Zylet: Package Insert and Label Information (Page 2 of 2)
In a controlled clinical study of ocular penetration, the levels of loteprednol etabonate in the aqueous humor were found to be comparable between LOTEMAX® and ZYLET treatment groups.
Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times.
The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate ophthalmic suspension 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited (<1 ng/mL) systemic absorption occurs with 0.5% loteprednol etabonate.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate or tobramycin.
Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma TK assay, a chromosome aberration test in human lymphocytes, or in an in vivo mouse micronucleus assay.
Impairment of Fertility
Oral treatment of female and male rats with 25 mg/kg/day of loteprednol etabonate (67 times the RHOD based on body surface area, assuming 100% absorption) prior to and during mating caused preimplantation loss and decreased the number of live fetuses/live births. The NOAEL for fertility in rats was 5 mg/kg/day (13 times the RHOD). Subcutaneous administration of male and female rats with tobramycin did not affect mating behavior or cause impairment of fertility at 100 mg/kg/day (450 times the RHOD based on body surface area, assuming 100% absorption).
16 HOW SUPPLIED/STORAGE AND HANDLING
ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension) 0.5%/0.3% is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes:
NDC 24208-358-05 5 mL fill in a 7.5 mL bottle
NDC 24208-358-10 10 mL fill in a 10 mL bottle
USE ONLY IF IMPRINTED NECKBAND IS INTACT.
Storage: Store upright at 15ºC to 25ºC (59ºF to 77ºF). PROTECT FROM FREEZING. SHAKE VIGOROUSLY BEFORE USING. After opening, ZYLET can be used until the expiration date on the bottle.
17 PATIENT COUNSELING INFORMATION
Risk of Contamination
This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the suspension.
Risk of Secondary Infection
Advise patients to consult a physician if pain develops, redness, itching or inflammation becomes aggravated.
Contact Lens Wear
As with all ophthalmic preparations containing benzalkonium chloride, advise patients not to wear soft contact lenses when using ZYLET.
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
ZYLET and LOTEMAX are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2022 Bausch & Lomb Incorporated or its affiliates
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
BAUSCH + LOMB
( loteprednol etabonate
and tobramycin ophthalmic
|ZYLET loteprednol etabonate and tobramycin suspension/ drops|
|Labeler — Bausch & Lomb Incorporated (196603781)|
|Bausch & Lomb Incoporated||079587625||MANUFACTURE (24208-358)|
Revised: 04/2022 Bausch & Lomb Incorporated
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