(NAR) VOL. 14 NOS. 1-2 / APRIL - JUNE 2003

[ BFAD BUREAU CIRCULAR NO. 03-A, s. 2003, March 17, 2003 ]

MANDATORY DISSEMINATION OF INFORMATION REGARDING THE PRECAUTION/WARNING OF DRUG PRODUCTS CONTAINING PHENYLPROPANOLAMINE (PPA)



All drug manufacturers/traders/importers/distributors of all products containing PPA are required to provide drugstores and other outlets patient information leaflets containing the precaution/warning mentioned in the BFAD Advisory No. 2003-002 which states that:

PPA is safe and effective if taken in the right dose and for the right indication i.e., for nasal stuffiness due to common colds, allergic rhinitis and sinusitis and taken at the following maximum doses:                               

For children:  
   

2-6 years of age 6.25 mg. every 6 hours
  7-12 years of age 12.5 mg. every 6 hours
   
For adults: 25 mg. every 6 hours
 

Be careful in taking PPA if you have the following health conditions: 1) high blood pressure, 2) toxic goiter, 3) benign prostatic hypertrophy, 4) heart rate irregularity, 5) glaucoma and 6) if you are taking antidepressants. 

Consult your doctor before taking PPA if you think you have the following conditions: 1) heart disease, 2) uncontrolled/untreated high blood pressure.

In the mean time while no leaflet has been printed, drug manufacturers/traders/importers/distributors shall provide all drugstores and outlets the BFAD Advisory No. 2003-002.

All drugstores and outlets are likewise required to provide each customer buying PPA containing product the patient information leaflet or the BFAD Advisory No. 2003-002.

This order takes effect immediately.

Adopted: 17 March 2003

(SGD.) LETICIA BARBARA B. GUTIERREZ, M.S.
  Director



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