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Fexofenadine (Fexofenadine Hydrochloride) - Summary

 
 



FEXOFENADINE SUMMARY

Fexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride.

Seasonal Allergic Rhinitis:

Fexofenadine hydrochloride 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.

Chronic Idiopathic Urticaria:

Fexofenadine hydrochloride 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 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 Fexofenadine

Fexofenadine (AllegraŽ) 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.

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

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

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 Fexofenadine Side Effects

Completed Suicide (17)Urticaria (6)Toxicity TO Various Agents (5)Drug Ineffective (4)Poisoning (4)LIP Swelling (3)Hypersensitivity (3)Fatigue (3)Condition Aggravated (3)Arrhythmia (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 5 ratings/reviews, Fexofenadine has an overall score of 7.60. The effectiveness score is 7.60 and the side effect score is 9.60. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Fexofenadine review by 14 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   dermagraphia, hives
Dosage & duration:   60mg taken 2x for the period of 6 months
Other conditions:   elevated blood pressure
Other drugs taken:   used to take Xyzal
  
Reported Results
Benefits:   Stops and Prevented breakouts of hives! I am severly allergic to most foods and plants, everything breaks me out. Thanks to this pill, this won't happen any more.
Side effects:   None
Comments:   I was to take 1 pill in the morning after breakfast, then 1 at night before I go to bed. I am to take it for 6 months as a test. The generic was a cheaper version for my parents.

 

Fexofenadine review by 47 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Chronic Idiopathic Urthicaria with Pruritis
Dosage & duration:   180Mg taken twice daily for the period of 3 years
Other conditions:   Brachioradial Pruritis, Cervical Radiopathy, ADD, Hypogonadism
Other drugs taken:   Methalphenadate, Diazipam, Androgel
  
Reported Results
Benefits:   Incidents reduced from daily to maybe every 6 to 8 weeks. If I missed my dose however by hour 14 I would start to break out. This would indicate to me that the histamine levels are ever present and the histamine blocker is what is keeping their ill effects at bay. I have however discovered that recently my pharmacy changed their generic manufacturer and the new version is very ineffective. I've had 5+ severe breakouts in 3 months
Side effects:   Virtually none. Not drowsiness, not upset stomach, no nothing. Just don't miss your dose.
Comments:   take one at 7 am when I wake up, the other at 7pm after supper.

 

Fexofenadine review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   allergic rhinitis
Dosage & duration:   180mg taken 1 tablet per day for the period of 6 months
Other conditions:   post nasal drip
Other drugs taken:   none
  
Reported Results
Benefits:   There were no benefits as the sniffling, dripping, coughing continued even on the medicine.
Side effects:   Dry mouth.
Comments:   Perscribed to help with the following symptoms: drippy nose, sinus congestion, post nasal drip, coughing, and sneezing. Medicine was taken as directed with no real help. The only side effect was being a little dry.

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Page last updated: 2013-02-10

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