Allegra (Fexofenadine Hydrochloride) - Summary

ALLEGRA SUMMARY

ALLEGRA^® (fexofenadine hydrochloride) Tablets, 30 mg, 60 mg and 180 mg

ALLEGRA^® (fexofenadine hydrochloride) Oral Suspension, 30 mg/5mL (6 mg/mL)

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.

See all Allegra indications & dosage >>

ALLEGRA NEWS HIGHLIGHTS

Published Studies Related to Allegra (Fexofenadine)

Fexofenadine effects on cognitive performance in aviators at ground level and simulated altitude. [2008.08]
INTRODUCTION: Antihistamines are used for the treatment of allergic rhinitis (AR) symptoms. However, the cognitive effects of some antihistamines can dramatically impair individuals in occupations that require sustained vigilance... CONCLUSION: Fexofenadine [generic for Allegra] is comparable to placebo in its effect on the cognitive skills important for piloting an aircraft, while cetirizine impairs cognition and may affect piloting ability.

Safety and tolerability of fexofenadine hydrochloride, 15 and 30 mg, twice daily in children aged 6 months to 2 years with allergic rhinitis. [2007.12]
BACKGROUND: Antihistamines are an established first-line treatment for allergic rhinitis and are widely prescribed in infants for allergic symptoms. OBJECTIVE: To establish the safety and tolerability of fexofenadine [generic for Allegra] hydrochloride in children aged 6 months to 2 years in 2 studies (T/3001 and T/3002)... CONCLUSION: Fexofenadine hydrochloride, 15 or 30 mg, given for a mean duration of 8 days is well tolerated, with a good safety profile, in children aged 6 months to 2 years.

Safety and tolerability of fexofenadine for the treatment of allergic rhinitis in children 2 to 5 years old. [2007.10]
BACKGROUND: The safety of fexofenadine [generic for Allegra] has been examined extensively in adults and school-age children. However, the safety of fexofenadine in children younger than 6 years has not been reported to date. OBJECTIVE: To compare the safety and tolerability of twice-daily fexofenadine hydrochloride, 30 mg, and placebo in preschool children aged 2 to 5 years with allergic rhinitis... CONCLUSIONS: The findings show that fexofenadine hydrochloride, 30 mg, is well tolerated and has a good safety profile in children aged 2 to 5 years with allergic rhinitis.

The effect of fexofenadine hydrochloride on productivity and quality of life in patients with chronic idiopathic urticaria. [2007.02]
The present study examined the impact of once-daily fexofenadine [generic for Allegra] hydrochloride (HCl) 180 mg on health-related quality of life (HRQL) in subjects with chronic idiopathic urticaria (CIU). This was a multicenter, randomized, double-blind... The results indicated that once-daily fexofenadine HCl 180 mg improved the HRQL of subjects with CIU, as assessed by change in total DLQI score.

Efficacy of fexofenadine versus desloratadine in suppressing histamine-induced wheal and flare. [2007.01]
To date, no published articles exist comparing the H1-receptor antagonist activities of fexofenadine [generic for Allegra] and desloratadine using the histamine-induced skin wheal-and-flare model. The aim of this study was to compare the efficacy of fexofenadine versus desloratadine in suppressing histamine-induced skin flares and wheals in adults and adolescents... Fexofenadine HCl, 180 mg, was superior to desloratadine, 5 mg, in histamine-induced wheal-and-flare suppression, suggesting increased in vivo H1-receptor antagonist potency of fexofenadine versus desloratadine.

more studies >>

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]

more trials >>

ALLEGRA PATIENT REVIEWS / RATINGS / COMMENTS

Allegra review by 41 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		allergies
Dosage & duration:		1 pill per day taken daily for the period of a few weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The treatment benefits included but were not limited to anti histamine blocker, decongestant, etc. I was sneezing, coughing, had laringitis, allergy shiners, and could not sleep.
Side effects:		There were side effects listed such as dizziness, nausea, hypertension etc. I did not expertise any of the ill side effects/
Comments:		I went to the doctor for the prescription. I went to the pharmacy to have the presciption filled. I took the prescribed dosage daily with a big glass of water. I took my dosage in the evening.

Allegra review by 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Allergies
Dosage & duration:		180 MG taken as needed for the period of Continuous for the last 10 years
Other conditions:		Itchy, dry eyes, congestion, sneezing
Other drugs taken:		None
		Reported Results
Benefits:		Allegra minimized the allergy symptoms without the side effect of drowsiness that is typical of over-the-counter allergy medications such as Benadryll. After taking the drug, congestion is greatly reduced and the constant sneezing stops. However, Allegra is not very effective for itchy, dry eyes, which continues to be a problem during peak allergy season.
Side effects:		No side effects have been observed during the 10 years of use. Drowsiness has not been an issue and no reactions to other medications have been experienced.
Comments:		One tablet is taken per day whenever allergy symptoms are moderate to severe. No medication is taken on days when allergies are mild.

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.