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Pronunciation |
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(fen
il proe pa NOLE a
meen) |
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U.S. Brand
Names |
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Acutrim® 16 Hours [OTC]; Acutrim®
II, Maximum Strength [OTC]; Acutrim® Late Day [OTC];
Control®[OTC]; Dexatrim® Pre-Meal [OTC]; Maximum Strength
Dex-A-Diet®[OTC]; Maximum Strength Dexatrim®[OTC];
Phenoxine®[OTC]; Phenyldrine®[OTC]; Propagest®[OTC];
Unitrol®[OTC] |
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Generic
Available |
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Yes |
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Synonyms |
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dl-Norephedrine
Hydrochloride; Phenylpropanolamine Hydrochloride; PPA |
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Pharmacological Index |
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Alpha/Beta Agonist |
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Use |
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Anorexiant; nasal decongestant |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Known hypersensitivity to drug |
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Warnings/Precautions |
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Use with caution in patients with high blood pressure, tachyarrhythmias,
pheochromocytoma, bradycardia, cardiac disease, arteriosclerosis; do not use for
more than 3 weeks for weight loss |
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Adverse
Reactions |
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>10%: Cardiovascular: Hypertension, palpitations
1% to 10%:
Central nervous system: Insomnia, restlessness, dizziness
Gastrointestinal: Xerostomia, nausea
<1%: Tightness in chest, bradycardia, arrhythmias, angina, severe
headache, anxiety, nervousness, restlessness, dysuria |
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Overdosage/Toxicology |
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Symptoms of overdose include vomiting, hypertension, palpitations,
paresthesia, excitation, seizures
Treatment is supportive; diazepam 5-10 mg I.V. (0.25-0.4 mg/kg for children)
may be used for excitation and seizures |
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Drug
Interactions |
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Decreased effect of antihypertensives
Increased effect/toxicity with MAO inhibitors (hypertensive crisis),
beta-blockers (increased pressor effects) |
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Mechanism of
Action |
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Releases tissue stores of epinephrine and thereby produces an alpha- and
beta-adrenergic stimulation; this causes vasoconstriction and nasal mucosa
blanching; also appears to depress central appetite centers |
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Pharmacodynamics/Kinetics |
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Duration: Up to 24 hours (timed release)
Absorption: Oral: Well absorbed
Metabolism: In the liver to norephedrine
Bioavailability: Close to 100%
Half-life: 4.6-6.6 hours
Elimination: In urine primarily as unchanged drug (80% to 90%)
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Usual Dosage |
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Oral:
2-6 years: 6.25 mg every 4 hours
6-12 years: 12.5 mg every 4 hours not to exceed 75 mg/day
Adults:
Decongestant: 25 mg every 4 hours or 50 mg every 8 hours, not to exceed 150
mg/day
Anorexic: 25 mg 3 times/day 30 minutes before meals or 75 mg (timed release)
once daily in the morning
Precision release: 75 mg after breakfast |
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Dietary
Considerations |
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Should be administered 30 minutes before meals |
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Monitoring
Parameters |
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Blood pressure, heart rate |
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Mental Health: Effects
on Mental Status |
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May cause dizziness, restlessness, anxiety, or insomnia |
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Mental Health:
Effects on Psychiatric
Treatment |
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Concurrent use with MAOIs may result in hypertensive crisis; avoid
combination |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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Use with caution since phenylpropanolamine is a sympathomimetic amine which
could interact with epinephrine to cause a pressor response |
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Dental Health:
Effects on Dental Treatment |
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Up to 10% of patients could experience tachycardia, palpitations, and dry
mouth; use vasoconstrictor with caution |
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Patient
Information |
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Nasal decongestant: Do not use for longer than recommended (4-5 days in a
row). Anorexiant: Do not use for longer than 3 weeks. With timed release form,
take early in day; do not chew or crush. Do not use more often, or in greater
dose than prescribed. You may experience dizziness or blurred vision (use
caution when driving or engaging in tasks requiring alertness until response to
drug is known). With nasal use you may experience burning or stinging (this will
resolve). Report rapid heartbeat, chest pain, palpitations; persistent vomiting;
excessive nervousness, trembling, or insomnia; difficult or painful urination;
unresolved burning or stinging (eyes or nose); or acute headache.
Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend
to be pregnant. Consult prescriber if breast-feeding. |
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Nursing
Implications |
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Administer dose early in day to prevent insomnia; observe for signs of
nervousness, excitability |
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Dosage Forms |
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Capsule, as hydrochloride: 37.5 mg
Capsule, as hydrochloride, timed release: 25 mg, 75 mg
Tablet, as hydrochloride: 25 mg, 50 mg
Tablet, as hydrochloride:
Precision release: 75 mg
Timed release: 75 mg |
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References |
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Bernstein E and Diskant BM,
"Phenylpropanolamine: A Potentially Hazardous Drug," Ann Emerg Med, 1982,
11(6):311-5.
Elkins B and Spoerke DG,
"An Estimation of the Toxicity of Nonprescription Diet Aids From Seventy Exposure Cases,"
Vet Hum Toxicol, 1983, 25:81-5.
Forman HP, Levin S, Stewart B, et al,
"Cerebral Vasculitis and Hemorrhage in an Adolescent Taking Diet Pills Containing Phenylpropanolamine: Case Report and Review of Literature,"
Pediatrics, 1989, 83(5):737-41.
Pentel P, "Toxicity of Over-the-Counter Stimulants," JAMA, 1984,
252(14):1898-903.
Puder KS and Morgan JP,
"Persuading by Citation: An Analysis of the References of Fifty-Three Published Reports of Phenylpropanolamine's Clinical Toxicity,"
Clin Pharmacol Ther, 1987, 42(1):1-9.
Romanowski GL, Shimp LA, Balson AB, et al,
"Urinary Incontinence in the Elderly: Etiology and Treatment," Drug Intell
Clin Pharm, 1988, 22(7-8):525-33. |
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