Maxitrol Sterile Ophthalmic Suspension

/ Novartis

Posology: Shake well before use. 1 to 2 drops topically in the conjunctival sac. In cases of acute disorder, drops may be instilled hourly, being tapered to discontinuation as the inflammation subsides. In mild disorders, instill 4 to 6 times daily.
Method of administration: For ocular use only. To prevent contamination of the dropper tip and suspension, care must be taken not to touch
the eyelids, surrounding areas, or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.

Indicated in ocular inflammation when concurrent use of antimicrobial in judged necessary.

Hypersensitivity to the active substance 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 ocular use only. Not for injection or ingestion.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
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 the use of this product.
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 of ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, 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).
Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be progressively discontinued.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. 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 ophthalmic suspension. 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.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
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 ophthalmic suspension.
Maxitrol ophthalmic suspension contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses prior to application of Maxitrol ophthalmic suspension and wait 15 minutes after instillation of the dose before reinsertion.

In clinical trials with MAXITROL suspension, 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.
CYP3A4 inhibitors (including ritonavir and cobicistat): may decrease dexamethasone clearance resulting in increased effects and adrenal suppression/Cushing’s syndrome. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.
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 suspension in pregnant women. Maxitrol ophthalmic suspension 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 suspension taking into account the benefit of breastfeeding
for the child and the benefit of the product to the woman.
See prescribing information for full details.

No case of overdose has been reported. Signs and symptoms of an overdosage of MAXITROL suspension may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching). Due to the characteristics of this preparation, intended for topical use, no toxic effects are expected when administered to the eye neither at the recommended dose nor in the event of
accidental ingestion of the contents of a bottle. A topical ophthalmic overdose of MAXITROL suspension may be flushed from the eye(s) with lukewarm water.

Shelf-life: Unopened 24 months. Discard 28 days after first opening.
Storage: Do not store above 25°C. Do not refrigerate.