ZERVIATE (cetirizine hcl)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 0 severe adverse reactions.

There are 4 less severe adverse reactions.

More Frequent	Less Frequent
Ocular pain Ocular redness Reduced visual acuity	None.

Rare/Very Rare
Anticholinergic toxicity

Risk Summary: There were no adequate or well-controlled studies with cetirizine hydrochloride ophthalmic solution (cetirizine 0.24%) in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data: Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose, on a mg/m 2 basis).

Cetirizine has been reported to be excreted in human breast milk following oral administration. Multiple doses of oral cetirizine (10 mg tablets once daily for 10 days) resulted in systemic levels (mean C max= 311 ng/mL) that were 100 times higher than the observed human exposure (mean C max= 3.1 ng/mL) following twice-daily administration of cetirizine ophthalmic solution 0.24% to both eyes for one week.

Comparable bioavailability has been found between the tablet and syrup dosage forms. However, it is not known whether the systemic absorption resulting from topical ocular administration of cetirizine hydrochloride could produce detectable quantities in human breast milk. There is no adequate information regarding the effects of cetirizine on breastfed infants, or the effects on milk production to inform risk of cetirizine hydrochloride to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cetirizine hydrochloride and any potential adverse effects on the breastfed child from cetirizine hydrochloride.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.