Recommended Dosage and Frequency of Pseudoephedrine (Sudafed) for Nasal Congestion
For adults and children 12 years and over, the recommended dosage of pseudoephedrine is 60 mg (2 tablets) every 4 to 6 hours, not exceeding 8 tablets (240 mg) in 24 hours. For children 6-11 years, the dose is 30 mg (1 tablet) every 4 to 6 hours, not exceeding 4 tablets (120 mg) in 24 hours. Pseudoephedrine should not be used in children under 6 years of age. 1
Age-Specific Dosing Guidelines
Adults and children 12+ years:
- 60 mg (2 tablets) every 4-6 hours
- Maximum: 240 mg (8 tablets) per 24 hours
Children 6-11 years:
- 30 mg (1 tablet) every 4-6 hours
- Maximum: 120 mg (4 tablets) per 24 hours
Children under 6 years:
Duration of Treatment
Pseudoephedrine should be limited to 3-5 consecutive days of use to avoid rhinitis medicamentosa (rebound congestion), as recommended by the American Academy of Allergy, Asthma, and Immunology 2. Prolonged use can lead to tolerance and potentially worsen nasal congestion when discontinued.
Efficacy and Mechanism
Pseudoephedrine is an effective oral decongestant that works by stimulating alpha-adrenergic receptors, causing vasoconstriction of blood vessels in the nasal mucosa, which reduces swelling and congestion 3. Clinical studies have demonstrated that pseudoephedrine 60 mg significantly reduces nasal airway resistance compared to placebo, with effects beginning within hours of administration 3.
Research shows that pseudoephedrine provides both objective and subjective improvement in nasal congestion associated with upper respiratory tract infections. A double-blind, placebo-controlled trial demonstrated that pseudoephedrine significantly reduced nasal airway resistance compared to placebo after both single and multiple doses 3.
Precautions and Contraindications
Pseudoephedrine should be used with caution in patients with:
- Hypertension
- Cardiovascular disease
- Hyperthyroidism
- Closed-angle glaucoma
- Bladder neck obstruction 4
Blood pressure should be monitored in patients with hypertension, as pseudoephedrine may cause elevations in blood pressure, though this is rare in normotensive patients 4.
Side Effects
Common side effects include:
- Insomnia
- Loss of appetite
- Irritability
- Palpitations 4
- Increased heart rate (typically 2-4 beats per minute higher than baseline) 3
Special Considerations
Combination therapy: For allergic rhinitis with significant nasal congestion, combining pseudoephedrine with an antihistamine may provide more comprehensive symptom relief than either medication alone 5, 6.
Comparison with topical decongestants: While pseudoephedrine is effective, studies show that topical decongestants like xylometazoline may provide more potent and longer-lasting decongestion of nasal mucosa 7. However, topical decongestants have their own limitations, including more severe rebound congestion with prolonged use.
Regulatory considerations: Due to pseudoephedrine's use in methamphetamine production, there are restrictions on its sale in many countries, requiring it to be kept behind the pharmacy counter 4.
Alternative Options
For patients who cannot take pseudoephedrine or for whom it is contraindicated, consider:
- Intranasal corticosteroids (most effective for allergic rhinitis)
- Saline nasal irrigation
- External nasal dilator strips 2
Remember that while pseudoephedrine effectively treats the symptom of nasal congestion, it does not address the underlying cause. If symptoms persist beyond 5-7 days, further evaluation may be warranted to identify and treat the root cause.