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(description)

Initial U.S. Approval: 2010
DESCRIPTION
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

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 

INDICATIONS AND USAGE
LASTACAFT® is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

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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.

Contraindications

None.

Precautions

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

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 and administration 

DOSAGE AND ADMINISTRATION
Instill one drop in each eye once daily.

How supplied

 DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).

Reference

Package Insert data: 

Manufactured for Allergan, Inc., Irvine, CA 92612, U.S.A.
© 2011 Allergan, Inc.
® marks owned by Allergan, Inc.
Made in the U.S.A.

72409US11C

NDC 0023-4290-03
LASTACAFT®
(alcaftadine ophthalmic
solution) 0.25%
3 mL Sterile
ALLERGAN

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

LASTACAFT ® (alcaftadine) solution/ drops