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

Interactions
PK
Renal impairment
References

Imipramine (hydrochloride)

Generic name
Imipramine (hydrochloride)
Brand name
ATC Code
N06AA02

Pharmacokinetics in children

The following kinetic parameters have been observed [Tamayo M, et al. 1992, Dell RB et al. 1990]:

  Imipramine Desipramine
t½ (6-13 years, n=49) 16.3 hours 19.3 hours
Vd (12-18 years, n=16) 27 ± 14.3 l/kg 27 ± 14.3 l/kg
Cl (12-18 years, n=16) 0.83 ± 0.2 l/kg/hour 0.67 ± 0.45 l/kg/hour

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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

Nocturnal enuresis
  • Oral
    • 5 years up to 9 years
      • 20 - 30 mg/day in 1 dose. Max: 2.5 mg/kg/day.
      • Directions for administration:

        Take after the evening meal. In children who wet their bed early in the night, however, part of the dose must be given earlier, i.e. around 16:00, and part before going to bed.

      • Once the desired effect has been achieved, lower the dose gradually to the individual maintenance dose and continue the treatment for a further 1-3 months.

    • 9 years up to 12 years
      • 25 - 50 mg/day in 1 dose. Max: 2.5 mg/kg/day.
      • Directions for administration:

        Take after the evening meal. In children who wet their bed early in the night, however, part of the dose must be given earlier, i.e. around 16:00, and part before going to bed.

      • Once the desired effect has been achieved, lower the dose gradually to the individual maintenance dose and continue the treatment for a further 1-3 months.

    • ≥ 12 years
      • 25 - 75 mg/day in 1 dose. Max: 2.5 mg/kg/day.
      • Directions for administration:

        Take after the evening meal. In children who wet their bed early in the night, however, part of the dose must be given earlier, i.e. around 16:00, and part before going to bed.

      • Once the desired effect has been achieved, lower the dose gradually to the individual maintenance dose and continue the treatment for a further 1-3 months.
At least one anxiety disorder plus depression plus truancy combined with cognitive behavioural therapy
  • Oral
    • 12 years up to 18 years
      • Initial dose: 0.25 - 0.5 mg/kg/day in 2 doses.
      • Maintenance dose: titrate over the course of 4 to 6 weeks depending on the clinical response, side effects, ECG and blood pressure/pulse parameters to 2 - 3 mg/kg/day in 2 doses. Max: 5 mg/kg/day.

      • The dosage should be set individually and the lowest possible dose should be used. Treatment with imipramine must not be stopped suddenly; the dose must be reduced gradually.

        Only use the maximum dose in individual cases.

        Imipramine should be prescribed by specialists in child and youth psychiatry or by doctors who are properly familiar with the use of this drug in children and adolescents.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Sedation, sleep disorders, dry mouth (sometimes causing more caries), weight gain, obstipation, dizziness, accommodation disorders, sinus tachycardia, orthostatic hypotension, changes to the ECG, arrhythmias, conduction disorders, palpitations, torsade de pointes and congestive heart failure. One case of dystonia has been described [Freitas 2012].

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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 a reduced capacity to react and concentrate; do not give in cases of depression, exacerbated anxiety disorders in the first weeks, monitor patients closely and high-risk patients in particular (suicidal thoughts, suicide attempts) due to the increased risk of suicide. Measure the blood pressure, pulse rate and ECG before and during the treatment; be aware also of cardiac complaints arising or being exacerbated. Symptoms such as dizziness and heart palpitations must be addressed immediately. Dental checks are indicated because of the greater risk of caries.

Contrary to the situation in adults, using TCAs is not recommended in children and adolescents with depression; the efficacy and safety have not been demonstrated and cases with fatal outcomes are known.

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

Increases in anxiety disorders can appear during the first weeks of the treatment.

Screening for suicide risks is indicated before the treatment. Treatment of depression and other psychiatric indications can increase the elevated risk of suicide yet further during the early stages of recovery.  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 must not be allowed to have large amounts of this drug available.

When TCAs are being used, attention must be paid to any cardiac problems in the patient and their family, as this group of drugs can worsen existing or hereditary vulnerability to arrhythmia. The blood pressure, pulse and ECG also need to be checked before and during treatment. In addition, because of these cardiac side effects, symptoms such as dizziness and heart palpitations require immediate attention.

In patients with an increased risk of side effects, blood concentrations may be measured to determine the lowest possible effective dose.

Dental checks are indicated because of the greater risk of caries.
 

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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
N06AA10
Selective serotonin reuptake inhibitors
N06AB04
N06AB10
N06AB03
N06AB08
N06AB06
Monoamine oxidase A inhibitors
N06AG02
Other antidepressants
N06AX01
N06AX12
N06AX21
N06AX11
N06AX11
N06AX16

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References

  1. Gutgesell H, et al, Cardiovascular monitoring of children and adolescents receiving psychotropic drugs: A statement for healthcare professionals from the Committee on Congenital Cardiac Defects, Council on Cardiovascular Disease in the Young, American Heart Association, Circulation, 1999, 99, 979-82
  2. Dopheide JA, Recognizing and treating depression in children and adolescents, Am J Health Syst Pharm, 2006, 63, 33-43
  3. Bernstein GA, et al, Imipramine plus cognitive-behavioral therapy in the treatment of school refusal, J Am Acad Child Adolesc Psychiatry, 2000, 39, 276-83
  4. Bernstein GA, et al, Treatment of school refusal: one-year follow-up, J Am Acad Child Adolesc Psychiatry., 2001, 40, 206-13
  5. Tamayo M, et al, Population pharmacokinetics of imipramine in children., Eur J Clin Pharmacol., 1992, 43, 89-92
  6. Wagner KD, Pharmacotherapy for major depression in children and adolescents, Prog Neuropsychopharmacol Biol Psychiatry, 2005, 29, 819-26
  7. Klein RG, et al, Imipramine treatment of children with separation anxiety disorder, J Am Acad Child Adolesc Psychiatry., 1992, 31, 21-8
  8. Ketelaars, K, Antidepressiva, Kenniscentrum-KJP, http://www.kenniscentrum-kjp.nl/index.php?id=584 (30 jan 2009)
  9. Centrapharm BV, SPC Imipramine (RVG 50113) , 22 aug 2014, Geraadpleegd 27 okt 2014
  10. Deshpande AV,et al. , Medical management of nocturnal enuresis. , Paediatr Drugs , 2012, 14(2), 71-7
  11. Zadeh MA, et al., Comparison between imipramine and imipramine combined with pseudoephedrine in 5-12-year old children with uncomplicated enuresis: A double-blind clinical trial., J Pediatr Urol, 2011, 7(1), 30-3
  12. Freitas FA, et al., Imipramine-induced dystonia in a child: a case-report. , Rev Bras Psiquiatr, 2012, 34(4), 497-500.
  13. Dell RB et al., Model for the kinetics of imipramine and its metabolites in adolescents., Ther Drug Mon, 1990, 12(5), 450-9.
  14. Fritz GK, et al., Plasma levels and efficacy of imipramine treatment for enuresis., J Am Acad Child Adolesc Psychiatry, 1994, 33(1), 60-4
  15. Preskom SH, et al, Plasma levels of imipramine and metabolites in 68 hospitalized children, J Am Acad Child Adolesc Psychiatry, 1989, 28(3), 373-5
  16. Deshpande AV,et al., Medical management of nocturnal enuresis., Paediatr Drugs, 2012, 14(2), 71-7
  17. Freitas FA, et al., Imipramine-induced dystonia in a child: a case-report., Rev Bras Psiquiatr, 2012, 34(4), 497-500.

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Changes

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