Venlafaxine

Generic name
Venlafaxine
Brand name
ATC Code
N06AX16
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Venlafaxine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No pharmacokinetic parameters are known for children.

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

Depression and anxiety disorder (social anxiety disorder and generalized anxiety disorder)
  • Oral
    • 12 years up to 18 years
      • Initial dose: 37.5 mg/day in 1 dose
      • Maintenance dose: can be raised depending on the clinical response and the tolerance every 2 weeks by 37.5 mg to 37.5 - 225 mg/day in 1 dose. Max: 225 mg/day.
        • Treatment with venlafaxine must not be stopped suddenly; the dose must be reduced gradually.
        • Controlled clinical studies with children and adolescents with more severe forms of depression have not been able to show any effects and do not support its use in these patients. Venlafaxine can be an option in individual cases for depression and anxiety disorders where other options have not proved to be effective.
        • Venlafaxine should be prescribed by a specialist in child and youth psychiatry. The dosage should be set individually and the lowest possible dose should be used.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
No adjustment required.
GFR 30-50 ml/min/1.73 m2
No adjustment required
GFR 10-30 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uur
GFR < 10 ml/min/1.73 m2
Generalized recommendations cannot be given.
Clinical consequences

In cases of overdose, the most commonly occurring symptoms are sleepiness, agitation, restlessness, gastrointestinal problems, tremors, hypertension, hypotension, tachycardia, bradycardia, ECG changes, vertigo, convulsions and coma. Cases with fatal outcomes have been reported, in particular in combination with alcohol and/or other medication.

 

Patients on dialysis

50% of the normal dose each time and the interval between two doses: 24 hours

 

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

The adverse reaction profile in children and teenagers (6-17 years) was similar to that in adults. The following side effects have been observed: reduced appetite, weight loss, increased blood pressure and higher cholesterol levels, abdominal pain, agitation, dyspepsia, small area skin bleeding, epistaxis and myalgia, suicidal thoughts, hostility (especially in major depression) self-injury.

[SmPC Trevilor retard]

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

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. When venlafaxine is being used, 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.

Screening for suicide risks is indicated before the treatment. Patients 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 do not need to have large amounts of this drug available.

Other psychiatric conditions for which venlafaxine 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.

There have been rare reports of serotonin syndrome with venlafaxine; 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.

If severe side effects occur of if there is no effect, it is possible that the metabolization of the drug may be different. CYP2D6 can determine the variation in response. Genotyping can be considered.

 

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
N06AB08
N06AB06
Monoamine oxidase A inhibitors
N06AG02
Other antidepressants
N06AX01
N06AX12
N06AX21
N06AX11
N06AX11

References

  1. Pfizer BV, SmPC Efexor (RVG 26661, 20862-20863) 12-05-2016, www.geneesmiddeleninformatiebank.nl
  2. Emslie GJ, et al., Venlafaxine ER for the treatment of pediatric subjects with depression: results of two placebo-controlled trials, J Am Acad Child Adolesc Psychiatry, 2007, 46, 479-88
  3. Brent D, et al., Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. , JAMA, 2008, 299, 901-13
  4. March JS, et al., Randomized controlled trial of venlafaxine ER versus placebo in pediatric social anxiety disorder, Biol Psychiatry, 2007, 62, 1149-54
  5. Rynn MA, et al., Efficacy and safety of extended-release venlafaxine in the treatment of generalized anxiety disorder in children and adolescents: two placebo-controlled trials, Am J Psychiatry, 2007, 164, 290-300
  6. Vitiello B, et al., Long-term outcome of adolescent depression initially resistant to selective serotonin reuptake inhibitor treatment: a follow-up study of the TORDIA sample, J Clin Psychiatry, 2001, 72, 388-96
  7. Kenniscentrum Kinder- en Jeugdpsychiatrie., Expertopinie dosering boulimia nervosa en body dysmorphic disorder, 13-07-2018
  8. ratiopharm, SmPC Venlafaxin-ratiopharm 37,5mg/75mg/150mg/225mg Retardtabletten (74540.00.00), 03/2017
  9. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed June 25, 2018
  10. Heumann, SmPC Venlafaxin 225mg Hartkapseln retardiert (93933.00.00), 03/2018
  11. Heumann, SmPC Venlafaxin 37,5mg/75mg/150mg Hartkapseln retardiert (73198.00.00), 20/2015
  12. Pfizer, SmPC Trevilor retard 37,5mg/75mg/150mg Hartkapseln retardiert (62104.00.00), 05/2018
  13. Puren, SmPC Venlafaxin 37,5mg/75mg Filmtabletten (60465.00.00), 01/2018
  14. Hexal, SmPC Venlafaxin 37,5mg/ 75mg/ 150mg (62231.00.00), 12/2016
  15. Pfizer, SmPC Trevilor retard 37,5mg/75mg/150mg Hartkapseln retardiert (62104.00.00), 05/2018
  16. March JS, et al., Randomized controlled trial of venlafaxine ER versus placebo in pediatric social anxiety disorder, Biol Psychiatry, 2007, 62, 1149-54
  17. Brent D, et al., Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial., JAMA, 2008, 299, 901-13

Changes

Therapeutic Drug Monitoring


Overdose