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| Initial U.S. Approval: 2010
LASTACAFT® is a sterile, topically administered H1 receptor antagonist containing alcaftadine for ophthalmic use.
Contains: Active: alcaftadine 0.25% (2.5 mg/mL). Preservative: benzalkonium chloride 0.005%. Inactives: edetate disodium; sodium phosphate, monobasic; purified water; sodium chloride; sodium hydroxide and/or hydrochloric acid to adjust pH.
The drug product has a pH of approximately 7 and an osmolality of approximately 290 mOsm/kg.
| CLINICAL PHARMACOLOGY
Mechanism of Action
Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
| INDICATIONS AND USAGE
LASTACAFT® is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
Contact Lens Use
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
| WARNINGS AND PRECAUTIONS
To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.
LASTACAFT® should not be used to treat contact lens-related irritation.
Remove contact lenses prior to instillation of LASTACAFT®.
| ADVERSE REACTIONS
The most common ocular adverse reactions, occurring in < 4% of LASTACAFT® treated eyes, were eye irritation, burning and/or stinging on instillation, eye redness, and eye pruritus.
The most common non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT® treated eyes, were nasopharyngitis, headache and influenza.
| DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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