Anti infectives details and description
One drop instilled into the conjunctival sac s every 4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the patient is awake.
This information is intended for use by health professionals 1.
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Qualitative and quantitative composition 1 ml suspension contains 1 mg dexamethasone, IU polymyxin B sulphate, IU neomycin sulphate as base. For a full list of excipients, see section 6. Pharmaceutical form White sterile suspension for topical ocular administration.
Vaccinia, varicella, and other viral infection of cornea or conjunctiva. Fungal diseases of ocular structures. 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. 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.
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.
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, viral, or fungal infections and mask the clinical signs of infection or may suppress hypersensitivity reactions to MAXITROL eye drops, 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. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems see section 4.
Visual disturbance 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. MAXITROL eye drops, 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 eye drops, suspension and wait 15 minutes after instillation of the dose before reinsertion.
Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems. CYP3A4 inhibitors including ritonavir and cobicistat: 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.
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. 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. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines.
If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery. Tabulated summary of adverse reactions The following adverse reactions are classified according to the following convention: Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.Cyanocobalamin is a cobalt-containing coordination compound produced by intestinal micro-organisms and found also in soil and water.
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