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.
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
Hepatic Impairment
Dosage adjustment not necessary.
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.
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. Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. 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.
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.
Increased absorption and decreased biliary excretion of fexofenadine, resulting in increased fexofenadine concentrations; however, no clinically important adverse effects or changes in the QT interval corrected for rate (QTc) reported
Fruit (apple, grapefruit, orange) juices
Possibly reduced bioavailability and systemic exposure of fexofenadine
Increased absorption and decreased secretion of fexofenadine, resulting in increased fexofenadine concentrations; however, no clinically important adverse effects or changes in the QTc reported
Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed from the GI tract following oral administration, with peak plasma concentrations achieved in about 2.6 hours after administration as conventional capsules or in about 1.8–2 hours after administration as extended-release tablets in fixed combination with pseudoephedrine hydrochloride.
Conventional capsules and tablets are bioequivalent when administered at equal doses.
Antihistaminic effect persists for about 12 hours following oral administration of 20- or 40-mg doses.
Food
No substantial alterations in fexofenadine pharmacokinetics observed in adults when contents of the 60-mg capsules were mixed with applesauce prior to administration.
Administration with fruit juices (e.g., apple, grapefruit, orange) may reduce fexofenadine bioavailability compared with administration with water.
Decreased rate and/or extent of absorption of fexofenadine observed when the fixed-combination preparations were administered concomitantly with a high-fat meal. (See Administration under Dosage and Administration.)
Special Populations
In patients with mild to severe renal impairment (Clcr of 11–80 mL/minute) and in those on hemodialysis (Clcr ≤ 10 mL/minute), peak plasma fexofenadine concentrations were increased by 87–111 and 82%, respectively, compared with those in healthy adults.
In geriatric patients ≥65 years of age, peak plasma fexofenadine concentrations were 99% greater than in younger adults.
Distribution
Extent
Distribution into human body tissues and fluid not fully elucidated; distributes into the small and large intestines, stomach, pancreas, liver, and kidney in animals. Distributed more extensively into plasma than blood or saliva. Does not appear to cross the blood-brain barrier.
Not known whether fexofenadine crosses the placenta or distributes into milk.
Plasma Protein Binding
60–70% (mainly albumin and α1-acid glycoprotein).
Elimination
Metabolism
About 0.5–1.5% of a dose is metabolized in the liver by CYP enzymes, while about 3.5% is metabolized by a second metabolic pathway.
Elimination Route
Excreted in feces (80%) and urine (11–12%).
Half-life
14.4–14.6 hours.
Special Populations
In patients with mild to severe renal impairment (Clcr of 11–80 mL/minute) and in those on hemodialysis (Clcr ≤10 mL/minute), half-life was 59–72 and 31% longer, respectively, compared with that in healthy adults.
Stability
Storage
Oral
Capsules and Tablets
20–25°C. Protect foil-backed blister packs containing capsules and all tablet packaging from excessive moisture.
Lacks cardiotoxic potential of terfenadine since it does not block the potassium channel involved in repolarization of cardiac cells (i.e., blockade of the delayed rectifier potassium current IK).
No appreciable anticholinergic, antidopaminergic, or α- or β-adrenergic blocking effects at usual antihistaminic doses in pharmacologic studies.
In clinical studies, incidence of CNS effects (e.g., sedation, EEG disturbances, impaired psychomotor performance) associated with fexofenadine is similar to that with placebo and less than that with first generation antihistamines (e.g., chlorpheniramine, clemastine, diphenhydramine, triprolidine).
Advice to Patients
Importance of taking only as prescribed; do not exceed prescribed dosage.
Importance of consulting a clinician if nervousness, dizziness, or sleeplessness occurs with fixed-combination preparations containing pseudoephedrine hydrochloride.
Importance of swallowing fixed-combination tablets whole; do not break, crush, or chew. Inform patients that inert ingredients of Allegra-D® 12 Hour tablets occasionally may be eliminated in feces in a form resembling the original tablet.
Advise patients to avoid concomitant use of fixed-combination preparations with other OTC antihistamines and/or decongestants.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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