What are the dosage instructions and precautions for taking pseudoephedrine (Pseudofed)?

Pseudoephedrine Dosage and Precautions

Pseudoephedrine should be dosed at 60 mg orally every 4-6 hours for nasal congestion, with a maximum daily dose of 240 mg, and can be safely used in most patients including those with controlled hypertension, though caution is warranted in specific high-risk cardiovascular conditions. 1

Standard Dosing

Adults:

• 60 mg orally every 4-6 hours as needed for nasal congestion 1, 2
• Maximum daily dose: 240 mg (four 60 mg doses) 1
• Available as tablets or syrup formulations 2

Pediatric considerations:

• Not recommended for empiric use in children below age 6 years due to insufficient evidence of benefit over risk 1
• The risks and benefits must be carefully weighed before use in young children 1

Efficacy Profile

Pseudoephedrine demonstrates proven decongestant efficacy through both objective and subjective measures:

• Single 60 mg doses significantly reduce nasal airway resistance compared to placebo (p=0.006 for 0-3 hours) 2
• Multiple doses over 3 days maintain superior objective efficacy (p<0.001) 2
• Subjective improvement in congestion is statistically significant, particularly with the first dose 2

Cardiovascular Precautions and Monitoring

Blood Pressure Effects:

• Pseudoephedrine causes minimal blood pressure elevation in normotensive patients: systolic BP increases by only 0.99 mmHg (95% CI, 0.08-1.90) and heart rate by 2.83 beats/min (95% CI, 2.0-3.6), with no significant effect on diastolic BP 1
• In patients with controlled hypertension, therapeutic doses (60 mg four times daily) do not cause clinically significant BP changes 3
• Even in hypertensive patients on beta-blockers (propranolol or atenolol), single 60 mg doses produce no significant cardiovascular effects 4

High-Risk Conditions Requiring Caution: Use pseudoephedrine with extreme caution or avoid entirely in patients with: 1

• Arrhythmias
• Angina pectoris or coronary artery disease
• Cerebrovascular disease
• Hyperthyroidism
• Uncontrolled hypertension (controlled hypertension is generally safe) 1, 3

Monitoring in hypertensive patients:

• Blood pressure should be monitored due to interindividual variation in response, even though most patients tolerate the medication well 1

Additional Adverse Effects

Common side effects include: 1

• Elevated blood pressure (minimal in most patients)
• Palpitations
• Loss of appetite
• Irritability and sleep disturbance
• Tremor

Concomitant caffeine use may produce additive adverse effects and should be avoided 1

Special Populations and Situations

Pregnancy:

• Use caution during the first trimester due to reports of fetal heart rate changes 1

Glaucoma:

• Oral decongestants may raise intraocular pressure 1

Drug interactions:

• Do not use with monoamine oxidase inhibitors due to risk of hypertensive crisis 1

Regulatory Considerations

Pseudoephedrine is maintained behind the pharmacy counter (not on shelves) due to its use as a precursor in methamphetamine production, though it remains available without prescription 1

Alternative Considerations

Phenylephrine has replaced pseudoephedrine in many over-the-counter formulations due to lack of regulatory restrictions, but it is significantly less efficacious as an oral decongestant due to extensive first-pass metabolism 1