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why is phenylpropanolamine a controlled substance

by Dr. Delores Spinka Jr. Published 3 years ago Updated 2 years ago

Because of its potential use in amphetamine manufacture, it is controlled by the Combat Methamphetamine Epidemic Act of 2005. It is still available for veterinary use in dogs, however, as a treatment for urinary incontinence.

Because of its potential use in amphetamine manufacture, it is controlled by the Combat Methamphetamine Epidemic Act of 2005. It is still available for veterinary use in dogs, however, as a treatment for urinary incontinence.

Full Answer

Is oxaprozin a controlled dangerous substance?

People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as oxaprozin may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time.

What products contain phenylpropanolamine?

Phenylpropanolamine

  • (+-)-Norephedrine
  • (+-)-Phenylpropanolamine
  • Fenilpropanolamina
  • Norephedrine
  • Phenylpropanolamin
  • Phenylpropanolamina
  • Phénylpropanolamine
  • Phenylpropanolamine
  • Phenylpropanolaminum
  • PPA

Is phenylpropanolamine banned by the FDA?

Lot more interesting detail can be read here. In this manner, why is phenylpropanolamine banned? FDA, today, is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Is prazole a controlled substance?

• The drug or other substance has a high potential for abuse. • The drug or other substance has no currently accepted medical use in treatment in the United States. • There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Is phenylpropanolamine a controlled substance?

While PPA is not a controlled substance, it is a listed chemical, and subject to federal regulation under the Combat Methamphetamine Epidemic Act of 2005.

Why was phenylpropanolamine taken off the market?

Phenylpropanolamine has been voluntarily removed from the market in the United States by its manufactures because of concerns raised about its ability to precipitate a stroke when used, or perhaps abused, as an appetite suppressant Kernan et al (2000).

What class of drug is phenylpropanolamine?

Phenylpropanolamine is a sympathomimetic agent that acts as a nonselective adrenergic receptor agonist and norepinephrine reuptake inhibitor. It has been used as a decongestant and appetite suppressant.

Is phenylpropanolamine banned?

In November 2000 the FDA asked manufacturers to stop marketing products containing phenylpropanolamine and subsequently banned such products, whether as nasal decongestants or appetite suppressants.

Can you still buy phenylpropanolamine?

In the United States, PPA is no longer sold due to an increased risk of haemorrhagic stroke. In a few countries in Europe, however, it is still available either by prescription or sometimes over-the-counter.

Can you buy phenylpropanolamine over the counter?

Phenylpropanolamine is a drug used to relieve nasal congestion due to colds , hay fever , upper respiratory allergies, and sinusitis . It is available in nonprescription products alone and in combination with other nonprescription drugs, to treat symptoms of allergy , colds, and upper respiratory infections.

Is Proin a controlled substance in California?

What is Proin? Proin is an aid in the management of urinary incontinence in dogs. Proin requires a prescription from your veterinarian, and is considered a controlled substance in some states.

What are the side effects of phenylpropanolamine?

Are there any potential side effects? The most common side effects include vomiting, diarrhea, lack of appetite, increased thirst, restlessness, irritability, and difficulty urinating. Serious side effects include seizures, collapse, or stroke-like signs (for example, not being able to walk).

What OTC drugs contain phenylpropanolamine?

Although most of these products have been taken off the market, the ones that contain phenylpropanolamine include Tavist-D, Dimetapp, Robitussin, Vicks, and Alka Seltzer Plus. Any cold and cough medicines purchased over the counter should be inspected for phenylpropanolamine, or a pharmacist may be consulted.

Why is phenylephrine banned?

But pharmacists are now calling for phenylephrine to be banned after research has shown that popping a pill or taking a spoonful of the stuff is ineffective for relieving nasal decongestion.

Is phenylephrine banned in USA?

Nasal decongestants such as Phenylephrine Hydrochloride have been banned and tested by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

What are the contraindications of phenylpropanolamine?

