Sudafed

Sudafed is a brand name and registered trademark for a family of over-the-counter (OTC) decongestants manufactured by Pfizer Inc. for sale in the United States, the United Kingdom, Australia and Canada. The name is a reference to the active ingredient, pseudoephedrine hydrochloride, traditionally associated with the product. However, because of legal restrictions on the sale of pseudoephedrine recently imposed in many markets, some products sold under the Sudafed brand name do not contain any form of pseudoephedrine.

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In late 2004, Pfizer started publicly disclosing its plans to make available a new OTC product, Sudafed PE, which does not include pseudoephedrine. Sudafed PE contains a different decongestant called phenylephrine, in a formulation sold for years. Decongestants with other ingredients will be completely converted to phenylephrine later in 2005, though original Sudafed will still be offered.

The new product was prompted by existing and proposed restrictions on the availability of pseudoephedrine-based products. State laws imposing such restrictions were in response to pseudoephedrine's role as an ingredient used to produce the illegal and highly addictive stimulant methamphetamine, also known as crystal meth.

Pfizer and its predecessor Warner-Lambert had studied at least two alternatives to its current formula in anticipation of pressure from state regulators and the Food and Drug Administration:

• In 1996, the company began testing a patented decongestant ingredient known as "minus" pseudoephedrine. The company claimed animal tests showed this altered version offered sinus relief comparable to the current "plus" pseudoephedrine. The difference was that it couldn't be converted to methamphetamine, an illegal drug used recreationally. Pfizer did not bring the new ingredient to market because of the cost and time involved in gaining regulatory approval.
• Pfizer spent $12 million trying to develop additives for Sudafed that might make it harder to remove the pseudoephedrine it contains. They abandoned the project in 2003, seven years after announcing its existence.

According to L. Hendeles of the University of Florida, "Phenylpropanolamine, pseudoephedrine, and phenylephrine are the most common decongestants. Although all are sympathomimetic amines, their efficacy varies. In particular, phenylephrine is subject to first-pass metabolism and therefore is not bioavailable in currently recommended doses."^[1], although 20mg doses do appear to be safe, and anecdotal evidence suggests greater decongestant action at this dose.

In Australia, Sudafed with up to 60mg of pseudoephedrine is available by prescription or subject to a pharmacist matching the purchaser's driver's license to a database and determining if the purchase history is consistent with personal use. If a driver's license is not provided, the pharmacist can, at his or her discretion, still provide the medication.

References

1. ^ Hendeles L. (1993 Nov-Dec). "Selecting a decongestant". Pharmacotherapy 13: 129S - 134S. PMID 7507590.