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Neomycin, polymyxin B, and dexamethasone: Drug information

Neomycin, polymyxin B, and dexamethasone: Drug information
(For additional information see "Neomycin, polymyxin B, and dexamethasone: Patient drug information" and see "Neomycin, polymyxin B, and dexamethasone: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Maxitrol
Brand Names: Canada
  • Dioptrol;
  • Maxitrol
Pharmacologic Category
  • Antibiotic/Corticosteroid, Ophthalmic
Dosing: Adult
Inflammatory ocular conditions

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-inch 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: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Neomycin, polymyxin B, and dexamethasone: Pediatric drug information")

Inflammatory ocular conditions

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment is unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment is unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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

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

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.

Warnings: Additional Pediatric Considerations

Increased IOP may occur especially with prolonged use; in children, increased IOP has been shown to be dose dependent and produce a greater IOP in children <6 years than older children (Lam 2005).

Dosage Forms: US

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]

Generic Equivalent Available: US

Yes

Pricing: US

Ointment (Maxitrol Ophthalmic)

3.5-10000-0.1 (per gram): $77.11

Suspension (Maxitrol Ophthalmic)

0.1% (per mL): $27.13

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.

Administration: Adult

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.

Administration: Pediatric

Ophthalmic: Note: Contact lenses should not be worn during therapy.

Suspension: Shake suspension well before using; instill drop into affected eye; avoid contacting bottle tip with skin or eye; apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation to decrease risk of absorption and systemic effects

Use: Labeled Indications

Inflammatory ocular conditions: Management of corticosteroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial infection exists

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

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.

CYP3A4 Inhibitors (Strong): May increase the serum concentration of DexAMETHasone (Ophthalmic). Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Ophthalmic). Risk C: 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. Risk C: Monitor therapy

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.

Breastfeeding Considerations

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/dexamethasone to breastfeeding women. Refer to individual agents.

Monitoring Parameters

Monitor intraocular pressure with use >10 days and in patients with glaucoma; reevaluate if signs and symptoms persist beyond 2 days.

Mechanism of Action

See individual agents.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Isoptomax;
  • (BD) Bangladesh: Neo DP;
  • (BG) Bulgaria: Trio vision;
  • (BR) Brazil: Dexametasona + sulfato de neomicina + sulfato de polimixina B | Maxinom | Maxiview;
  • (CO) Colombia: Corticol 3 | Cortidron | Maxitrol | Nepoldex | Trimazol;
  • (DE) Germany: Isopto max | Maxitrol | Maxitrol Eurim;
  • (EC) Ecuador: Maxitrol;
  • (EG) Egypt: Dexagrand | Dexaron Plus | Neopolydex;
  • (HR) Croatia: Maxitrol;
  • (KE) Kenya: Dexatrol | Maxitrol;
  • (KR) Korea, Republic of: Maxitrol;
  • (LV) Latvia: Maxitrol;
  • (MX) Mexico: Maxitrol;
  • (PH) Philippines: Dexatrol | Maxidin | Vistacom;
  • (PK) Pakistan: Maxitrol;
  • (PL) Poland: Maxitrol | Primadex;
  • (PR) Puerto Rico: Ak-trol | Dexacidin | Dexasporin | Maxitrol;
  • (PY) Paraguay: Isoptomax;
  • (QA) Qatar: Dexaron Plus | Dexatrol | Maxitrol;
  • (TW) Taiwan: Dexasporin;
  • (UA) Ukraine: Dexapol;
  • (UY) Uruguay: Isoptomax | Polyplex;
  • (VE) Venezuela, Bolivarian Republic of: Maxicort | Neobactrol;
  • (ZM) Zambia: Maxitrol
  1. Lam DS, Fan DS, Ng JS, et al, "Ocular Hypertensive and Anti-Inflammatory Responses to Different Dosages of Topical Dexamethasone in Children: A Randomized Trial," Clin Experiment Ophthalmol, 2005, 33(3):252-8. [PubMed 15932528]
  2. Maxitrol (neomycin, polymyxin B, dexamethasone) ophthalmic suspension [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; May 2021.
  3. Maxitrol (neomycin, polymyxin B, dexamethasone) ophthalmic ointment [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; November 2019.
  4. Maxitrol (neomycin, polymyxin B, dexamethasone) ophthalmic ointment and suspension [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; August 2018.
  5. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-523. [PubMed 2903673]
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