Phenylpropanolamine (Systemic)


Note: Products containing phenylpropanolamine were removed from the U.S. and Canadian Markets in November 2000.{60}


VA CLASSIFICATION
Primary: AU100
Secondary: GA751; RE200



Another commonly used name is
PPA .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.



Category:


Sympathomimetic (adrenergic) agent—

appetite suppressant—

decongestant, nasal (systemic)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Note: In November 2000, the Food and Drug Administration (FDA) issued a public warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by the final report of The Hemorrhagic Stroke Project (HSP){61}, requested that manufacturers voluntarily discontinue marketing products that contain PPA and consumers work with their healthcare providers to select alternative products.{60}


Accepted

Obesity, exogenous (treatment)—Phenylpropanolamine (PPA) is indicated in the management of exogenous obesity for short-term use (6 to 12 weeks) in conjunction with a regimen of weight reduction based on caloric restriction, exercise, and behavior modification.

Nasal congestion (treatment)—Administered orally, phenylpropanolamine is indicated in the temporary, symptomatic relief of local swelling and congestion of nasal mucous membranes.

[Urinary incontinence (treatment)]—Phenylpropanolamine is used in the treatment of mild to moderate {12} stress incontinence {11} {12} {13} {26} {27} {28}; it may be effective in up to 75% of patients with mild to moderate conditions. {12} In females, phenylpropanolamine may be used in combination with estrogen therapy {11} {12} {13} {26} {28} for a synergistic clinical effect. {12} {13}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    187.67

pKa—
    9


Other characteristics
    Similar in structure and action to ephedrine and amphetamine {06} {08} {09} {13} but with less potency for central nervous system (CNS) stimulation. {06} {13}

Mechanism of action/Effect:

Appetite suppression—A mixed-acting {13} sympathomimetic amine {05} {06} {08} {09} {10} {13} with predominantly alpha-adrenergic activity, {13} phenylpropanolamine is believed to suppress the appetite control center in the hypothalamus. {05} Other CNS actions and/or metabolic effects may also be involved. {05} PPA acts as an agonist at central norepinephrine receptors and may also have dopamine agonist properties. {05} {06}

Decongestion, nasal—Phenylpropanolamine acts on alpha-adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal passages. {13}

Urinary incontinence—Phenylpropanolamine produces contraction of the bladder neck and of the smooth muscle of the urethra, possibly due to stimulation of alpha-adrenergic receptors. {13}


Other actions/effects:

Increases heart rate, force of contraction, and cardiac output and excitability, {09} {12} possibly by stimulating beta-adrenergic receptors in the heart. {13}

Causes CNS stimulation {09} by releasing norepinephrine from storage sites.

Produces mydriasis. {09} {13}

Absorption:

Readily absorbed. {05} {09} {13} {17}

Biotransformation:

Hepatic {05} {09}, to an active hydroxylated metabolite. {05}

Onset of action:

Nasal decongestion—15 to 30 minutes.

Duration of action:

Capsules and tablets—3 hours.

Extended-release—12 to 16 hours.

Elimination:
    Renal {17}; about 80 to 90% excreted unchanged within 24 hours. {05} {09} {10}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other sympathomimetics (for example, amphetamines, ephedrine, epinephrine, isoproterenol, metaproterenol, norepinephrine, phenylephrine, pseudoephedrine, terbutaline) may be sensitive to this medication also.

Pregnancy/Reproduction

Pregnancy—
Problems with teratogenicity in humans have not been documented. {01}

Postpartum —
Evidence shows that postpartum women may be at greater risk than the rest of the population of developing psychiatric disorders with the use of phenylpropanolamine at recommended doses and with overdose. {01}

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies have not been performed in children up to 12 years of age. However, recent evidence shows that children under 6 years of age may be at greater risk than the rest of the population of developing psychiatric disorders with the use of phenylpropanolamine at recommended doses and with overdose. {01} {09}

Phenylpropanolamine is not recommended as an appetite suppressant in children up to 12 years of age. {05} In children between 12 and 18 years of age, the use of phenylpropanolamine as an appetite suppressant must be carefully supervised by a physician. {05} {07} {09}


Geriatrics


No information is available on the relationship of age to the effects of phenylpropanolamine in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Anesthetics, hydrocarbon inhalation{04}{05}    (chronic use of phenylpropanolamine prior to anesthesia with these agents may increase the risk of cardiac arrhythmias, since these medications may sensitize the myocardium to the effects of phenylpropanolamine; arrhythmias may respond to a beta-adrenergic blocking agent such as propranolol)


Antidepressants, tricyclic{05}{06}{08}{09}{13}    (tricyclic antidepressants may potentiate the response to sympathomimetic amines such as PPA by blocking the reuptake of biogenic amines by nerve terminals {13})