The following conditions are contraindicated with this drug....Conditions:overactive thyroid gland.increased pressure in the eye.closed angle glaucoma.high blood pressure.stenosing peptic ulcer.blockage of the urinary bladder.enlarged prostate.an inability to completely empty the bladder.More items...

What Is Phenylpropanolamine?

Phenylpropanolamine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood...

What Is The Most Important Information I Should Know About Phenylpropanolamine?

Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain)...

Who Should Not Take Phenylpropanolamine?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tra...

How Should I Take Phenylpropanolamine?

Take phenylpropanolamine exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these...

What Happens If I Miss A Dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regula...

What Happens If I Overdose?

Seek emergency medical attention.Symptoms of a phenylpropanolamine overdose include extreme tiredness, sweating, dizziness, a slow heart beat, and...

What Should I Avoid While Taking Phenylpropanolamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If...

Phenylpropanolamine Side Effects

If you experience any of the following serious side effects from this medication, stop taking phenylpropanolamine and seek emergency medical attent...

Phenylpropanolamine Dosing Information

Usual Adult Dose for Nasal Congestion:25 mg orally every 4 hours.-or-75 mg orally extended release every 12 hours.Not to exceed 150 mg/day.Usual Ad...

What Other Drugs Will Affect Phenylpropanolamine?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tra...

What is the simplest unsubstituted phenylisopropylamine?

The simplest unsubstituted phenylisopropylamine, 1-phenyl-2-aminopropane, or amphetamine , serves as a common structural template for hallucinogens and psychostimulants. Amphetamine produces central stimulant, anorectic, and sympathomimetic actions, and it is the prototype member of this class (39). ...

What is the compound of d-norephedrine?

The compound exists as four stereoisomers, which include d - and l -norephedrine and d - and l -norpseudoephedrine. d -Norpseudoephedrine is also known as cathine, and is found naturally in Catha edulis ( khat ).

What is PPA used for?

It was commonly used in prescription and over-the-counter cough and cold preparations. In veterinary medicine, it is used to control urinary incontinence in dogs.

What is a Category 1 PPA?

A European Category 1 Licence is required to purchase PPA for academic use. In the United States, the Food and Drug Administration (FDA) issued a public health advisory against the use of the drug in November 2000.

What is the phase 1 metabolism of amphetamines?

The phase 1 metabolism of amphetamine analogs is catalyzed by two systems: cytochrome P450 and flavin monooxygenase. ... Amphetamine can also undergo aromatic hydroxylation to p-hydroxyamphetamine. ... Subsequent oxidation at the benzylic position by DA β-hydroxylase affords p-hydroxynorephedrine.

When was PPA banned in India?

Drugs containing PPA were banned in India on 27 January 2011.

How many optical isomers are there in PPA?

There are four optical isomers of PPA: dextro- and levo-norephedrine, and dextro- and levo-norpseudoephedrine. d-Norpseudoephedrine is also known as cathine, and occurs naturally in Catha edulis ("Khat").

Is phenylpropanolamine removed from all drugs?

FDA, today, is taking steps to remove phenylprop anolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Is phenylpropanolamine an over the counter medication?

Phenylpropanolamine is an ingredient used in many over-the-counter (OTC) and pre scription cough and cold medications as a decongestant and in OTC weight loss products. Adverse events reported with these products led to concerns that this ingredient might increase the risk of hemorrhagic strokes.

What is phenylpropanolamine used for?

Phenylpropanolamine is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold.

What are the side effects of taking phenylpropanolamine?

Other, less serious side effects may be more likely to occur. Continue to take phenylpropanolamine and talk to your doctor if you experience. dizziness, lightheadedness, or drowsiness; headache; insomnia; anxiety;

What drugs can interact with phenylpropanolamine?

Phenylpropanolamine may also interact with the following medicines: tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);

How long can you take phenylpropanolamine?

Do not take phenylpropanolamine for longer than 7 days if your condition does not improve or if your symptoms are accompanied by a high fever.

What are some other medications that interact with phenothiazines?

other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine). Drugs other than those listed here may also interact with phenylpropanolamine.

Can you use phenylpropanolamine for a stroke?

Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine. Phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

Does phenylpropanolamine cause a stroke?

Phenylpropanolamine also causes a decrease in appetite and is used in some over-the-counter diet aids. Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissu e surrounding the brain) in women . Men may also be at risk.

What is phenylpropanolamine used for?

NOTICE - Phenylpropanolamine can be used in Illicit Amphetamine Manufacture. The Drug Enforcement Administration (DEA) is issuing this notice to inform individuals and businesses handling phenylpropanolamine that this chemical is used in the illicit manufacture of amphetamine.

Who reports phenylpropanolamine to the DEA?

Per federal regulations, each handler (regulated person) shall report to the DEA Special Agent in Charge of the local DEA office the following information: any other circumstance that the regulated person believes may indicate that the phenylpropanolamine will be used in violation of the Controlled Substances Act.

Is phenylpropanolamine a list I chemical?

Phenylpropanolamine is a List I chemical under federal law. Handlers of phenylpropanolamine need to know their customers so as not to become an unwitting supplier to a clandestine amphetamine laboratory.

What is phenylpropanolamine used for?

Phenylpropanolamine (Propalin Vetoquinol) is used in cases of urinary incontinence due to urethral sphincter incompetence. It is categorized as an α1 -adrenergic agonist; however, it also has some α 2 -agonist properties ( Flavahan, 2005 ). The mechanism of action is increased urethral outflow resistance.

What is PPA pharmacodynamics?

Targets: Pharmacodynamics#N#PPA is a substrate for NET and dopamine transporters, but not the serotonin transporter. PPA is a low-affinity, weak partial agonist at alpha-1 adrenergic receptors, with a higher affinity at alpha-2 adrenergic receptors. Although in vivo it can act as both a direct and indirect sympathomimetic amine, depending on tissue and species, it has a predominately direct action in vascular smooth muscle ( Johnson, 1991; Hricik and Johnson, 1996 ). Its ability to reduce nasal decongestion appears to be due its direct agonist action at vasoconstrictor alpha-2 adrenergic receptors, which are unusually abundant in the vasculature of the nasal mucosa ( Flavahan, 2005 ).

What is PPA in medicine?

Phenylpropanolamine (PPA) is a mixed-acting sympathomimetic amine similar to ephedrine. Its primary mechanism of action is through direct α-adrenergic agonism, but there is also indirect stimulation of norepinephrine release. In November 2000, the US Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee determined ...

What is PPA used for?

The most common use in animals is for treating urinary incontinence.

Is phenylpropanolamine a sympathomimetic?

Phenylpropanolamine [ (±)-norephedrine] is a sympathomimetic first introduced in the 1930s. It has been used widely as a nasal decongestant and an appetite suppressant. In vitro, it is a partial agonist at alpha-2 and alpha-1 adrenoceptors, and inhibits the reuptake of norepinephrine and dopamine. In vivo, its therapeutic action to reduced nasal decongestion appears to be due its agonist activity at vasoconstrictor alpha-2 adrenoceptors, which are unusually abundant in the vasculature of the nasal mucosa. Phenylpropanolamine has been voluntarily removed from the market in the United States by its manufactures because of concerns raised about its ability to precipitate a stroke when used, or perhaps abused, as an appetite suppressant Kernan et al (2000).

Is phenylpropanolamine a weight control drug?

Phenylpropanolamine is structurally similar to amphetamine. Used both as a nasal decongestant and as a weight control medication, it can increase plasma caffeine levels when taken in combination ( Lake et al., 1990 ).

Is PPA soluble in water?

PPA is very soluble in water (149gl−1) and methanol, soluble in ethanol, sparingly soluble in isopropanol, and insoluble in ether, ethyl acetate, chloroform, benzene, carbon tetrachloride, acetonitrile, acetone, and cyclohexane (Kanfer et al., 1983)

What is phenylpropanolamine? What is its function?

