No

Antihistamine

Nonsedating antihistamine indicated for the relief of seasonal allergic rhinitis and chronic idiopathic urticaria

C

Individuals demonstrating hypersensitivity to fexofenadine or any components of its formulation

Safety and effectiveness in pediatric patients <12 years of age has not been established. Fexofenadine is classified in FDA pregnancy category C and no data is yet available evaluating its use in breast-feeding women.

1% to 10%:

Endocrine & metabolic: Dysmenorrhea (1.5%)

Gastrointestinal: Nausea (1.5%), dyspepsia (1.3%)

Miscellaneous: Viral infection (2.5%)

Limited information from overdose describes dizziness, drowsiness, and dry mouth. Not effectively removed by hemodialysis. Doses up to 690 mg twice daily were administered for 1 month without significant adverse effects. Treatment is supportive.

CYP3A3/4 enzyme substrate

In two separate studies, fexofenadine 120 mg twice daily (high doses) was coadministered with standard doses of erythromycin or ketoconazole to healthy volunteers and although fexofenadine peak plasma concentrations increased, no differences in adverse events or QT_c intervals were observed. It remains unknown if a similar interaction occurs with other azole antifungal agents (eg, itraconazole) or other macrolide antibiotics (eg, clarithromycin).

Capsules should be stored at controlled room temperature 20°C to 25°C and protected from excessive moisture

Fexofenadine is an active metabolite of terfenadine and like terfenadine it competes with histamine for H₁-receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract; it appears that fexofenadine does not cross the blood brain barrier to any appreciable degree, resulting in a reduced potential for sedation

Onset of action: 60 minutes

Duration of antihistaminic effect: At least 12 hours

Metabolism: ~5% metabolized mostly by gut flora; only 0.5% to 1.5% metabolized by cytochrome P-450 enzymes

Half-life: 14.4 hours

Time to peak serum concentration: ~2.6 hours after oral administration

Elimination: Primarily in feces (~80%) and in urine (~11%) as unchanged drug

Oral:

Children greater than or equal to 12 years and Adults:

Seasonal allergic rhinitis: 60 mg twice daily or 180 mg once daily

Chronic idiopathic urticaria: 60 mg twice daily

Dosing adjustment in renal impairment: Recommended initial doses of 60 mg once daily

Relief of symptoms

May cause drowsiness or dizziness

None reported

No information available to require special precautions

No effects or complications reported

Take as directed; do not exceed recommended dose. Store at room temperature in a dry place. Avoid use of other depressants, alcohol, or sleep-inducing medications unless approved by prescriber. You may experience mild drowsiness or dizziness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or nausea (frequent small meals, frequent mouth care, chewing gum, or sucking hard candy may help). Report persistent sedation or drowsiness, menstrual irregularities, or lack of improvement or worsening or condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Capsule, as hydrochloride: 60 mg

Tablet: 30 mg, 60 mg, 180 mg

"Fexofenadine," Med Lett Drugs Ther, 1996, 38(986):95-6.

Simons FE, Bergman JN, Watson WT, et al, "The Clinical Pharmacology of Fexofenadine in Children," J Allergy Clin Immunol, 1996, 98(6 Pt 1):1062-4.