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Pseudoephedrine/Fexofenadine

    Brands

    DEA Class; OTC

    Common Brand Names; Allegra D, Allegra-D 12 Hour Allergy & Congestion, Allegra-D 24 Hour Allergy & Congestion

    • Antihistamine/Decongestant Combos

    Oral non-sedating antihistamine and sympathomimetic decongestant combination
    Used to relieve symptoms of allergic rhinitis in adults and children 12 years of age and older
    Available without a prescription

    Indicated for the temporary relief of symptoms due to seasonal allergic rhinitis or the common cold, including sneezing, rhinorrhea, itching of the nose or throat, nasal congestion, and itchy, watery eyes.

    Documented hypersensitivity to drug or ingredients

    Premature newborns and neonates

    Narrow-angle glaucoma

    Urinary retention

    Within fourteen (14) days of taking monoamine oxidase inhibitor

    Severe hypertension or severe coronary artery disease

    • Headache (7.2%)
    • Vomiting (8%)
    • Drowsiness (1.3%)
    • Fatigue (1.3%)
    • Somnolence (1.5%)
    • Dizziness (2%)
    • Diarrhea (3%)
    • Otitis media (2.5%)
    • Dyspepsia (1.2%)
    • Myalgia (3%)
    • CNS depression
    • Sedation ranging from mild drowsiness to deep sleep (most frequent)
    • Lassitude
    • Disturbed coordination
    • Muscular weakness
    • Restlessness, euphoria, nervousness, delirium, palpitation, seizures is less common
    • Epigastric distress
    • Anorexia
    • Nausea
    • Vomiting
    • Diarrhea
    • Constipation

    Administer lower initial dose (one tablet per day) to patients with decreased renal function; they have reduced elimination of fexofenadine and pseudoephedrine

    Patients should be instructed to take medication only as prescribed; do not exceed recommended dose; if nervousness, dizziness, or sleeplessness occur, discontinue use and consult doctor

    Patients should be advised against concurrent use of this drug with over-the-counter antihistamines and decongestants

    Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children

    Patients should be told that the inactive ingredients may occasionally be eliminated in the feces in a form that may resemble the original tablet

    Giving with fruit juice may decrease efficacy

    There are no adequate and well-controlled studies on pregnant women; the drug combination should be used during pregnancy only if potential benefit justifies potential risk to fetus

    Not known if fexofenadine is excreted in human milk; because many drugs are excreted in human milk, use caution when fexofenadine hydrochloride is administered to a nursing woman; pseudoephedrine hydrochloride administered alone distributes into breast milk of lactating human females

    Adults

    180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.

    Geriatric

    180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine. 

    Adolescents

    180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.

    Children

    12 years: 180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.
    Less than 12 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Pseudoephedrine/fexofenadine

    tablet, extended-release 12 hr

    • 120mg/60mg

    tablet, extented-release 24 hr

    • 240mg/180mg