Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride

Pronunciation: (fex-oh-FEN-ah-deen HIGH-droe-KLOR-ide/SUE-doe-eh-FED-rin)Class: Antihistamine, Decongestant

Trade Names:Allegra-D- Tablets 120 mg pseudoephedrine/60 mg fexofenadine

Pharmacology

Fexofenadine

Competitively antagonizes histamine at the H ₁ -receptor site.

Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, promoting nasal drainage.

Indications and Usage

Relief of symptoms associated with seasonal allergic rhinitis.

Contraindications

Hypersensitivity to any ingredient of the product; patients with narrow-angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease; MAOI therapy; idiosyncratic reactions to adrenergic agents.

Dosage and Administration

Adults and Children 12 yr of age and older

PO 1 tablet (60 mg fexofenadine/120 mg pseudoephedrine) twice daily.

General Advice

• Give on an empty stomach, 1 h before or 2 h after eating.

Storage/Stability

Store tablets at controlled room temperature. Keep container tightly closed.

Drug Interactions

Because the following interactions may occur with the components of this product, take these interactions into consideration when administering the agents that are listed.

Fexofenadine Erythromycin, ketoconazole

Plasma levels of fexofenadine may be increased.

Pseudoephedrine MAOIs

Contraindicated in patients taking MAOIs and for 14 days after stopping use of an MAOI.

Antihypertensive agents that interfere with sympathetic activity (eg, mecamylamine, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effect of these agents may be reduced.

Digitalis

Increased ectopic pacemaker activity may occur.

Laboratory Test Interactions

May diminish or prevent positive reactions to skin tests.

Adverse Reactions

Cardiovascular

Palpitations; tachycardia, pressor activity, cardiac arrhythmias, CV collapse (pseudoephedrine).

CNS

Headache; insomnia; dizziness; agitation; nervousness; anxiety; excitability, restlessness, weakness, drowsiness, fear, tenseness, hallucinations, seizures (pseudoephedrine).

Dermatologic

Pallor.

EENT

Throat irritation.

GI

Nausea; dry mouth; dyspepsia; abdominal pain.

Genitourinary

Dysuria.

Respiratory

Upper respiratory infection; respiratory difficulties.

Miscellaneous

Back pain.

Precautions

Monitor Assess for allergy symptoms before and periodically throughout therapy. Monitor pulse and BP periodically during therapy.

Pregnancy

Category C .

Lactation

Fexofenadine

Undetermined.

Pseudoephedrine

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Elderly

Use lower starting dose, reflecting increased incidence of adverse reactions due to decreased hepatic, renal, or cardiac function and comorbidity.

Special Risk Patients

Use with caution in patients with hyperthyroidism, severe hypertension, diabetes, CV disease, increased IOP, or prostatic hypertrophy.

Sympathomimetic amines (eg, pseudoephedrine)

May cause CNS stimulation with convulsions or CV collapse with accompanying hypotension. Monitor patient for nervousness, dizziness, and insomnia.

Overdosage

Symptoms

Dizziness, drowsiness, dry mouth, giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tension, anxiety, restlessness, insomnia, toxic psychosis with delusions and hallucinations, cardiac arrhythmias, circulatory collapse, convulsions, coma, respiratory failure.

Patient Information

• Advise patient to take twice daily as prescribed, on an empty stomach, 1 h before or 2 h after eating.
• Advise patient to take last dose late in afternoon or early evening to reduce chance of drug causing sleeplessness.
• Caution patient not to break, chew, or crush tablet and to swallow whole.
• Advise patient that if allergy symptoms are not controlled, not to increase the dose of medication but to inform the health care provider.
• Do not take this medication more than  4 days before having allergy skin test.
• Instruct patient to stop taking the drug and immediately report any of the following symptoms to health care provider: nervousness, dizziness, or sleeplessness.

Copyright © 2009 Wolters Kluwer Health.