E-DRUG: Strength indication of FDCs
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This letter was printed in todays issue of Pharmaceutical Journal
http://www.pharmj.com/Editorial/20060325/comment/lett06.html
Strength indication of Fixed Dose Combination Medicinal Products, FDCs, is a dangerous unregulated mess in all countries. Increase in FDCs is a major trend globally, and the World Health Organisation is recommending use of FDCs for treatment of HIV and tuberculosis. [and malaria WB]
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. All containing the same.
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 replaced by (renamed to) Diovan Comp 160/12.5.
Zestoretic and Renitec Comp both have 20mg ACE inhibitor and 12.5mg hydrochlorthiazid, and they are therapeutically equivalent. Both have a weaker variety, Zestoretic Mite and Renitec Comp Mite, respectively. Mite is Latin for weak, but the Mites are not therapeutically equivalent, as one manufacturer has reduced the ACE inhibitor and the other has reduced the thiazid. 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
stein@lyftingsmo.no
www.lyftingsmo.no