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Drug overview for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
Generic name: NEOMYCIN SULFATE/POLYMYXIN B SULFATE/HYDROCORTISONE (NEE-oh-MYE-sin/POL-ee-MIX-in/HYE-droe-KOR-ti-sone)
Drug class: Otic Antibiotics
Therapeutic class: Otic (Ear)
Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Neomycin is an aminoglycoside antibiotic. Polymyxin B is a polymyxin antibiotic.
No enhanced Uses information available for this drug.
Generic name: NEOMYCIN SULFATE/POLYMYXIN B SULFATE/HYDROCORTISONE (NEE-oh-MYE-sin/POL-ee-MIX-in/HYE-droe-KOR-ti-sone)
Drug class: Otic Antibiotics
Therapeutic class: Otic (Ear)
Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Neomycin is an aminoglycoside antibiotic. Polymyxin B is a polymyxin antibiotic.
No enhanced Uses information available for this drug.
DRUG IMAGES
NEOMYCIN-POLYMYXIN-HC EAR SOLN
The following indications for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone) have been approved by the FDA:
Indications:
Mastoidectomy cavity infections
Otitis externa
Professional Synonyms:
Infection in mastoidectomy cavity
Inflammation of the outer ear and ear canal
Mastoidectomy cavity infection
Swimmer's ear
Indications:
Mastoidectomy cavity infections
Otitis externa
Professional Synonyms:
Infection in mastoidectomy cavity
Inflammation of the outer ear and ear canal
Mastoidectomy cavity infection
Swimmer's ear
The following dosing information is available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
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.
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).
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.
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).
No enhanced Administration information available for this drug.
No dosing information available.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NEOMYCIN-POLYMYXIN-HC EAR SOLN | Maintenance | Adults instill 4 drops into affected ear(s) by otic route 3 times per day |
The following drug interaction information is available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| 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. |
BUMETANIDE, EDECRIN, ETHACRYNATE SODIUM, ETHACRYNIC ACID, FUROSCIX, FUROSEMIDE, FUROSEMIDE-0.9% NACL, LASIX, SOAANZ, TORSEMIDE |
The following contraindication information is available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Perforated eardrum |
There are 6 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bullous myringitis |
| Fungal infection in the ear |
| Herpes simplex infection |
| Herpes zoster oticus |
| Tuberculosis of the ear |
| Viral infection in the ear |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 1 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Ear stinging |
The following precautions are available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
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.
The following prioritized warning is available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NEOMYCIN-POLYMYXIN-HYDROCORT (neomycin sulfate/polymyxin b sulfate/hydrocortisone)'s list of indications:
| Mastoidectomy cavity infections | |
| H95.19 | Other disorders following mastoidectomy |
| H95.191 | Other disorders following mastoidectomy, right ear |
| H95.192 | Other disorders following mastoidectomy, left ear |
| H95.193 | Other disorders following mastoidectomy, bilateral ears |
| H95.199 | Other disorders following mastoidectomy, unspecified ear |
| Otitis externa | |
| H60.33 | Swimmer's ear |
| H60.331 | Swimmer's ear, right ear |
| H60.332 | Swimmer's ear, left ear |
| H60.333 | Swimmer's ear, bilateral |
| H60.339 | Swimmer's ear, unspecified ear |
| H60.9 | Unspecified otitis externa |
| H60.90 | Unspecified otitis externa, unspecified ear |
| H60.91 | Unspecified otitis externa, right ear |
| H60.92 | Unspecified otitis externa, left ear |
| H60.93 | Unspecified otitis externa, bilateral |
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