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Letters to the Editor
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Nasal sprays
What is the dose of nasal pump spray?
From Mr S. Lyftingsmo
Nasal pump spray decongestants in Norway have different pump mechanisms.
They deliver at least three different dose volumes and vary even within
brands. For one international brand of xylometazoline spray the children’s
strength is half the concentration of the adult strength but the pump
stroke gives only one quarter.
This made me look at the situation in several countries. Twenty-eight
bottles from five countries (Australia, Norway, Denmark, Germany and
the UK) were collected (nasal decongestant, no combination products,
only pump spray, no squeeze bottles). A table of the bottles can be found
at www.lyftingsmo.no under “labelling”.
None of the bottles had an amount per dose indicated as part of the product
name. For one of the UK bottles the number of doses in the bottle was
indicated in the patient information leaflet, so the amount per dose
could be calculated. For 11 of the bottles (including the remaining two
from the UK) it was not possible to find out how much active ingredient
there was in one pump stroke.
The patient information leaflet of one of the UK bottles contains the
following text: “Important information about some of the ingredients
in this product. Each 5ml product contains 1.4%w/v sorbitol, which may
cause upset and diarrhoea when taken in large doses.” Such fuss
about 210mg total content of sorbitol in the bottle makes it difficult
for patients to find the more important and relevant information about
the product.
EU directive 2001/83 is not clear on the question of strength. It says: “The
name of the medicinal product followed by the common name where the product
contains only one active substance and if its name is an invented name;
where a medicinal product is available in several pharmaceutical forms
and/or several strengths, the pharmaceutical form and/or the strength
(baby, child or adult as appropriate) must be included in the name of
the medicinal product.” I am sure this obscure language is no hindrance
for manufacturers who wish to express strength in a clear way.
Strength indicated as concentration is a throwback from the times when
bottles and droppers were used but there is no reason for us today to
accept strength indications that are both insufficient and misleading.
There is no doubt in my mind that the nasal pump spray is what Americans
call a “metered dose” product. And one dose can be nothing
else than one pump stroke. It should not only be possible, it should
be easy to find out how large the dose is of the medicine you are taking.
Stein Lyftingsmo
Hospital Pharmacy of Elverum
Norway
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Pharmaceutical Journal