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

Interactions
PK
Renal impairment
References

Diphenhydramin

Generic name
Diphenhydramin
Brand name
ATC Code
R06AA02

Pharmacokinetics in children

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

  • Prophylaxe und symptomatische Therapie von Übelkeit und Erbrechen unterschiedlicher Genese, insbesondere von Kinetosen
    • rektal
      • 0 bis <1 Jahr: off-label
      • ≥1 bis <12 Jahre, ≥8 kg: zugelassen*[1]
      • ≥12 bis <18 Jahre: zugelassen[2]
    •  oral
      • 0 bis <6 Jahre: off-label
      • ≥6 bis <18 Jahre: zugelassen[3]

*Die Fachinformation beinhaltet nur Dosierungsangaben für (Klein-)Kinder mit einem Gewicht zwischen ≥8 - ≤39 kg sowie für Jugendliche ab 12 Jahren.[1,2]

Licensed use Licensed use

Registration Status Title

Prophylaxe und symptomatische Therapie von Übelkeit und Erbrechen unterschiedlicher Genese, insbesondere von Kinetosen.

rektal

  • Kleinkinder mit 8 bis 16 kg Körpergewicht: 1-mal 20 mg Diphenhydraminhydrochlorid pro Tag[1]
  • Kleinkinder mit 16 bis 39 kg Körpergewicht: 1 – 2-mal täglich 20 mg, entsprechend 20 mg – 40 mg Diphenhydraminhydrochlorid pro Tag[1]
  • Spezielle Hinweise zur Dosierung: Zur Prophylaxe sollte zunächst eine Rektalkapsel (20 mg Diphenhydraminhydrochlorid) pro Tag verabreicht werden. Beim Auftreten akuter Symptome kann die Dosis auf maximal 40 mg pro Tag (Kinder 3 bis 6 Jahre) bzw. maximal 60 mg pro Tag (Kinder ab 6 Jahre) erhöht werden, wobei ein Dosierungsintervall von mindestens 4 – 6 Stunden eingehalten werden sollte.[1,2]
  • Jugendliche ab 12 Jahren: 1 – 2-mal täglich 50 mg, entsprechend 50 mg–100 mg Diphenhydraminhydrochlorid pro Tag[2]

oral

  • Kinder von 6 – 12 Jahre: 1 – 2-mal täglich 25mg – 50mg Diphenhydraminhydrochlorid pro Tag[3]
  • Kinder über 12 Jahre und Jugendliche:
    1 – 2-mal täglich 50 mg– 100 mg Diphenhydraminhydrochlorid pro Tag [3]
  • Hinweis: Zwischen der Gabe von zwei Einzeldosen sollte mindestens ein Zeitabstand von 4 – 6 Stunden liegen.

Zur Kurzzeitbehandlung von Schlafstörungen.

oral

  • nur für Erwachsene zugelassen. Dosierung siehe aktuelle Fachinformation.[4,5]

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Available formulations

Allgemein

Diphenhydramin, zugelassen zur Behandlung von Kindern und Jugendlichen, ist in Form von Tabletten und Rektalkapseln im Handel verfügbar. Daneben gibt es Dragees in geeigneter Stärke, jedoch sind diese nur für Erwachsene zugelassen.

Diphenhydramin liegt dabei stets als Hydrochlorid vor, worauf sich auch die Dosisangabe bezieht.

