pseudoephedrine

Therapeutic Classification: allergy, cold and cough remedies, nasal drying agents/decongestants

Pharmacologic Classification: adrenergics, alpha adrenergic agonists

Indications ⬆ ⬇

REMS

Symptomatic management of nasal congestion associated with acute viral upper respiratory tract infections.
Used in combination with antihistamines in the management of allergic conditions.
Used to open obstructed eustachian tubes in chronic otic inflammation or infection.

Action ⬆ ⬇

Stimulates alpha- and beta-adrenergic receptors.
Produces vasoconstriction in the respiratory tract mucosa (alpha-adrenergic stimulation) and possibly bronchodilation (beta₂-adrenergic stimulation).

Therapeutic effects:

Reduction of nasal congestion, hyperemia, and swelling in nasal passages.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after oral administration.

Distribution: Appears to enter the CSF.

Metabolism/Excretion: Partially metabolized by the liver. 55–75% excreted unchanged by the kidneys (depends on urine pH).

Half-Life: Children: 3.1 hr; Adults: 9–16 hr (depends on urine pH).

Time/Action Profile ⬆ ⬇

(decongestant effects)

ROUTE	ONSET	PEAK	DURATION
PO	15–30 min	unknown	4–6 hr
PO-ER	60 min	unknown	12 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to sympathomimetic amines;
Hypertension, severe coronary artery disease;
Concurrent MAO inhibitor therapy;
Known alcohol intolerance (some liquid products).

Use Cautiously in:

Hyperthyroidism;
Diabetes mellitus;
Prostatic hyperplasia;
Ischemic heart disease;
Glaucoma;
OB: Safety not established;
Pedi: Avoid OTC cough and cold products containing this medication in children 4 yr.

Adv. Reactions/Side Effects ⬆ ⬇

CV: palpitations, CARDIOVASCULAR COLLAPSE, hypertension, tachycardia

Derm: diaphoresis

GI: anorexia, dry mouth

GU: dysuria

Neuro: anxiety, nervousness, dizziness, drowsiness, excitability, fear, hallucinations, headache, insomnia, restlessness, SEIZURES, weakness

Resp: respiratory difficulty

Interactions ⬆ ⬇

Drug-drug:

Concurrent use withMAO inhibitors may cause hypertensive crisis.
Additive adrenergic effects with other adrenergics.
Concurrent use with beta blockers may result in hypertension or bradycardia.
Drugs that acidify the urine may ↓ effectiveness.
Phenothiazines and tricyclic antidepressants potentiate pressor effects.
Drugs that alkalinize the urine (sodium bicarbonate, high-dose antacid therapy) may intensify effectiveness.

Foods that acidify the urine may ↓ effectiveness.
Foods that alkalinize the urine may intensify effectiveness (see lists in Food Sources for Specific Nutrients).

Route/Dosage ⬆ ⬇

PO (Adults and Children >12 yr): 60 mg every 6 hr as needed (not to exceed 240 mg/day) or 120 mg extended-release preparation every 12 hr or 240 mg extended-release preparation every 24 hr.
PO (Children 6–12 yr): 30 mg every 6 hr as needed (not to exceed 120 mg/day).
PO (Children 4–5 yr): 15 mg every 6 hr (not to exceed 60 mg/day).

Availability ⬆ ⬇

(Generic available)

Tablets: 30 mg^OTC; 60 mg^OTC
Extended-release tablets: 120 mg^OTC; 240 mg^OTC
Capsules: 60 mg^OTC
Extended-release capsules: 240 mg^OTC
Liquidgrape and others: 15 mg/5 mL^OTC; 30 mg/5 mL^OTC
In combination with: antihistamines, acetaminophen, cough suppressants, and expectorantsOTC. See Appendix [not included in this PDA edition].

Assessment ⬆ ⬇

Assess congestion (nasal, sinus, eustachian tube) before and periodically during therapy.
Monitor pulse and BP before beginning therapy and periodically during therapy.
Assess lung sounds and character of bronchial secretions. Maintain fluid intake of 1500–2000 mL/day to decrease viscosity of secretions.

Implementation ⬆ ⬇

Do not confuse Sudafed with sotalol or Sudafed PE.
Administer pseudoephedrine at least 2 hr before bedtime to minimize insomnia.
PO: DNC: Extended-release tablets and capsules should be swallowed whole; do not crush, break, or chew.Contents of the capsule can be mixed with jam or jelly and swallowed without chewing for patients with difficulty swallowing.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed and not to take more than recommended. Take missed doses within 1 hr; if remembered later, omit. Do not double doses. Caution parents to avoid OTC cough and cold products in children <4 yr.
Instruct patient to notify health care professional if nervousness, slow or fast heart rate, breathing difficulties, hallucinations, or seizures occur, because these symptoms may indicate overdose.
Instruct patient to contact health care professional if symptoms do not improve within 7 days or if fever is present.
Rep: Avoid use during 1st trimester of pregnancy because of potential fetal harm. Prolonged use later in pregnancy should also be avoided. Avoid use during breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