Zyrtec (Cetirizine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

ZYRTEC can be taken without regard to food consumption. ZYRTEC is available as 5 mg and 10 mg tablets, 1 mg/mL syrup, and 5 mg and 10 mg chewable tablets which can be taken with or without water.

Adults and Children 12 Years and Older

The recommended initial dose of ZYRTEC is 5 mg 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 is given as a single daily dose. The time of administration may be varied to suit individual patient needs.

Children 6 to 11 Years

The recommended initial dose of ZYRTEC in children aged 6 to 11 years is 5 mg or 10 mg 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 in children aged 2 to 5 years is 2.5 mg (½ teaspoon) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoon syrup once a day or one ½ teaspoon syrup given every 12 hours, or one 5 mg chewable tablet once a day.

Children 6 months to <2 years

The recommended dose of ZYRTEC syrup in children 6 months to 23 months of age is 2.5 mg (½ teaspoon) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoon (2.5 mg) every 12 hours. Syrup is recommended for children under the age of 2 years.

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 syrup and in the absence of pharmacokinetic and safety information for 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.

Dose Adjustment for Geriatric Patients

In patients 77 years of age and older, a dose of 5 mg once daily is recommended.

HOW SUPPLIED

ZYRTEC tablets are white, film-coated, rounded-off rectangular shaped containing 5 mg or 10 mg cetirizine hydrochloride.

     5 mg tablets are engraved with "ZYRTEC" on one side and "5" on the other.
     Bottles of 100: NDC 0069-0732-66

     10 mg tablets are engraved with "ZYRTEC" on one side and "10" on the other.
     Bottles of 100: NDC 0069-0731-66

STORAGE: Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

ZYRTEC chewable tablets are purple round tablets containing 5 mg or 10 mg cetirizine hydrochloride. The tablets are packaged in blister cards as follows:

     5 mg tablets are engraved with "ZYRTEC C5" on one side.
     Boxes of 3 (Blister Cards of 10) NDC 0069-1440-03

     10 mg tablets are engraved with "ZYRTEC C10" on one side.
     Boxes of 3 (Blister Cards of 10) NDC 0069-1450-03

STORAGE: Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

ZYRTEC syrup is colorless to slightly yellow with a banana-grape flavor. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride. ZYRTEC syrup is supplied as follows:

     120 mL amber glass bottles      NDC 0069-5530-47
     480 mL amber glass bottles      NDC 0069-5530-93

STORAGE: Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2–8°C (36–46°F).

Cetirizine is licensed from UCB, Inc.

Rx only

Marketed by

UCB, Inc.
Smyrna, GA 30080

LAB-0037-7.0

May 2006