EYE ALLERGY ITCH-REDNESS RLF (olopatadine 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 1 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Hypersensitivity drug reaction

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder	Blurred vision Cold symptoms Conjunctival hyperemia Dry eye Dysgeusia Eyelid edema General weakness Keratitis Nausea Ocular irritation Ocular itching Ocular pain Punctate keratitis Rhinitis Rhinorrhea Sinusitis

Rare/Very Rare
Eyelid crusting Ocular redness Pharyngitis Sore throat Xerostomia

Reproduction studies in rats and rabbits receiving oral olopatadine dosages of 600 or 400 mg/kg daily, respectively (i.e., 93,750 or 62,500 times the maximum recommended human ocular dosage, respectively, based on a drop size of 40 mcL, and approximately 1000 or 1400 times the maximum recommended human dose, respectively, for adults on a mg/m2 basis), have not revealed evidence of teratogenicity. However, a decrease in the number of live fetuses was observed in rabbits and rats receiving oral olopatadine dosages of 25 and 60 mg/kg (approximately 88 and 100 times the maximum recommended human dose, respectively, for adults on a mg/m2 basis) or higher. In rats receiving an oral olopatadine dose of 60 mg/kg (approximately 100 times the maximum recommended human dose for adults on a mg/m2 basis), viability and body weights of pups were reduced on day 4 postpartum; however, no effect on viability was observed at a dose of 20 mg/kg (approximately 35 times the maximum recommended human dose for adults on a mg/m2 basis). There are no adequate and well-controlled studies to date using olopatadine in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the possible risks to the embryo or fetus.

Olopatadine is distributed into milk in rats following oral administration. It is not known whether topical ophthalmic administration of olopatadine could result in sufficient systemic absorption to produce detectable quantities in milk; therefore, olopatadine ophthalmic solutions should be used with caution in nursing women. Olopatadine nasal spray should be used in nursing women only if the potential benefits to the woman outweigh the potential risks to the infant.

No enhanced Geriatric Use information available for this drug.