Alprazolam

Generic name
Alprazolam
Brand name
ATC Code
N05BA12
Compare …

Alprazolam

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No studies have been carried out on the pharmacokinetics of a normal preparation with alprazolam (without controlled release) in children. Children generally metabolize benzodiazepine agonists faster than adolescents and adults. One study (Glue P, et al. 2006) shows that the pharmacokinetic parameters of adolescents are comparable to those of adults.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Short-term treatment of acute anxiety and sudden extreme insomnia
  • Oral
    • Normal preparation (immediate release)
      • 6 years up to 18 years
        • Initial dose: 0.125 mg/day, once only.
        • Maintenance dose: Increase in steps of 0.125-0.25 mg/dose based on the clinical picture to a maximum of 0.05 mg/kg/day in 3 doses. Max: 3 mg/day.
        • Directions for administration:

          Divide the daily dose into 3 doses if possible.

          • In the event of sudden extreme sleeplessness: only take at night; increase the dosage depending on the effect to a maximum of 0.05 mg/kg, not exceeding 3 mg/day
          • The effectiveness in treating acute anxiety is open to debate.
      • 6 years up to 18 years
        [1] [2] [3] [4]
        • Initial dose: 0.125 mg/day, once only.
        • Maintenance dose: Increase in steps of 0.125-0.25 mg/dose based on the clinical picture to a maximum of 0.05 mg/kg/day in 3 doses. Max: 3 mg/day.
        • Directions for administration:

          Divide the daily dose into 3 doses if possible.

          • In the event of sudden extreme sleeplessness: only take at night; increase the dosage depending on the effect to a maximum of 0.05 mg/kg, not exceeding 3 mg/day
          • The effectiveness in treating acute anxiety is open to debate.

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.

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

Sleepiness during the day, agitation, headaches, nausea, weight gain, dystonia, sedation, concentration/memory problems, tolerance/dependence (in prolonged use).  Paradoxical reactions such as restlessness, agitation, irritability, aggression, anger attacks, delusions, hallucinations, psychoses, nightmares, behavioural disorders. One case of self-destructive behaviour and suicidal ideation (Türkoğlu S. 2015) has also been described.

 

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

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.

Benzodiazepine derivatives
N05BA08
N05BA09
N05BA01
N05BA06
N05BA04
Diphenylmethane derivatives
N05BB01
Azaspirodecanedione derivatives
N05BE01

References

  1. Landelijk Kenniscentrum Kind-enJeugdpsychiatrie (Ketelaars), Anxiolytica/hypnotica, 2009
  2. Pfefferbaum B, et al, Alprazolam in the treatment of anticipatory and acute situational anxiety in children with cancer, J Am Acad Child Adolesc Psychiatry, 1987, Jul;26(4):, 532-5
  3. Simeon JG, et al, Alprazolam effects in children with anxiety disorders, Can J Psychiatry, 1987, Oct;32(7):, 570-4
  4. Simeon JG, et al, Clinical, cognitive, and neurophysiological effects of alprazolam in children and adolescents with overanxious and avoidant disorders, J Am Acad Child Adolesc Psychiatry, 1992, Jan;31(1), 29-33
  5. Anderson BJ, et al, Oral premedication in children: a comparison of chloral hydrate, diazepam, alprazolam, midazolam and placebo for day surgery, Anaesth Intensive Care, 1990, May;18(2), 185-93
  6. Pfizer BV, SmPC Xanax (RVG 14409) 01-05-2018, www.geneesmiddelinformatiebank.nl
  7. Türkoğlu S. ., Paradoxical reactions related to alprazolam., J Child Adolesc Psychopharmacol, 2015, Apr;25(3), 276
  8. Glue P et al., Pharmacokinetics of an extended release formulation of alprazolam (Xanax XR) in healthy normal adolescent and adult volunteers., Am J Ther., 2006, Sep-Oct;13(5), 418-22
  9. Pfizer, Tafil® 0,5/1,0 mg Tabletten (29946.00.00), 03/19

Changes

Therapeutic Drug Monitoring


Overdose