MAXITROL (neomycin/polymyxin b sulfate/dexamethasone)

There are 4 contraindications. Absolute contraindication.

Contraindication List
Fungal infection of eye
Herpes simplex dendritic keratitis
Tuberculosis of the eye
Vaccinia virus keratitis

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Amebic infection of the eye
Ocular hypertension

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
Krukenberg spindle
No disease contraindications
Open angle glaucoma
Severe myopia

There are 28 severe adverse reactions.

More Frequent	Less Frequent
Contact dermatitis Ocular inflammation Ocular itching Ocular redness Skin rash	Ocular hypertension Ocular irritation

Rare/Very Rare
Adrenocortical insufficiency Anaphylaxis Bullous dermatitis Cataracts Central serous chorioretinopathy Corneal degeneration Corneal edema Corneal erosion Corneal ulcer Fungal infection of eye Glaucoma Globe perforation Hypercortisolism Hypersensitivity drug reaction Keratitis Optic nerve damage Punctate keratitis Reduced visual acuity Uveitis Visual changes Visual field defect

There are 25 less severe adverse reactions.

More Frequent	Less Frequent
Blurred vision	Blurred vision Headache disorder Iritis Ocular irritation Ocular pain

Rare/Very Rare
Accommodation disorder Allergic dermatitis Blepharoptosis Calcification of cornea Chemosis Conjunctival hyperemia Conjunctivitis Dizziness Dysgeusia Eye tearing Foreign body sensation of eye Impaired wound healing Mydriasis Ocular infection Ocular irritation Ocular itching Ocular redness Photophobia Urticaria

Animal reproduction studies have not been conducted with neomycin sulfate. It is not known whether ophthalmic or otic preparations containing neomycin sulfate can cause fetal harm when administered to a pregnant woman. Fixed-combination ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, and either bacitracin zinc or gramicidin should be used during pregnancy only if clearly needed.

Fixed-combination ophthalmic preparations containing neomycin sulfate, other anti-infectives (i.e., polymyxin B sulfate, bacitracin zinc), and a corticosteroid (i.e., dexamethasone, hydrocortisone, hydrocortisone acetate) should be used during pregnancy only if potential benefits justify potential risks to the fetus. Fixed-combination otic preparations containing neomycin sulfate, colistin, and hydrocortisone acetate should be used during pregnancy only if potential benefits justify potential risks to the fetus. Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, the manufacturers state that clinically important systemic concentrations of neomycin are not anticipated when otic preparations containing neomycin are used as directed.

Fixed-combination otic preparations containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be used during pregnancy only if potential benefits justify potential risks to the fetus. Animal reproduction studies have not been performed with polymyxin B sulfate. It is not known whether ophthalmic preparations containing polymyxin B sulfate can cause fetal harm when administered to pregnant women.

Fixed-combination ophthalmic preparations of polymyxin B sulfate and bacitracin zinc or polymyxin B sulfate, neomycin sulfate, and either bacitracin zinc or gramicidin should be used during pregnancy only if clearly needed. Because trimethoprim may interfere with folic acid metabolism, fixed-combination ophthalmic preparations containing polymyxin B sulfate and trimethoprim sulfate should be used during pregnancy only if potential benefits justify potential risks to the fetus. Fixed-combination ophthalmic preparations containing polymyxin B sulfate, other anti-infectives (i.e., neomycin sulfate, bacitracin zinc), and a corticosteroid (i.e., dexamethasone, hydrocortisone, hydrocortisone acetate) should be used during pregnancy only if potential benefits justify potential risks to the fetus. Fixed-combination otic preparations containing polymyxin B sulfate, neomycin sulfate, and hydrocortisone should be used during pregnancy only if potential benefits justify potential risks to the fetus.

It is not known whether neomycin is distributed into milk. Fixed-combination ophthalmic preparations containing neomycin sulfate and other anti-infectives (i.e., bacitracin zinc, gramicidin, polymyxin B sulfate) should be used with caution in nursing women. Fixed-combination ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, and dexamethasone should be used with caution in nursing women.

The manufacturers of fixed-combination ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone or hydrocortisone acetate state that a decision should be made whether to discontinue nursing or the ophthalmic preparation, taking into account the importance of the drug to the woman. Fixed-combination otic preparations containing neomycin sulfate, colistin, and hydrocortisone acetate and fixed-combination otic preparations containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be used with caution in nursing women. Fixed-combination ophthalmic preparations containing polymyxin B sulfate and other anti-infectives (i.e., bacitracin zinc, gramicidin, neomycin sulfate, trimethoprim sulfate) should be used with caution in nursing women.

Fixed-combination ophthalmic preparations containing polymyxin B sulfate, neomycin sulfate, and dexamethasone should be used with caution in nursing women. The manufacturers of fixed-combination ophthalmic preparations containing polymyxin B sulfate, neomycin sulfate, bacitracin zinc, and hydrocortisone or hydrocortisone acetate state that a decision should be made whether to discontinue nursing or the ophthalmic preparation, taking into account the importance of the drug to the woman. Fixed-combination otic preparations containing polymyxin B sulfate, neomycin sulfate, and hydrocortisone should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.