- 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).
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Obsessive compulsive disorder, anxiety disorders (social phobia, separation disorder and/or generalized anxiety disorder) |
|---|
|
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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.
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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
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]
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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 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.
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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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| 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 | ||
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References
- 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
- Labellarte M, et al, Multiple-dose pharmacokinetics of fluvoxamine in children and adolescents., J Am Acad Child Adolesc Psychiatry, 2004, 43, 1497-505
- [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
- Cheer SM, et al., Spotlight on fluvoxamine in anxiety disorders in children and adolescents., CNS Drugs, 2002, 16, 139-44
- De Vries MH, et al, Single and multiple oral dose fluvoxamine kinetics in young and elderly subjects, Ther Drug Monit., 1992, 14, 493-8
- 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
- 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
- neuraxpharm, SmPC Fluvoxamin-neuraxpharm® 50/ 100 mg (38667.01.00/ 38667.02.00), 07/19
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Changes
Changes