Orale Anwendung

Tabletten

Anwendungshinweis: Die Tabletten sollten unzerkaut mit Flüssigkeit (z.B. ½ Glas Wasser) eingenommen und rasch hinuntergeschluckt werden. So lässt sich eine Entfaltung des produktspezifischen Eigengeschmacks im Mund vermeiden.[3]

Präparate im Handel (Beispiele):

Präparat Stärke Problematische Hilfsstoffe Ref.
Emesan® Tabletten 50 mgT2 Lactose [3,6]
Vivinox® Sleep Schlafdragees* 25 mgT0 Lactose [4]

T2 = teilbar in 2 gleiche Dosen; *nur zugelassen in der Indikation Schlafstörungen bei Erwachsenen

Rektale Anwendung

Rektalkapseln

Anwendungshinweis: Die Rektalkapseln müssen mit dem dicken Ende voraus in den Mastdarm eingeführt werden (evtl. nach leichtem Anfeuchten mit etwas Wasser). Dadurch gleiten die Rektalkapseln leichter in den Darm und ein unerwünschtes Herausgleiten kann so verhindert werden.[1,2]

Präparate im Handel (Beispiele):

Präparat Stärke Problematische Hilfsstoffe Ref.
Emesan® K Kinderzäpfchen 20 mgT0 Sojaöl, Phospholipide aus Sojabohnen, Macrogolglycerolricinoleat [1]
Emesan® Erwachsenenzäpfchen 50 mgT0 Sojaöl, Phospholipide aus Sojabohnen, Macrogolglycerolricinoleat [2]

T0 = nicht teilbar

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Dosages

Treatment of banal Gastroenteritis
  • Oral
    • 0 years up to 3 years

      • Studies have shown that the administration of diphenhydramine to infants and young children for the treatment of trivial gastroenteritis shows no advantage compared to fluid and electrolyte replacement alone. In view of the frequent occurrence of serious adverse reactions in children up to three years of age in this indication, diphenhydramine should not be used for the treatment of trivial gastroenteritis.
Prophylaxis and symptomatic therapy of nausea and vomiting, especially kinetosis
  • Oral
    • 6 years up to 12 years
      • 25 - 50 mg/day in 1 - 2 doses. There should be an interval of at least 4 - 6 hours between the administration of two single doses..
      • Directions for administration:

        For the prophylaxis of motion sickness, administer at least 30 minutes before travelling.

      • There is no evidence to support the use of diphenhydramine for the treatment of acute gastroenteritis induced nausea and vomiting (Guarino et al. 2014).

  • Rectal
    • 1 year up to 12 years and 8 up to 16 kg
      • 20 mg/day in 1 dose There should be an interval of at least 4 - 6 hours between the administration of two rectal capsules..

      • Overdosage with diphenhydramine hydrochloride can be life-threatening, especially in children under 3 years of age, and must therefore be avoided in this age group under all circumstances. 

    • 1 year up to 12 years and 16 up to 21 kg
      • 20 - 40 mg/day in 1 - 2 doses. There should be an interval of at least 4 - 6 hours between the administration of two rectal capsules..

      • Overdosage with diphenhydramine hydrochloride can be life-threatening, especially in children under 3 years of age, and must therefore be avoided in this age group under all circumstances. 

    • 1 year up to 12 years and ≥ 21 kg
      • 20 - 60 mg/day in 1 - 3 doses. There should be an interval of at least 4 - 6 hours between the administration of two rectal capsules..
Insomnia
  • Oral
    • 2 years up to 3 years
      • 15 -30 minutes before going to bed:  5 mg/day in 1 dose
    • 3 years up to 6 years
      • 15-30 minutes before going to bed: 10 mg/day in 1 dose
    • 6 years up to 10 years
      • 15-30 minutes before going to bed:  15 mg/day in 1 dose
    • 10 years up to 12 years
      • 15-30 minutes before going to bed: 20 mg/day in 1 dose
    • 2 years up to 3 years
      [7]
      • 15 -30 minutes before going to bed:  5 mg/day in 1 dose
    • 3 years up to 6 years
      [7]
      • 15-30 minutes before going to bed: 10 mg/day in 1 dose
    • 6 years up to 10 years
      [7]
      • 15-30 minutes before going to bed:  15 mg/day in 1 dose
    • 10 years up to 12 years
      • 15-30 minutes before going to bed: 20 mg/day in 1 dose
  • Intravenous
    • 2 years up to 12 years
      • Before going to bed:  1 mg/kg/day in 1 dose
    • 2 years up to 12 years
      [8]
      • Before going to bed:  1 mg/kg/day in 1 dose
    • 12 years up to 18 years
      [8]
      • Before going to bed:  30 - 60 mg/day in 1 dose
    • 12 years up to 18 years
      • Before going to bed:  30 - 60 mg/day in 1 dose
    • 12 years up to 18 years
      • Before going to bed:  30 - 60 mg/day in 1 dose
Prevention and symptomatic treatment of allergic reactions and anaphylaxia
  • Intravenous
    • 12 years up to 18 years
      [8]
      • 90 - 180 mg/day in 3 doses.
    • 12 years up to 18 years
      • 90 - 180 mg/day in 3 doses.
    • 12 years up to 18 years
      • 90 - 180 mg/day in 3 doses.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

