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Uses

Allergic Rhinitis

Symptomatic relief (alone or in fixed combination with pseudoephedrine hydrochloride) of seasonal allergic rhinitis (e.g., hay fever).

Use fixed-combination preparation only when both antihistamine and nasal decongestant activity are desired.

Chronic Idiopathic Urticaria

Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Substantially reduces pruritus and the number of wheals.

Dosage and Administration

Administration

Oral Administration

Administer conventional tablets or capsules orally without regard to meals.

Fixed-combination fexofenadine hydrochloride/pseudoephedrine hydrochloride preparations: Administer orally on an empty stomach with water. Swallow tablets whole; do not break, crush, or chew.

Dosage

Available as fexofenadine hydrochloride; dosage expressed in terms of the salt.

Fixed-combination preparations available as Allegra-D^® 12 Hour and Allegra-D^® 24 Hour. Allegra-D^® 12 Hour and Allegra-D^® 24 Hour tablets contain 60 or 180 mg of fexofenadine hydrochloride, respectively, in an immediate-release layer and 120 or 240 mg of pseudoephedrine hydrochloride, respectively, in an extended-release matrix layer that slowly releases the drug.

Pediatric Patients

Allergic Rhinitis

Oral

Children 6–11 years of age: 30 mg twice daily (as conventional tablets).

Children ≥12 years of age: 60 mg twice daily or 180 mg once daily (as conventional capsules or tablets).

Children ≥12 years of age: 60 mg twice daily (as Allegra-D^® 12 Hour) or 180 mg once daily (as Allegra-D^® 24 Hour).

Chronic Idiopathic Urticaria

Oral

Children 6–11 years of age: 30 mg twice daily (as conventional tablets).

Children ≥12 years of age: 60 mg twice daily (as conventional capsules or tablets).

Adults

Allergic Rhinitis

Oral

60 mg twice daily or 180 mg once daily (as conventional capsules or tablets).

60 mg twice daily (as Allegra-D^® 12 Hour) or 180 mg once daily (as Allegra-D^® 24 Hour).

Chronic Idiopathic Urticaria

Oral

60 mg twice daily (as conventional capsules or tablets).

Special Populations

Dosage in Hepatic Impairment

Dosage adjustment not necessary.

Dosage in Renal Impairment

Children 6–11 years of age with decreased renal function: 30 mg once daily (as conventional tablets).

Adults and children ≥12 years of age with decreased renal function: 60 mg once daily (as conventional capsules or tablets or in fixed combination with 120 mg of pseudoephedrine hydrochloride [Allegra-D^® 12 Hour]). Avoid use of fixed-combination preparation containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride (Allegra-D^® 24 Hour) in patients with renal impairment because of possible risk of pseudoephedrine accumulation.

Geriatric Patients

Select dosage carefully. (See Geriatric Use under Cautions.)

Cautions

Contraindications

• Known hypersensitivity to fexofenadine or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Rash, urticaria, pruritus, and hypersensitivity reactions (e.g., angioedema, chest tightness, dyspnea, flushing, anaphylaxis) reported rarely.

General Precautions

Fixed-combination Preparations

When used in fixed combination with pseudoephedrine, consider the cautions, precautions, and contraindications associated with pseudoephedrine.

Specific Populations

Pregnancy

Category C.

Lactation

Not known if fexofenadine is distributed into milk; however, pseudoephedrine (a component of the fixed-combination preparations) distributes into milk. Use with caution in nursing women. Discontinue nursing or fixed-combination preparation.

Pediatric Use

Conventional tablets or capsules: Safety and efficacy not established in children <6 years of age.

Extended-release fexofenadine hydrochloride/pseudoephedrine hydrochloride preparations: Safety and efficacy not established in children <12 years of age; use not recommended in this age group. Doses of fexofenadine hydrochloride and pseudoephedrine hydrochloride in these preparations exceed those recommended for children <12 years of age.

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Use such preparations in children <2 years of age with caution and only as directed by clinician. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Geriatric Use

Insufficient experience in patients ≥65 years of age in clinical trials, but other clinical experience has not identified overall differences in response relative to younger patients.

Risk of severe adverse reactions may be increased in patients with impaired renal function since fexofenadine is substantially excreted by the kidney. Select dosage carefully due to greater frequency of decreased renal function; renal function monitoring may be useful.

Renal Impairment

Dosage reduction necessary. (See Renal Impairment under Dosage and Administration.)

Avoid use of fixed-combination preparation containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride (Allegra-D^® 24 Hour) in patients with renal impairment; possible risk of pseudoephedrine accumulation.

Common Adverse Effects

Children 6–11 years of age receiving conventional tablets: Headache, upper respiratory tract infection, coughing, accidental injury, fever, pain, otitis media.

Adults and children ≥12 years of age receiving conventional capsules or tablets: Viral infection (e.g., cold, flu), nausea, dysmenorrhea, sinusitis, dizziness, drowsiness, dyspepsia, fatigue, headache, upper respiratory tract infection, back pain.

Fixed-combination fexofenadine hydrochloride (60 mg)/pseudoephedrine hydrochloride (120 mg): Headache, insomnia, nausea, dry mouth, dyspepsia, throat irritation, dizziness, agitation, back pain, palpitation, nervousness, anxiety, upper respiratory tract infection, abdominal pain.