Maxitrol

Ophthalmological Corticosteroid and Anti-infective Combinations

Ophthalmic Suspension:
Neomycin; polymyxin B; dexamethasone suspension is indicated for topical administration to the eye; do NOT administer parenterally.
Instruct patient on proper instillation of eye solution and suspension.
Wash hands before and after use.
Do not touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
Shake suspension well prior to each use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1 to 2 minutes following application to the eye.
To avoid contamination or the spread of infection, do not use dropper for more than one person.
 
Ophthalmic Ointment:
Instruct patient on proper application of eye ointment.
Do not touch the tip of the tube to the eye, fingertips, or other surface to prevent contamination.
Wash hands before and after use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Place a small amount (about one-half of an inch) of the ointment into the pouch. Look downward before closing eyes.
To avoid contamination or the spread of infection, do not use tube for more than one person.

ocular hypertension / Delayed / 0-1.0
keratitis / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

cataracts / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known
conjunctival hyperemia / Early / Incidence not known
impaired wound healing / Delayed / Incidence not known
superinfection / Delayed / Incidence not known
ocular infection / Delayed / Incidence not known
bullous rash / Early / Incidence not known
erythema / Early / Incidence not known
Cushing's syndrome / Delayed / Incidence not known

ocular pruritus / Rapid / Incidence not known
ocular irritation / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
urticaria / Rapid / Incidence not known
rash / Early / Incidence not known
headache / Early / Incidence not known

AK-Trol, Dexacidin, Dexasporin, Gatol, Maxitrol, Methadex, NeoPolyDex, Ocu-Trol, Poly-Dex

Rx

Ophthalmic suspension or ointment for inflammatory and antibacterial combination
Used for inflammatory conditions of the eyes where there is high risk of infection or where infection coexists

1 to 2 drops in the affected eye(s) every 4 to 6 hours for mild disease and every hour for severe disease. Reduce dose gradually as warranted by clinical improvement.

1 to 2 drops in the affected eye(s) every 4 to 6 hours for mild disease and every hour for severe disease. Reduce dose gradually as warranted by clinical improvement.

0.5 inch ribbon in the affected eye(s) up to 3 to 4 times daily.

0.5 inch ribbon in each eye 4 times daily, initially. Reduce dose to 0.5 inch ribbon in each eye twice daily after 1 to 2 weeks if positive response in signs and/or symptoms and start cyclosporine, then taper or discontinue steroid therapy after 2 to 4 weeks. Consider extending duration to 4 weeks if no response at 2 weeks, especially in patients with moderate to severe disease.

†Indicates off-label use

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Neomycin; Polymyxin B; Dexamethasone products.

AK-Trol/Dexacidin/Dexamethasone, Neomycin, Polymyxin B/Dexasporin/Gatol/Maxitrol/Methadex/NeoPolyDex/Ocu-Trol/Poly-Dex Ophthalmic Susp: 1mL, 0.1-3.5-10000U
AK-Trol/Dexamethasone, Neomycin, Polymyxin B/Maxitrol/NeoPolyDex/Ocu-Trol/Poly-Dex Ophthalmic Ointment: 1g, 0.1-3.5-10000U

48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).

48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).

48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).

2 years and older: 48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
less than 2 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Neomycin; polymyxin B; dexamethasone is indicated for the treatment of inflammatory ocular conditions where a risk of superficial bacterial infection exists. Clinicians may wish to consult the individual monographs for more information about each component.
Neomycin: Neomycin is bacteriocidal. It is actively transported into the bacterial cell where it binds to receptors present on the 30S ribosomal subunit of susceptible bacteria. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial mRNA. Eventually, susceptible bacteria die because of the lack of functional proteins.
Polymyxin B: Polymyxin B binds to gram-negative bacterial cell membrane phospholipids. This binding destroys bacterial membranes with a surface detergent-like mechanism and increases the permeability of the cell membrane, which results in loss of metabolites essential to bacterial existence. Polymyxin B is bactericidal against most gram-negative bacilli. Polymyxin B has no in vitro activity against gram-positive organisms.
Dexamethasone: Dexamethasone is a corticosteroid with anti-inflammatory action. Corticosteroids are naturally occurring hormones that bind to specific protein receptors on targeted tissues. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. The anti-inflammatory action of dexamethasone results from the inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. The end result of treatment with dexamethasone includes reduction in edema or scar tissue as well as a general suppression of the immune response.

Neomycin; polymyxin B; dexamethasone is administered topically to the eyes. No pharmacokinetic information is available from the manufacturers of the combination ophthalmic products. See individual drug monographs for additional information.

No adequate studies in pregnant women are available with neomycin; polymyxin B; dexamethasone. In animal studies, ophthalmic administration of corticosteroids, such as dexamethasone, have been shown to be teratogenic in rabbits and mice. In mice, corticosteroids resulted in fetal resorption and an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Administer neomycin; polymyxin B; dexamethasone during pregnancy only when the benefits clearly outweigh the potential risk to the fetus. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses during pregnancy.

Neomycin; polymyxin B; dexamethasone ophthalmic formulations may be used with caution during breast-feeding. According to the manufacturer, it is not known if ophthalmic administered dexamethasone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Topically applied dexamethasone to the eye in the mother is unlikely to cause significant concern to the infant with limited dosage and duration of use. Neomycin and polymyxin B are both poorly absorbed orally, so whatever minor systemic exposure may occur maternally would be unlikely to cause infant harm during nursing. Short term use of usual moderate ocular doses for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to maternally administered neomycin; polymyxin B; dexamethasone, health care providers are encouraged to report the adverse effect to the FDA.