Prescription Drug Information: Loteprednol Etabonate (Page 2 of 2)

ADVERSE REACTIONS

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

Ocular adverse reactions occurring in 5% to 15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% to 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied.

Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis.
In controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mmHg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

SHAKE VIGOROUSLY BEFORE USING.

Steroid Responsive Disease Treatment: Apply one to two drops of loteprednol etabonate ophthalmic suspension into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

Post-Operative Inflammation: Apply one to two drops of loteprednol etabonate ophthalmic suspension into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

HOW SUPPLIED

Loteprednol etabonate ophthalmic suspension is supplied in a white opaque LDPE plastic dropper bottle with LDPE white opaque plug and HDPE pilfer-proof pink cap as follows:

5 mL (NDC 62756-232-90)

10 mL (NDC 62756-232-55)

15 mL (NDC 62756-232-56)

Storage: Store upright between 20°C-25°C (68°-77°F). DO NOT FREEZE.

KEEP OUT OF REACH OF CHILDREN.
Rx only

Manufactured by:

Sun Pharmaceutical Medicare Ltd.

Baska Ujeti Road, Ujeti,

Halol-389350, Gujarat, India.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Version Date:

ISS. 08/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-Carton

NDC 62756-232-90
Loteprednol Etabonate Ophthalmic Suspension 0.5%
For Ophthalmic Use Only
Rx only
Sterile
5 mL SUN PHARMA

spl-loteprednol-carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-Label

NDC 62756-232-90
Loteprednol Etabonate Ophthalmic Suspension 0.5%
For Ophthalmic Use Only5 mL

LOTEPREDNOL ETABONATE loteprednol etabonate suspension/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-232 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOTEPREDNOL ETABONATE (LOTEPREDNOL) LOTEPREDNOL ETABONATE 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM GLYCERIN POVIDONE, UNSPECIFIED WATER TYLOXAPOL HYDROCHLORIC ACID SODIUM HYDROXIDE BENZALKONIUM CHLORIDE 0.2 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62756-232-90 1 BOTTLE in 1 CARTON contains a BOTTLE 1 5 mL in 1 BOTTLE This package is contained within the CARTON (62756-232-90) 2 NDC:62756-232-55 1 BOTTLE in 1 CARTON contains a BOTTLE 2 10 mL in 1 BOTTLE This package is contained within the CARTON (62756-232-55) 3 NDC:62756-232-56 1 BOTTLE in 1 CARTON contains a BOTTLE 3 15 mL in 1 BOTTLE This package is contained within the CARTON (62756-232-56)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212450 05/01/2021

Labeler — Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Operations
Sun Pharmaceutical Medicare Limited		725420835	ANALYSIS (62756-232), MANUFACTURE (62756-232)

Revised: 05/2021 Sun Pharmaceutical Industries, Inc.