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Pronunciation
(soo doe e FED rin)
Generic Available (U.S.)
Yes: Excludes extended release products
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Temporary symptomatic relief of nasal congestion due to common cold, upper respiratory allergies, and sinusitis; also promotes nasal or sinus drainage
Use: Dental
Temporary symptomatic relief of nasal congestion due to common cold, upper respiratory allergies, and sinusitis; also promotes nasal or sinus drainage
Pregnancy Considerations
Use of pseudoephedrine during the first trimester may be associated with a possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine's vasoconstrictive effects; additional studies are needed to define the magnitude of risk. Single doses of pseudoephedrine were not found to adversely affect the fetus during the third trimester of pregnancy (limited data); however, fetal tachycardia was noted in a case report following maternal use of an extended release product for multiple days. Decongestants are not the preferred agents for the treatment of rhinitis during pregnancy. Oral pseudoephedrine should be avoided during the first trimester.
Lactation
Enters breast milk (AAP rates “compatible”; AAP 2001 update pending)
Breast-Feeding Considerations
Pseudoephedrine is excreted into breast milk in concentrations that are ~4% of the weight adjusted maternal dose. The time to maximum milk concentration is ~1-2 hours after the maternal dose. Irritability has been reported in nursing infants (limited data; dose, duration, relationship to breast-feeding not provided). Milk production may be decreased in some women.
Contraindications
Hypersensitivity to pseudoephedrine or any component of the formulation; with or within 14 days of MAO inhibitor therapy
Warnings/Precautions
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).
• Diabetes: Use with caution in patients with diabetes mellitus.
• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or angle-closure glaucoma.
• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.
• Renal impairment: Use caution in patient with renal impairment; consider dosage adjustments.
• Seizure disorder: Use with caution in patients with seizure disorder; may produce CNS stimulation.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations:
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.
Dosage form specific issues:
• Sodium: Some products may contain sodium.
Other warnings/precautions:
• Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms do not improve within 7 days or are accompanied by fever. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur. Not for OTC use in children <4 years of age.
Adverse Reactions
Frequency not defined.
Cardiovascular: Arrhythmia, cardiovascular collapse with hypotension, hypertension, palpitation, tachycardia
Central nervous system: Chills, confusion, coordination impaired, dizziness, drowsiness, excitability, fatigue, hallucination, headache, insomnia, nervousness, neuritis, restlessness, seizure, transient stimulation, vertigo
Dermatologic: Photosensitivity, rash, urticaria
Gastrointestinal: Anorexia, constipation, diarrhea, dry throat, ischemic colitis, nausea, vomiting, xerostomia
Genitourinary: Difficult urination, dysuria, polyuria, urinary retention
Hematologic: Agranulocytosis, hemolytic anemia, thrombocytopenia
Neuromuscular & skeletal: Tremor, weakness
Ocular: Blurred vision, diplopia
Otic: Tinnitus
Respiratory: Chest/throat tightness, dry nose, dyspnea, nasal congestion, thickening of bronchial secretions, wheezing
Miscellaneous: Anaphylaxis, diaphoresis
Metabolism/Transport Effects
None known.
Drug Interactions
Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Benzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modification
Bromocriptine: Alpha-/Beta-Agonists may enhance the adverse/toxic effect of Bromocriptine. Including increased blood pressure, ventricular arrhythmias, and seizure. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy
Ergot Derivatives: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Exceptions: Ergoloid Mesylates. Risk X: Avoid combination
FentaNYL: Alpha-/Beta-Agonists (Indirect-Acting) may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Risk C: Monitor therapy
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid combination
Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Risk D: Consider therapy modification
Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Onset of effect may be delayed if pseudoephedrine is taken with food.
Herb/Nutraceutical: Avoid ephedra, yohimbe (may cause hypertension).
Mechanism of Action
Directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility
Pharmacodynamics/Kinetics
Onset of action: Decongestant: Oral: 30 minutes (Chua 1989)
Peak effect: Decongestant: Oral: ~1-2 hours (Chua, 1989)
Duration: Immediate release tablet: 3-8 hours (Chua 1989)
Absorption: Rapid (Simons 1996)
Distribution: Children: ~2.5 L/kg (Simons 1996); Adults: 2.64-3.51 L/kg (Kanfer 1993)
Metabolism: Undergoes n-demethylation to norpseudoephedrine (active) (Chua 1989, Kanfer 1993); Hepatic (<1%) (Kanfer 1993)
Half-life elimination: Varies by urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine (Kanfer 1993)
Children: ~3 hours (urine pH ~6.5) (Simons 1996)
Adults: 9-16 hours (pH 8); 3-6 hours (pH 5) (Chua 1989)
Time to peak:
Children (immediate release) ~2 hours (Simons 1996)
Adults (immediate release): 1-3 hours (dose dependent) (Kanfer 1993)
Excretion: Urine (43% to 96% as unchanged drug, 1% to 6% as active norpseudoephedrine); dependent on urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine (Kanfer 1993)
Dosage
Oral: General dosing guidelines:
Children:
4-5 years: 15 mg every 4-6 hours: maximum 60 mg/24 hours
6-12 years: 30 mg every 4-6 hours; maximum: 120 mg/24 hours
Children >12 years and Adults: Immediate release: 60 mg every 4-6 hours; Extended release: 120 mg every 12 hours or 240 mg every 24 hours; maximum: 240 mg/24 hours
Dosing adjustment in renal impairment: Consider reducing dose
Administration: Oral
Do not crush extended release drug product, swallow whole. May administer with or without food. Sudafed® 24 Hour tablet may not completely dissolve and appear in stool
Test Interactions
Interferes with urine detection of amphetamine (false-positive)
Dietary Considerations
Some products may contain sodium. May be taken with or without food.
