 20–30 minutes and peak effects are seen about 1.5–2.0 hours after oral administration.

Butalbital/acetaminophen, sold under the brand name Butapap among others, is a combination medication used to treat tension headaches and migraine headaches. It contains butalbital, a barbiturate and paracetamol (acetaminophen), an analgesic. Versions also containing caffeine are sold under the brand name Fioricet among others. It is taken by mouth. The combination is also sold with codeine.

<span class="mw-page-title-main">Thebacon</span> Opioid medication

Thebacon, or dihydrocodeinone enol acetate, is a semisynthetic opioid that is similar to hydrocodone and is most commonly synthesised from thebaine. Thebacon was invented in Germany in 1924, four years after the first synthesis of hydrocodone. Thebacon is a derivative of acetyldihydrocodeine, where only the 6–7 double bond is saturated. Thebacon is marketed as its hydrochloride salt under the trade name Acedicon, and as its bitartrate under Diacodin and other trade names. The hydrochloride salt has a free base conversion ratio of 0.846. Other salts used in research and other settings include thebacon's phosphate, hydrobromide, citrate, hydroiodide, and sulfate.

<span class="mw-page-title-main">Codeine</span> Opiate and prodrug of morphine used to treat pain

Codeine is an opiate and prodrug of morphine mainly used to treat pain, coughing, and diarrhea. It is also commonly used as a recreational drug. It is found naturally in the sap of the opium poppy, Papaver somniferum. It is typically used to treat mild to moderate degrees of pain. Greater benefit may occur when combined with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Evidence does not support its use for acute cough suppression in children or adults. In Europe, it is not recommended as a cough medicine in those under 12 years of age. It is generally taken by mouth. It typically starts working after half an hour, with maximum effect at two hours. Its effects last for about four to six hours. Codeine exhibits abuse potential similar to other opioid medications, including a risk of habituation and overdose.

<span class="mw-page-title-main">Tapentadol</span> Opioid analgesic of benzenoid class

Tapentadol, brand names Nucynta among others, is a centrally acting opioid analgesic of the benzenoid class with a dual mode of action as an agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor (NRI). Analgesia occurs within 32 minutes of oral administration, and lasts for 4–6 hours.

An equianalgesic chart is a conversion chart that lists equivalent doses of analgesics. Equianalgesic charts are used for calculation of an equivalent dose between different analgesics. Tables of this general type are also available for NSAIDs, benzodiazepines, depressants, stimulants, anticholinergics and others.

<span class="mw-page-title-main">Opiate</span> Substance derived from opium

An opiate is an alkaloid substance derived from opium. It differs from the similar term opioid in that the latter is used to designate all substances, both natural and synthetic, that bind to opioid receptors in the brain. Opiates are alkaloid compounds naturally found in the opium poppy plant Papaver somniferum. The psychoactive compounds found in the opium plant include morphine, codeine, and thebaine. Opiates have long been used for a variety of medical conditions, with evidence of opiate trade and use for pain relief as early as the eighth century AD. Most opiates are considered drugs with moderate to high abuse potential and are listed on various "Substance-Control Schedules" under the Uniform Controlled Substances Act of the United States of America.

<span class="mw-page-title-main">Hydrocodone/ibuprofen</span> Combination drug

Hydrocodone/ibuprofen (INNs), sold under the brand name Vicoprofen, is a fixed-dose combination analgesic medication used in short-term therapy to relieve severe pain. Vicoprofen combines the analgesic and antitussive properties of hydrocodone with the analgesic, anti-inflammatory, and antipyretic properties of ibuprofen. In contrast to hydrocodone/acetaminophen combination analgesics such as Vicodin, this hydrocodone/ibuprofen avoids some of the liver toxicity which may occur from acetaminophen, but still presents significant dangers in hydrocodone overdose, namely respiratory depression. Vicoprofen is supplied in a fixed dose combination tablet which contains hydrocodone bitartrate, USP 7.5 mg with ibuprofen, USP 200 mg. Additional strengths of generic Vicoprofen are now available, in combinations of 5 mg/200 mg and 10 mg/200 mg respectively.

Ibuprofen/paracetamol, is a fixed-dose combination of two medications, ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and paracetamol (acetaminophen). It is available as a generic medication and common brand names include Combiflam.

<span class="mw-page-title-main">Benzhydrocodone</span> Chemical compound

Benzhydrocodone (INN) is an opioid prodrug of the morphinan class. Its chemical structure consists of hydrocodone coupled with benzoic acid. Benzhydrocodone itself is inactive and acts as a prodrug to hydrocodone upon cleavage of the benzoate portion of the molecule.

Tramadol/paracetamol, also known as tramadol/acetaminophen and sold under the brand name Ultracet, is a fixed-dose combination medication used for the treatment of moderate to severe pain. It contains tramadol hydrochloride and paracetamol. It is taken by mouth.

