Published: 3 December 2020

Publications

Do not use oral sedating antihistamines for sedation of children

Published: 3 December 2020
Prescriber Update 41(4): 68

December 2020

Key Messages

  • Oral sedating antihistamines are no longer indicated for sedation of children. This predominantly affects oral promethazine-containing medicines.
  • Updated product packaging, with the changed indication of oral promethazine-containing medicines for sedation in adults only, may not appear in pharmacies for some time.
  • Refer parents and caregivers looking at over-the-counter treatment options to sedate their child to a medical practitioner.


Oral sedating antihistamines are available over-the-counter and can be used for a range of conditions in both adults and children. Table 1 summarises the various uses of oral sedating antihistamines and age restrictions that apply for each use.

Importantly, oral sedating antihistamines must not be used for sedation of children due to the lack of data for this indication. Parents and caregivers looking at over-the-counter options to sedate their child must be referred to a medical practitioner.

The restriction for the use of oral sedating antihistamines for sedation to adults only is a recent change recommended by the Medicines Adverse Reactions Committee.1 The use of oral sedating antihistamines for all other indications remains unchanged.

Oral promethazine-containing medicines are predominantly affected by this change. Data sheets and product packaging for promethazine-containing medicines are being updated so that the use for sedation is for adults only.2–4 There is likely to be a lag-time before the updated packaging appears in pharmacies.

Table 1: Uses of oral sedating antihistamines, by indication and age

Indicationa Age
Allergy From 2 years of age
Nausea and vomiting (including travel sickness) From 2 years of age
In cough and cold medicines From 6 years of age
Insomnia From 12 years of age
Sedationb Adults only


Notes:

  1. Refer to the medicine data sheet or product packaging for the full wording.
  2. Updated product packaging for the use of promethazine-containing medicines for sedation in adults only may not appear in pharmacies for some time.

References

  1. Medsafe. 2020. Minutes of the 182nd Medicines Adverse Reactions Committee Meeting. URL: medsafe.govt.nz/profs/adverse/Minutes182.htm (accessed 5 October 2020).
  2. sanofi-aventis new zealand limited. 2019. Phenergan New Zealand Data Sheet February 2019. URL: medsafe.govt.nz/profs/Datasheet/p/Phenergantabelixir.pdf (accessed 5 October 2020).
  3. AFT Pharmaceuticals Ltd. 2019. Allersoothe elixir New Zealand Data Sheet August 2019. URL: medsafe.govt.nz/profs/Datasheet/a/Allersoothetabelix.pdf (accessed 5 October 2020).
  4. AFT Pharmaceuticals Ltd. 2019. Allersoothe tablets New Zealand Data Sheet February 2019. URL: medsafe.govt.nz/profs/Datasheet/a/Allersoothetab.pdf (accessed 5 October 2020).
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