Version May 2024
Ocular inflammatory conditions: Ophthalmic: Instill 1 to 2 drops into the affected eye(s) every 4 to 6 hours; may increase frequency during the first 24 to 48 hours to every 1 to 2 hours. Frequency should decrease as signs and symptoms improve. Further evaluation should occur for use of greater than 20 mL.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Loteprednol and tobramycin: Pediatric drug information")
Ocular inflammatory conditions: Note: Initial prescription should be ≤20 mL; further evaluation is necessary if use exceeds 20 mL.
Infants, Children, and Adolescents: Ophthalmic: Instill 1 to 2 drops into the affected eye(s) every 4 to 6 hours. May increase frequency during the first 24 to 48 hours to every 1 to 2 hours. Frequency should be gradually decreased as signs and symptoms improve.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
>10%: Nervous system: Headache (~14%)
1% to 10%: Ophthalmic: Burning sensation of eyes (≤9%), corneal deposits (<4%), disease of the lacrimal apparatus (<4%), eye discharge (<4%), eye discomfort (<4%), eye pruritus (<4%), eyelid disease (<4%), increased intraocular pressure (10%), photophobia (<4%), stinging of eyes (≤9%), visual disturbance (<4%)
Postmarketing: Ophthalmic: Corneal erosion (Mah 2021), dry eye syndrome (Mah 2021), eye irritation (Mah 2021), eye pain (Mah 2021)
Viral disease of the cornea and conjunctiva (including epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial infection of the eye; fungal disease of ocular structures.
Concerns related to adverse effects:
• Immunosuppression: Prolonged use of corticosteroids (including ophthalmic preparations) may increase the incidence of secondary ocular infections (including fungal infections). Acute purulent ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
• Ocular effects: Prolonged use may result in glaucoma, injury to the optic nerve, visual defects in acuity and field of vision, and formation of posterior subcapsular cataracts. Use with caution in presence of glaucoma (steroids increase intraocular pressure). Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation. Intraocular pressure should be monitored if this product is used >10 days.
• Sensitivity reactions: Sensitivity to tobramycin may develop; discontinue if sensitivity reaction occurs. Cross-sensitivity to other aminoglycoside antibiotics may occur.
Disease-related concerns:
• Ocular herpes simplex: Corticosteroids should not be used to treat ocular herpes simplex; use extreme caution in patients with a history of ocular herpes simplex.
Special populations:
• Contact lens wearers: Some preparations contain benzalkonium chloride which may be absorbed by contact lenses; contact lenses should not be worn during treatment.
Other warnings/precautions:
• Appropriate use: For ophthalmic use only; patients should be reevaluated if symptoms do not improve after 2 days. Initial prescription and renewal of medication should be made by health care provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). Avoid contamination; do not touch tip of applicator or let tip of applicator touch eye.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, ophthalmic [drops]:
Zylet: Loteprednol etabonate 0.5% and tobramycin 0.3% (2.5 mL, 5 mL, 10 mL) [contains benzalkonium chloride]
No
Suspension (Zylet Ophthalmic)
0.5-0.3% (per mL): $79.46
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Contact lenses should not be worn during therapy. Shake well before using; tilt head back, instill suspension in conjunctival sac and close eye(s). Do not touch dropper to eye. Apply light finger pressure on lacrimal sac for 1 minute following instillation.
Ophthalmic: Shake well prior to use. Tilt head back, instill suspension in conjunctival sac and close eye(s). To avoid contamination, do not touch dropper to eye, eyelids, or other surfaces. Solution contains benzalkonium chloride; contact lenses should not be worn during therapy.
Ocular inflammatory conditions: Treatment of steroid-responsive ocular inflammatory conditions (where either a superficial bacterial ocular infection or the risk of a superficial bacterial ocular infection exists) of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation); chronic anterior uveitis; corneal injury from chemical, radiation or thermal burns; penetration of foreign bodies.
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted with ophthalmic use of this combination. Refer to individual monographs for additional information.
It is unknown if topical use results in sufficient absorption to produce detectable quantities in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Refer to individual monographs for additional information.
Reevaluate if signs and symptoms persist beyond 2 days; measure intraocular pressure if used for >10 days; culture for fungus with long-term use. Reexamine with use of >20 mL; exams for use >14 days should include magnification and (when appropriate) fluorescein staining
Corticosteroids inhibit the inflammatory response including edema, capillary dilation, leukocyte migration, and scar formation. Loteprednol is highly lipid soluble and penetrates cells readily to induce the production of lipocortins. These proteins modulate the activity of prostaglandins and leukotrienes. Tobramycin interferes with bacterial protein synthesis by binding to 30S ribosomal subunit resulting in a defective bacterial cell membrane.
See individual agents.
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