Antihypertensives{02}{03}{04}{06}{09}{13} or
Diuretics used as antihypertensives    (hypotensive effects of these medications may be reduced during concurrent use with phenylpropanolamine; the patient should be carefully monitored to confirm that the desired effect is being obtained)


» Beta-adrenergic blocking agents{02}{08}{13}    (concurrent use with phenylpropanolamine may result in significant hypertension and excessive bradycardia with possible heart block; concurrent use requires careful monitoring)


» CNS stimulation–producing medications (see Appendix II ) or
» Sympathomimetics, other{05}{09}{13}{33}{34}{35}{36}{37}{38}{39}{40}    (concurrent use with phenylpropanolamine may result in additive CNS stimulation to excessive levels, causing nervousness, irritability, insomnia, or possibly seizures or cardiac arrhythmias; close monitoring is recommended)

    (also, concurrent use of other sympathomimetics with phenylpropanolamine may increase the pressor or cardiovascular effects of either medication)


» Digitalis glycosides{13}    (concurrent use may result in cardiac arrhythmias)


» Monoamine oxidase (MAO) inhibitors,{02}{03}{04}{05}{06}{08}{09}{10}{13}{33}{34}{35} including furazolidone, procarbazine, and selegiline    (concurrent use may potentiate the pressor effect of phenylpropanolamine precipitating a hypertensive crisis by releasing catecholamines, which accumulate during therapy with MAO inhibitors, from intraneuronal storage sites; phenylpropanolamine should not be administered during or within 14 days {33} {34} {35} following administration of MAO inhibitors)


» Rauwolfia alkaloids{04}{05}    (concurrent use may inhibit the indirect-acting sympathomimetic action of phenylpropanolamine by depleting catecholamine stores)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Coronary artery disease, severe{05}{06}{09}    (phenylpropanolamine may increase heart rate and force of contraction, resulting in decreased cardiac efficiency)


» Hypertension, severe{05}{06}{09}    (pressor effect of phenylpropanolamine may result in hypertensive crisis)


Risk-benefit should be considered when the following medical problems exist
» Cardiovascular disorders{05}{06}{09}{12}{33}{34}{35}{36}{37}{38}{39}{40}    (phenylpropanolamine may cause cardiac excitation leading to arrhythmias)


Diabetes mellitus{05}{06}{09}{33}{34}{35}{36}{37}{38}{39}{40}    (adrenergic properties of phenylpropanolamine may lead to increased blood glucose concentrations)


Glaucoma, angle-closure{30}    (condition may be aggravated)


» Hypertension, mild{05}{06}{09}{33}{34}{35}{36}{37}{38}{39}{40}    (vasoconstrictive properties of phenylpropanolamine may exacerbate condition)


Hyperthyroidism{05}{06}{09}{33}{34}{35}{36}{37}{38}{39}{40}    (symptoms may be exacerbated by cardiac stimulant properties of phenylpropanolamine)


Prostatic hypertrophy{30}    (urinary retention may be precipitated)


Psychosis or other psychiatric disorders, history of    (phenylpropanolamine may precipitate psychiatric disorders {01} {08} {09})


Sensitivity to phenylpropanolamine or other sympathomimetics


Side/Adverse Effects

Note: The safety profile of phenylpropanolamine is controversial. {08} Most controlled studies have demonstrated minimal side effects from phenylpropanolamine (PPA). Serious adverse reactions including hypertensive crises {08} {09}, stroke {08} {09}, arrhythmias {08} {09}, acute renal failure {09}, rhabdomyolysis {09}, psychotic disturbances {08} {09}, hallucinations {09}, and seizures {08} {09} have been reported following consumption of PPA; however, case studies in many of these patients have revealed confounding factors such as pre-existing conditions and/or consumption of other medications concurrently with PPA. {08} {09}
Some investigators have suggested that serious cardiovascular side effects may be more likely to occur in patients prone to hypertension {06} {08} {16} {22}(such as obese patients {06} {08}, patients under stress {08}, elderly patients {08}, or female patients receiving oral contraceptives {08}); in patients with eating disorders, such as anorexia nervosa or bulimia (these patients may tend to abuse weight control medications); and in females and children who, because of their smaller size, receive a greater dose per unit of body weight. {08}
Similarly, serious CNS side effects may occur more frequently in patients with a history of pre-existing neurologic {13} or psychiatric {06} {09} {13} conditions. In addition, one study noted that organic symptoms (such as dizziness, loss of motor coordination, confusion, and photophobia) that have occurred in many patients are comparable to CNS dysfunction due to increased blood pressure. {08}
Increases in blood pressure {09} {22} and CNS toxicity {13} may represent idiosyncratic reactions in some patients.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Headache, severe —may be prodromal of severe side effects related to elevated blood pressure{08}
    
increased blood pressure{08}{18}{19}{20}{22}
    
painful or difficult urination{13}
    
tightness in chest



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
—more frequent with high doses    
Dizziness {05}{08}{09}
    
dryness of nose or mouth {13}
    
false sense of well-being {05}{08}{12}
    
headache, mild {05}{08}{12}
    
insomnia {05}{12}{13}(trouble in sleeping)
    
nausea, mild {08}{09}
    
nervousness, mild{05}{08}{12}{13}
    
restlessness, mild {08}{12}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Early symptoms of overdose
    
