WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Voir le document au format PDF
Table des matières
Fermer ce répertoireREGULATORY MATTERS
Afficher le documentAMIODARONE - Medication Guide to be dispensed along with medicine
Afficher le documentATOMOXETINE - Labelling to include liver injury warning
Afficher le documentBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
Afficher le documentMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
Afficher le documentPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
Afficher le documentSMALLPOX VACCINE - Label to highlight reports of myopericarditis
Afficher le documentTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Ouvrir ce répertoire et afficher son contenuSAFETY OF MEDICINES
Ouvrir ce répertoire et afficher son contenuDRUGS OF CURRENT INTEREST
Ouvrir ce répertoire et afficher son contenuFEATURE
 

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.

Reference:

'Dear Health-care Professional' letter from King Pharmaceuticals Inc., November 2004. Available on the Internet at www.fda.gov

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