Fexofenadine Hydrochloride
Pronouncation: (fex-oh-FEN-ah-deen HIGH-droe-KLOR-ide)Class: Piperidine, peripherally selective
Trade Names:
Allegra
- Tablets 30 mg
- Tablets 60 mg
- Tablets 180 mg
- Capsules 60 mg
Allegra 24 Hour (Canada)
Pharmacology
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Competitively antagonizes histamine at the H 1 -receptor site.
Pharmacokinetics
Absorption
T max is 2.6 h; C max is 131 ng/mL.
Distribution
60% to 70% is bound to plasma proteins. The drug does not cross the blood-brain barrier.
Metabolism
About 5% is metabolized.
Elimination
Mean t ½ is 14.4 h. About 80% is excreted in the feces and 11% in the urine.
Onset
1 h.
Peak
2 to 3 h.
Duration
8 to 12 h.
Special Populations
Renal Function ImpairmentMild to moderate with a CrCl of 41 to 80 mL/min has an 87% increase in C max and a 59% longer t ½ . Severe with a CrCl of 11 to 40 mL/min has a 111% increase in C max and a 72% longer t ½ .
ElderlyC max is increased 99%.
ChildrenAUC increased 56%.
HemodialysisWith CrCl 10 mL/min or less, C max is increased 82% and t ½ is 31% longer.
Indications and Usage
Symptomatic relief of symptoms (nasal and nonnasal) associated with seasonal allergic rhinitis; treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Contraindications
Standard considerations.
Dosage and Administration
Seasonal Allergic RhinitisAdults and Children 12 yr of age and older
PO 60 mg twice daily or 180 mg once daily.
Children 6 to 11 yr of agePO 30 mg twice daily.
Chronic Idiopathic UrticariaAdults and children 12 yr of age and older
PO 60 mg twice daily.
Children 6 to 11 yr of agePO 30 mg twice daily.
Renal Function ImpairmentAdults and children 12 yr of age and older
PO 60 mg once daily as a starting dose.
Children 6 to 11 yr of agePO 30 mg once daily as a starting dose.
General Advice
- Administer without regard to meals. Administer with food if GI upset occurs.
Storage/Stability
Store tablets and capsules at controlled room temperature (68° to 77°F). Protect from excessive moisture.
Drug Interactions
Aluminum/Magnesium antacidsTaken concomitantly, fexofenadine AUC decreased 41%, and C max decreased 43%.
ErythromycinIncreased plasma levels of fexofenadine.
KetoconazoleIncreased plasma levels of fexofenadine.
Laboratory Test Interactions
May prevent or diminish otherwise positive reactions to skin tests.
Adverse Reactions
CNS
Headache (11%); drowsiness, dizziness (2%); fatigue (1%).
EENT
Coughing (4%); otitis media, sinusitis (2%).
GI
Nausea (2%); dyspepsia (1%).
Genitourinary
Dysmenorrhea (2%).
Respiratory
Upper respiratory tract infection (4%).
Miscellaneous
Viral infection (eg, cold, flu); accidental injury, back pain (3%); fever, pain (2%).
Precautions
MonitorAssess patient for allergy symptoms before starting therapy and periodically throughout therapy. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established in children younger than 6 yr of age.
Renal Function
Use lower starting dose.
Overdosage
Symptoms
Dizziness, drowsiness, dry mouth.
Patient Information
- Advise patient to take without regard to meals but to take with food if stomach upset occurs.
- Advise patient that if allergy symptoms are not controlled not to increase the dose of medication or frequency of use but to inform health care provider.
- Inform patient that larger doses or more frequent dosing does not increase effectiveness and may cause drowsiness.
- Caution patient not to take any OTC antihistamines while taking this medication unless advised by health care provider.
- Caution patient to avoid alcohol and other CNS depressants (eg, sedatives) while using this medication.
- If patient is to have allergy skin testing, advise not to take the medication for at least 4 days before the skin testing.
- Caution patient that drug may cause drowsiness and to use caution driving or performing other tasks requiring mental alertness until tolerance is determined.
- Instruct patient to stop taking drug and report any symptoms of persistent dizziness or excessive drowsiness to health care provider.
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