LOTEMAX (Page 2 of 2)

Pregnancy

Teratogenic effects

Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day.

Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period.

Nursing mothers

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when LOTEMAX is administered to a nursing woman.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

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 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2%-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 a summation of 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.

Dosage and Administration

SHAKE VIGOROUSLY BEFORE USING.

Steroid Responsive Disease Treatment: Apply one to two drops of LOTEMAX 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 LOTEMAX 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

LOTEMAX® (loteprednol etabonate ophthalmic suspension) is supplied in a plastic bottle with a controlled drop tip in the following sizes:

5 mL (NDC 54868-4278-1)

15 mL (NDC 54868-4278-0)

DO NOT USE IF NECKBAND IMPRINTED WITH “Protective Seal” AND YELLOW IS NOT INTACT.

Storage

Store upright between 15°–25°C (59°–77°F). DO NOT FREEZE.

KEEP OUT OF REACH OF CHILDREN.

STERILE OPHTHALMIC SUSPENSION

Rx Only

Manufacturer Information

Revised April 2006

Bausch & Lomb Incorporated, Tampa, Florida 33637

U.S. Patent No. 4,996,335

U.S. Patent No. 5,540,930

U.S. Patent No. 5,747,061

©Bausch & Lomb Incorporated

Lotemax is a registered trademark of Bausch & Lomb Incorporated.

9007802 (Folded)
9005902 (Flat)

Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

Principal Display Panel

NDC 54868-4278-0

image of 15 mL package label
(click image for full-size original)

Lotemax®
loteprednol etabonate
ophthmalic suspension 0.5%
Sterile
Rx only
15 mL

LOTEMAX
loteprednol etabonate suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4278(NDC:24208-299)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
GLYCERIN
POVIDONE
WATER
TYLOXAPOL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4278-0 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (54868-4278-0)
2 NDC:54868-4278-1 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
2 5 mL in 1 BOTTLE This package is contained within the CARTON (54868-4278-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020583 10/17/2002
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 04/2010 Physicians Total Care, Inc.

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