Faa use of sedating antihistamines

The following briefly outlines allergy and cold medications which are approved by the FAA* on a case by case basis: OVER-THE-COUNTER MEDICATIONS Sudafed (pseudoephedrine) Entex (phenylpropanolamine) are approved by the FAA provided they are not combined with an antihistamine.

Over the counter medications – FAA publication OTHER MEDICATIONS Vitamin B-12 or other prophylactic injections are approved provided there are no side effects.

However, the TGA considers that all paediatric-only sedating antihistamine products should be required to display a label statement advising care-givers that the medicine may cause drowsiness.

With this update, it is considered appropriate to now require the statement ' for all paediatric-only sedating-antihistamine medicines (as per the current requirement for cetirizine and levocetirizine).

Astelin (Azelastine), Dymista (Azelastine HCl / Fluticasone propionate), Claritin (Loratadine), Clarinex (Desloratadine) and Allegra (Fexofenadine) are acceptable to the FAA provided there are no adverse effects.

APPROVED INHALERS Sedating medications are not acceptable.

While the death was not attributed to ingestion of promethazine, the incident raised the issue of the risk of respiratory depression when promethazine is given to infants.

In regards to product labels the MSU article concluded that: 'In response to this safety concern, the TGA will be seeking to make the statement 'Do not give to children under two years of age' (which is currently a recommended statement in the applicable OTC guidelines) a mandatory warning statement on the labels of OTC liquid oral formulations of first-generation oral sedating antihistamines'.

The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) sets out the level of control on the availability of medicines in Australia.The TGA Labelling Orders require medicine labels to include 'warning statements' where these apply to the medicines, including any advisory statements specified in the instrument made under subsection 3(5A) of the ('the Act'), as in force from time to time.The RASML is registered on the Federal Register of Legislative Instruments under subsection 3(5A) of the Act, as the Medicines Advisory Statements Specification ('the Specification'). The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified during development and evaluation of new medicines, or subsequent pharmacovigilance activities, testing, adverse event reports or from other scientific or clinical information.The RASML sets out the advisory statements that are required to be included on the labels of specified medicines. The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same.The current version of the Specification is the Medicines Advisory Statements Specification 2017 (MASS 2017). First-generation antihistamines are available in a variety of doses and formulations.

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