Pseudoephedrine

Therapeutic Class
Decongestant
Indications

Temporary relief of nasal congestion due to common cold, hay fever, or other upper respiratory allergies. Temporary relief of sinus congestion and pressure. (24 Hr) Reduce swelling of nasal passages. (Liq) Promotion of nasal and/or sinus drainage.

Oral
Adult: As hydrochloride or sulfate: 60 mg every 4-6 hr. Max: 4 doses in 24 hr. As modified-release preparation: 120 mg every 12 hr or 240 mg every 24 hr. 
Child: As hydrochloride or sulfate: 2-6 yr: 15 mg 3-4 times daily; 6-12 yr: 30 mg 3-4 times daily.

Contraindications

Severe hypertension, phaeochromocytoma.

Warnings / Precautions

Do not exceed recommended dosage.
Hyperthyroidism; ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders e.g. arteriosclerosis, hypertension or aneurysms; DM and closed-angle glaucoma; renal impairment, prostatic enlargement. Pregnancy, lactation.

D/C if nervousness, dizziness, or sleeplessness occur, and if symptoms do not improve within 7 days or occur with a fever. (Tab/12 Hr/24 Hr) Caution with difficulty urinating due to enlarged prostate gland. (Liq) Contains 5mg sodium per 5mL. (24 Hr) May cause bowel obstruction; caution with history of obstruction/narrowing of bowel. D/C if persistent abdominal pain/vomiting occur.( tab contains 10mg sodium )

Adverse Reactions

Anginal pain; rebound congestion and rhinorrhoea; fear, anxiety, restlessness, tremor, insomnia, confusion, irritability and psychotic states; reduced appetite, nausea, vomiting; gangrene; cerebral haemorrhage and pulmonary oedema; reflex bradycardia, tachycardia and cardiac arrhythmias, palpitations and cardiac arrest, hypotension and dizziness, fainting and flushing. Tissue necrosis and sloughing; myocardial and arterial necrosis.

Drug Interactions

Increased risk of hypertension and arrhythmias if given with cardiac glycosides, quinidine or TCAs. Increased risk of vasoconstrictor effects if given with ergot alkaloids or oxytocin. Co-admin with MAOIs may cause hypertensive crisis. Anaesthetics e.g. cyclopropane, halothane and other halogenated anaesthestics; antihypertensive agents.

Mechanism of Actions

Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.
Onset: Oral: 15-30 minutes.
Duration: As immediate-release tablet: 4-6 hr. As sustained-release preparation: 12 hr.
Absorption: Rapidly absorbed from the GI tract.
Distribution: Small amounts are distributed into breast milk.
Metabolism: Hepatic.
Excretion: Via the urine largely as unchanged drug with some of its hepatic metabolites. Half-life: about 5-8 hr.

Assesment

Assess for heart disease, high BP, thyroid disease, diabetes, and possible drug interactions. Assess for trouble urinating due to enlarged prostate gland and pregnancy/nursing status.  Assess for history of obstruction or narrowing of the bowel.

Monitoring

Monitor for nervousness, dizziness, sleeplessness, fever, and worsening of symptoms. Monitor for bowel obstruction and persistent abdominal pain or vomiting.

Patient Counselling

Instruct to inform physician if patient has heart disease, high BP, thyroid disease, diabetes, or difficulty urinating due to enlarged prostate gland. Inform to d/c and notify physician if nervousness, dizziness, or sleeplessness occur, or if symptoms do not improve within 7 days or occur with fever. Inform to notify physician before use if pregnant/nursing. Inform that tab does not completely dissolve and that it is normal to see tab in the stool. Instruct to inform physician if patient has history of obstruction/narrowing of bowel; d/c and notify physician if persistent abdominal pain/vomiting occur.

Administration

Administration:
May be taken with or without food.
Oral route. (24 Hr) Do not divide, crush, chew, or dissolve tab.
Storage: (Tab/Liq) 20-25°C (68-77°F). (Tab, ER) 15-25°C (59-77°F). Store in a dry place. (12 Hr/Liq) Protect from light.

Pregnancy Category

C: Drug Pregnancy Category Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

ATC Classification
R01BA02
GenericPedia Classification
  • Available As
  • Pseudoephedrine 10 mg
  • Pseudoephedrine 100 mg
  • Pseudoephedrine 12.5 mg
  • Pseudoephedrine 120 mg
  • Pseudoephedrine 15 mg
  • Pseudoephedrine 180 mg
  • Pseudoephedrine 20 mg
  • Pseudoephedrine 25 mg
  • Pseudoephedrine 30 mg
  • Pseudoephedrine 5 mg
  • Pseudoephedrine 50 mg
  • Pseudoephedrine 60 mg
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