What is the recommended dose for oral pseudoephedrine (PSE) hydrochloride?

Recommended Dosage for Oral Pseudoephedrine Hydrochloride

The recommended adult dosage for oral pseudoephedrine hydrochloride is 60 mg every 4-6 hours, with a maximum of 240 mg in 24 hours. 1

Adult Dosing

• 60 mg is the optimal single adult dose, as it achieves maximal nasal decongestion without cardiovascular or other unwanted side effects 2
• Doses can be taken every 4-6 hours as needed for symptom relief 1
• Maximum daily dose should not exceed 240 mg in a 24-hour period 3
• Extended-release formulations of 240 mg can be administered once daily 4

Pediatric Dosing

• Pseudoephedrine should be used with caution in children under 6 years of age due to potential risks including agitated psychosis, ataxia, hallucinations, and in rare cases, death 3
• For children over 6 years, dosing should be adjusted based on weight and age, with careful monitoring for stimulatory side effects 3

Clinical Efficacy

• Pseudoephedrine is effective at relieving nasal congestion in patients with allergic and nonallergic rhinitis 3
• Studies demonstrate that pseudoephedrine significantly reduces nasal airway resistance compared to placebo 1
• A single 60 mg dose provides significant reduction in nasal congestion for up to 4 hours 1
• Multiple doses over several days continue to provide objective improvement in nasal airway resistance 1

Side Effects and Monitoring

• At the recommended 60 mg dose, pseudoephedrine typically does not cause significant cardiovascular effects 2
• Higher doses (120 mg and 180 mg) may cause small but statistically significant increases in pulse and systolic blood pressure 2
• Patients should be monitored for potential side effects including:
  • Insomnia, irritability, and loss of appetite 3
  • Palpitations and changes in blood pressure 3
  • Stimulatory effects, especially when combined with other stimulant medications 3

Precautions

• Use with caution in patients with:
  • Hypertension (monitor blood pressure) 3
  • Cardiovascular disease 3
  • Hyperthyroidism 3
  • Closed-angle glaucoma 3
  • Bladder neck obstruction 3
• Concomitant use with caffeine and other stimulants may increase adverse events 3

Special Considerations

• Phenylephrine has been substituted for pseudoephedrine in many OTC cold remedies due to restrictions on pseudoephedrine sales (to reduce illicit methamphetamine production) 3
• However, phenylephrine is extensively metabolized in the gut and appears to be less effective than pseudoephedrine as an oral decongestant 3, 5