(2005; 12 pages)
BENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
USA. King Pharmaceuticals Inc., has issued a 'Dear Health-care Professional' letter advising of changes to the US labelling of benzathine benzylpenicillin/procaine benzylpenicillin (Bicillin C-R) and benzathine benzylpenicillin (Bicillin L-A) that highlight appropriate use and administration of these products. The letter advises that benzathine benzylpenicillin (Bicillin L-A) is the only approved benzylpenicillin indicated for the treatment of venereal disorders, including syphilis, in the USA. However, King Pharmaceuticals has been made aware of post-marketing reports of benzathine benzylpenicillin/procaine benzylpenicillin (Bicillin C-R) being used to treat patients with syphilis; they warn that use of Bicillin C-R instead of Bicillin L-A may result in inadequate treatment. To reflect this important difference, the cartons and syringe labels of the two agents have been modified. In addition, a boxed warning has been added to the labelling of both Bicillin C-R and Bicillin L-A to emphasize that these products are not intended for IV use, which has been associated with heart arrest and death.
'Dear Health-care Professional' letter from King Pharmaceuticals Inc., November 2004. Available on the Internet at www.fda.gov