Sudafed
Encyclopedia
Sudafed is a brand
name and registered trademark
for over the counter (OTC) decongestant
s manufactured by McNeil Laboratories
(a division of Johnson & Johnson
) for sale in Australia
, New Zealand
, Canada
, Ireland
, the United Kingdom
, and the United States
. Before being acquired by Johnson & Johnson in 2006, Sudafed was owned by Pfizer
.
Sudafed is used to treat symptoms of the common cold
, sinusitis
and nasal congestion
The original formulation
of Sudafed contains the active ingredient pseudoephedrine
, but formulations without pseudoephedrine are also being sold under the Sudafed brand.
that contain different active ingredients:
According to the packaging of Sudafed in the UK, Sudafed capsules also contain paracetamol
. Not all formulations contain paracetamol, so it is important for users to check the active ingredients to determine which formulation is being sold.
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 synthesize the 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
:
Several pharmacists have questioned the effectiveness of orally-administered phenylephrine as a nasal decongestant. At least one meta-analysis has concluded that it is more effective than placebos, while other research has not found sufficient evidence to support this claim.
, "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. The version that contains phenylephrine is not restricted and may be purchased off the shelf from supermarkets and other stores.
In Australia, Sudafed with up to 60 mg of pseudoephedrine is available subject to a pharmacist matching the purchaser's identity to the Project STOP database to determine if the purchase history is consistent with personal use. Under Project STOP, a maximum of one pseudoephedrine containing drugs can be sold over the counter per day. However, doctors still retain the ability to prescribe the drugs. In Queensland, all pharmacists dispensing pseudoephedrine based substances must use the Project STOP database. If identification is not provided, the pharmacist may, at his or her discretion, still provide the medication.
In Canada, 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, section 711 of the Combat Methamphetamine Epidemic Act of 2005 reclassifies phenylpropanolamine, pseudoephedrine and ephedrine as Schedule Listed Chemicals (SLC). 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.
Brand
The American Marketing Association defines a brand as a "Name, term, design, symbol, or any other feature that identifies one seller's good or service as distinct from those of other sellers."...
name and registered trademark
Trademark
A trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or...
for over the counter (OTC) decongestant
Decongestant
A decongestant or nasal decongestant is a type of drug that is used to relieve nasal congestion.-Pharmacology:The vast majority of decongestants act via enhancing norepinephrine and epinephrine or adrenergic activity by stimulating the α-adrenergic receptors...
s manufactured by McNeil Laboratories
McNeil Laboratories
McNeil Consumer Healthcare is a medicals products company belonging to the Johnson & Johnson healthcare products group.-History:The company was founded on March 16, 1879 by 23-year-old Robert McNeil, who paid $167 for a drugstore complete with fixtures, inventory and soda fountain, as a retail...
(a division of Johnson & Johnson
Johnson & Johnson
Johnson & Johnson is an American multinational pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune 500....
) for sale in Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
, New Zealand
New Zealand
New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...
, Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
, Ireland
Republic of Ireland
Ireland , described as the Republic of Ireland , is a sovereign state in Europe occupying approximately five-sixths of the island of the same name. Its capital is Dublin. Ireland, which had a population of 4.58 million in 2011, is a constitutional republic governed as a parliamentary democracy,...
, the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, and the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. Before being acquired by Johnson & Johnson in 2006, Sudafed was owned by Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
.
Sudafed is used to treat symptoms of the common cold
Common cold
The common cold is a viral infectious disease of the upper respiratory system, caused primarily by rhinoviruses and coronaviruses. Common symptoms include a cough, sore throat, runny nose, and fever...
, sinusitis
Sinusitis
Sinusitis is inflammation of the paranasal sinuses, which may be due to infection, allergy, or autoimmune issues. Most cases are due to a viral infection and resolve over the course of 10 days...
and nasal congestion
The original formulation
Formulation
Formulation may refer to:* Clinical formulation* Formulations * Formulation science* Pharmaceutical formulation:** Galenic formulation* Pesticide formulation...
of Sudafed contains the active ingredient pseudoephedrine
Pseudoephedrine
Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
, but formulations without pseudoephedrine are also being sold under the Sudafed brand.
Summary of active ingredients
The brand name Sudafed is used for several formulationsFormulations
Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formula...
that contain different active ingredients:
- PseudoephedrinePseudoephedrinePseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
is the active ingredient (as the hydrochlorideHydrochlorideIn chemistry, hydrochlorides are salts resulting, or regarded as resulting, from the reaction of hydrochloric acid with an organic base . This is also known as muriate, derived from hydrochloric acid's other name: muriatic acid....
salt) of the original Sudafed. - PhenylephrinePhenylephrinePhenylephrine is a selective α1-adrenergic receptor agonist used primarily as a decongestant, as an agent to dilate the pupil, and to increase blood pressure...
