Adult Dosing

Steroid-responsive inflammatory ocular conditions; inflammatory conditions of the palpebral and bulbar conjunctiva; chronic anterior uveitis and corneal injury; risk of superficial ocular infection

• Instill 1-2 gtt into the conjunctival sac of the affected eye(s) q4-6 hrs; during the first 24-48 hrs, the dose may be titrated to q1-2 hrs

Note:

• Gradually taper the dose after clinical improvement has been achieved; do not discontinue therapy prematurely

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists
• Inflammatory conditions of palpebral and bulbar conjunctiva, cornea, anterior segment of the globe, and where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation
• Indicated in chronic anterior uveitis and corneal injury from chemical, radiation, thermal burns, or penetration of foreign bodies
• Used in combination with an anti-infective component when there is an increased risk of superficial ocular infection or when there is an expectation that potentially dangerous numbers of bacteria will be present in the eye

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to other corticosteroids
• Viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella infections
• Mycobacterial infections of the eye
• Fungal diseases of ocular structures

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• For topical ophthalmic use only; not for injection into the eye
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation; monitor IOP regularly if this product is used for 10 days or longer
• Long-term use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Re-evaluate the patient if signs/symptoms fail to improve after 2 days
• Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations may occur with topical steroid use
• The initial prescription and its renewal should be made by physicians only following slit-lamp biomicroscopy and fluorescein staining, if indicated
• Ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye
• Fungal infections of the cornea may develop coincidentally with prolonged use of topical steroids. Consider fungus invasion in any persistent corneal ulceration where a steroid has been used or is in use
• Therapy may cause cross-sensitivity to other aminoglycoside antibiotics; discontinue use if hypersensitivity develops with this product and begin appropriate therapy. When this drug is used in combination with other systemic aminoglycoside antibiotics, monitor the patients for total serum concentration
• Long-term use may result in overgrowth of nonsusceptible organisms, including fungi; initiate appropriate therapy if superinfection occurs

Caution: Use cautiously in

• Glaucoma
• Prolonged use
• Patients with a history of herpes simplex virus

Supplemental Patient Information

• Advise patients to promptly report their physician if they experience any pain and if the redness, itching or inflammation gets aggravated
• Advise patients who use soft contact lenses to wait at least 10 min after instilling eye drops before inserting lenses
• Advise patients to avoid touching the dropper tip to any surface including the eye, as this may contaminate the suspension

Pregnancy Category:C

Breastfeeding: Safety unknown. Minimal systemic absorption; maternal use of ophthalmic tobramycin is unlikely to affect the breastfed infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 July 2011). Manufacturer advises caution while administering to a nursing woman.

• CNS: Headache
• EENT: Eyelid pruritus, eyelid edema, elevated IOP, posterior subcapsular cataract formation (prolonged use), defect in visual acuity, blurred vision, infection exacerbation, secondary ocular infection, fungal infections, glaucoma (prolonged use), delayed ocular wound healing, infrequent optic nerve damage, eye pain, lid itching and swelling, conjunctival erythema, superficial punctate keratitis, ocular burning and stinging, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, globe perforation, ocular discharge, ocular pruritus
• LOCAL: Localized ocular toxicity
• HYPERSENSITIVITY: Hypersensitivity reactions, photophobia

Loteprednol

• Corticosteroid; exact mechanism of action unknown; probably acts by the induction of phospholipase A2 inhibitory proteins (lipocortins). These proteins inhibit release of their common precursor, arachidonic acid, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes
• Metabolism: Extensively hydrolyzed
• Excretion: Unknown
• Half-life: Unknown

Tobramycin

• Aminoglycoside; binds to bacterial 30S ribosomal subunit, thereby inhibiting bacterial protein synthesis
• Minimal systemic absorption/metabolism
• Excretion: Urine
• Half-life: Unknown

US Trade Name(s)

• Zylet

US Availability

Zylet (loteprednol/tobramycin)

• OPTH SUSP: 0.5%/0.3%

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Ophthalmic Steroids With Anti-infectives

Infectious Disease

Ophthalmic Steroids With Anti-infectives

Ophthalmic

Ophthalmic Steroids With Anti-infectives

Pricing data from www.DrugStore.com in U.S.A.

• Zylet 0.5-0.3 % SUSP [Bottle] (BAUSCH & LOMB)
  10 % = $238.35
  30 % = $696.16
• Zylet 0.5-0.3 % SUSP [Bottle] (BAUSCH & LOMB)
  5 % = $136.48
  15 % = $384.25

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.