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)

Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine on psychomotor function and histamine-induced wheal- and flare-responses: a randomized double-blind, placebo-controlled study in healthy volunteers. [2012]
Since most first-generation antihistamines have undesirable sedative effects on the central nervous systems (CNS), newer (second-generation) antihistamines have been developed to improve patients' quality of life. However, there are few reports that directly compare the antihistaminic efficacy and impairment of psychomotor functions...

Intranasal phototherapy is more effective than fexofenadine hydrochloride in the treatment of seasonal allergic rhinitis: results of a pilot study. [2011.03]
We recently showed that intranasal phototherapy represents an efficient therapeutic modality for the treatment of patients with seasonal allergic rhinitis (SAR). The aim of this pilot study was to compare the efficacy of intranasal phototherapy with that of the new generation antihistamine fexofenadine HCl in SAR...

The effects of the SLCO2B1 c.1457C > T polymorphism and apple juice on the pharmacokinetics of fexofenadine and midazolam in humans. [2011.02]
OBJECTIVE: The objective was to determine the effects of the SLCO2B1 c.1457C> T polymorphism and apple juice on the pharmacokinetics of fexofenadine and midazolam in humans... CONCLUSION: The results suggest that fexofenadine is a substrate of OATP2B1, and the transport function of OATP2B1 is subject to the genotype of SLCO2B1 c.1457C> T and apple juice. It is likely that apple juice has little effect on CYP3A.

Systematic review on the efficacy of fexofenadine in seasonal allergic rhinitis: a meta-analysis of randomized, double-blind, placebo-controlled clinical trials. [2011]
RATIONALE: Evidence-based medicine represents the effort to highlight the best intervention for patients, clinicians, and policy makers, each from their respective viewpoint, to solve a particular health condition. According to a recently diffused grading system of evidence and recommendations for medical interventions, efficacy and safety represent 2 of the most important features to consider, and data from meta-analyses of randomized controlled clinical trials (RCTs) is the strongest supporting demonstration. Fexofenadine has been used for its efficacy and safety in the treatment of allergic rhinitis (AR) for many years although no meta-analyses supporting its use currently exist. The aim of this study is to assess for the first time the efficacy and safety of fexofenadine in the treatment of AR by means of a meta-analytic analysis of existing RCTs. Since specific evidence should be provided to address recommendations in a pediatric population, the quality of the estimates of this subgroup analysis is assessed... CONCLUSIONS: This study has 5 major strengths: it represents the first attempt to evaluate the efficacy and safety of fexofenadine in the treatment of AR by means of a meta-analysis of RCTs; there was consistency between positive results in terms of efficacy in TSS and in individual symptoms; a large population was studied; there was an irrelevant interstudy heterogeneity, and the AE frequency was similar in both groups. All of these values encourage the recommendation of fexofenadine for AR. Further research focused on the benefits and disadvantages for a pediatric population is needed.

Effect of metronidazole on the pharmacokinetics of fexofenadine, a P-glycoprotein substrate, in healthy male volunteers. [2010.07]
OBJECTIVE: Metronidazole has been reported to cause various drug interactions when co-administered with certain drugs. One possible mechanism for this action is through an inhibition of P-glycoprotein (P-gp). We have assessed the possible inhibitory effects of metronidazole on P-gp-mediated drug disposition in healthy subjects using fexofenadine as a P-gp substrate... CONCLUSION: These results show that metronidazole did not have any inhibitory effect on the pharmacokinetics of fexofenadine. The results of the present study provide evidence that metronidazole does not act as an inhibitor of P-gp-mediated disposition in humans.

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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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Reports of Suspected Allegra (Fexofenadine) Side Effects

Drug Ineffective (17),  Pruritus (12),  Urticaria (9),  Loss of Consciousness (8),  Condition Aggravated (8),  Insomnia (8),  Headache (7),  Malaise (7),  Dizziness (7),  Abdominal Distension (7), more >>

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 31 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Seasonal allergies
Dosage & duration:		60mg taken twice a day for the period of 3 months
Other conditions:		none
Other drugs taken:		nuva ring
		Reported Results
Benefits:		It greatly reduced the effects I get from seasonal allergies including sneezing, stuffy or runny nose, itchy, watery eyes, and an itchy upper soft palate at the back/roof of my mouth. It takes care of most of it, but I still get some itchiness at roof of my mouth.
Side effects:		No side effects!
Comments:		I take one pill in the morning, and one at night.

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.