Pseudoephedrine
Pseudoephedrine (hydrochloride; sulfate)
Sudafed (IR, 12-hour, 24-hour); many combination products including Claritin-D, Allegra-D, Zyrtec-D, Mucinex-D
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Summary
Common uses
Nasal congestion from common cold (OTC, FDA)0, Allergic rhinitis nasal congestion (OTC, FDA)0, Acute sinusitis nasal congestion (OTC, FDA)0, Eustachian tube congestion (off-label)0
Pharmacy
Starting dose
IR: 60 mg PO every 4-6 hours. 12-hour ER: 120 mg PO every 12 hours. 24-hour ER: 240 mg PO once daily. Pediatric: weight-based
Preparations
IR tablets 30, 60 mg; 12-hour ER tablets 120 mg; 24-hour ER tablets 240 mg; oral liquid; multiple combination products with antihistamines, NSAIDs, or expectorants
US FDA Max
240 mg/day
Pharmacology
Routes
Oral
Onset
30-60 minutes
Duration
4-6 hours (IR); 12-24 hours (ER)
Half-life
9-16 hours (pH-dependent: acidic urine shortens, alkaline urine substantially extends)[1]
Bioavailability
~90% (oral, low first-pass)[1]
Pregnancy
Some controversial signal for first-trimester gastroschisis association in observational studies; limited use is generally considered acceptable after the first trimester.[citation needed]
Legal status
Behind-the-counter in US under the Combat Methamphetamine Epidemic Act 2005: purchase restricted to ≤3.6 g/day and ≤9 g/30 days, with photo ID, logbook signature, and quantity logging required. Several states schedule higher than federal
Purported mechanism
Indirect-acting sympathomimetic. Taken up by adrenergic nerve terminals where it displaces stored norepinephrine into the synaptic cleft via vesicular monoamine transporter activity. Peripheral α1- and β-adrenergic receptor stimulation produces vasoconstriction in nasal mucosa (the decongestant effect, the principal clinical action). Central sympathomimetic effects (mild insomnia, restlessness, anxiety) are substantially less than amphetamines because pseudoephedrine penetrates the CNS poorly compared to amphetamine-class agents.0 Cardiovascular adverse effects (elevated blood pressure, tachycardia, occasional arrhythmia) are the principal safety concern; avoid in uncontrolled hypertension and severe coronary artery disease. Urinary retention in benign prostatic hyperplasia is a common counseling point[1].
References
- ↑ 1.0 1.1 1.2 FDA OTC Monograph for Nasal Decongestants. https://www.accessdata.fda.gov/scripts/cder/ob/ (reference for the IR and ER pseudoephedrine formulations)