Source: FDA, National Drug Code (US) Revision Year: 2022
ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension) is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.
Loteprednol etabonate:
Chemical name:
chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate
Tobramycin:
Chemical name:
O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)O[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxystreptamine
Each mL contains:
Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5 to 6.2. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg.
| Dosage Forms and Strengths |
|---|
|
Ophthalmic suspension containing 5 mg/mL (0.5%) loteprednol etabonate and 3 mg/mL (0.3%) tobramycin. |
| How Supplied |
|---|
|
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. Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637 USA |
| Drug | Countries | |
|---|---|---|
| ZYLET | Brazil, Israel, Singapore, Turkey, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
