Sudafed

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Sudafed is a brand name and registered trademark for a family of over-the-counter (OTC) decongestants manufactured by Johnson & Johnson for sale in Australia, Canada, Ireland, the United Kingdom and the United States. It is used to treat symptoms of the common cold. Original Sudafed contains the active ingredient pseudoephedrine, though formulations without that ingredient are also being sold under the Sudafed brand. Before being acquired by Johnson & Johnson in 2006, Sudafed was owned by Pfizer.

Product summary

Original Sudafed contains the active ingredient pseudoephedrine (as the hydrochloride salt), with products using the name Sudafed.

The brand name Sudafed is also used for formulations containing other principal active ingredients:

• Phenylephrine (hydrochloride), with products using the name Sudafed PE (except in the United Kingdom where the name Sudafed is used), ostensibly positioned as alternatives to pseudoephedrine formulations
• Oxymetazoline (hydrochloride), with products using the name Sudafed OM in the United States, formulated as topical nasal sprays
• Xylometazoline (hydrochloride), with products using the name Sudafed in the United Kingdom, formulated as topical nasal sprays

Switch to phenylephrine

In late 2004, Pfizer publicly disclosed its plans to make available a new over-the-counter 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 were completely converted to phenylephrine later in 2005, though original Sudafed is still offered behind the counter upon request requiring a signature.

The new product was prompted by existing and proposed restrictions on the availability of pseudoephedrine-based products. U.S. state laws imposing such restrictions were in response to pseudoephedrine's role as an ingredient used to produce the prescription only and addictive stimulant methamphetamine.

Pfizer and its predecessor Warner-Lambert had studied at least two alternatives to the pseudoephedrine-containing formula in anticipation of pressure from state regulators and the Food and Drug Administration^[1]:

• 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, a prescription only 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 US$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.

A prior report from a single study has questioned phenylephrine's effectiveness, but a recent meta-analysis of existing studies supports the efficiency of a single dose of phenylephrine 10 mg compared with placebo in adults with acute nasal congestion due to the common cold.^[2]

Regulation on sale

In the United Kingdom, "Sudafed Decongestant" containing 60 mg of pseudoephedrine hydrochloride per tablet is available in packs of 12 tablets from pharmacies and is classified as a Pharmacy Only Medication ("[P]"), so any sale follows a series of questions from the pharmacist to determine if it is safe. Historically, packs of 24 tablets were also available, but the maximum pack size for OTC sales was reduced to 12 tablets as a measure to counteract misuse.

In Australia, Sudafed with up to 60 mg of pseudoephedrine is available subject to a pharmacist matching the purchaser's identity to a database to determine if the purchase history is consistent with personal use. If identification is not provided, the pharmacist may, at his or her discretion, still provide the medication.

In Canada[1], Sudafed contains phenylephrine hydrochloride, pseudoephedrine hydrochloride in a 120mg "12 hour time release" capsule, or pseudoephedrine hydrochloride combined with other ingredients (e.g. Ibuprofen).

In the United States[2], section 711 of the Combat Methamphetamine Epidemic Act of 2005 reclassifies phenylpropanolamine, pseudoephedrine and ephedrine as Schedule Listed Chemicals. SLCs were reduced by the Federal pertransaction sales limit from 9 grams to 3.6 grams. The amount recently proposed by the Administration requires behind-the-counter storage or locked cabinet storage.

References

External links

• Official Website
• Was the West's methamphetamine epidemic allowed to happen?, a five-part series published in The Oregonian in October 2004
• Official Canadian Website