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Drug overview for COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
Generic name: NEOMYCIN SULFATE/COLISTIN SULFATE/HYDROCORTISONE/THONZONIUM (nee-oh-MY-sin/koh-LIH-stin/hi-dro-KOR-tih-sown/thon-ZHO-nee-um)
Drug class: Otic Antibiotics
Therapeutic class: Otic (Ear)
Colistimethate sodium is a prodrug of colistin. Colistin (also known as Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Neomycin is an aminoglycoside antibiotic. polymyxin E) is a polymyxin antibiotic structurally and pharmacologically related to polymyxin B.
No enhanced Uses information available for this drug.
Generic name: NEOMYCIN SULFATE/COLISTIN SULFATE/HYDROCORTISONE/THONZONIUM (nee-oh-MY-sin/koh-LIH-stin/hi-dro-KOR-tih-sown/thon-ZHO-nee-um)
Drug class: Otic Antibiotics
Therapeutic class: Otic (Ear)
Colistimethate sodium is a prodrug of colistin. Colistin (also known as Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Neomycin is an aminoglycoside antibiotic. polymyxin E) is a polymyxin antibiotic structurally and pharmacologically related to polymyxin B.
No enhanced Uses information available for this drug.
DRUG IMAGES
CORTISPORIN-TC EAR SUSPENSION
The following indications for COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium) 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 COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
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.
The Institute for Safe Medication Practices (ISMP) alerted healthcare professionals about the risk of serious and potentially fatal medication errors related to dosage of colistimethate sodium.
Colistimethate sodium is a prodrug of colistin and is inactive until hydrolyzed in vivo to colistin. In the US, vials and carton packaging of colistimethate sulfate are labeled as colistimethate for injection; however, strength and dosage of the drug are expressed in terms of colistin base activity (colistin). This dosage convention must be considered when prescribing, preparing, and dispensing colistimethate sodium.
Healthcare professionals should be aware that, in the US, colistimethate sodium must only be prescribed in terms of colistin. If the drug is prescribed as colistimethate or colistimethate sodium, the prescriber should be contacted to verify the dosage in terms of colistin. At least 1 fatality related to acute renal failure and other complications occurred when colistimethate sodium was prescribed in terms of the prodrug (instead of colistin), resulting in administration of a dosage approximately 2.5
times greater than it should have been.
Healthcare professionals also should be aware that strength and dosage of colistimethate sodium preparations commercially available in some other countries may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. (See Dosage and Administration: Dosage.)
Any medication errors involving colistimethate sodium should be reported to the ISMP National Medication Error Reporting Program and the FDA MedWatch program.
Dosage of neomycin sulfate is expressed in terms of the base.
Dosage of colistimethate sodium commercially available in the US is expressed in terms of colistin.
Dosage of colistimethate sodium preparations commercially available in some other countries (e.g., United Kingdom, Greece) may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. The fact that dosages reported in published clinical studies or case reports may vary depending on the country of origin and the preparation used should be considered.
Although not the dosage convention in the US, it has been suggested that dosage of colistimethate sodium should preferably be expressed in terms of international units to avoid confusion. When expressed in terms of international units, each mg of colistin base has a potency of 30,000 international units and each mg of colistimethate sodium has a potency of 12,500 international units.
The usual IM or IV dosage of colistimethate sodium for adults and children with normal renal function is 2.5-5 mg/kg of colistin daily given in 2-4 divided doses, depending on the severity of the infection.
The maximum IM or IV dosage of colistimethate sodium recommended by the manufacturer for patients with normal renal function is 5 mg/kg of colistin daily.
The manufacturer recommends that dosage for obese patients should be based on an estimate of ideal body weight.
For early treatment of Pseudomonas aeruginosa respiratory tract infections in adult and pediatric cystic fibrosis patients or for suppressive therapy in adult or pediatric cystic fibrosis patients colonized with Ps. aeruginosa, colistimethate sodium has been given by oral inhalation via nebulization+ in a dosage of 33.33-66.66
mg of colistin 2 or 3 times daily. This corresponds to a dosage of 1-2 million international units 2 or 3 times daily.
In patients with renal impairment, dosage of colistimethate sodium should be decreased in proportion to the degree of renal impairment.
Dosage for Adults with Renal Impairment
Creatinine Clearance (mL/minute) IM or IV Dosage (of Colistin) 80 or greater 2.5-5 mg/kg daily given in 2-4 divided doses 50-79 2.5-3.8
mg/kg daily given in 2 divided doses 30-49 2.5 mg/kg daily given as a single dose or in 2 divided doses 10-29 1.5 mg/kg given once every 36 hours
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.
The Institute for Safe Medication Practices (ISMP) alerted healthcare professionals about the risk of serious and potentially fatal medication errors related to dosage of colistimethate sodium.
Colistimethate sodium is a prodrug of colistin and is inactive until hydrolyzed in vivo to colistin. In the US, vials and carton packaging of colistimethate sulfate are labeled as colistimethate for injection; however, strength and dosage of the drug are expressed in terms of colistin base activity (colistin). This dosage convention must be considered when prescribing, preparing, and dispensing colistimethate sodium.
Healthcare professionals should be aware that, in the US, colistimethate sodium must only be prescribed in terms of colistin. If the drug is prescribed as colistimethate or colistimethate sodium, the prescriber should be contacted to verify the dosage in terms of colistin. At least 1 fatality related to acute renal failure and other complications occurred when colistimethate sodium was prescribed in terms of the prodrug (instead of colistin), resulting in administration of a dosage approximately 2.5
times greater than it should have been.
