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Lastacaft

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Lastacaft

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Contamination of Tip and Solution

To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

Contact Lens Use

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT™ (alcaftadine ophthalmic solution) should not be used to treat contact lens-related irritation.

LASTACAFT™ (alcaftadine ophthalmic solution) should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of LASTACAFT™ (alcaftadine ophthalmic solution) . The preservative in LASTACAFT™ (alcaftadine ophthalmic solution) , benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after i0 minutes following administration of LASTACAFT™ (alcaftadine ophthalmic solution) .

Topical Ophthalmic Use Only

LASTACAFT™ (alcaftadine ophthalmic solution) is for topical ophthalmic use only.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Alcaftadine was not mutagenic or genotoxic in the Ames test, the mouse lymphoma assay or the mouse micronucleus assay.

Alcaftadine was found to have no effect on fertility of male and female rats at oral doses up to 20 mg/kg/day (approximately 200 times the plasma exposure at the recommended human ocular dose).

Use In Specific Populations

Pregnancy

Pregnancy Category B. Reproduction studies performed in rats and rabbits revealed no evidence of impaired female reproduction or harm to the fetus due to alcaftadine. Oral doses in rats and rabbits of 20 and 80 mg/kg/day, respectively, produced plasma exposure levels approximately 200 and 9000 times the plasma exposure at the recommended human ocular dose. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LASTACAFT™ (alcaftadine ophthalmic solution) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger subjects.

Last reviewed on RxList: 8/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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