Uses
Allergic Rhinitis
Symptomatic relief (alone or in fixed combination with pseudoephedrine hydrochloride) of seasonal (e.g., hay fever) and perennial (nonseasonal) allergic rhinitis; use fixed combination preparation only when both antihistamine and nasal decongestant activity are needed concurrently.
Chronic Idiopathic Urticaria
Symptomatic treatment of chronic idiopathic urticaria.
Dosage and Administration
Administration
Oral Administration
Administer orally without regard to food. May adjust time of administration for individual patient requirements.
Take chewable tablets with or without water.
Swallow tablets containing cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride (Zyrtec®-D 12 Hour) whole; do not break or chew.
Dosage
Available as cetirizine hydrochloride; dosage expressed in terms of the salt.
Pediatric Patients
Allergic Rhinitis
Seasonal
Children 2–5 years of age: 2.5 mg once daily (as oral solution); may increase dosage to a maximum of 5 mg daily, given either as a 5-mg dose once daily (as chewable tablets or oral solution) or, alternatively, as a 2.5-mg dose every 12 hours (as oral solution).
Children ≥6 years of age: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity. In clinical trials, most children ≥12 years of age received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.
Children ≥12 years of age: 5 mg twice daily (every 12 hours) (as fixed combination with 120 mg pseudoephedrine hydrochloride).
Perennial
Oral
Children 6 months to <2 years of age: 2.5 mg once daily (as oral solution). In children 12–23 months of age, may increase dosage to a maximum of 5 mg daily, given as 2.5 mg every 12 hours.
Children 2–5 years of age: 2.5 mg once daily (as oral solution); may increase dosage to a maximum of 5 mg daily, given either as a 5-mg dose once daily (as chewable tablets or oral solution) or, alternatively, as a 2.5-mg dose every 12 hours (as oral solution).
Children ≥6 years of age: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity. In clinical trials, most children ≥12 years of age received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.
Children ≥12 years of age: 5 mg twice daily (every 12 hours) (as fixed combination with 120 mg pseudoephedrine hydrochloride).
Chronic Idiopathic Urticaria
Oral
Children 6 months to <2 years of age: 2.5 mg once daily (as oral solution). In children 12–23 months of age, may increase dosage to a maximum of 5 mg daily, given as 2.5 mg every 12 hours.
Children 2–5 years of age: 2.5 mg once daily (as oral solution); may increase dosage to a maximum of 5 mg daily, given either as a 5-mg dose once daily (as chewable tablets or oral solution) or, alternatively, as a 2.5-mg dose every 12 hours (as oral solution).
Children ≥6 years of age: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity. In clinical trials, most children ≥12 years of age received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.
Adults
Allergic Rhinitis
Oral
5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity. In clinical trials, most patients received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.
5 mg twice daily (every 12 hours) (as fixed combination with 120 mg pseudoephedrine hydrochloride).
Chronic Idiopathic Urticaria
Oral
5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity. In clinical trials, most patients received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.
Prescribing Limits
Pediatric Patients
Allergic Rhinitis
Oral
Children 12 months to 5 years of age: Maximum 5 mg daily.
Children ≥12 years of age: In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.
Fixed-combination cetirizine hydrochloride/pseudoephedrine hydrochloride not recommended for children <12 years of age; contains 120 mg pseudoephedrine hydrochloride, which exceeds recommended single dose in such patients.
Chronic Idiopathic Urticaria
Oral
Children 12 months to 5 years of age: Maximum 5 mg daily.
Children ≥12 years of age: In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.
Adults
Allergic Rhinitis
Oral
In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.
Chronic Idiopathic Urticaria
Oral
In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.
Special Populations
Dosage in Hepatic Impairment
Children <6 years of age: use not recommended.
Adults and children ≥6 years of age: 5 mg once daily (as chewable or conventional tablets or oral solution).
Adults and children ≥12 years of age: 5 mg once daily (in fixed combination with 120 mg pseudoephedrine hydrochloride).
Dosage in Renal Impairment
Children <6 years of age: use not recommended.
Adults and children ≥6 years of age: 5 mg once daily (as chewable or conventional tablets or oral solution) in patients with impaired renal function (e.g., Clcr of 11–31 mL/minute) or those on hemodialysis (e.g., Clcr <7 mL/minute).
Adults and children ≥12 years of age: 5 mg once daily (in fixed combination with 120 mg pseudoephedrine hydrochloride) in patients with impaired renal function (e.g., Clcr of 11–31 mL/minute) or those on hemodialysis (e.g., Clcr <7 mL/minute).
Geriatric Patients
Patients ≥77 years of age: 5 mg once daily (as chewable or conventional tablets or oral solution) recommended.
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