Version May 2024
Ocular inflammatory conditions: Ophthalmic: Instill 1 to 2 drops into affected eye(s) every 3 to 4 hours, or more frequently as required for severe infections Reevaluate patient if improvement not observed after 2 days of therapy.
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 "Neomycin, polymyxin B, and hydrocortisone (ophthalmic): Pediatric drug information")
Ocular inflammation/infection: Limited data available: Children and Adolescents: Ophthalmic: 1 to 2 drops in the affected eye(s) every 3 to 4 hours has been used by some centers; dosing based on experience with other combination ophthalmic products with similar ingredients
There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined: Ophthalmic: Eye irritation
Hypersensitivity to neomycin, polymyxin B, hydrocortisone, or any component of the formulation; viral disease of the cornea and conjunctiva (including epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial ophthalmic infection; fungal diseases of ocular structures
Concerns related to adverse effects:
• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• 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.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
• Neomycin sensitization: Neomycin may cause cutaneous sensitization. Symptoms of neomycin sensitization include itching, reddening, edema, and failure to heal. Discontinuation of product and avoidance of similar products should be considered.
• Ocular effects: Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma; damage to the optic nerve, defects in visual acuity and fields of vision, corneal and scleral thinning (leading to perforation), and posterior subcapsular cataract formation may occur. Use following cataract surgery may delay healing or increase the incidence of bleb formation.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Disease-related concerns:
• Glaucoma: Use with caution in patients with glaucoma.
• Ocular herpes simplex: Use with extreme caution in patients with a history of ocular herpes simplex; frequent slit lamp microscopy is recommended.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Sulfites: Some formulations may contain sulfites, which may cause allergic-type reactions in susceptible individuals.
Other warnings/precautions:
• Appropriate use: Ophthalmic suspension: Never directly introduce (eg, inject) into the anterior chamber. A maximum of 20 mL of suspension should be prescribed initially; re-evaluate patients (eg, intraocular pressure and exams using magnification and fluorescein staining, where appropriate) prior to additional refills. Use >10 days should include routine monitoring of intraocular pressure. Inadvertent contamination of multiple-dose ophthalmic bottle dropper tip has caused bacterial keratitis.
The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to HPA axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Ophthalmic:
Generic: Neomycin sulfate 3.5 mg/mL, polymyxin B 10,000 units/mL, and hydrocortisone 1% (7.5 mL)
Yes
Ophthalmic: Shake well before using. Tilt head back, instill suspension into the conjunctival sac and close eye(s). Apply light finger pressure on lacrimal sac for 1 minute following instillation. To avoid contamination, do not touch dropper to eye.
For ophthalmic use only: Shake well before using. Avoid contamination of the tip of the eye dropper. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref).
Ocular inflammatory conditions: Management of steroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial infection exists.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Adverse events have been observed with topical corticosteroids in animal reproduction studies If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988). Refer to individual agents.
It is not known if systemic absorption following topical administration results in detectable quantities in human milk. The manufacturer recommends that caution be exercised when administering neomycin/polymyxin B/hydrocortisone to nursing women. Refer to individual agents.
Monitor intraocular pressure with use longer than 10 days and in patients with glaucoma
See individual agents.
See individual agents.
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