It has been used widely as a nasal decongestant and an appetite suppressant. In vitro, it is a partial agonist at alpha-2 and alpha-1 adrenoceptors, and inhibits the reuptake of norepinephrine and dopamine. In vivo, its therapeutic action to reduced nasal decongestion appears to be due its agonist activity at vasoconstrictor alpha-2 adrenoceptors, which are unusually abundant in the vasculature of the nasal mucosa. Phenylpropanolamine has been voluntarily removed from the market in the United States by its manufactures because of concerns raised about its ability to precipitate a stroke when used, or perhaps abused, as an appetite suppressant Kernan et al (2000).

Is phenylpropanolamine a sympathomimetic amine?

Phenylprop anolamine (PPA) is a mixed-acting sympathomimetic amine similar to ephedrine. Its primary mechanism of action is through direct α-adrenergic agonism, but there is also indirect stimulation of norepinephrine release. In November 2000, the US Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee determined that there is a significant association between PPA and hemorrhagic stroke and recommended that PPA not be considered safe for over-the-counter use. At this time, a letter was issued to manufacturers requesting voluntary removal of PPA from their products. Later, in 2005, the FDA published a Tentative Final Monograph for PPA-containing products proposing Category II status (not generally recognized as safe and effective). To date, no Final Monograph has been released; however, all manufacturers have removed PPA from their products.

Is pseudoephedrine an alpha agonist?

Phenylpropanolamine and pseudoephedrine, both alpha agonists, are commonly found in over-the-counter medications and known for their stimulant effects. In fact, since the U.S. Food and Drug Administration banned dietary supplements containing ephedrine, many manufacturers have replaced ephedrine with a variety of alpha agonist compounds. Numerous studies of the effects of phenylpropanolamine and pseudoephedrine on aerobic and anaerobic exercise have failed to show ergogenic benefits, with no significant benefits to power, work, O 2max, or perceived exhaustion. 95–100 These studies have tended to demonstrate a relatively safe cardiovascular profile, which would parallel the safety of these compounds in over-the-counter medications. 96,98 However, one study has suggested increased heart rate at submaximal exercise levels and prolonged time to heart rate recovery with a common nonprescription dose of pseudoephedrine. 100 An older trial also demonstrated an increased incidence of sinus arrhythmias without complication at maximal over-the-counter dose of pseudoephedrine. 101 Cardiovascular side effects at supratherapeutic doses have not been studied, although these risks persist in theory. However, even at therapeutic doses, phenylpropanolamine and pseudoephedrine are easily detected with blood and urine testing. 99

Is pseudoephedrine a nasal decongestant?

Pseudoephedrine and phenylpropanolamine are orally effective nasal decongestants and sympathomimetics. An RCT comparing the efficacy and safety of cetirizine (5 mg), pseudoephedrine (120 mg bid), and their combination found that insomnia was the most common complaint in patients taking pseudoephedrine (Bertrand et al., 1996 ).

What is the Purpose of the Controlled Substances Act?

The controlled substances act is a legal framework that defines federal drug policy in the United States. It governs the manufacture, importation, possession, and distribution of controlled substances.

How are controlled substances classified?

Controlled substances are grouped into five categories (also known as schedules) depending on their medical uses and ability to lead to abuse or dependency. 3

List of Controlled Substances

The complete list of controlled substances in the United States is too broad to cover in this article. You can find the complete list of all controlled chemicals, drugs, and substances on the Drug Enforcement Agency website.

What Drugs Have the Highest Potential for Abuse?

Schedule I and II drugs have the highest potential for abuse. The substances listed under these categories have the greatest potential to cause psychological or physical dependence.

What Drugs Have the Lowest Potential for Abuse?

Schedule 5 drugs have the least potential for abuse. They are also the least regulated of all scheduled substances.

