Rx Item-Lastacaft 0.25% Drops 3Ml By Allergan Pharma

LASTACAFT- alcaftadine solution/ drops
Allergan, Inc.

1 INDICATIONS AND USAGE

LASTACAFT� is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

2 DOSAGE AND ADMINISTRATION

Instill one drop in each eye once daily. If more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

3 DOSAGE FORMS AND STRENGTHS

Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).

4 CONTRAINDICATIONS



?LASTACAFT� is contraindicated in patients with hypersensitivity to any component in the product.

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Eye Injury and Contamination
To minimize eye injury and contamination of 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.

5.2 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�.

6 ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

6.1 Clinical Studies Experience
The most frequent ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT� , were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus.

6.2 Non-ocular Adverse Reactions
The most frequent non-ocular adverse reactions, occurring in less than 3% of subjects with eyes treated with LASTACAFT� , were nasopharyngitis and headache. Some of these events were similar to the underlying disease being studied.

6.3 Postmarketing Experience
The following adverse reactions have been identified during postmarketing use of LASTACAFT� in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions include eye discharge, eye swelling, erythema of eyelid, eyelid edema, lacrimation increased, vision blurred, hypersensitivity reactions including swelling of the face or allergic dermatitis, and somnolence.

RX ITEM-Lastacaft 0.25% Drops 3Ml By All
NDC 00023-4290-03 UPC/GTIN No.3-00234-29003-2 Mfg.Part No.429003

Lastacaft 0.25% Drops 3Ml By Allergan Ph
BRAND: LASTACAFT NDC: 00023-4290-03,23429003 UPC: 3-00234-29003-2,300234290032 Allergan USA, Inc.

ALCAFTADINE OPHTHALMIC DR
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