Patient Education
Do not chew or crush extended release forms. Maintain adequate hydration unless instructed to restrict fluid intake. You may experience nervousness, insomnia, dizziness, or drowsiness. Report persistent CNS changes (dizziness, tremor, or agitation), respiratory difficulty, chest pain, palpitations, rapid heartbeat; muscle tremor, or lack of improvement or worsening of condition.
Geriatric Considerations
Elderly patients should be counseled about the proper use of over-the-counter cough and cold preparations. Elderly are more predisposed to adverse effects of sympathomimetics since they frequently have cardiovascular diseases and diabetes mellitus as well as multiple drug therapies. It may be advisable to treat with a short-acting/immediate-release formulation before initiating sustained-release/long-acting formulations.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response
Mental Health: Effects on Mental Status
Dizziness, drowsiness, nervousness, and insomnia are common; may rarely cause hallucinations
Mental Health: Effects on Psychiatric Treatment
Contraindicated with MAO inhibitors
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non-Drowsy: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Caplet, extended release, oral, as hydrochloride:
Sudafed® 12 Hour: 120 mg
Liquid, oral, as hydrochloride: 30 mg/5 mL (473 mL)
Children's Nasal Decongestant: 30 mg/5 mL (118 mL) [contains sodium benzoate; raspberry flavor]
Silfedrine Children's: 15 mg/5 mL (118 mL, 237 mL) [ethanol free, sugar free; grape flavor]
Sudafed® Children's: 15 mg/5 mL (118 mL) [ethanol free, sugar free; contains menthol, sodium 5 mg/5 mL, sodium benzoate; grape flavor]
Syrup, oral, as hydrochloride: 30 mg/5 mL (118 mL)
SudoGest Children's: 15 mg/5 mL (118 mL) [ethanol free, sugar free; contains sodium 5 mg/5 mL, sodium benzoate; grape flavor]
Tablet, oral, as hydrochloride: 30 mg
Genaphed™: 30 mg [DSC]
Oranyl: 30 mg [sugar free]
Sudafed® Maximum Strength Nasal Decongestant: 30 mg [contains sodium benzoate]
Sudo-Tab®: 30 mg [contains sodium benzoate]
SudoGest: 30 mg
SudoGest: 60 mg [scored]
Tablet, extended release, oral, as hydrochloride:
Sudafed® 24 Hour: 240 mg
SudoGest 12 Hour: 120 mg
Pricing: U.S. (www.drugstore.com)
Tablet, 12-hour (SudoGest 12 Hour)
120 mg (10): $14.99
Tablets (Pseudoephedrine HCl)
60 mg (100): $18.99
Tablets (SudoGest)
30 mg (100): $13.99
60 mg (100): $14.99
References
American Academy of Pediatrics Committee on Drugs, "Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics, 2001, 108(3):776-89.
Chua SS, Benrimoj SI, and Triggs EJ, “Pharmacokinetics of Non-Prescription Sympathomimetic Agents,” Biopharm Drug Dispos, 1989, 10(1):1-14.
Kanfer I, Dowse R, and Vuma V, “Pharmacokinetics of Oral Decongestants,” Pharmacotherapy, 1993, 13(6 Pt 2):116-28; discussion 143-6.
Pentel P, “Toxicity of Over-the-Counter Stimulants,” JAMA, 1984, 252(14):1898-903.
Salmon J and Nicholson D, “DIC and Rhabdomyolysis Following Pseudoephedrine Overdose,” Am J Emerg Med, 1988, 6(5):545-6.
Simons FE, Gu X, Watson WT, et al, “Pharmacokinetics of the Orally Administered Decongestants Pseudoephedrine and Phenylpropanolamine in Children,” J Pediatr, 1996, 129(5):729-34.
Werler MM, “Teratogen Update: Pseudoephedrine,” Birth Defects Res A Clin Mol Teratol, 2006, 76(6):445-52.
Wezorek C, Dean B, and Krenzelok E, “Pseudoephedrine: A Prospective Study to Establish a Toxic Dose in Children,” Clin Toxicol, 1995, 33(5):554.
Wright S and Tomassoni A, “Acute Myocardial Infarction Following Therapeutic Use of Pseudoephedrine,” Vet Hum Toxicol, 1994, 36:366.
International Brand Names
Lexi-Comp.com
Last full review/revision February 2012
Content last modified February 2012
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