Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Buspiron

Generic name
Buspiron
Brand name
ATC Code
N05BE01

Pharmacokinetics in children

De volgende kinetische parameters zijn gevonden na een eenmalige dosis van 2,5-5 mg buspiron [Edwards 2006] en bij steady state na tweemaal daagse doses [Salazar 2001]:

Studie Edwards 2006 Salazar 2001
Leeftijd (jaar) 2-6 6-12 13-17
n 20 12 12
Dosis (mg/d) 2.5-5 15 30 60 15 30 60
Cmax (ng/ml) 1,14 ± 0,75 0,67 1,96 3,96 0,54 1,44 2,64
Tmax (uur) 0,80 ± 0,40 1,0 1 1 1 1 1
t½ (uur) 1,61 ± 0,32 1,99 3,13 2,70 2,90 3,44 3,37
Cl/F (l/uur/kg) 87,8 ± 44,8 - - - - - -

 

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

Off-label

Licensed use Licensed use

Registration Status Title

Niet geregistreerd voor toepassing bij kinderen.

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Available formulations

Tablet (hydrochloride) 10 mg

 

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Dosages

Anxiety disorders
  • Oral
    • 6 years up to 18 years
      • Initial dose: 5 mg/day in 2 doses.
      • Maintenance dose: Increase dose after a few weeks, if needed every 3 days, based on clinical response and side effects with dose increments of 5 mg/day in 2-3 doses to an usual dose of 10 - 30 mg/day in 2 - 3 doses. Max: 45 mg/day.
        • The onset of effect is after 1-3 weeks.
        • The effect in pediatric anxiety disorders has only been demonstrated in open-label studies and case reports. Buspiron can offer a solution for anxiety disorders in individual patients, where other options have not been effective.
        • Buspiron should be administerred every day at the same time and consistently with or without food.
        • Buspiron must be prescribed by a specialist in child and adolescent psychiatry. The dose should be determined individually and the lowest possible dose should be applied.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

Clinical consequences

At creatinine clearance <10 ml / min, a study in adults found an increased AUC with reduced kidney function, but the t½ did not differ significantly. In another study in adults, no difference in pharmacokinetic parameters was observed with a decrease in renal function. There is a large inter-individual variation in t½. Buspiron is dosed according to the effect and side effects; this is no different with reduced kidney function.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Abnormal involuntary movements [Buitelaar 1998] and occasional cases of sleep walking and nightmares have been reported [Simeon 1994.] An increase in aggression, agitation and euphoric mania has been reported in psychiatric prepubertal patients with anxiety symptoms and moderate aggressive behavior [Pfeffer 1997].

 

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Adult Side Effects

Zeer vaak (≥ 10%): duizeligheid en licht gevoel in het hoofd, hoofdpijn, slaperigheid, sufheid.

Vaak (1-10%): nervositeit slapeloosheid, concentratiestoornis, verwardheid, depressie, woede, wazig zien, paresthesieën, coördinatiestoornissen, tremoren, tinnitus, tachycardie, pijn op de borst, hartkloppingen, keelpijn, verstopte neus, faryngolaryngeale pijn, maag-darmstoornissen, hyperhidrose of klamheid, huiduitslag, pijn in spieren en gewrichten, vermoeidheid, zwakte.

Zelden (0,01-0,1%): angioneurotisch oedeem, ecchymose, urticaria, pruritus, alopecia.

Zeer zelden (< 0,01%): hallucinaties, psychose, labiliteit, serotonine syndroom, convulsies, tunnelvisie, extrapiramidale stoornis, tandrad stijfheid, dyskinesie, dystonie, syncope, amnesie, ataxie, parkinsonisme, acathisie, rusteloze benensyndroom, rusteloosheid, urineretentie, galactorroe

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Benzodiazepine derivatives
N05BA12
N05BA08
N05BA09
N05BA01
N05BA06
N05BA04
Diphenylmethane derivatives
N05BB01

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References

  1. Edwards DJ et al., Pharmacokinetics of buspirone in autistic children, J Clin Pharmacol, 2006, May;46(5), 508-14
  2. Salazar DE et al., Pharmacokinetics and tolerability of buspirone during oral administration to children and adolescents with anxiety disorder and normal healthy adults., J Clin Pharmacol, 2001, Dec;41(12), 1351-8
  3. Mylan BV, SmPC Buspiron HCL(RVG 27118) 03-07-2018, www.geneesmiddeleninformatiebank
  4. Simeon JG et al., Buspirone therapy of mixed anxiety disorders in childhood and adolescence: A pilot study, Journal of Child and Adolescent Pharmacology, 1994, 4(3), 159-170
  5. Pfeffer CR et al., Buspirone treatment of psychiatrically hospitalized prepubertal children with symptoms of anxiety and moderately severe aggression., J Child Adolesc Psychopharmacol, 1997, 7(3), 145-55
  6. Buitelaar JK et al. , Buspirone in the management of anxiety and irritability in children with pervasive developmental disorders: results of an open-label study. , The Journal of Clinical Psychiatry , 1998, 59(2), 56-59
  7. Kranzler HR., Use of buspirone in an adolescent with overanxious disorder, J Am Acad Child Adolesc Psychiatry, 1988, 27(6), 789-90
  8. Zwier KJ, et al, Buspirone use in an adolescent with social phobia and mixed personality disorder (cluster A type), J Am Acad Child Adolesc Psychiatry, 1194, 33(7), 1007-11
  9. Hanna GL, et al, Buspirone treatment of anxiety associated with pharyngeal dysphagia in a four-year-old., J Child Adolesc Psychopharmacol, 1997, 7(2), 137-43
  10. FDA, Drugs@FDA: Review documents Buspar (buspirone), July 2001., https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-731S043_review.pdf.
  11. Buitelaar JK et al., Buspirone in the management of anxiety and irritability in children with pervasive developmental disorders: results of an open-label study., The Journal of Clinical Psychiatry, 1998, 59(2), 56-59

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Changes

Changes