Hydrocodone/paracetamol (also known as hydrocodone/acetaminophen) is the combination of the pain medications hydrocodone (an opioid) 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]
Common side effects include dizziness, sleepiness, constipation, and vomiting.[1][3] Serious side effects include addiction, decreased rate of breathing, low blood pressure, 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]
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 2023, it was the 25th most commonly prescribed medication in the United States, with more than 21million 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 have escalated due to its opioid effects.[12]
Side effects
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, and 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]
Pharmacology
Hydrocodone
- Mechanism of action: Hydrocodone acts primarily as an agonist at the mu-opioid receptors, but is also a weak agonist against the delta opioid and kappa opioid receptors.[15]
- Absorption/distribution: The oral formulation can be absorbed from the gastrointestinal tract and remain 20–50% bound to plasma proteins.[15] The onset of analgesia is about 20 to 30 minutes with a duration of 4 to 8 hours and t1/2 of 3 to 4 hours.[15] Maximum serum levels are achieved at 1.3 hours.[1]
- Metabolism/excretion: It is metabolized to
Society and culture
Legal status
In June 2009, a US 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". 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.[21] Each year, paracetamol overdose is linked to about 400 deaths and 42,000 hospitalizations.[22]
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.[23][24]
References
- Norco (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) CII Revised: March 2021 DailyMed, retrieved 23 November 2022^
- Vicodin Vicodin ES Vicodin HP (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) Rx only CS-II DailyMed, retrieved 23 November 2022^
- Frequently Prescribed Medications