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|Fexofenadine Hydrochloride/Pseudoephedrine Hydrochloride

Fexofenadine Hydrochloride/Pseudoephedrine Hydrochloride

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

Mechanism of Action

Pharmacology

Competitively antagonizes histamine at the H ₁ -receptor site.

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; MAO inhibitor therapy; idiosyncratic reactions to adrenergic agents.

Dosage and Administration

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

General Advice

• Give on an empty stomach, 1 hr before or 2 hr 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 into consideration these interactions when administering the agents that are listed.

Plasma levels of fexofenadine may be increased.

Contraindicated in patients taking MAO inhibitors and for 14 days after stopping use of an MAO inhibitor.

Antihypertensive effect of these agents may be reduced.

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, cardiovascular 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

Pregnancy

Category C .

Lactation

Undetermined.

Excreted in breast milk.

Children

Safety and efficacy not established in children less than 12 yr.

Elderly

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

Special Risk Patients

Use with caution in patients with hyperthyroidism, severe hypertension, diabetes, cardiovascular disease, increased intraocular pressure, or prostatic hypertrophy.

Sympathomimetic amines (eg, pseudoephedrine)

May cause CNS stimulation with convulsions or cardiovascular 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

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to take bid as prescribed, on an empty stomach, 1 hr before or 2 hr after eating.
• Advise patient to take last dose late in the 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 for ≥ 4 days if having an allergy skin test.
• Instruct women to notify health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to stop taking the drug and immediately report any of the following symptoms to health care provider: nervousness, dizziness, or sleeplessness.
• Caution patient to not take any prescription or otc medications, or dietary supplements unless advised by health care provider.