Yes

Alpha/Beta Agonist

Temporary symptomatic relief of nasal congestion due to common cold, upper respiratory allergies, and sinusitis; also promotes nasal or sinus drainage

C

Hypersensitivity to pseudoephedrine or any component; MAO inhibitor therapy

Use with caution in patients >60 years of age; administer with caution to patients with hypertension, hyperthyroidism, diabetes mellitus, cardiovascular disease, ischemic heart disease, increased intraocular pressure, or prostatic hypertrophy. Elderly patients are more likely to experience adverse reactions to sympathomimetics. Overdosage may cause hallucinations, seizures, CNS depression, and death.

>10%:

Cardiovascular: Tachycardia, palpitations, arrhythmias

Central nervous system: Nervousness, transient stimulation, insomnia, excitability, dizziness, drowsiness

Neuromuscular & skeletal: Tremor

1% to 10%:

Central nervous system: Headache

Neuromuscular & skeletal: Weakness

Miscellaneous: Diaphoresis

<1%: Convulsions, hallucinations, nausea, vomiting, dysuria, shortness of breath, dyspnea

Symptoms of overdose include seizures, nausea, vomiting, cardiac arrhythmias, hypertension, agitation

There is no specific antidote for pseudoephedrine intoxication; the bulk treatment is supportive. Hyperactivity and agitation usually respond to reduced sensory input; however, with extreme agitation, haloperidol (2-5 mg I.M. for adults) may be required. Hyperthermia is best treated with external cooling measures; or when severe or unresponsive, muscle paralysis with pancuronium may be needed. Hypertension is usually transient and generally does not require treatment unless severe. For diastolic blood pressures >110 mm Hg, a nitroprusside infusion should be initiated. Seizures usually respond to diazepam I.V. and/or phenytoin maintenance regimens.

Decreased effect of methyldopa, reserpine

Increased toxicity: MAO inhibitors may increase blood pressure effects of pseudoephedrine; propranolol, sympathomimetic agents may increase toxicity

Directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility

Onset of decongestant effect: Oral: 15-30 minutes

Duration: 4-6 hours (up to 12 hours with extended release formulation administration)

Metabolism: Partially in the liver

Half-life: 9-16 hours

Elimination: 70% to 90% of dose excreted in urine as unchanged drug and 1% to 6% as norpseudoephedrine (active); renal elimination is dependent on urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine

Oral:

<2 years: 4 mg/kg/day in divided doses every 6 hours

2-5 years: 15 mg every 6 hours; maximum: 60 mg/24 hours

6-12 years: 30 mg every 6 hours; maximum: 120 mg/24 hours

Adults: 30-60 mg every 4-6 hours, sustained release: 120 mg every 12 hours; maximum: 240 mg/24 hours

Dosing adjustment in renal impairment: Reduce dose

Should be administered with water or milk to decrease GI distress

Interferes with urine detection of amphetamine (false-positive)

Dizziness, drowsiness, nervousness, and insomnia are common; may rarely cause hallucinations

Contraindicated with MAOIs

Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response

Up to 10% of patients could experience tachycardia, palpitations, and dry mouth; use vasoconstrictor with caution

Take only as prescribed; do not exceed prescribed dose or frequency. Do not chew or crush timed release capsule. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience nervousness, insomnia, dizziness, or drowsiness (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report persistent CNS changes (dizziness, sedation, tremor, agitation, or convulsions); difficulty breathing; chest pain, palpitations, or rapid heartbeat; muscle tremor; or lack of improvement or worsening or condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Do not crush extended release drug product; elderly patients should be counseled about the proper use of over-the-counter cough and cold preparations

Capsule: 60 mg

Capsule, timed release, as hydrochloride: 120 mg

Drops, oral, as hydrochloride: 7.5 mg/0.8 mL (15 mL)

Liquid, as hydrochloride: 15 mg/5 mL (120 mL); 30 mg/5 mL (120 mL, 240 mL, 473 mL)

Syrup, as hydrochloride: 15 mg/5 mL (118 mL)

Tablet, as hydrochloride: 30 mg, 60 mg

Tablet:

Timed release, as hydrochloride: 120 mg

Extended release, as sulfate: 120 mg, 240 mg

Pentel P, "Toxicity of Over-the-Counter Stimulants," JAMA, 1984, 252(14):1898-903.

Salmon J and Nicholson D, "DIC and Rhabdomyolysis Following Pseudoephedrine Overdose," Am J Emerg Med, 1988, 6(5):545-6.

Simons FE, Gu X, Watson WT, et al, "Pharmacokinetics of the Orally Administered Decongestants Pseudoephedrine and Phenylpropanolamine in Children," J Pediatr, 1996, 129(5):729-34.

Wezorek C, Dean B, and Krenzelok E, "Pseudoephedrine: A Prospective Study to Establish a Toxic Dose in Children," Clin Toxicol, 1995, 33(5):554.