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]:

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

Off-label

Available formulations

Dosages

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.

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

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.

Interactions

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

• NERVOUS SYSTEM
• PSYCHOLEPTICS

ANXIOLYTICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

Changes

Therapeutic Drug Monitoring

Overdose