Maxitrol Oph Oint Generic Name & Formulations
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.
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.
Maxitrol Oph Oint 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
Maxitrol Oph Oint 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
Maxitrol Oph Oint 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.
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.
Safety and effectiveness of Maxitrol in pediatric patients below the age of 2 years have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Maxitrol Oph Oint Pharmacokinetics
Maxitrol Oph Oint Interactions
Maxitrol Oph Oint Adverse Reactions
Maxitrol Oph Oint Clinical Trials
Maxitrol Oph Oint Note
Maxitrol Oph Oint 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.