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LATANOPROST Ophthalmic Solution (GREENSTONE LLC) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use latanoprost ophthalmic solution safely and effectively. See full prescribing information for latanoprost ophthalmic solution.

Latanoprost ophthalmic solution 0.005%, for topical ophthalmic use
Initial U.S. Approval: 1996

INDICATIONS AND USAGE

Latanoprost ophthalmic solution is a prostaglandin F analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)

DOSAGE AND ADMINISTRATION

One drop in the affected eye(s) once daily in the evening. (2)

DOSAGE FORMS AND STRENGTHS

Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%). (3)

CONTRAINDICATIONS

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. (4)

WARNINGS AND PRECAUTIONS

  • Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. (5.1)
  • Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. (5.2)

ADVERSE REACTIONS

Most common adverse reactions (5–15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate keratitis. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2020

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