Treatment Options for Substance Use Disorder (SUD)

There is no cure for substance use disorder (SUD). However, there are several treatment approaches that can help the affected person overcome it and remain drug-free. The strategy used depends on the drug used and any co-occurring mental health disorders. 2

image

Overview

Society and culture

In Sweden, PPA is still available in prescription decongestants, PPA is also still available in Germany. It is used in some polypill medications like Wick DayMed capsules.
In the United Kingdom, PPA was available in many 'all in one' cough and cold medications which usually also feature paracetamol or another analgesic and caffeine and could also be purchased on its own; however, it is no longer approved for human use. A European Category 1 Licence is requ…

Chemistry

PPA is also known as β-hydroxyamphetamine, and is a member of the phenethylamine and amphetamine chemical classes. It is closely related to the cathinones (β-ketoamphetamines). The compound exists as four stereoisomers, which include d- and l-norephedrine and d- and l-norpseudoephedrine. d-Norpseudoephedrine is also known as cathine, and is found naturally in Catha edulis (khat). Pharmaceutical drug preparations of PPA have varied in their stereoisomer co…

History

Phenylpropanolamine was patented in 1938. In the United States, PPA is no longer sold due to an increased risk of haemorrhagic stroke. In a few countries in Europe, however, it is still available either by prescription or sometimes over-the-counter. In Canada, it was withdrawn from the market on 31 May 2001. It was voluntarily withdrawn from the Australian market by July 2001. In India, human use of PPA and its formulations was banned on 10 February 2011, but the ban was overt…

Pharmacology

Although originally thought to act as a direct agonist of adrenergic receptors, PPA was subsequently found to show only weak or negligible affinity for these receptors, and has been instead characterized as an indirect sympathomimetic which acts by inducing norepinephrine release and thereby activating adrenergic receptors.
PPA acts primarily as a selective norepinephrine releasing agent. It also acts as a dopamine relea…

Drug interactions

Certain drugs increase the chances of déjà vu occurring in the user, resulting in a strong sensation that an event or experience currently being experienced has already been experienced in the past. Some pharmaceutical drugs, when taken together, have also been implicated in the cause of déjà vu. Taiminen and Jääskeläinen (2001) reported the case of an otherwise healthy male who started experiencing intense and recurrent sensations of déjà vu upon taking the drugs amantadine and …

External links

• Phenylpropanolamine Information Page at FDA.gov (update, includes earlier reports)
• U.S. National Library of Medicine: Drug Information Portal – Phenylpropanolamine

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      receivinghelpdeskask
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        Metadata
        Bindings
        • 0. 2025-06-10 23:50:40
        • 1. why-is-phenylpropanolamine-a-controlled-substance
        Backtrace
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        • 18. /vendor/laravel/framework/src/Illuminate/Routing/Router.php:842
        • 19. Route binding:39
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        • 21. /vendor/laravel/framework/src/Illuminate/Foundation/Http/Middleware/VerifyCsrfToken.php:78
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        Metadata
        Bindings
        • 0. 215683
        • 1. 0
        Backtrace
        • 19. middleware::checkdate:30
        • 20. /vendor/laravel/framework/src/Illuminate/Pipeline/Pipeline.php:167
        • 21. /vendor/laravel/jetstream/src/Http/Middleware/ShareInertiaData.php:61
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        • 23. /vendor/laravel/framework/src/Illuminate/Routing/Middleware/SubstituteBindings.php:50
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        Metadata
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        Backtrace
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        • 18. /vendor/laravel/framework/src/Illuminate/Routing/ControllerDispatcher.php:45
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        • 20. /vendor/outl1ne/nova-menu-builder/src/helpers.php:33
        • 22. /vendor/laravel/framework/src/Illuminate/Routing/Controller.php:54
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        Backtrace
        • 24. /vendor/outl1ne/nova-menu-builder/src/Models/Menu.php:35
        • 25. /vendor/outl1ne/nova-menu-builder/src/helpers.php:33
        • 27. /vendor/laravel/framework/src/Illuminate/Routing/Controller.php:54
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        Metadata
        Bindings
        • 0. publish
        Backtrace
        • 14. /app/View/Composers/SidebarView.php:22
        • 15. /app/View/Composers/SidebarView.php:12
        • 16. /vendor/laravel/framework/src/Illuminate/View/Concerns/ManagesEvents.php:124
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        • 20. /vendor/laravel/framework/src/Illuminate/View/Concerns/ManagesEvents.php:177
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