Loading…
MAXITROL is a brand name for Polymyxin B. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MAXITROL eye ointment is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
Verbatim from this product's MHRA label. Tap a section to expand.
Children and Adults (including the Elderly) Apply a small amount into the conjunctival sac(s) up to three to four times daily or, may be used adjunctively with drops at bedtime. Do not touch the top of the tube to any surface as this may contaminate the contents.
For topical ophthalmic use only. Not for injection or ingestion. Hepatic and renal impairment Maxitrol Eye Ointment has not been studied in these subject populations. However, due to low systemic absorption of the active substances after topical administration of this product, dose adjustment is not necessary.
9% of patients. Tabulated summary of adverse reactions The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical trials and post-marketing experience. 4), photophobia, mydriasis, eyelid ptosis, eye pain, eye swelling, foreign body sensation in eyes, ocular hyperaemia, increased lacrimation Skin and subcutaneous tissue disorders Not known: Stevens-Johnson syndrome Description of selected adverse event Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (See Section Special warnings and precautions for use).
Topical ophthalmic steroid use may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior subcapsular cataract formation (See Section Special warnings and precautions for use).
Sensitivity to topically administered aminoglycosides may occur in some patients (See Section Special warnings and precautions for use). Systemic side effects may occur with extensive use. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
4 Special warnings and special precautions for use • 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, urticarial, 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 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.
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).
• 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 non- susceptible bacterial, fungal, parasitic or viral infections and mask the clinical signs of infection, or may suppress hypersensitivity reactions to substances in the product.
Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs and corticosteroid therapy should be discontinued if fungal infection occurs. • To avoid the risk of enhancement of herpetic corneal disease, frequent slip 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. 5). • 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 eye ointment. • This product contains methylparahydroxybenzoate and propylparahydroxybenzoate which may cause allergic reactions (possibly delayed).
g. contact dermatitis). • In patients receiving systemic corticosteroids, new-onset or exacerbation of pre-existing diabetes mellitus may occur. Because of the possibility of reduced glucose tolerance/diabetes mellitus with topical ophthalmic corticosteroids, caution is recommended when administering MAXITROL eye ointment to patients with a personal or family history of diabetes.