Dosage Forms
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)
Pharmacology
Mechanism of Action
See individual agents.
Use: Labeled Indications
Ocular inflammatory conditions: Management of steroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial infection exists
Contraindications
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
Dosage and Administration
Dosing: Adult
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. Monitor IOP if therapy exceeds 10 days
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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
Administration
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.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Drug Interactions
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. Monitor therapy
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
Frequency not defined.
Ophthalmic: Eye irritation
Warnings/Precautions
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.
Monitoring Parameters
Monitor intraocular pressure with use longer than 10 days and in patients with glaucoma
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
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.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
