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
Drugs Generic
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