Very rarely, especially in children: paradoxical reactions in the form of excitation of the central nervous system such as restlessness, irritability, anxiety and tremor.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

Studies have shown that the administration of dimenhydrinate/diphenhydramine to infants and young children for the treatment of banal gastroenteritis shows no advantage compared to substitution with fluids and electrolytes alone. Against the background of the increased occurrence of serious side effects in children up to three years of age in this indication, dimenhydrinate/diphenhydramine should not be used to treat common gastroenteritis.
Since dimenhydrinate/diphenhydramine can cause seizures, especially in infants and young children, and this group of patients is also prone to febrile seizures, dimenhydrinate/diphenhydramine should not be given in febrile infections.

The indication is strict for children up to 3 years of age. In this age group, the maximum recommended dose must not be exceeded under any circumstances.

 

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

Alerts And Precautions Adults

Überdosierung[1-3]

  • sofort intensivmedizinische Behandlung einleiten
    • Magenspülung
    • wiederholte Gabe von Aktivkohle
  • weitere Therapie symptomatisch
    • z.B. künstliche Beatmung, Kühlung bei Hyperthermie, Volumensubstitution, Antikonvulsivagabe
  • Antidot bei schweren Vergiftungen bzw. anticholinergem Syndrom
    • Physostigminsalicylat

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Interactions

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Aminoalkyl ethers
R06AA04
R06AA52
Substituted alkylamines
R06AB03
Phenothiazine derivatives
R06AD01
R06AD08
R06AD02
Piperazine derivatives
R06AE07
R06AE03
R06AE09
R06AE05
Other antihistamines for systemic use
R06AX18
R06AX29
R06AX02
R06AX27
R06AX26
R06AX17
R06AX13
R06AX25
R06AX28

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

References

  1. MMI, Gelbe Liste Online , Accessed Dec. 05, 2018
  2. Cheplapharm Arzneimittel GmbH, SmPC Halbmond-Tabletten® (318.00.00), 07/2017
  3. Dr. Gerhard Mann GmbH/Bausch & Lomb GmbH, SmPC Vivinox® Sleep Schlafdragees (51827.00.00), 12/2014
  4. Aristo Pharma GmbH, SmPC Emesan® Tabletten (6389624.00.01), 05/2017
  5. Aristo Pharma GmbH, SmPC Emesan® E Erwachsenenzäpfchen (6389624.00.00), 05/2017
  6. Aristo Pharma GmbH, SmPC Emesan® K Kinderzäpfchen (6389624.01.00), 12/2017
  7. Pharm. Fabrik Montavit, SmPC Dibondrin liquid (11361), https://aspregister.basg.gv.at/aspregister/, aufgerufen am 04.02.2021
  8. Pharm. Fabrik Montavit, SmPC Dibondrin Ampullen (7162), https://aspregister.basg.gv.at/aspregister/, aufgerufen am 04.02.2021
  9. MMI, Gelbe Liste Online, Accessed Dec. 05, 2018

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Changes

Changes