Generic Zyrtec Information


Zyrtec Information
Generic Names: Cetirizine HCl
Seasonal Allergic Rhinitis:
Zyrtec (cetirizine) 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 (cetirizine) 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 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria:
Zyrtec (cetirizine) is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 2 years of age and older. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

How Does Zyrtec Work?
Cetirizine, the active ingredient of Zyrtec, and a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 receptors. The antihistaminic activity of Zyrtec (cetirizine) has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H1 receptors.

How To Take Zyrtec and Zyrtec Dosage and Administration
Adults and Children 12 Years and Older:
The recommended initial dose of Zyrtec (cetirizine) is 5 or 10 mg per day in adults and children 12 years and older, depending on symptom severity. Most patients in clinical trials started at 10 mg. Zyrtec (cetirizine) is given as a single daily dose, with or without food. The time of administration may be varied to suit individual patient needs.

Children 6 to 11 Years:
The recommended initial dose of Zyrtec (cetirizine) in children aged 6 to 11 years is 5 or 10 mg (1 or 2 teaspoons) once daily depending on symptom severity. The time of administration may be varied to suit individual patient needs.

Children 2 to 5 Years:
The recommended initial dose of Zyrtec (cetirizine) syrup in children aged 2 to 5 years is 2.5 mg (½ teaspoon) once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoon (5 mg) once daily, or as ½ teaspoon (2.5 mg) given every 12 hours, depending on symptom severity and patient response.

Dose Adjustment for Renal and Hepatic Impairment:
In patients 12 years of age and older with decreased renal function (creatinine clearance 11-31 ml/min), patients on hemodialysis (creatinine clearance less than 7 ml/min), and in hepatically impaired patients, a dose of 5 mg once daily is recommended. Similarly, pediatric patients aged 6 to 11 years with impaired renal or hepatic function should use the lower recommended dose. Because of the difficulty in reliably administering doses of less than 2.5 mg (½ teaspoon) of Zyrtec (cetirizine) syrup and in the absence of pharmacokinetic and safety information for Zyrtec (cetirizine) in children below the age of 6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended.

If you suspect a Zyrtec Overdose
Zyrtec overdose has been reported. In one adult patient who took 150 mg of cetirizine, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18-month-old pediatric patient who took an overdose of Zyrtec () (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine. Zyrtec (cetirizine) is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 55 times the maximum recommended daily oral dose in children on a mg/m2 basis) and 562 mg/kg in rats (approximately 460 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 270 times the maximum recommended daily oral dose in children on a mg/m2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.

Zyrtec Side Effects
Controlled and uncontrolled clinical trials aimed at Zyrtec side effects, conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving cetirizine at doses of 5 to 20 mg per day. The duration of treatment ranged from 1 week to 6 months, with a mean exposure of 30 days.

Most side effects reported during therapy with Zyrtec (cetirizine) were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving cetirizine 5 or 10 mg was not significantly different from placebo (2.9% vs. 2.4%, respectively).

The most common side effect in patients aged 12 years and older that occurred more frequently on cetirizine than placebo was somnolence. The incidence of somnolence associated with Zyrtec (cetirizine) was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for cetirizine were uncommon (1.0% on cetirizine vs. 0.6% on placebo). Fatigue and dry mouth also appeared to be Zyrtec side effects. There were no differences by age, race, gender or by body weight with regard to the incidence of adverse reactions.

Zyrtec side effects are as follows:

somnolence
fatigue
dry mouth
pharyingits
dizziness

Zyrtec Precautions and Contraindications
Activities Requiring Mental Alertness:
In clinical trials, the occurrence of somnolence has been reported in some patients taking Zyrtec (cetirizine); due caution should therefore be exercised when driving a car or operating potentially dangerous machinery.

Zyrtec and Alcohol Interaction
Concurrent use of Zyrtec with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Storing Zyrtec
Store at room temperature 59-86°F (15-30°C).


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