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fexofenadine (Allegra, Allegra Allergy 12 Hour, Allegra Allergy 24 Hour, Children's Allegra Allergy, Mucinex Allergy)

 

Classes: Antihistamines, 2nd Generation

Dosing and uses of Allegra (fexofenadine)

 

Adult dosage forms and strengths

tablets

  • 30mg
  • 60mg
  • 180mg

oral suspension

  • 30mg/5mL

oral disintegrating tablets

  • 30mg

 

Seasonal Allergic Rhinitis/Chronic Idiopathic Urticaria

180 mg PO qDay or 60 mg PO BId

 

Dosing Modifications

Renal impairment (CrCl <80 mL/min): 60 mg PO qDay initially

 

Administration

Allegra ODT: Allow to disintegrate on tongue, followed by swallowing with or without water; take on empty stomach; do not chew

Coadministration with grapefruit, apple, or orange juice reduces bioavailability of fexofenadine by inhibiting P-gp; separate administration by at least 4 hr

 

Pediatric dosage forms and strengths

tablets

  • 30mg
  • 60mg
  • 180mg

oral suspension

  • 30mg/5mL

oral disintegrating tablets

  • 30mg

 

Seasonal Allergic Rhinitis

<2 years: Use not recommended

2-12 years: 30 mg PO BId

>12 years: 60 mg PO BID OR 180 mg PO qDay

Allegra ODt

  • 6-12 years: 30 mg PO BID

 

Chronic Idiopathic Urticaria

<6 months: Use not recommended

6 months-2 years: 15 mg PO BId

2-12 years: 30 mg PO BId

>12 years: 60 mg PO BID OR 180 mg PO qDay

Allegra ODt

  • 6-12 years: 30 mg PO BID

 

Dosing Modifications

Renal impairment (CrCl <80mL/min)

  • <6 months: Safety and efficacy not established
  • 6 months to 2 years: 15 mg PO qDay, initially
  • 2-12 years: 30 mg PO qDay, initially
  • >12 years: 60 mg PO qDay, initially

 

Administration

Allegra ODT: Allow to disintegrate on tongue, followed by swallowing with or without water; take on empty stomach; do not chew

Coadministration with grapefruit, apple, or orange juice reduces bioavailability of fexofenadine by inhibiting P-gp; separate administration by at least 4 hr

 

Allegra (fexofenadine) adverse (side) effects

Varies in incidence and severity with the individual drug; also, individual patients vary in susceptibility

 

>10%

Vomiting (6-12%)

 

1-10%

Headache (5-10%)

Cough (4%)

Diarrhea (3-4%)

URTI (3%)

Back pain (2-3%)

Pyrexia (2%)

Dysmenorrhea (2%)

Dizziness (2%)

Stomach discomfort (2%)

Pain in extremity (2%)

Somnolence (1-3%)

Rhinorrhea (1-2%)

 

Postmarketing Reports

Sleep disorders (insomnia, paranoia)

Nervousness

Hypersensitivity reactions (anaphylaxis, urticaria, angioedema, chest tightness, dyspnea, flushing, pruritus, rash)

 

Warnings

Contraindications

Hypersensitivity

 

Cautions

Allegra ODT contains phenylalanine

Severe renal impairment

Coadministration with fruit juice may decrease efficacy

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretion in milk unknown; use with caution (AAP states “compatible with nursing”)

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Allegra (fexofenadine)

Mechanism of action

H1 histamine receptor antagonist; competes for H1-receptor sites in target cells in the respiratory tract, blood vessels, and gastrointestinal tract; major metabolite of terfenadine

 

Absorption

Duration: ≥12 hr

Peak serum time: 2-3 hr (tablet); 2 hr (ODT); 1 hr (suspension)

Peak plasma concentration: 131 ng/mL

 

Distribution

Protein bound: 60-70%

 

Metabolism

Hepatic (5%)

 

Elimination

Half-life: 14.4 hr (31-72% longer in renal impairment)

Excretion: Feces (80%), urine (11%)