They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2. Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent.
The anti-infective component in the combination tobramycin is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H.
The results were obtained following the ocular administration of one drop in each eye of 0. 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. ZYLET loteprednol etabonate and tobramycin ophthalmic suspension 0.
This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the suspension. Advise patients to consult a physician if pain develops, redness, itching or inflammation becomes aggravated.
As with all ophthalmic preparations containing benzalkonium chloride, advise patients not to wear soft contact lenses when using ZYLET. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Approval: If this product is used for 10 days or longer, IOP should be monitored.
The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of a magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. In acute purulent conditions, steroids may mask infection or enhance existing infection. The particular anti-infective drug in this product tobramycin is active against the following common bacterial eye pathogens: Staphylococci, including S.
If this product is used for 10 days or longer, intraocular pressure should be monitored. Loteprednol etabonate ophthalmic suspension 0. Tobramycin ophthalmic solution 0. Secondary Infection The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.
Commercial Relationships S. Rhee, None; F. Mah, Alcon Labs, Inc. Alerts User Alerts. You will receive an email whenever this article is corrected, updated, or cited in the literature. You can manage this and all other alerts in My Account. This feature is available to authenticated users only. Get Citation Citation. Get Permissions. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication?
What other information should I know? Brand names Brand names of combination products. To instill the eye drops, follow these steps: Wash your hands thoroughly with soap and water. Check the dropper tip to make sure that it is not chipped or cracked. Avoid touching the dropper tip against your eye or anything else; eye drops and droppers must be kept clean. While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
Hold the dropper tip down with the other hand, as close to the eye as possible without touching it. Brace the remaining fingers of that hand against your face. While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids. Place a finger on the tear duct and apply gentle pressure.
Wipe any excess liquid from your face with a tissue. If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop. Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip. Wash your hands to remove any medication.
To use the eye ointment, follow these instructions: Wash your hands thoroughly with soap and water. Use a mirror or have someone else apply the ointment. Avoid touching the tip of the tube against your eye or anything else. The ointment must be kept clean.
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