[e-drug] FDC in India (5)

["Stein Lyftingsmo" <stein@lyftingsmo.no>]

E-DRUG: FDC in India (5)
---------------------------------------------------------

Not all FDCs are bad. However, regulation to present the strength of FDCs
is often missing or weak. For example, I have seen 4 different ways to do
it for the same tablet of Sinemet (levodopa and carbidopa):

A) No strength, only a word like 'mite'; 
B) Only the milligrams of levodopa, 100
C) The sum of milligrams of levodopa and carbidopa, 125
D) The two strengths with a dash between, 25/100. This is the best way to do
it.

When there is more than one strength of an FDC, which amount has changed?
Ingredient A? Ingredient B? Or both ingredients A and B?

I have written an article (2001) and a letter (2006) in Pharmaceutical
Journal in UK about the problem. 
http://www.pharmj.com/Editorial/20010623/comment/spectrum.html
http://www.pharmj.com/Editorial/20060325/comment/lett06.html

My recommendation:
 
For FDCs with fantasy name and two or three active ingredients, as a minimum
the numerical strength should be indicated in the product name.

If denotations (mg, Units) are omitted, the values should be separated by a
dash (solidus) or '+'.

For FDCs with four or more active ingredients the term 'multi ingredient'
should be printed directly beneath the product name.


Stein Lyftingsmo
Hospital Pharmacy of Elverum
Norway
www.lyftingsmo.no