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 "Norco (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) CII Revised: March 2021". DailyMed. Retrieved 23 November 2022.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 "Vicodin Vicodin ES Vicodin HP (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) Rx only CS-II". DailyMed. Retrieved 23 November 2022.
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  4. ↑ Parrillo VN (2008). Encyclopedia of Social Problems. SAGE. p. 262. ISBN   9781412941655.
  5. ↑ Singla A, Sloan P (2013). "Pharmacokinetic evaluation of hydrocodone/acetaminophen for pain management". Journal of Opioid Management. 9 (1): 71–80. doi:10.5055/jom.2013.0149. PMID   23709306.
  6. 1 2 Graham GG, Scott KF (1 February 2005). "Mechanism of action of paracetamol". American Journal of Therapeutics. 12 (1): 46–55. doi:10.1097/00045391-200501000-00008. PMID   15662292. S2CID   38261222.
  7. ↑ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  8. ↑ "Acetaminophen; Hydrocodone - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
  9. ↑ Atkins L (16 August 2001). "Know what a Vike is?". The Guardian. Retrieved 23 December 2018.
  10. ↑ "Co-codamol 30/500 Tablets - Summary of Product Characteristics (SmPC) - (eMC)". www.medicines.org.uk. Retrieved 7 August 2019.
  11. 1 2 3 4 "Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II". Federal Register. 22 August 2014. Retrieved 23 November 2022.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  12. ↑ "Norco Addiction". The Fix. 21 January 2015. Retrieved 4 November 2015.
  13. ↑ "Hydrocodone (Trade Names: Vicodin, Lortab, Lorcet-HD, Hycodan, Vicoprofen)" (PDF). Drug Enforcement Administration. April 2013. Archived (PDF) from the original on 18 April 2013. Retrieved 21 May 2013.
  14. ↑ Becker DE (1 January 2011). "Adverse drug interactions". Anesthesia Progress. 58 (1): 31–41. doi:10.2344/0003-3006-58.1.31. PMC   3265267 . PMID   21410363.
  15. 1 2 3 Vallejo R, Barkin RL, Wang VC (1 August 2011). "Pharmacology of opioids in the treatment of chronic pain syndromes". Pain Physician. 14 (4): E343-60. doi: 10.36076/ppj.2011/14/E343 . PMID   21785485.
  16. ↑ "Labeling-Package Insert: Hydrocodone/acetaminophen 7.5 mg/325 mg" (PDF). Drugs@FDA: FDA-Approved Drugs. Chartwell. 18 October 2013. Retrieved 22 January 2024.
  17. ↑ Cone EJ, Darwin WD, Gorodetzky CW, Tan T (1 August 1978). "Comparative metabolism of hydrocodone in man, rat, guinea pig, rabbit, and dog". Drug Metabolism and Disposition. 6 (4): 488–93. PMID   28931.
  18. 1 2 Kaye AD (2015). Essentials of Pharmacology for Anesthesia, Pain Medicine, and Critical Care. Springer. pp. 134–13. ISBN   9781461489481.
  19. ↑ Hydrocodone and acetaminophen (paracetamol): Drug information (Version 390.0 ed.). Lexicomp®. 2024.
  20. ↑ Golan DE (2008). Principles of Pharmacology: The Pathophysiologic Basis of Drug Therapy. Lippincott Williams & Wilkins. pp. 275–276. ISBN   978-0-7817-8355-2.
  21. 1 2 3 Sinatra RS (2011). The Essence of Analgesia and Analgesics. Cambridge University Press. p. 256. ISBN   978-0-521-14450-6.
  22. 1 2 "FDA advisers vote to take Vicodin, Percocet off market". CNN.
  23. ↑ Harris G (13 January 2011). "F.D.A. Plans New Limits on Prescription Painkillers". The New York Times. ISSN   0362-4331 . Retrieved 4 November 2015.
  24. 1 2 "FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings" (Press release). U.S. Food and Drug Administration. 13 January 2011. Retrieved 13 January 2011.
  25. 1 2 "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". U.S. Food and Drug Administration (FDA). 13 January 2011. Retrieved 13 January 2011.
  26. ↑ Perrone M (13 January 2011). "FDA orders lowering pain reliever in Vicodin". The Boston Globe . Associated Press. Retrieved 13 January 2011.
  27. 1 2 Harris G (13 January 2011). "F.D.A. Plans New Limits on Prescription Painkillers". The New York Times . Retrieved 13 January 2011.
  28. ↑ Diver, Tony (29 October 2023). "'No one would be surprised if I died': How Matthew Perry opened up about his addiction". The Telegraph. ISSN   0307-1235 . Retrieved 17 December 2023.
  29. ↑ "Police release dashcam footage of Tiger Woods' DUI arrest". Guardian. Associated press. 1 June 2017. Retrieved 1 June 2017.
  30. ↑ Murray E (29 May 2017). "Tiger Woods says medication, not alcohol led to Florida DUI arrest". The Guardian. Retrieved 1 June 2017.
  31. ↑ "Pilot". House, M.D. Season 1. Episode 1. 16 November 2004.
  32. ↑ "Twenty Vicodin". House, M.D. Season 8. Episode 1. 3 October 2011.
  33. ↑ "Adol (Hydrocodone-Acetaminoph) Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing – WebMD". WebMD. Retrieved 26 July 2017.
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