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Baclofen
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| Clinical data | |
|---|---|
| Trade names | Lioresal, others |
| Other names | β-(4-chlorophenyl)-γ-aminobutyric acid (β-(4-chlorophenyl)-GABA) |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a682530 |
| License data | |
| Pregnancy category |
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| Routes of administration | oral, intrathecal, transdermal |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | Well-absorbed |
| Protein binding | 30% |
| Metabolism | 85% excreted in urine/faeces unchanged. 15% metabolised by deamination |
| Elimination half-life | 1.5 to 4 hours |
| Excretion | Kidney (70–80%) |
| Identifiers | |
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| CAS Number | |
| PubChem CID | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider | |
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| KEGG | |
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| ChEMBL | |
| CompTox Dashboard (EPA) | |
| ECHA InfoCard | 100.013.170 |
| Chemical and physical data | |
| Formula | C10H12ClNO2 |
| Molar mass | 213.66 g·mol−1 |
| 3D model (JSmol) | |
| Chirality | Racemic mixture |
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Baclofen, sold under the brand name Lioresal among others, is a medication used to treat muscle spasticity, such as from a spinal cord injury or multiple sclerosis.[8][9] It may also be used for hiccups and muscle spasms near the end of life,[9] and off-label to treat alcohol use disorder[10][11] or opioid withdrawal symptoms.[12] It is taken orally or by intrathecal pump (delivered into the spinal canal via an implantable pump device).[8] It is sometimes used transdermally (applied topically to the skin) in combination with gabapentin and clonidine prepared at a compounding pharmacy.[13] It is believed to work by decreasing levels of certain neurotransmitters.[8]
Common side effects include sleepiness, weakness, and dizziness.[8] Serious side effects, such as seizures and rhabdomyolysis, may occur if use of baclofen is stopped abruptly.[8] Use during pregnancy is of unclear safety, whilst use during breastfeeding is likely safe, and even more so if oral administration is avoided.[14]
The adverse effects and safety profile associated with baclofen when it is combined with sedative drugs (for example alcohol or benzodiazepines) range depending on the dose and the individual. The interaction may increase the sedative effects of all ingested sedatives and as such is not generally recommended.[15] In high doses the interaction can cause de novo seizures.[16]
Baclofen was approved for medical use in the United States in 1977.[8] It is available as a generic medication.[9][17] In 2022, it was the 104th most commonly prescribed medication in the United States, with more than 6 million prescriptions.[18][19]
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ "Product monograph brand safety updates". Health Canada. 6 June 2024. Archived from the original on 29 March 2024. Retrieved 8 June 2024.
- ^ Cite error: The named reference
Gablofen FDA labelwas invoked but never defined (see the help page). - ^ "Lioresal (baclofen)- baclofen kit; Lioresal (baclofen)- baclofen injection". DailyMed. 9 December 2022. Archived from the original on 3 August 2024. Retrieved 28 December 2024.
- ^ "Ozobax- baclofen solution". DailyMed. Archived from the original on 21 September 2022. Retrieved 7 November 2021.
- ^ "Lyvispah- baclofen granule". DailyMed. Archived from the original on 21 September 2022. Retrieved 19 December 2021.
- ^ "Fleqsuvy- baclofen suspension". DailyMed. 4 February 2022. Archived from the original on 21 September 2022. Retrieved 16 March 2022.
- ^ a b c d e f "Baclofen Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 26 April 2019. Retrieved 3 March 2019.
- ^ a b c British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 1092. ISBN 978-0-85711-338-2.
- ^ Agabio R, Saulle R, Rösner S, Minozzi S (January 2023). "Baclofen for alcohol use disorder". The Cochrane Database of Systematic Reviews. 1 (1): CD012557. doi:10.1002/14651858.cd012557.pub3. PMC 9837849. PMID 36637087.
- ^ Ahmadi-Abhari SA, Akhondzadeh S, Assadi SM, Shabestari OL, Farzanehgan ZM, Kamlipour A (February 2001). "Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial". Journal of Clinical Pharmacy and Therapeutics. 26 (1): 67–71. doi:10.1111/j.1365-2710.2001.00325.x. PMID 11286609. S2CID 28295723.
- ^ Assadi SM, Radgoodarzi R, Ahmadi-Abhari SA (November 2003). "Baclofen for maintenance treatment of opioid dependence: a randomized double-blind placebo-controlled clinical trial [ISRCTN32121581]". BMC Psychiatry. 3: 16. doi:10.1186/1471-244X-3-16. PMC 293465. PMID 14624703.
- ^ Allen Jr LV (17 November 2010). "Baclofen 2%, Gabapentin 6%, and Clonidine Hydrochloride 0.1% in Pluronic Lecithin Organogel". U.S. Pharmacist. Jobson Medical Information LLC. Archived from the original on 10 August 2023. Retrieved 9 August 2023.
- ^ "Baclofen use while Breastfeeding". Drugs.com. Archived from the original on 19 June 2024. Retrieved 28 December 2024.
- ^ "Common questions about baclofen". nhs.uk. 3 March 2022. Archived from the original on 24 March 2024. Retrieved 24 March 2024.
- ^ "Seizures Following High-Dose Baclofen With Alcohol". Medscape. Archived from the original on 28 June 2022. Retrieved 24 March 2024.
- ^ "Competitive Generic Therapy Approvals". U.S. Food and Drug Administration (FDA). 29 June 2023. Archived from the original on 29 June 2023. Retrieved 29 June 2023.
- ^ "The Top 300 of 2022". ClinCalc. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
- ^ "Baclofen Drug Usage Statistics, United States, 2013 - 2022". ClinCalc. Archived from the original on 12 April 2020. Retrieved 30 August 2024.
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