Zyrtec-D (Cetirizine Hydrochloride / Pseudoephedrine Hydrochloride) - Summary

ZYRTEC-D SUMMARY

ZYRTEC-D 12 HOUR®
(cetirizine hydrochloride 5 mg and
pseudoephedrine hydrochloride 120 mg)
Extended Release Tablets
For Oral Use

ZYRTEC-D 12 HOUR™ (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) Extended Release Tablets for oral administration contain 5 mg of cetirizine hydrochloride for immediate release and 120 mg of pseudoephedrine hydrochloride for extended release in a bilayer tablet.

ZYRTEC-D 12 HOUR Extended Release Tablets should be administered when both the antihistaminic properties of cetirizine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired.

ZYRTEC-D 12 HOUR Extended Release Tablets are indicated for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 12 years of age and older.

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NEWS HIGHLIGHTS

Published Studies Related to Zyrtec-D (Cetirizine / Pseudoephedrine)

Montelukast with desloratadine or levocetirizine for the treatment of persistent allergic rhinitis. [2006.11]
BACKGROUND: Montelukast sodium is approved as a treatment for intermittent and persistent allergic rhinitis (AR), but it has not been evaluated as combined therapy with antihistamines for persistent AR. OBJECTIVE: To investigate the effects of 6 weeks of treatment of persistent AR with desloratadine, levocetirizine, or montelukast alone or in combination... CONCLUSIONS: For persistent AR, the combination of montelukast and either desloratadine or levocetirizine is more effective than monotherapy with these agents.

Comparison of cetirizine-pseudoephedrine and placebo in patients with seasonal allergic rhinitis and concomitant mild-to-moderate asthma: randomized, double-blind study. [2006.09]
BACKGROUND: Allergic rhinitis (AR) and asthma are common concurrent conditions. OBJECTIVES: To evaluate the effects of cetirizine hydrochloride (5 mg)-pseudoephedrine hydrochloride (120 mg) (cetirizine-D) twice daily on AR and asthma symptoms, pulmonary function, and asthma-related quality of life in 274 patients with confirmed seasonal AR and concomitant mild-to-moderate asthma... CONCLUSIONS: Treatment with cetirizine-D twice daily significantly reduced rhinitis and asthma symptoms and improved overall asthma quality of life in patients with seasonal AR and concomitant mild-to-moderate asthma.

Severe arrhythmia as a result of the interaction of cetirizine and pilsicainide in a patient with renal insufficiency: first case presentation showing competition for excretion via renal multidrug resistance protein 1 and organic cation transporter 2. [2006.04]
A 72-year-old woman with renal insufficiency who was taking oral pilsicainide (150 mg/d) complained of feeling faint 3 days after she was prescribed oral cetirizine (20 mg/d). She was found to have a wide QRS wave with bradycardia... Although cetirizine has less potential for causing arrhythmias than other histamine 1 blockers, such an interaction should be considered, especially in patients with renal insufficiency who are receiving pilsicainide.

Repeated-dose effects of mequitazine, cetirizine and dexchlorpheniramine on driving and psychomotor performance. [2006.01]
AIMS: Previous studies have demonstrated that the antihistamines mequitazine, cetirizine and dexchlorpheniramine produce mild sedation after single doses. It is unknown, however, whether acute sedation persists after repeated dosing. Therefore, this study assessed the effects of repeated dosing of these antihistamines on driving and psychomotor performance... CONCLUSIONS: Single doses of mequitazine 10 mg and dexchlorpheniramine Repetab 6 mg cause mild driving impairment. However, when taken over several days, the impairing effect wears off, possibly as a result of tolerance.

Evaluation of the cognitive, psychomotor and pharmacokinetic profiles of rupatadine, hydroxyzine and cetirizine, in combination with alcohol, in healthy volunteers. [2006.01]
INTRODUCTION: The Central Nervous System (CNS) impairment induced by moderate alcohol (ALC) ingestion may be enhanced if other drugs are taken simultaneously. Rupatadine (RUP) is a new H(1)-antihistamine which also inhibits platelet activating factor (PAF) release in inflammatory reactions. OBJECTIVE: The main aim of the study was to assess the effects of ALC 0.8 g/Kg on RUP (10 mg and 20 mg) CNS effects. An evaluation of alcohol and RUP pharmacokinetics was also attained... CONCLUSIONS: Present results showed that single oral doses of rupatadine 10 mg in combination with alcohol do not produce more cognitive and psychomotor impairment than alcohol alone. Higher doses of rupatadine, in combination with alcohol, may induce cognitive and psychomotor deterioration as hydroxyzine and cetirizine at therapeutic doses. Copyright (c) 2006 John Wiley & Sons, Ltd.

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Clinical Trials Related to Zyrtec-D (Cetirizine / Pseudoephedrine)

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-D review by 44 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		pollen, dust, mold and tree allergies
Dosage & duration:		1 tab bid taken once to twice daily for the period of 3 years
Other conditions:		obsessive compulsive disorder
Other drugs taken:		prozac, wellbutrin, yasmin
		Reported Results
Benefits:		I notice the benefit of being able to be calmer and not so "on edge". I am not so short tempered and I am able to handle situations that are mentally or emotionally challenging. I also notice the benefit of not being very emotional. My physician and I decided to wean me down to 20 mg. and when this happened, I noticed an immediate effect. I was very short tempered and "on edge". I was also not able to deal with situations that were mentally or emotionally challenging. I also was very tearful. Needless to say, my physician and I knew I needed to go back on the medication again.
Side effects:		A slightly lowered libido, tiredness in the evening. Also notice I am not as tearful when dealing with emotionally challenging issues, which can have it's pros and cons.
Comments:		I have been on Prozac for 12 years. I was titered starting with 20 mg. days, then 40 mg then 60 mg which is my current dose.

Zyrtec-D review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		allergies
Dosage & duration:		1 pill taken every 12 hours for the period of 14 days
Other conditions:		asthma
Other drugs taken:		n/a
		Reported Results
Benefits:		I benefited by being able to breathe better. My nose cleared up, my sinuses didn't hurt as bad, and my chest was looser. I didn't feel confined in my house.
Side effects:		The side effects were sometimes being tired. It really didn't affect my day to much, except that I felt better.
Comments:		I took one pill first thing in the morning. Within a couple hours, I forgot how rotten i was feeling earlier. 12 hours later, i took another pill. I really could have skipped it, but wanted to help my self sleep better. So that night I slept the best I have slept in 2 weeks.