| · EPS
· Public health
· Supervision
· Assisted dying
· Paracetamol
· FDCs
· Branded prescribing
· Methadone mixture
· Incontinence products
· CPD
· The Society (2)
Letters to the Editor
|
Fixed dose combination medicinal products (FDCs)
Trade names are a cause of confusion
From Mr S. Lyftingsmo
Trade names for fixed dose combination medicinal products (FDCs) are a
dangerous, unregulated mess in all countries. An increase in the use of
FDCs is a major trend and the World Health Organization is recommending
their use in HIV and tuberculosis.
Sinemet is a medicine that is marketed in many countries. I have seen packages
labelled Sinemet Mite, Sinemet 10/100, Sinemet 100, and Sinemet 110. They
all contain the same formulation.
Below are two examples from Norway. If you think they are confusing, then
think about the therapeutic situation. Then look at the situation in your
own country.
Diovan Comp Forte had the strength 160/12.5 and was strong compared to
Diovan Comp (which now is called Diovan Comp 80/12.5). But calling it Forte
(strong in Latin) became problematic when Diovan Comp 160/25 was marketed.
So Diovan Comp Forte was renamed Diovan Comp 160/12.5.
Zestoretic and Renitec Comp both have 20mg of an ACE inhibitor and 12.5mg
of hydrochlorthiazide and they are therapeutically equivalent. Both have
a weaker variety, Zestoretic Mite and Renitec Comp Mite, respectively.
Mite is Latin for weak, but these two are not therapeutically equivalent,
as one manufacturer has reduced the ACE inhibitor and the other has reduced
the thiazide. Neither of these packages has strength indicated as part
of the product name.
For medicinal products with more than one active ingredient, strength should
be indicated in the product name with the numerical value for each substance
separated with a slash (solidus). Nominations may be omitted. For products
with four or more active ingredients strength can be omitted if the front
side of the package contains statements like “combination product” or “multi
ingredient”.
Stein Lyftingsmo
Hospital Pharmacy of Elverum,
Norway |
The
Pharmaceutical Journal