Fexofenadine and Pseudoephedrine

Pronunciation

(feks oh FEN a deen & soo doe e FED rin)

U.S. Brand Names

Allegra-D® 12 Hour; Allegra-D® 24 Hour

Synonyms

Pseudoephedrine and Fexofenadine

Generic Available

Canadian Brand Names

Allegra-D®

Use

Relief of symptoms associated with seasonal allergic rhinitis in adults and children

12 years of age

Pregnancy Risk Factor

Pregnancy Implications

Animal studies using this combination showed reduced fetal weight, delayed ossification, and decreased survival. Also refer to individual monographs.

Lactation

Enters breast milk/use caution (AAP rates "compatible")

Contraindications

Hypersensitivity to fexofenadine, pseudoephedrine, or any component of the formulation; narrow-angle glaucoma; urinary retention; during or within 14 days of MAO inhibitor therapy; severe hypertension or coronary heart disease

Warnings/Precautions

Use caution with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hyperplasia. Safety and efficacy in children <12 years of age have not been established.

Adverse Reactions

See individual agents.

Drug Interactions

Fexofenadine: Substrate of CYP3A4 (minor); Inhibits CYP2D6 (weak)

Also see individual agents.

Pharmacodynamics/Kinetics

See individual agents.

Dosage

Oral: Children

12 years and Adults:

Allegra-D® 12 Hour: One tablet twice daily

Allegra-D® 24 Hour: One tablet once daily

Dosage adjustment in renal impairment:

Allegra-D® 12 Hour: Clcr<80 mL/minute (based on fexofenadine component): One tablet once daily

Allegra-D® 24 Hour: Avoid use.

Administration

Tablets should be swallowed whole; do not crush or chew. Administer with water.

Patient Education

Patients should be instructed to take tablets only as prescribed. Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the physician. Patients should also be advised against the concurrent use of the tablets with over-the-counter antihistamines and decongestants. The product should not be used by patients who are hypersensitive to it or to any of its ingredients. Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of MAO inhibitor. It also should not be used by patients with severe hypertension or severe coronary artery disease. Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant. Patients should be cautioned not to break or chew the tablet. Patients should be directed to swallow the tablet whole. Patients should be instructed not to take the tablet with food. Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Pseudoephedrine: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

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

Mental Health: Effects on Mental Status

May cause drowsiness or dizziness, nervousness, and insomnia; may rarely cause hallucinations

Mental Health: Effects on Psychiatric Treatment

Contraindicated with MAO inhibitors

Dosage Forms

Tablet, extended release:

Allegra-D® 12 Hour: Fexofenadine hydrochloride 60 mg [immediate release] and pseudoephedrine hydrochloride 120 mg [extended release]

Allegra-D® 24 Hour: Fexofenadine hydrochloride 180 mg [immediate release] and pseudoephedrine hydrochloride 240 mg [extended release]

International Brand Names

Allegra-D® (CA)

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