Clinical Information
Gen. Code and Des.
27370 latanoprost OPHTHALMIC DROPS 0.005 %
GCN and Des.
32749 latanoprost OPHTHALMIC DROPS 0.005 %
Strength
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
52402800 PROSTAGLANDIN ANALOGS
Active Ingredients
6059 latanoprost 130209824
Inactive Ingredients
3141 benzalkonium chloride 8001545
Active Ingredients
Latanoprost
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 F2α 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 to 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2023
