Biperiden
Regulatory sources consulted
- AEMPS CIMA Ficha Técnica: 51224
- https://cima.aemps.es/cima/dochtml/ft/51224/FT_51224.html
- PubMed PMID:38451521 ↗
- PubMed PMID:34575901 ↗
- PubMed PMID:36421870 ↗
- AEMPS CIMA · nº registro 51224 ↗
- RxNorm rxcui 1589 ↗
Approved indications
- Treatment of parkinsonian syndromes, especially to control rigidity and tremor.
- Treatment of extrapyramidal symptoms (acute dystonia, akathisia, parkinsonism) induced by neuroleptics and drugs with similar action.
- Treatment of antipsychotic-induced akathisia (AIA). A network meta-analysis showed significant efficacy (SMD -1.01) with doses of 6 mg/day.
- Potential to reduce the incidence of post-traumatic epilepsy in patients with brain injuries. · investigational
Contraindications
Absolute
- Hypersensitivity to biperiden.
- Untreated narrow-angle glaucoma.
- Mechanical stenosis of the gastrointestinal tract.
- Megacolon or paralytic ileus.
Clinical warnings
- Use with caution in patients with prostatic hypertrophy, urinary retention, or cardiac arrhythmias. — AEMPS CIMA
- Major warning · Elderly patients are more susceptible to CNS side effects, such as confusion, agitation, and delirium. Careful dose titration is recommended. — Clinical Practice
Drug interactions
- HighOther drugs with anticholinergic properties (e.g., tricyclic antidepressants, H1 antihistamines, quinidine)N06AA
Mechanism: Additive anticholinergic effects at muscarinic receptors, both centrally (confusion, delirium) and peripherally (dry mouth, constipation, urinary retention, tachycardia).
Recommendation: Avoid combination whenever possible, especially in elderly patients. If necessary, monitor closely for the appearance of anticholinergic adverse effects and consider a dose reduction of one or both drugs.
AEMPS CIMA
- ModerateLevodopaN04BA01
Mechanism: Concomitant administration may potentiate levodopa-induced dyskinesias.
Recommendation: Monitor for the appearance or worsening of involuntary movements. Dose adjustment of biperiden or levodopa may be necessary.
AEMPS CIMA
Adverse events
Common (≥1%)
dry mouth · blurred vision · constipation · urinary retention · dizziness · drowsiness · confusion
Rare but serious
acute angle-closure glaucoma · paralytic ileus · anticholinergic delirium · psychosis · suppression of sweating with risk of hyperthermia
Pregnancy and lactation
FDA category: C
There is insufficient data on its use in pregnant women. Use only if the potential benefit justifies the risk to the fetus. Biperiden is excreted in breast milk and may inhibit lactation; a decision should be made whether to discontinue breastfeeding or the treatment.
Recent literature (PubMed)
Esta metaanálisis en red de 15 ECA (492 participantes) comparó 10 tratamientos para la acatisia inducida por antipsicóticos. El biperideno (6 mg/día) fue uno de los tratamientos más eficaces, mostrando una reducción significativa en la severidad de la acatisia (DME -1.01), similar a mirtazapina y superior a propranolol en las dosis estudiadas.
Revisión sobre fármacos con potencial antiepileptogénico. El biperideno se menciona como un fármaco no antiepiléptico prometedor, citando datos clínicos limitados que sugieren que es bien tolerado y parece reducir la incidencia de epilepsia postraumática en pacientes con lesiones cerebrales.
Revisión sistemática de 130 ECA sobre tratamientos para el 'craving' de cocaína. El biperideno se identifica como uno de los fármacos con efectos prometedores a largo plazo para reducir el 'craving', aunque se necesitan más estudios para confirmar estos hallazgos.