Maxitrol Ophthalmic Ointment

/ Novartis

Children and Adults (including the Elderly): Apply a small amount (1-1.5 cm) in the conjunctival sac 3 to 4 times daily, or use as a supplement to the eye drops at bedtime. After application of the ointment, look downward for a moment before closing the eyes.
Method of administration: For ocular use. To prevent contamination of the tube tip and ointment, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the tube tip. Keep the tube tightly closed when not in use.

Indicated for the treatment of eye infections which are responsive to steroids, when an antibiotic is also needed.

Hypersensitivity to the active substances or to any of the excipients; Herpes simplex keratitis; Vaccinia, varicella, and other viral infection of cornea or conjunctiva; Fungal diseases of ocular structures or untreated parasitic eye infections; Mycobacterial ocular infections.

For topical ophthalmic use only. Not for injection or ingestion.
As with all antibacterial preparation prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
Sensitivity to topically applied aminoglycosides may occur in some patients. Cross-sensitivity to other aminoglycosides may also occur. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If signs of serious reactions or hypersensitivity occur, discontinue use of MAXITROL eye ointment. Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin. Nephrotoxic and neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects have not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside or polymyxin B therapy.
Prolonged use may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, decrease of visual acuity and field of vision, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently. This is especially important in paediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults.
The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
Corticosteroids may reduce resistance to and aid in the establishment of nonsusceptible bacterial, fungal, parasitic or viral infections and mask the clinical signs of infection or may suppress hypersensitivity reactions to MAXITROL eye ointment. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs; corticosteroid therapy should be discontinued if fungal infection occurs.
To avoid the risk of enhancement of herpetic corneal disease, frequent slit lamp examination is essential.
Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
Contact lens wear is discouraged during treatment of an ocular infection. Therefore patients should be advised not to wear contact lenses during treatment with MAXITROL eye ointment.
This product contains methylparahydroxybenzoate and propylparahydroxybenzoate which may cause allergic reactions (possibly delayed).
This product also contains lanolin which may cause local skin reactions (e.g. contact dermatitis).

In clinical trials with MAXITROL eye ointment the most common adverse reactions were ocular discomfort, keratitis and eye irritation, occurring in 0.7% to 0.9% of patients.
See prescribing information for full details.

No interaction studies have been performed. Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems. Concomitant and/or sequential use of an aminoglycoside (neomycin) and other systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, whenever possible. If more than one ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Pregnancy: There are no or limited amount of data from the use of MAXITROL eye ointment in pregnant women. Studies in animals with some active components of MAXITROL eye ointment have shown reproductive toxicity. MAXITROL eye ointment is not recommended during pregnancy.
Lactation: It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B are excreted in human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue/abstain from breast-feeding or to discontinue therapy with MAXITROL eye ointment taking into account the benefit of breast-feeding for the child and the benefit of the product to the woman.

No case of overdose has been reported. Signs and symptoms of an overdosage of MAXITROL eye ointment may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching).
See prescribing information for full details.

Storage: Do not store above 25°C. Do not refrigerate. Do not freeze.
Shelf-life: 4 years. Discard 28 days after first opening.