Fluvoxamine (maleate)

Generic name
Fluvoxamine (maleate)
Brand name
ATC Code
N06AB08
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Fluvoxamine (maleate)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following Cmax and Cl/F values were found in a pharmacokinetic study [Labellarte 2004] of 34 paediatric patients:

Age Dosing Cmax (ng/ml) Cl/F (litres/hour)
6-12 years 25 mg twice daily 41.27 44.68
6-12 years 50 mg twice daily 182.45 20.34
6-12 years 100 mg twice daily 371.47 19.36
12-18 years 25 mg twice daily 26.37 77.60
12-18 years 50 mg twice daily 67.50 55.58
12-18 years 100 mg twice daily 217.89 33.21

Plasma levels in adolescents are comparable to the plasma levels in adults. This pharmacokinetic study also showed that the Cmax and AUC values for girls aged < 12 years (6–11 years) were higher than in boys aged < 12 years (6–11 years).

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

Obsessive compulsive disorder, anxiety disorders (social phobia, separation disorder and/or generalized anxiety disorder)
  • Oral
    • 8 years up to 12 years
      • Initial dose: 25 mg/day in 1 dose
      • Maintenance dose: the dose can be raised every 4-7 days depending on the clinical response and the tolerance by 25 mg to 25 - 200 mg/day in 2 doses. Max: 200 mg/day.

      • A daily dosage of > 50 mg/day should be divided over 2 doses. If these two amounts are not equal, the higher dose should be taken before going to bed.

        In obsessive compulsive disorders, it sometimes only has an effect after 12 weeks.

        Caution: Abrupt discontinuation of the treatment should be avoided. When treatment with fluvoxamine is stopped, the dose should be gradually phased out over at least one or two weeks to avoid the risk of withdrawal symptoms. If unacceptable symptoms occur as a result of a dosage reduction or because of discontinuation of treatment, the dosage previously prescribed should be reconsidered. The doctor can then reduce the dosage, but more gradually.

        Fluvoxamine should be prescribed by a child and youth psychiatry specialist. The dose should be set individually and the lowest possible dose should be used

    • 12 years up to 18 years
      • Initial dose: 25 mg/day in 1 dose
      • Maintenance dose: the dose can be raised every 4-7 days depending on the clinical response and the tolerance by 25 mg to 50 - 300 mg/day in 2 doses. Max: 300 mg/day.

      • A daily dosage of > 50 mg/day should be divided over 2 doses. If these two amounts are not equal, the higher dose should be taken before going to bed.

        In obsessive compulsive disorders, it sometimes only has an effect after 12 weeks.

        Note: Abrupt discontinuation of the treatment should be avoided. When treatment with fluvoxamine is stopped, the dose should be gradually phased out over at least one or two weeks to avoid the risk of withdrawal symptoms. If unacceptable symptoms occur as a result of a dosage reduction or because of discontinuation of treatment, the dosage previously prescribed should be reconsidered. The doctor can then reduce the dosage, but more gradually.

        Fluvoxamine should be prescribed by a child and youth psychiatry specialist. The dose should be set individually and the lowest possible dose should be used

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

In children and adolescents with OCD: greater risk of insomnia, asthenia, hyperkinesia, sleepiness, dyspepsia, agitation, mania and hypomania as serious side effects, and furthermore: convulsions.

Also noted: Hyperactivity, disinhibition, fatigue, infections, pharyngitis and rhinitis.

Suicidal behaviors (suicide attempts and suicidal thoughts) and hostility (mainly aggression, oppositional behaviour and anger) were observed more frequently in children and adolescents treated with antidepressants than in children and adolescents treated with placebo in clinical trials. [SmPC]

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 in children

Summary
Results in reduced reaction and concentration capacity; do not give to depressive patients with suicidal thoughts; observe patients closely because of the increased suicide risk; discontinue if there are seizures. Be aware also of the possibility of serotonin syndrome occurring.

Using it can result in reduced capacity to react and concentrate. This can hinder numerous day-to-day activities.

Severe psychiatric side effects such as hostility, aggression, self-harming behaviour, suicidal thoughts and suicide attempts occur in children with depressive symptoms. Screening for suicide risks is indicated before the treatment. Patients – particularly those at high risk because of suicidal thoughts or suicide attempts – must be monitored closely during treatment with these drugs, in particular when treatment is commenced and after dosage changes. Patients must be made aware of the need to keep an eye on any clinical exacerbation, suicidal behaviour or suicidal thoughts and unusual behavioural changes and of the need to obtain medical advice immediately if these symptoms occur. Patients should not be allowed to have large amounts of this drug available, in order to prevent misuse.

Other psychiatric conditions for which fluvoxamine is prescribed can also be associated with an increased risk of suicide-related events. Moreover, there may be comorbidity of these conditions with episodes of more severe depression. The same precautionary measures that need to be considered when treating patients with severe depression disorders must therefore be considered when treating patients with other psychiatric conditions.

In addition, there is no long-term safety data on growth, maturation and cognitive behavioural development in children and adolescents.

There have been rare reports of serotonin syndrome with SSRIs; this should be borne in mind if there is a combination of symptoms such as agitation, tremors, myoclonic episodes and hyperthermia. If there are seizures, the medication should be discontinued.

Interactions

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

ANTIDEPRESSANTS

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

Non-selective monoamine reuptake inhibitors
N06AA09
N06AA04
N06AA02
N06AA10
Selective serotonin reuptake inhibitors
N06AB04
N06AB10
N06AB03
N06AB06
Monoamine oxidase A inhibitors
N06AG02
Other antidepressants
N06AX01
N06AX12
N06AX21
N06AX11
N06AX11
N06AX16

References

  1. Riddle MA, et al, Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial., J Am Acad Child Adolesc Psychiatry, 2001, 40, 222-9
  2. Labellarte M, et al, Multiple-dose pharmacokinetics of fluvoxamine in children and adolescents., J Am Acad Child Adolesc Psychiatry, 2004, 43, 1497-505
  3. [The Research Unit on Pediatric Psychopharmacology Anxiety Study Group], Fluvoxamine for the treatment of anxiety disorders in children and adolescents., N Engl J Med., 2001, 344, 1279-85
  4. Cheer SM, et al., Spotlight on fluvoxamine in anxiety disorders in children and adolescents., CNS Drugs, 2002, 16, 139-44
  5. De Vries MH, et al, Single and multiple oral dose fluvoxamine kinetics in young and elderly subjects, Ther Drug Monit., 1992, 14, 493-8
  6. Walkup J, et al, Research Units on Pediatric Psychopharmacology Anxiety Study Group. Treatment of pediatric anxiety disorders: an open-label extension of the research units on pediatric psychopharmacology anxiety study, J Child Adolesc Psychopharmacol., 2002, 12, 175-88
  7. Reinblatt SP, et al., Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents., J Child Adolesc Psychopharmacol, 2009, 19, 119-26
  8. neuraxpharm, SmPC Fluvoxamin-neuraxpharm® 50/ 100 mg (38667.01.00/ 38667.02.00), 07/19

Changes

Therapeutic Drug Monitoring


Overdose