Neomycin-Polymyxin-Hc (neomycin sulfate/polymyxin B sulfate/hydrocortisone)

Dosage of neomycin sulfate is expressed in terms of the base.

Potency and dosage of polymyxin B sulfate are expressed in terms of polymyxin B activity (units of polymyxin B).

Hydrocortisone or its acetate ester is applied topically to the eye or ear. For ophthalmic or otic use, hydrocortisone and hydrocortisone acetate currently are commercially available only in fixed-combination preparations.

Care should be taken to avoid contamination of the tip of the ointment tube or dropper of the solution or suspension when the drug is used ophthalmically.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Aminoglycosides/Loop Diuretics

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The coadministration of aminoglycosides and loop diuretics may result in additive or synergistic ototoxicity and/or nephrotoxicity.

CLINICAL EFFECTS: The combination of an aminoglycoside and a loop diuretic may increase risk for serious nephrotoxicity or ototoxicity.(1,2) Vestibular or auditory ototoxicity may be permanent.(1,3)

PREDISPOSING FACTORS: Preexisting renal impairment, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, rapid injection or high doses of loop diuretics, concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin, or sepsis appear to increase the risk for nephrotoxicity and ototoxicity.(1-6). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides.(7)

PATIENT MANAGEMENT: Administer aminoglycoside dosage every 24 to > 48 hours based upon renal function and continue therapy for less than 4 to 7 days, whenever possible.(4,5) The recommended maximal infusion rate for high dose furosemide therapy is 4 mg/minute.(2) When concurrent therapy is necessary monitor renal, hearing, and vestibular function. Signs of vestibular dysfunction include loss of balance and/or the visual sensation that stationary objects are moving (oscillopsia). In hospitalized or bedbound patients these symptoms may not be noticed or may be ascribed to other etiologies.(3)

DISCUSSION: Several studies and case reports have documented altered aminoglycoside levels, nephrotoxicity, and ototoxicity with concurrent therapy.(8-14) Otic aminoglycosides are included in this interaction because high aminoglycoside concentrations in the ear have been associated with an increased risk for hearing loss.

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• Fungal infection of eye
• Herpes simplex dendritic keratitis
• Perforated eardrum
• Tuberculosis of the eye
• Vaccinia virus keratitis

• Amebic infection of the eye
• Bullous myringitis
• Fungal infection in the ear
• Herpes simplex infection
• Herpes zoster oticus
• Ocular hypertension
• Ocular injury
• Tuberculosis of the ear
• Viral infection in the ear

• Corneal erosion
• Diabetes mellitus
• Krukenberg spindle
• No disease contraindications
• Open angle glaucoma
• Severe myopia

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More Frequent

• Contact dermatitis
• Ocular inflammation
• Ocular itching
• Ocular redness
• Skin rash

Less Frequent

• Ocular hypertension
• Ocular irritation

Rare or 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

More Frequent

• Blurred vision

Less Frequent

• Blurred vision
• Headache disorder
• Iritis
• Ocular irritation
• Ocular pain

Rare or Very Rare

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

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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.

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