Healthcare professionals also should be aware that strength and dosage of colistimethate sodium preparations commercially available in some other countries may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. (See Dosage and Administration: Dosage.)
Any medication errors involving colistimethate sodium should be reported to the ISMP National Medication Error Reporting Program and the FDA MedWatch program.
Dosage of neomycin sulfate is expressed in terms of the base.
Dosage of colistimethate sodium commercially available in the US is expressed in terms of colistin.
Dosage of colistimethate sodium preparations commercially available in some other countries (e.g., United Kingdom, Greece) may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. The fact that dosages reported in published clinical studies or case reports may vary depending on the country of origin and the preparation used should be considered.
Although not the dosage convention in the US, it has been suggested that dosage of colistimethate sodium should preferably be expressed in terms of international units to avoid confusion. When expressed in terms of international units, each mg of colistin base has a potency of 30,000 international units and each mg of colistimethate sodium has a potency of 12,500 international units.
The usual IM or IV dosage of colistimethate sodium for adults and children with normal renal function is 2.5-5 mg/kg of colistin daily given in 2-4 divided doses, depending on the severity of the infection.
The maximum IM or IV dosage of colistimethate sodium recommended by the manufacturer for patients with normal renal function is 5 mg/kg of colistin daily.
The manufacturer recommends that dosage for obese patients should be based on an estimate of ideal body weight.
For early treatment of Pseudomonas aeruginosa respiratory tract infections in adult and pediatric cystic fibrosis patients or for suppressive therapy in adult or pediatric cystic fibrosis patients colonized with Ps. aeruginosa, colistimethate sodium has been given by oral inhalation via nebulization+ in a dosage of 33.33-66.66
mg of colistin 2 or 3 times daily. This corresponds to a dosage of 1-2 million international units 2 or 3 times daily.
In patients with renal impairment, dosage of colistimethate sodium should be decreased in proportion to the degree of renal impairment.
Dosage for Adults with Renal Impairment
Creatinine Clearance (mL/minute) IM or IV Dosage (of Colistin) 80 or greater 2.5-5 mg/kg daily given in 2-4 divided doses 50-79 2.5-3.8
mg/kg daily given in 2 divided doses 30-49 2.5 mg/kg daily given as a single dose or in 2 divided doses 10-29 1.5 mg/kg given once every 36 hours
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
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 COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
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 COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
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 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypersensitivity drug reaction |
None. |
| Rare/Very Rare |
|---|
|
Hearing loss |
There are 4 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Ear itching Ear stinging Folliculitis |
The following precautions are available for COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| Aminoglycosides (Otic) | 1 Day – 6 Years | Potential for ototoxicity. Avoid use in children with tympanostomy tubes or a perforated tympanic membrane. |
Management or Monitoring Precaution
| Colistin-Neomycin-HC Otic | 1 Day – 364 Days | Safety and efficacy not established age <1 year. |
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. Safe use of colistimethate sodium during pregnancy has not been established. When colistimethate sodium was given to rabbits during organogenesis in an IM dosage of 4.15
or 9.3 mg/kg (0.25 or 0.55 times, respectively, the maximum daily human dosage based on mg/m2), talipes varus occurred in 2.6 or 2.9%
of fetuses, respectively. In addition, increased resorption occurred at the 9.3 mg/kg dosage.
The drug was not teratogenic when the same dosages were used in rats (0.13 or 0.3 times the maximum daily human dosage, respectively, based on mg/mm2). There are no adequate and controlled studies to date using colistimethate sodium in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible 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. Safe use of colistimethate sodium during pregnancy has not been established. When colistimethate sodium was given to rabbits during organogenesis in an IM dosage of 4.15
or 9.3 mg/kg (0.25 or 0.55 times, respectively, the maximum daily human dosage based on mg/m2), talipes varus occurred in 2.6 or 2.9%
of fetuses, respectively. In addition, increased resorption occurred at the 9.3 mg/kg dosage.
The drug was not teratogenic when the same dosages were used in rats (0.13 or 0.3 times the maximum daily human dosage, respectively, based on mg/mm2). There are no adequate and controlled studies to date using colistimethate sodium in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
| Drug/Drug Class | Severity | Precaution Description | Pregnancy Category Description |
|---|---|---|---|
| Hydrocortisone (topical, Non-systemic) | 2 | Insufficient human data available | No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information. |
| Neomycin (otic) | C | Fda cat c in combination otic products | Animal studies have shown adverse effect on fetus but no well-controlled studies in humans: potential benefits may warrant use in pregnant women despite potential risks; or no animal reproduction studies and no adequate and well-controlled studies in humans. |
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. It is not known whether colistimethate sodium is distributed into milk, but colistin sulfate has been detected in milk. Therefore, colistimethate sodium should be used with caution in nursing women.
No Known Risk
No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation.
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. It is not known whether colistimethate sodium is distributed into milk, but colistin sulfate has been detected in milk. Therefore, colistimethate sodium should be used with caution in nursing women.
No Known Risk
No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Hydrocortisone (sys) | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insufficient data available; normal constituent of breastmilk |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for COLY-MYCIN S (neomycin sulfate/colistin sulfate/hydrocortisone/thonzonium)'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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