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Xyzal (Levocetirizine Dihydrochloride) - Summary

 



XYZAL SUMMARY

Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1- receptor antagonist.

Allergic Rhinitis

XYZAL® is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.

Chronic Idiopathic Urticaria

XYZAL is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.


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NEWS HIGHLIGHTS

Media Articles Related to Xyzal (Levocetirizine)

Xyzal Approved for Younger Kids
Source: MedicineNet Constipation Specialty [2009.08.26]
Title: Xyzal Approved for Younger Kids
Category: Health News
Created: 8/25/2009 12:10:00 PM
Last Editorial Review: 8/26/2009

Treatment Of Allergic Rhinitis Improves Coexisting Diseases
Source: Allergy News From Medical News Today [2009.11.09]
The treatment of allergic rhinitis is shown to improve co-existing conditions including conjunctivitis, asthma, sinusitis, otitis media with effusion (fluid in the middle ear) and sleep disorders according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.

Allergy drug tackles nasal congestion: study (Reuters)
Source: Y! Health Allergy News [2009.11.12]
Reuters - The "second generation" allergy drug desloratadine (brand name Clarinex) significantly reduces both the runny nose and congestion of seasonal and persistent allergic rhinitis, a study shows.

ACAAI: Drug Combo Effective in Allergic Eye Symptoms (CME/CE)
Source: MedPage Today Allergy & Immunology [2009.11.11]
MIAMI BEACH (MedPage Today) -- A combination of two standard drugs delivered together was safe and effective in treating the itchy and watery eyes associated with seasonal allergic rhinitis, a researcher said.

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Published Studies Related to Xyzal (Levocetirizine)

Comparison of the efficacy of levocetirizine 5 mg and desloratadine 5 mg in chronic idiopathic urticaria patients. [2009.04]
BACKGROUND: Nonsedating H(1)-antihistamines are recommended for the treatment of urticaria by the recent EAACI/GA(2)LEN/EDF guidelines. The aim of this study was to compare the efficacy, after 4 weeks of treatment, with levocetirizine 5 mg and desloratadine 5 mg, both once daily in the morning, in symptomatic chronic idiopathic urticaria (CIU) patients... CONCLUSIONS: Levocetirizine 5 mg was significantly more efficacious than desloratadine 5 mg in the treatment of CIU symptoms.

Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. [2008.09]
BACKGROUND: To date, no adequate data are available on direct comparison of the efficacy of levocetirizine, a recently approved histamine1-antihistamine, with that of a leukotriene antagonist in the treatment of seasonal allergic rhinitis (SAR) symptoms. OBJECTIVE: To compare the efficacy of therapeutic doses of 5 mg of levocetirizine and 10 mg of montelukast in ragweed sensitized patients... CONCLUSIONS: This study in an environmental exposure chamber confirms the therapeutic efficacy of 5 mg of levocetirizine in improving symptoms of SAR, which was superior to 10 mg of montelukast.

Determination of levocetirizine in human plasma by liquid chromatography-electrospray tandem mass spectrometry: application to a bioequivalence study. [2008.02.01]
We describe a liquid chromatography-tandem mass spectrometric method (LC-MS/MS) for levocetirizine quantification (I) in human plasma. Sample preparation was made using a fexofenadine (II) addition as internal standard (IS), liquid-liquid extraction using cold dichloromethane, and dissolving the final extract in acetonitrile...

Inhibition of allergen-induced wheal and flare reactions by levocetirizine and desloratadine. [2008.02]
What is already known about this subject: The reproducible and standardized histamine-induced wheal and flare model helps identify the objective effectiveness of antihistamines in humans, as well as their differences in onset and duration of action. Some of the newest antihistamines have already been compared in a head-to-head setting using this model. However, their objective action at inhibiting the allergen-induced wheal and flare response has not been reported yet. What this study adds: The time-response study presented here shows the objective activity of two of the newest generation of antihistamines, levocetirizine and desloratadine, at inhibiting the allergen-induced wheal and flare response in a randomized, cross over, placebo-controlled trial. This model is interesting to the clinical setting since allergic subjects are recruited, and the response to allergen involves mast cell degranulation and release of numerous vasoactive and pro-inflammatory mediators additionally to histamine. In addition, this study reports receptor occupancy for both antihistamines at therapeutic dosage, leading to analysis of potential differences in activity. This study clearly shows the potential anti-inflammatory properties of desloratadine and levocetirizine in their skin activity when allergen is the challenging agent as occurs in the clinical situation. AIMS: To evaluate the inhibitory activity of the new-generation antihistamines levocetirizine and desloratadine at their therapeutic doses on the allergen-induced wheal and flare reaction at 1.5 h, 4 h, 7 h, 12 h and 24 h postdose, and to measure their plasma and skin concentrations... CONCLUSIONS: Levocetirizine suppressed the cutaneous allergic reactions with a higher potency than desloratadine, which correlated with its high receptor occupancy. Receptor occupancy rather than drug affinity or plasma half-life is more representative of antihistamine potency.

Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study. [2007.11]
OBJECTIVE: To conduct a thorough QT study of levocetirizine, a non-sedating antihistamine, in accordance with International Conference on Harmonisation (ICH) E14 guidance... CONCLUSIONS: Overall, the results of this thorough QT study indicate that the methodology of the trial was valid and sensitive enough to demonstrate the absence of effect of levocetirizine at both therapeutic (5 mg) and supra-therapeutic (30 mg) doses on cardiac repolarisation.

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Clinical Trials Related to Xyzal (Levocetirizine)

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months [Recruiting]
The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 6-11 months who suffer from atopic disease.

Management of Pruritus With Xyzal in Atopic Dermatitis [Recruiting]
It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus associated with atopic dermatitis.

The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria [Recruiting]
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.

Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Primary end point: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects’ diaries during the first two weeks of the treatment.

Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.

Is Levocetirizine Less Sedating Than Cetirizine? [Recruiting]
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Xyzal has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Xyzal review by 42 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   seasonal allergies
Dosage & duration:   5 mg taken 1x per 24 hrs for the period of 2 weeks
Other conditions:   bug bite histamine reaction
Other drugs taken:   none
  
Reported Results
Benefits:   I did not see any significant benefits for treating the histamine reaction- which was due to a bug bite and subsequent allergic response. Sensations and symptoms included inflammation, redness, swelling to the point of limited mobility (bite was on hand) and itching, which the Xyzal did not effectively treat; however, the xyzal appeared to help with the seasonal allergies related to hay fever. For the topical condition, diphenhydramine was preferred.
Side effects:   Drowsiness. Slight dizziness, but not remarkable. I also thought that the drug's slow-release effect may not be as modulated as one would hope since the drowsiness and related symptoms came in spurts rather than in a constant flow, if you know what i mean. I did not find that caffeine was helpful to promote alertness and I was nervous about driving while taking this particular medication.
Comments:   I took the every evening every 24 hours for 14 days, according to my doctor's instructions. He did not want me to "mix antihistamines" and even though I thought Benadryl might be more effective, I didn't want a drug that would make me that sleepy and also that I would have to take every 6 hours, as opposed to every 24 hours. I would have prefferred a Xyzal dose that i could take every 12 hours, and then i could use benadryl at night without worrying about mixing anti-histamines, but since this was not possible I just used the Xyzal plus topical antihistamine creme on site of bug bite.

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Page last updated: 2009-11-12

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