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Lastacaft (Alcaftadine) - Warnings and Precautions

 
 



WARNINGS AND 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™ should not be used to treat contact lens-related irritation.

LASTACAFT™ should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of LASTACAFT™. The preservative in LASTACAFT™, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT™.

Topical Ophthalmic Use Only

LASTACAFT™ is for topical ophthalmic use only.

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™ 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.

Page last updated: 2010-08-06

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