Pseudoephedrine

 

1. Generic Name & Brand Names

• Generic Name: Pseudoephedrine HCl or Sulfate

• Common Brands:

  • Sudafed® (Global)

  • Nexafed® (tamper-resistant)

  • SudoGest®

  • Generic/store brands ("Nasal Decongestant")

• Combination Products:

  • Allegra-D® (fexofenadine + pseudoephedrine)

  • Claritin-D® (loratadine + pseudoephedrine)

  • Zyrtec-D® (cetirizine + pseudoephedrine)

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2. Dosage Forms

• Oral:

  • Immediate-release tablets (30 mg, 60 mg)

  • Extended-release tablets (120 mg, 240 mg)

  • Liquid suspensions (15 mg/5mL)

• No topical/injectable forms

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3. Drug Class

• Indirect-Acting Sympathomimetic

• α and β-adrenergic agonist

• Vasoconstrictor/Decongestant

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4. Uses

• Nasal/Sinus Congestion:

  • Common cold, allergic rhinitis, sinusitis

• Eustachian Tube Congestion:

  • Pressure relief in air travel/altitude changes

• Off-label:

  • Mild orthostatic hypotension

  • Urinary incontinence (rare)

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5. Side Effects

Common (≥5%)	Serious (Discontinue Immediately)
Insomnia	Hypertensive Crisis
Nervousness	Cardiac Arrhythmias
Tachycardia	Stroke
Dry mouth	Seizures
Headache	Acute Glaucoma

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6. Critical Warnings

• 🚫 Contraindications:

  • Severe hypertension/Coronary artery disease

  • MAOI use within 14 days

  • Closed-angle glaucoma

  • Severe prostatic hypertrophy

• Regulatory Restrictions (USA):

  • Combat Methamphetamine Epidemic Act (2005):

    • Sold "behind-the-counter"

    • Photo ID required

    • Purchase limit: 3.6 g/day, 9 g/month

  • Electronic tracking (NPLEx system)

• Drug Interactions:

  • ⚠️ MAOIs: Hypertensive crisis (potentially fatal)

  • ⚠️ Beta-blockers: Unopposed α-stimulation → severe HTN

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7. How to Take

Form	Adult Dose	Max Daily	Timing
Immediate-Release	60 mg q4-6hrs	240 mg	Avoid after 5 PM
Extended-Release	120 mg q12hrs	240 mg	Morning/early PM

• Key Instructions:

  • Take with water (food optional)

  • Last dose before 5 PM to prevent insomnia

  • Duration: ≤7 days (prevents rebound congestion)

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8. Pediatric Use

Age	Dose (Liquid)	Frequency
6-11 years	30 mg (10 mL)	q4-6hrs
2-5 years*	15 mg (5 mL)	q4-6hrs

**Avoid <2 years - risk of seizures/hypertension*

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9. Efficacy vs. Alternatives

Agent	Bioavailability	Onset	Efficacy
Pseudoephedrine	90-100%	30 min	⭐⭐⭐⭐⭐
Phenylephrine (PO)	<1%	Slow	⭐☆☆☆☆
Oxymetazoline (NS)	Local	5 min	⭐⭐⭐⭐☆

✅ Proven superior to placebo for congestion relief (J Allergy Clin Immunol)

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10. Overdose

• Symptoms:

  Hypertension, hallucinations, tachycardia >150 bpm, cardiac arrest

• Management:

  • IV phentolamine (α-blocker)

  • Benzodiazepines for agitation/seizures

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11. Storage & Regulatory Compliance

• Pharmacy Storage:

  • Behind counter in locked case

  • Logbook/electronic tracking required

• Home Storage:

  • Locked cabinet (high abuse potential)

  • Temperature: 20-25°C (68-77°F)

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Critical Safety Alerts

⚠️ Cardiovascular Risk:

Avoid in uncontrolled HTN - monitor BP before/during use.
⚠️ Methamphetamine Precursor:
96% of illicit US meth derives from diverted pseudoephedrine (DEA Report).
⚠️ "Stuffed but Wired" Effect:
Combines decongestion with CNS stimulation - caution in anxiety disorders.

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Pseudoephedrine vs. Phenylephrine

Parameter	Pseudoephedrine	Phenylephrine (Oral)
Bioavailability	90-100%	<1%
Efficacy	High	None
Regulation	Behind-counter	Shelf
Duration	4-6h (IR), 12h (ER)	4h
CNS Stimulation	Moderate	Minimal

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Clinical Recommendations

✅ Optimal Use:

• First-choice oral decongestant for adults/children >6 yrs

• Combine with antihistamine (e.g., Claritin-D®) for allergic congestion
  ❌ Avoid In:

• Hypertension, hyperthyroidism, BPH

• Late pregnancy (Category C)
  💡 Pro Tip:

Use saline nasal spray + pseudoephedrine for synergistic congestion relief.

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📊 Evidence Note:

• 60 mg pseudoephedrine improves nasal airflow by 35% vs. placebo (Rhinology)

• More effective than intranasal steroids for acute cold-related congestion (Cochrane)

Legal Status: OTC with restrictions in US/Canada/Australia; prescription-only in Mexico/parts of EU.