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All about: Fexofenadine Hydrochloride

Big Image 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 12 Hour (Canada)
Allegra 24 Hour (Canada)

Mechanism of Action

Pharmacology

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 Impairment

Mild 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 .

Elderly

C max is increased 99%.

Children

AUC increased 56%.

Hemodialysis

With 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 Rhinitis
Adults and Children 12 yr of age and older

PO 60 mg twice daily or 180 mg once daily.

Children 6 to 11 yr of age

PO 30 mg twice daily.

Chronic Idiopathic Urticaria
Adults and children 12 yr of age and older

PO 60 mg twice daily.

Children 6 to 11 yr of age

PO 30 mg twice daily.

Renal Function Impairment
Adults and children 12 yr of age and older

PO 60 mg once daily as a starting dose.

Children 6 to 11 yr of age

PO 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 antacids

Taken concomitantly, fexofenadine AUC decreased 41%, and C max decreased 43%.

Erythromycin

Increased plasma levels of fexofenadine.

Ketoconazole

Increased 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

Monitor

Assess 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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