Abdominal or stomach pain {09}
    
fast, pounding, or irregular heartbeat {09}
    
headache, severe {09}
    
increased sweating not associated with exercise {09}
    
nausea and vomiting, severe {09}
    
nervousness or restlessness, severe {09}

Late symptoms of overdose
    
Confusion {30}
    
fast breathing {30}
    
fast and irregular pulse {30}
    
hallucinations (seeing, hearing, or feeling things that are not there){30}
    
hostile behavior
    
muscle trembling {30}
    
seizures


Treatment of overdose
Since there is no specific antidote for overdosage with phenylpropanolamine, treatment is symptomatic and supportive with possible use of the following:

• Induction of emesis and/or use of gastric lavage is primary.


• Barbiturate sedatives are sometimes used to control excessive CNS stimulation.


• Cardiovascular and respiratory monitoring.


• Intravenous fluids to control hypotension.


• Intravenous phentolamine or nitrates to control hypertension.


• Acidification of urine and forced diuresis.


• Protecting patient from self-injury by use of restraints if necessary.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Phenylpropanolamine (Systemic).

Note: Products containing phenylpropanolamine were removed from the U.S. and Canadian Markets in November 2000.


In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to phenylpropanolamine or other sympathomimetics

Pregnancy—Psychiatric side effects more likely in postpartum women





Use in children—Psychiatric side effects more likely in children up to 6 years of age; not recommended for use as appetite suppressant in children up to 12 years of age; in adolescents between 12 and 18 years of age, use for appetite suppression recommended only with doctor"s supervision

Other medications, especially beta-adrenergic blocking agents, CNS stimulation–producing medications, other sympathomimetics, digitalis glycosides, monoamine oxidase (MAO) inhibitors, or rauwolfia alkaloids
Other medical problems, especially severe coronary artery disease, other cardiovascular disorders, or hypertension

Proper use of this medication
Proper administration of extended-release dosage forms: swallowing whole; not breaking, crushing, or chewing; taking with a full glass of water; taking around 10 am if taking only one dose of medication a day

» Importance of not taking more medication than the amount recommended or for a longer period of time than directed

Taking the last dose of medication a few hours before bedtime to minimize the possibility of insomnia

» Proper dosing

» Proper storage

For decongestant use only
Missed dose: Taking as soon as possible; not taking within 2 hours (12 hours for extended-release dosage forms) of next scheduled dose; not doubling doses

For appetite suppressant use only
Not taking for longer than a few weeks without physician's permission

Precautions while using this medication
Not drinking large amounts of caffeine-containing beverages, such as coffee, tea, or colas

» Caution if dizziness occurs; not driving, using machines, or doing anything else that requires alertness while taking medication

For decongestant use only
» Checking with physician if cold symptoms do not improve within 7 days or if fever is present


Side/adverse effects
Signs of potential side effects, especially severe headache, increased blood pressure, painful or difficult urination, or tightness in chest


General Dosing Information
To minimize the possibility of insomnia, the last dose of phenylpropanolamine for each day should be administered a few hours before bedtime.

With prolonged use or too frequent administration, tolerance to the therapeutic effects of phenylpropanolamine may develop. Phenylpropanolamine is effective as an appetite suppressant only for a few weeks. {30}


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications not included in U.S. product labeling.

PHENYLPROPANOLAMINE HYDROCHLORIDE CAPSULES

Strength(s) usually available
U.S.—

Note: Not commercially available


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light.


PHENYLPROPANOLAMINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP

Strength(s) usually available
U.S.—

Note: Not commercially available


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container.

Auxiliary labeling:
   • Swallow capsules whole.


PHENYLPROPANOLAMINE HYDROCHLORIDE TABLETS

Strength(s) usually available
U.S.—

Note: Not commercially available


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light.


PHENYLPROPANOLAMINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Strength(s) usually available
U.S.—

Note: Not commercially avaialable


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light. {33} {34} {35}

Auxiliary labeling:
   • Swallow tablets whole.



Revised: 06/04/2002



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