(hydrochloride) is the active ingredient in products using the name Sudafed PE (except in the United Kingdom, where the name Sudafed is used). These products are sold as alternatives to pseudoephedrinePseudoephedrinePseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
formulations. - OxymetazolineOxymetazolineOxymetazoline is a selective alpha-1 agonist and partial alpha-2 agonist topical decongestant, used in the form of Oxymetazoline hydrochloride, in products such as Afrin, Dristan, Nasivin, Logicin, Vicks Sinex, Visine L.R., Sudafed OM, and Zicam. It was developed from Xylometazoline at E.Merck...
(hydrochloride) is the active ingredient in products using the name Sudafed OM in the United States; these are formulated as topical nasal sprayNasal sprayNasal sprays come in a variety of forms. Medicated such as Astelin, Afrin and Nasonex and natural such as Sinusoothe and Sterimar. Although delivery methods vary, most nasal sprays function by instilling a fine mist into the nostril by action of a hand-operated pump mechanism.-Antihistamine nasal...
s. - XylometazolineXylometazolineXylometazoline is a drug which is used as a topical nasal decongestant. It is applied directly into the nose, either as a spray or as drops....
(hydrochloride) is the active ingredient in products using the name Sudafed in the United Kingdom; these are also formulated as topical nasal sprayNasal sprayNasal sprays come in a variety of forms. Medicated such as Astelin, Afrin and Nasonex and natural such as Sinusoothe and Sterimar. Although delivery methods vary, most nasal sprays function by instilling a fine mist into the nostril by action of a hand-operated pump mechanism.-Antihistamine nasal...
s.
According to the packaging of Sudafed in the UK, Sudafed capsules also contain paracetamol
Paracetamol
Paracetamol INN , or acetaminophen USAN , is a widely used over-the-counter analgesic and antipyretic . It is commonly used for the relief of headaches and other minor aches and pains and is a major ingredient in numerous cold and flu remedies...
. Not all formulations contain paracetamol, so it is important for users to check the active ingredients to determine which formulation is being sold.
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 and less effective decongestant called phenylephrine, in a formulation sold for years. Decongestants with other ingredients were completely converted to phenylephrine later in 2005. Original Sudafed is still offered behind the counter to customers 18 years of age or older upon request, requiring the customer to show ID and sign a sales log next to a record of their name and address.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 synthesize the stimulant
Stimulant
Stimulants are psychoactive drugs which induce temporary improvements in either mental or physical function or both. Examples of these kinds of effects may include enhanced alertness, wakefulness, and locomotion, among others...
methamphetamine
Methamphetamine
Methamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...
.
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
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
:
- 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$United States dollarThe United States dollar , also referred to as the American dollar, is the official currency of the United States of America. It is divided into 100 smaller units called cents or pennies....
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.
Several pharmacists have questioned the effectiveness of orally-administered phenylephrine as a nasal decongestant. At least one meta-analysis has concluded that it is more effective than placebos, while other research has not found sufficient evidence to support this claim.
Regulation on sale
In the United KingdomUnited Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, "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. The version that contains phenylephrine is not restricted and may be purchased off the shelf from supermarkets and other stores.
In Australia, Sudafed with up to 60 mg of pseudoephedrine is available subject to a pharmacist matching the purchaser's identity to the Project STOP database to determine if the purchase history is consistent with personal use. Under Project STOP, a maximum of one pseudoephedrine containing drugs can be sold over the counter per day. However, doctors still retain the ability to prescribe the drugs. In Queensland, all pharmacists dispensing pseudoephedrine based substances must use the Project STOP database. If identification is not provided, the pharmacist may, at his or her discretion, still provide the medication.
In Canada, 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, section 711 of the Combat Methamphetamine Epidemic Act of 2005 reclassifies phenylpropanolamine, pseudoephedrine and ephedrine as Schedule Listed Chemicals (SLC). 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.
External links
- Official Website
- Was the West's methamphetamine epidemic allowed to happen?, a five-part series published in The OregonianThe OregonianThe Oregonian is the major daily newspaper in Portland, Oregon, owned by Advance Publications. It is the oldest continuously published newspaper on the U.S. west coast, founded as a weekly by Thomas J. Dryer on December 4, 1850...
in October 2004 - Official Canadian Website