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Neomycin, Polymyxin B, and Dexamethasone

Pronunciation

(nee oh MYE sin, pol i MIKS in bee, & deks a METH a sone)

Index Terms

  • Dexamethasone, Neomycin, and Polymyxin B
  • Neo/Polymyx B Sulf/Dexameth
  • Neomycin/Polymyxin/Dexameth
  • Polymyxin B, Neomycin, and Dexamethasone

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]

Brand Names: U.S.

  • Maxitrol

Pharmacologic Category

  • Antibiotic/Corticosteroid, Ophthalmic

Pharmacology

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.

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: Children ≥2 years and Adolescents: Ophthalmic: Suspension: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to insignificant systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to insignificant systemic absorption.

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.

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.

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

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

NSAID (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

Adverse Reactions

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

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. 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 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 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 punctual 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.

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