Maxitrol Oph Oint

— THERAPEUTIC CATEGORIES —
  • Ocular allergy/inflammation
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Maxitrol Oph Oint Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Neomycin 3.5mg, polymyxin B sulfate 10000Units/g, dexamethasone 0.1%.

    Pharmacological Class

    Antibiotics + steroid.

    See Also

    How Supplied

    Susp—5mL; Oint—3.5g

    How Supplied

    Maxitrol is supplied as a sterile ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: 3.5g in an aluminum tube.

    Storage

    Ointment: Store at 2°C to 25°C (36°F to 77°F). After opening, Maxitrol can be used until the expiration date on the tube.

    Manufacturer

    Alcon Laboratories, Inc.

    Generic Availability

    YES

    Maxitrol Oph Oint Indications

    Indications

    Ocular inflammation associated with infection.

    Indications

    For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. 

    Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.  

    The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

    The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. 

    This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.

    Maxitrol Oph Oint Dosage and Administration

    Adult

    Small amount of ointment 3–4 times daily. Ointment may be used adjunctively with drops at bedtime. Then prolong dosing interval as condition improves; max 8g per therapeutic course.

    Children

    Not established.

    Maxitrol Oph Oint Contraindications

    Contraindications

    Fungal, viral, or mycobacterial infections of the cornea and conjunctiva. Hypersensitivity to corticosteroids.

    Contraindications

    Maxitrol is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

    Maxitrol Oph Oint Boxed Warnings

    Not Applicable

    Maxitrol Oph Oint Warnings/Precautions

    Warnings/Precautions

    Not for injection. Corneal or scleral thinning. Glaucoma. Monitor for secondary infections and intraocular pressure in prolonged use. Aminoglycoside cross-sensitivity; discontinue if hypersensitivity develops. May mask signs of acute purulent or parasitic infection. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Warnings/Precautions

    • Not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

    • Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. 

    • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

    • May cause corneal and scleral thinning with various ocular diseases and long-term use of topical corticosteroids. May lead to perforation with the use of topical corticosteroids in the presence of thin corneal or scleral tissue.

    • Routinely monitor intraocular pressure If this product is used for 10 days or longer, even though it may be difficult in children and uncooperative patients. Use caution in the presence of glaucoma.

    • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 

    • Products containing neomycin sulfate may cause cutaneous sensitization. Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. Discontinue if hypersensitivity develops during use of the product.

    • Consider cross-hypersensitivity to other aminoglycosides, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides. 

    Pregnancy Considerations

    • Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. 

    • There are no adequate or well-controlled studies in pregnant women. However, there may be an increased risk of intra-uterine growth retardation with prolonged or repeated corticoid use during pregnancy.

    • Only use during pregnancy if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Carefully observe for signs of hypoadrenalism in infants born of mothers who have received substantial doses of corticosteroids during pregnancy.  

    Nursing Mother Considerations

    • It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. 

    • Because many drugs are excreted in human milk, caution should be exercised when Maxitrol is administered to a nursing woman.

    Pediatric Considerations

    Safety and effectiveness of Maxitrol in pediatric patients below the age of 2 years have not been established.

    Geriatric Considerations

    No overall differences in safety or effectiveness have been observed between elderly and younger patients.

    Maxitrol Oph Oint Pharmacokinetics

    Elimination

    Renal.

    Maxitrol Oph Oint Interactions

    Not Applicable

    Maxitrol Oph Oint Adverse Reactions

    Adverse Reactions

    Allergic sensitization, increased intraocular pressure, cataracts, corneal perforation, optic nerve damage, visual defects, delayed wound healing, bleb formation, allergic dermatitis.

    Maxitrol Oph Oint Clinical Trials

    See Literature

    Maxitrol Oph Oint Note

    Not Applicable

    Maxitrol Oph Oint Patient Counseling

    Patient Counseling

    • If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. 

    • Use care to avoid touching the bottle tip to eyelids or to any other surface to prevent contamination. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children.

    • Advise patients that their vision may be temporarily blurred following dosing with Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension). Use caution when operating machinery or driving a motor vehicle. 

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