E-drug: Phenylpropanolamine (cont)
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The lack of a replacement decongestant, such as pseudoephedrine, for
these cold remedies in Japan may be the major factor in this decision.
Pseudoephedrine is not approved in Japan and is considered a
stimulant drug of abuse.
Frequently, dosing is lower in Japan compared to other regions.
Here is a formula and dosing for a cold remedy (Alguard) in Japan:
Chlorpheniramine Maleate 4.0mg
Phenylpropanolamine Hydrochloride 25.0mg
Anhydrous Caffeine 50.0mg
Lysozyme Chloride 25.0mg
Total Alkaloids in Belladonna Extract 0.133mg
Take 1 capsule 3 times per day after meals (adults over 15 years)
In the US, Dimetapp, for example, has had this formula and dosing:
Brompheniramine maleate 4mg
Phenylpropanolamine Hydrochloride 25.0mg
The labeling indicates "...one tablet very 4 hours. DO NOT EXCEED 6
DOSES IN A 24-HOUR PERIOD"
Hank Malinowski
Mansfield Fellow
USA
Henry Malinowski <MALINOWSKI@cder.fda.gov>
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