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ALLEGRA ORAL

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Uses & Dosage • Uses • Dosage • Dosage in Renal and Hepatic Impairment

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ALLEGRA ORAL Uses & Dosage

Uses from First DataBank

Labeled Uses

Unlabeled Uses

ALLERGIC RHINITISCHRONIC IDIOPATHIC URTICARIACONJUNCTIVITIS, ALLERGICNASAL CONGESTION,RHINORRHEASNEEZING

(Uses not currently included in the labeling approved by the US Food and Drug Administration.)

None listed

Uses from AHFS DI™

Fexofenadine shares the uses of other antihistamines, including the management of allergic rhinitis and chronic idiopathic urticaria. For additional information on these and other uses of antihistamines, see Uses in the Antihistamines General Statement 4:00. ...more

Dosage from AHFS DI™

Allergic Rhinitis For symptomatic relief of seasonal allergic rhinitis, the usual dosage of fexofenadine hydrochloride for adults and children 12 years of age and older is 60 mg twice daily or 180 mg once daily. Fexofenadine hydrochloride dosages exceeding 60 mg twice daily (up to a dosage of 240 mg twice daily) do not appear to provide additional therapeutic benefit. When the fixed combination containing fexofenadine hydrochloride with pseudoephedrine hydrochloride is used for symptomatic relief of allergic rhinitis in adults and children 12 years of age and older, the usual dosage is 60 mg of fexofenadine hydrochloride twice daily.

For symptomatic relief of seasonal allergic rhinitis, the usual dosage of fexofenadine hydrochloride for children 6 to younger than 12 years of age is 30 mg twice daily.

Although peak plasma fexofenadine concentrations increased by 99% in healthy adults 65 years of age and older when compared with those in younger adults, there appears to be no evidence of age-related differences in the mean elimination half-lives between geriatric and younger adults. In addition, limited data indicate that the safety profile of the drug in adults 60—68 years of age is similar to that in adults younger than 60 years of age. Therefore, dosage adjustment of fexofenadine hydrochloride solely on the basis of age generally is not required for healthy geriatric patients. However, the possible need for dosage adjustment in geriatric patients should be considered for those with decreased renal function since clearance of the drugmay be decreased and half-life prolonged in such patients. The manufacturer of Allegra-D® (extended-release tablets containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride) also states that appropriate dosage in geriatric patients should be selected with caution, usually initiating therapy at the low end of the dosage range since decreased hepatic, renal, or cardiac function occurs more frequently in these patients. (See Dosage: Dosage in Renal and Hepatic Impairment, in Dosage and Administration.)

Chronic Idiopathic Urticaria For the management of chronic idiopathic urticaria, the usual dosage of fexofenadine hydrochloride for adults and children 12 years of age and older is 60 mg twice daily. The usual dosage for children 6 to younger than 12 years of age is 30 mg twicedaily.

Dosage in Renal and Hepatic Impairment from AHFS DI™

Adjustment of fexofenadine hydrochloride dosage may be necessary in patients with renal impairment. Peak plasma fexofenadine concentrations increased by 87 or 111%, and elimination half-life increased by 59 or 72% in patients with mild (e.g., creatinine clearance of 41—80 mL/minute) or severe (creatinine clearance of 11—40 mL/minute) renal impairment, respectively, when compared with those observed in healthy individuals. In addition, peak plasma fexofenadine concentration increased by 82% and elimination half-life increased by 31% in those on hemodialysis (creatinine clearance of 10 mL/minute or less) compared with healthy individuals. Therefore, the manufacturer states that adults and children 12 years of age and older with impaired renal function or those on hemodialysis should receive an initial fexofenadine hydrochloride (either when given alone or in fixed combination with pseudoephedrine hydrochloride) dosage of 60 mg daily. Children 6 to younger than 12 years of age with impaired renal function should receive an initial fexofenadine hydrochloride dosage of 30 mg daily.

Since the pharmacokinetics of fexofenadine appear not to be altered in patients with hepatic impairment, the manufacturer states that dosage adjustment is not necessary in such patients. The manufacturer of Allegra-D®(extended-release tablets containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride) does not make specific recommendations for dosage adjustment in patients with hepatic impairment, although it is not known if pharmacokinetics of pseudoephedrine are altered in patients with hepatic impairment.

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