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Pramipexole information


Pramipexole
Clinical data
Pronunciation/ˌpræmɪˈpɛksl/
Trade namesMirapex, Mirapexin, Sifrol, others
AHFS/Drugs.comMonograph
MedlinePlusa697029
License data
  • US DailyMed: Pramipexole
Pregnancy
category
  • AU: B3[1]
Routes of
administration
By mouth
ATC code
  • N04BC05 (WHO)
Legal status
Legal status
  • BR: Class C1 (Other controlled substances)[2]
  • CA: ℞-only[3]
  • US: ℞-only[4][5]
  • EU: Rx-only[6][7]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability>90%
Protein binding15%
Elimination half-life8–12 hours
ExcretionUrine (90%), feces (2%)
Identifiers
IUPAC name
  • (S)-N6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
CAS Number
  • 104632-26-0 checkY
PubChem CID
  • 119570
IUPHAR/BPS
  • 953
DrugBank
  • DB00413 checkY
ChemSpider
  • 106770 checkY
UNII
  • 83619PEU5T
KEGG
  • D05575 checkY
  • as salt: D00559 checkY
ChEBI
  • CHEBI:8356 checkY
ChEMBL
  • ChEMBL301265 checkY
CompTox Dashboard (EPA)
  • DTXSID6023496 Edit this at Wikidata
ECHA InfoCard100.124.761 Edit this at Wikidata
Chemical and physical data
FormulaC10H17N3S
Molar mass211.33 g·mol−1
3D model (JSmol)
  • Interactive image
SMILES
  • n1c2c(sc1N)C[C@@H](NCCC)CC2
InChI
  • InChI=1S/C10H17N3S/c1-2-5-12-7-3-4-8-9(6-7)14-10(11)13-8/h7,12H,2-6H2,1H3,(H2,11,13)/t7-/m0/s1 checkY
  • Key:FASDKYOPVNHBLU-ZETCQYMHSA-N checkY
  (verify)

Pramipexole, sold under the brand Mirapex among others, is medication used to treat Parkinson's disease (PD) and restless legs syndrome (RLS).[8] In Parkinson's disease it may be used alone or together with levodopa.[8] It is taken by mouth.[8] Pramipexole is a dopamine agonist of the non-ergoline class.[8]

Pramipexole (and related D3-preferring dopamine agonist medications such as ropinirole) can induce "impulsive-compulsive spectrum disorders"[9] such as compulsive gambling, punding, hypersexuality, and overeating, even in people without any prior history of these behaviours.[10][11][12] There have also been reported detrimental side effects related to impulse-control disorders resulting from off-label use of pramipexole or other dopamine agonists in treating clinical depression.[13] The incidence and severity of impulse-control disorders for those taking the drug for depression is not fully understood because the drug has not been approved for the treatment of depression and the first major studies of its efficacy in treating anhedonic depression were conducted in 2022. There have been anecdotal reports of abrupt and severe personality changes related to impulsivity and loss of self-control in a minority of patients regardless of the condition being treated, although the incidence of these side effects is not yet fully known.[13]

Pramipexole was approved for medical use in the United States in 1997.[8] Use in pregnancy and breastfeeding is of unclear safety.[1] It is available as a generic medication.[14] In 2021, it was the 209th most commonly prescribed medication in the United States, with more than 2 million prescriptions.[15][16]

  1. ^ a b "Pramipexole Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 22 March 2019. Retrieved 3 March 2019.
  2. ^ Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 16 August 2023.
  3. ^ "Product monograph brand safety updates". Health Canada. February 2024. Retrieved 24 March 2024.
  4. ^ Cite error: The named reference Mirapex FDA label was invoked but never defined (see the help page).
  5. ^ Cite error: The named reference Mirapex ER FDA label was invoked but never defined (see the help page).
  6. ^ "Sifrol EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 18 October 2020. Retrieved 17 October 2020.
  7. ^ "Mirapexin EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 18 October 2020. Retrieved 17 October 2020.
  8. ^ a b c d e "Pramipexole Dihydrochloride Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 3 April 2019. Retrieved 22 March 2019.
  9. ^ Napier TC, Kirby A, Persons AL (August 2020). "The role of dopamine pharmacotherapy and addiction-like behaviors in Parkinson's disease". Progress in Neuro-Psychopharmacology & Biological Psychiatry. 102: 109942. doi:10.1016/j.pnpbp.2020.109942. PMID 32272129. S2CID 215237629. ... features of ICSDs [impulsive-compulsive spectrum disorders] during D2/D3R treatment are consistent with the pharmacological profile of the drugs, the known role of D2/D3R in these behaviors, and the neuroanatomical substrates of D2/D3R-expressing brain systems of ICSDs as shown by modern human imaging studies. While we pose that D2/D3R agonist treatment is sufficient to mediate ICSDs, there likely are many factors that overlay this profile, e.g., genetic vulnerabilities, brain disease state, and maladaptations to the chronic therapy.
  10. ^ Bostwick JM, Hecksel KA, Stevens SR, Bower JH, Ahlskog JE (April 2009). "Frequency of new-onset pathologic compulsive gambling or hypersexuality after drug treatment of idiopathic Parkinson disease". Mayo Clinic Proceedings. 84 (4): 310–316. doi:10.4065/84.4.310. PMC 2665974. PMID 19339647.
  11. ^ Moore TJ, Glenmullen J, Mattison DR (December 2014). "Reports of pathological gambling, hypersexuality, and compulsive shopping associated with dopamine receptor agonist drugs". JAMA Internal Medicine. 174 (12): 1930–1933. doi:10.1001/jamainternmed.2014.5262. PMID 25329919.
  12. ^ Wolters EC, van der Werf YD, van den Heuvel OA (September 2008). "Parkinson's disease-related disorders in the impulsive-compulsive spectrum". Journal of Neurology. 255 (Suppl 5): 48–56. doi:10.1007/s00415-008-5010-5. PMID 18787882. S2CID 24531331.
  13. ^ a b Elliott C. "The Degradation Drug". The American Scholar. Archived from the original on 15 September 2022. Retrieved 15 September 2022.
  14. ^ British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 417–418. ISBN 9780857113382.
  15. ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  16. ^ "Pramipexole - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.

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