Skip to content

Pseudoephedrine

    Brands

    DEA Class;  OTC

    Common Brand Names; Sudafed, Nexafed, Zephrex-D

    • Decongestants, Systemic

    Oral sympathomimetic decongestant agent
    Primarily used in adults and pediatric patients 4 years and older to temporarily relieve nasal congestion due to the common cold, allergic rhinitis, or other upper respiratory conditions
    Due to potential for diversion as a substrate for the illegal synthesis of amphetamine and methamphetamine, sales of pseudoephedrine-containing products are regulated by the Combat Methamphetamine Epidemic Act

    For the temporary relief of the symptoms of sinus and nasal congestion due to the common cold, allergic rhinitis or other upper respiratory allergies or conditions, including eustachian tube congestion.
    For otalgia prophylaxis† prior to air-pressure changes induced by jet-travel.
    For the treatment of urinary incontinence† in adult patients with stress incontinence due to urethral sphincter weakness.

    Hypersensitivity

    Severe hypertension, severe CAD

    Within 14 days of MAO inhibitor therapy

    • Tremor
    • Restlessness
    • Insomnia
    • Nausea
    • Vomiting
    • Nervousness
    • Hypertension
    • Atrial fibrillation
    • Myocardial infarction
    • Ventricular premature beats
    • Ischemic colitis

    Use caution in mild to moderate hypertension, cardiac disease, hyperthyroidism, hyperglycemia, BPH, DM, renal impairment, seizure disorder, thyroid dysfunction, glaucoma, lactation

    Elderly may be more sensitive to side effects

    When used for self-medication, see health-care provider if symptoms do not improve within 7 days or are accompanied by fever

    Some products may contain sodium

    Some dosage forms may contain sodium benzoate/benzoic acid; large amounts have been associated with a potentially fatal toxicity (gasping syndrome) in neonates

    Many combo formulations are switching to phenylephrine due to restrictions arising from easy conversion to methamphetamine (the Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients, such as pseudoephedrine, commonly used to make methamphetamine)

    Avoid, during first trimester; may be associated with possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine’s vasoconstrictive effects; magnitude of risk unknown

    Excreted in breast milk; irritability reported in nursing infants (limited data); milk production may be decreased in some women

    Adults

    240 mg/day PO.

    Geriatric

    240 mg/day PO.

    Adolescents

    240 mg/day PO.

    Children

    12 years: 240 mg/day PO.
    6 to 11 years: 120 mg/day PO.
    4 to 5 years: 60 mg/day PO.
    2 to 3 years: Safety and efficacy have not been established for non-prescription (OTC) use. Consult doctor prior to use. Previously recommended maximum dose was 60 mg/day PO.
    Less than 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Pseudoephedrine hydrochloride

    tablet, immediate-release

    • 30mg
    • 60mg

    tablet, extended-release

    • 120mg
    • 240mg

    tablet, IMPEDE technology (Nexafed)

    • 30mg
    • IMPEDE technology utilizes an advanced polymer matrix to limit extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing

    tablet, TAREX technology (Zephrex-D)

    • 30mg
    • TAREX technology utilizes an advanced polymer matrix to limit extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing

    syrup

    • 3mg/mL