Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, ophthalmic: Neomycin 3.5 mg, polymyxin B sulfate 10,000 units, and dexamethasone 0.1% per g (3.5 g)
Maxitrol: Neomycin 3.5 mg, polymyxin B sulfate 10,000 units, and dexamethasone 0.1% per g (3.5 g)
Suspension, ophthalmic [drops]: Neomycin 3.5 mg, polymyxin B sulfate 10,000 units, and dexamethasone 0.1% per 1 mL (5 mL)
Maxitrol: Neomycin 3.5 mg, polymyxin B sulfate 10,000 units, and dexamethasone 0.1% per 1 mL (5 mL) [contains benzalkonium chloride]
Pharmacology
Mechanism of Action
See individual agents.
Use: Labeled Indications
Inflammatory ocular conditions: Management of corticosteroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial infection exists
Contraindications
Hypersensitivity to neomycin, polymyxin B, dexamethasone, 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
Canadian labeling: Additional contraindications (not in US labeling): Untreated parasitic ophthalmic infection
Dosage and Administration
Dosing: Adult
Inflammatory ocular conditions: Ophthalmic:
Suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 to 6 times daily. In severe disease, drops may be used hourly; frequency should decrease as signs and symptoms improve.
Ointment: Place ~1/2” ribbon in the conjunctival sac of the affected eye(s) 3 to 4 times daily
Note: If signs and symptoms do not improve after 2 days of treatment, the patient should be reevaluated.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Inflammatory ocular conditions: Ophthalmic: Suspension: Children ≥2 years and Adolescents: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 to 6 times daily; in severe disease, drops may be used hourly and tapered to discontinuation
Administration
Ophthalmic: Note: Contact lenses should not be worn during therapy.
Ointment: Apply into pocket between eyeball and lower lid; patient should look downward before closing eye. To avoid contamination, do not touch tip of tube to eye or any other surface.
Suspension: 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 or any other surface.
Storage
Ointment: Store between 2°C to 25°C (36°F to 77°F).
Suspension: Store between 8°C to 27°C (46°F to 80°F).
Drug Interactions
CYP3A4 Inhibitors (Strong): May increase the serum concentration of DexAMETHasone (Ophthalmic). Monitor therapy
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
Also see individual agents.
Frequency not defined:
Hypersensitivity: Hypersensitivity reaction
Infection: Secondary infection
Ophthalmic: Glaucoma, increased intraocular pressure, optic nerve damage (infrequent), subcapsular posterior cataract
Miscellaneous: Wound healing impairment
<1%, postmarketing, and/or case reports: Headache, keratitis (ulcerative), Stevens-Johnson syndrome
Warnings/Precautions
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.
- Neomycin sensitization: Neomycin may cause cutaneous sensitization. Discontinue use if hypersensitivity occurs. Cross-sensitivity to other topical or systemic aminoglycosides may occur.
- Ocular effects: Prolonged use of corticosteroids may result in 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.
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.
Dosage-forms specific issues:
- Ophthalmic suspension: May contain benzalkonium chloride, which may be absorbed by soft contact lenses; contact lenses should not be worn during treatment of ophthalmologic infections.
Other warnings/precautions:
- Appropriate use: Never directly introduce (eg, inject) into the anterior chamber. A maximum of 8 g of ointment or 20 mL of suspension should be prescribed initially; reevaluate 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 and tips has caused bacterial keratitis.
Monitoring Parameters
Monitor intraocular pressure with use >10 days and in patients with glaucoma; reevaluate if signs and symptoms persist beyond 2 days.
Pregnancy
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
What is this drug used for?
- It is used to treat or prevent eye infections.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
