Coly-Mycin S (neomycin sulf/colistin sul/hydrocortisone ac/thonzonium brom)

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.

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.

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 dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Since nephrotoxic and/or neurotoxic effects may be additive, concurrent or sequential use of colistimethate sodium and other drugs with similar toxic potentials (e.g., aminoglycosides, amphotericin B, capreomycin, methoxyflurane (no longer commercially available in the US), polymyxin B sulfate, vancomycin) should be avoided, if possible.

Neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, ether, decamethonium (no longer commercially available in the US), gallamine (no longer commercially available in the US), decamethonium) and other drugs (e.g., sodium citrate) potentiate neuromuscular blockade induced by colistimethate sodium and these drugs should be used with extreme caution in patients receiving colistimethate sodium.

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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• Perforated eardrum

• Bullous myringitis
• Fungal infection in the ear
• Herpes simplex infection
• Herpes zoster oticus
• Tuberculosis of the ear
• Viral infection in the ear

• No disease contraindications

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More Frequent

• Hypersensitivity drug reaction

Rare or Very Rare

• Hearing loss

Rare or Very Rare

• Allergic dermatitis
• Ear itching
• Ear stinging
• Folliculitis

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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.

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.

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.

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