Allegra (Fexofenadine Hydrochloride) - Summary

ALLEGRA SUMMARY

Fexofenadine hydrochloride, the active ingredient of ALLEGRA, is a histamine H₁-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-(alpha), (alpha)-dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure

ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.

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NEWS HIGHLIGHTS

Published Studies Related to Allegra (Fexofenadine)

Short-term effect of quercetin on the pharmacokinetics of fexofenadine, a substrate of P-glycoprotein, in healthy volunteers. [2009.06]
OBJECTIVE: The aim of the present study was to assess whether quercetin exhibited any inhibitory effect on P-glycoprotein (P-gp)-mediated drug disposition in humans using fexofenadine as a P-gp substrate... CONCLUSION: The results of the present study showed that short-term use of quercetin elevated the plasma concentrations of fexofenadine, probably by the inhibition of P-gp-mediated efflux in humans.

Enantioselective disposition of fexofenadine with the P-glycoprotein inhibitor verapamil. [2009.05]
AIMS: The aim was to compare possible effects of verapamil, as a P-glycoprotein (P-gp) inhibitor, on the pharmacokinetics of each fexofenadine enantiomer, as a P-gp substrate... CONCLUSION: This study indicates that P-gp plays a key role in the stereoselectivity of fexofenadine pharmacokinetics, since the pharmacokinetics of fexofenadine enantiomers were altered by the P-gp inhibitor verapamil, and this effect was greater for S-fexofenadine compared with R-fexofenadine.

Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy. [2009.03]
Nasal symptoms of allergic rhinitis are an important cause of sleep disturbance... FFNS once daily was more effective than fexofenadine and placebo with respect to nighttime sleep disturbance caused by seasonal allergy symptoms.

Bioequivalence of fexofenadine tablet formulations assessed in healthy Iranian volunteers. [2009]
BACKGROUND AND OBJECTIVE: Many drug products containing the same amount of active drug are made and marketed by more than one pharmaceutics manufacturer. Since the quality of final drug product is affected by the source of ingredients, type and amount of excipients and manufacturing process, bioequivalence studies are used to determine the bioavailability and characterize the pharmacokinetics of the new formulation relative to a reference formulation. In the present study the bioavailability of a new capsule formulation of fexofenadine (CAS 153439-40-8) was compared to a reference formulation in 12 healthy male volunteers... CONCLUSION: Based on the obtained results the two fexofenadine formulations are considered to be equivalent.

Evaluation of the efficacy and safety of olopatadine and fexofenadine compared with placebo in Japanese cedar pollinosis using an environmental exposure unit. [2009]
BACKGROUND: Second-generation oral H1-antihistamines have become a mainstay of treatment for the symptoms of seasonal allergic rhinitis; however, the effect of olopatadine has not been widely reported to date. OBJECTIVES: To evaluate the efficacy of 2 oral H1-antihistamines, olopatadine and fexofenadine, in the treatment of the nasal symptoms of Japanese cedar pollinosis and their possible side effects... CONCLUSIONS: These findings suggest that olopatadine is more effective than placebo and fexofenadine in improving nasal symptoms of Japanese cedar pollinosis.

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Clinical Trials Related to Allegra (Fexofenadine)

Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fed conditions.

Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fasting conditions.

Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine [Completed]
To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.

Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel [Completed]
To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

Allegra review by 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Allergies
Dosage & duration:		60 mg taken twice per day for the period of 2 years
Other conditions:		Ocular hypertension
Other drugs taken:		Xalatan
		Reported Results
Benefits:		This drug alleviates my allergic responses--itchy eyes and sneezing. It's effective because if I don't use it, my symptoms return.
Side effects:		I'm not sure if this drug has a drying effect. I don't think so, but I really don't know how to tell.
Comments:		I take a pill approximately every 12 hours. I try to keep well hydrated.

Allegra review by 35 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		allergy
Dosage & duration:		1 pill a day taken 1 a day for the period of 6 month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		feel better overall, not felling dizzy and able to drive safely , frequent headaches are gone, able to concentrate on work and family, better vision at night time
Side effects:		weight gain, moodiness, feel tired all the time, can not operate the car
Comments:		i have to take one pill a day for six weeks

Allegra review by 60 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		itchy watery eyes
Dosage & duration:		1 tab twice a day taken 10 days for the period of on and off over 3 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		suppose to stop my watery eyes. Had little or no effect
Side effects:		no side effects
Comments:		I was to take it twice a day, which I did. It was suppose to work for hayfever, watery eyes. With a severe hayfever attack the pills were of no value or effect. The pills don't stop the eyes from watering.