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| Combination of | |
|---|---|
| Hydrocodone | Opioid analgesic |
| Paracetamol | Anilide analgesic |
| Clinical data | |
| Trade names | Lorcet, Norco, Vicodin, others |
| Other names | Hydrocodone/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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| CompTox Dashboard (EPA) | |
 N Y (what is this?) (verify) | |
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]
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]
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]
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]
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]
Use with caution due to possible risk of toxicity.[1]
"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]
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]
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]
Laboratory function tests should be used to monitor therapy in people with severe liver or renal disease.[2]
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 jet ski 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]
Gregory House, the main protagonist of House, constantly carries Vicodin with him and often takes it to relieve his leg pain, something that plays a major role throughout the series.[31][32]
Brand names include Adol, Hycet, Lortab, Lorcet, Norco, and Vicodin among others.[33]
| pyrazolones / pyrazolidines | |
|---|---|
| salicylates | |
| acetic acid derivatives and related substances | |
| oxicams | |
| propionic acid derivatives (profens) |
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| n-arylanthranilic acids (fenamates) | |
| COX-2 inhibitors (coxibs) | |
| other | |
| NSAID combinations | |
Key: underline indicates initially developed first-in-class compound of specific group; #WHO-Essential Medicines; †withdrawn drugs; ‡veterinary use. | |
| μ-opioid (MOR) |
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|---|---|---|---|---|---|
| δ-opioid (DOR) |
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| κ-opioid (KOR) |
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| Nociceptin (NOP) |
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| Others |
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