Zyrtec (Cetirizine Hydrochloride) - Summary

ZYRTEC SUMMARY

ZYRTEC^®
(cetirizine hydrochloride)
Tablets, Chewable Tablets and Syrup
For Oral Use

Cetirizine hydrochloride, the active component of ZYRTEC^® tablets and syrup, is an orally active and selective H₁-receptor antagonist.

ZYRTEC is indicated for the following:

Seasonal Allergic Rhinitis: ZYRTEC is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes.

Perennial Allergic Rhinitis: ZYRTEC is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 6 months of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: ZYRTEC is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

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NEWS HIGHLIGHTS

Published Studies Related to Zyrtec (Cetirizine)

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.

Effect of levocetirizine on nasal provocation testing with adenosine monophosphate compared with allergen challenge in allergic rhinitis. [2009.03]
BACKGROUND: End-organ hyperreactivity is an important feature of the allergic airway. There are no data directly comparing the responsiveness to treatment of different nasal provocation tests (NPT). OBJECTIVE: We compared the effect of levocetirizine on nasal adenosine 5'-monophosphate (AMP) with specific allergen challenge in patients with intermittent and persistent allergic rhinitis (AR)... CONCLUSION: A high correlation and statistical agreement has been demonstrated between AMP and allergen challenge for all outcome measures. In particular, the recovery profile after NPT is a sensitive and discriminatory measure of anti-allergic treatment.

A combination of cetirizine and pseudoephedrine has therapeutic benefits when compared to single drug treatment in allergic rhinitis. [2009.02]
CONCLUSION: The combination treatment with CET and PSE is more effective than treatment with single substances in subjects with allergic rhinitis.

Hydroxyzine and cetirizine pharmacokinetics and pharmacodynamics after oral and intravenous administration of hydroxyzine to healthy dogs. [2008.12]
Pharmacokinetic parameters of hydroxyzine and its active metabolite cetirizine were determined after oral and intravenous administration of 2 mg kg(-1) of hydroxyzine to six healthy dogs. Plasma drug levels were determined with high-pressure liquid chromatography... Pharmacodynamic modelling predicted that maximal antihistamine effect would occur with twice daily oral administration of hydroxyzine at 2 mg kg(-1).

Levocetirizine in persistent allergic rhinitis: continuous or on-demand use? A pilot study. [2008.10]
BACKGROUND: Allergic rhinitis is a high-prevalence disease that affects quality of life (QOL), sleep quality and productivity of patients. According to the ARIA initiative, it is classified as intermittent and persistent, the latter being the most troublesome... CONCLUSION: The present open label study in 62 patients indicates that levocetirizine 5 mg reliably controls persistent rhinitis over a period of 6 months, and shows a trend to be more effective in controlling the symptoms of rhinitis, improving QOL and decreasing nasal inflammation, when administered as long-term continuous therapy rather than as on-demand therapy.

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Clinical Trials Related to Zyrtec (Cetirizine)

Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed conditions.

Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg [Completed]
"The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10 mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.

Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema [Completed]
Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms in Patients With Allergic Rhinitis. [Completed]

Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis [Completed]
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.

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PATIENT REVIEWS / RATINGS / COMMENTS

Zyrtec review by care giver of 16 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hives, itching, swelling due to allergies
Dosage & duration:		1 teaspoon daily (dosage frequency: once a day) for the period of 5 years
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		No allergic reactions while taking daily doses of Zyrtec and no side effects at all.
Side effects:		None
Comments:		My son had been having terrible problems with allergies. The cause is still unknown. Constant hives, itching and worst of all his lips & eyes would swell excessively to the point where he couldn't leave the house. He was prescribed Zyrtec 5 years ago and the only time he has a reaction is when he forgets to take his daily dose. It has been wonderful. Absolutely no side effects.

Zyrtec review by 24 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		allergies
Dosage & duration:		10 mg taken daily for the period of 3 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I was able to live without allerigies. Zyrtec alleviated my symptoms except for a slight cough without the drowsiness of other medications.
Side effects:		None
Comments:		I was taking benadryl prior to zyrtec. I found that benadryl was way too drowsy and zyrtec isn't. I take zyrtec in the morning and it alleviates my symptoms. My doctor said it was better to take it at night because it might cause drowsiness. I find it easier to take in the morning because I usually forget at night. I find it to be very effective in alleviating most symptoms.

Zyrtec review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		sinusitis
Dosage & duration:		One tablet (?) taken 1 x d for the period of 1 month
Other conditions:		none
Other drugs taken:		oral contraceptives, nasalchrom
		Reported Results
Benefits:		Moderate reduction in alergy symptoms
Side effects:		an intollerable level of sedation. Even though I took the medication before bedtime, the next day I felt exhausted and mentally dull for the entire day. Given the moderate level of symptom relief, this was not a reasonable trade-off.
Comments:		Was instructed to take medication at bedtime to reduce sedating effects.