colistin/hydrocortisone/neomycin/thonzonium otic (Rx)

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Brand and Other Names:Coly-Mycin S, Cortisporin-TC Otic

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

colistin/hydrocortisone/neomycin/thonzonium

otic suspension

  • (3mg/10mg/3.3mg/0.5mg)/mL

Bacterial Otitis Externa

Instill 5 gtt into affected ear TID/QID; not to exceed 10 days of therapy

Administration

Thoroughly clean and dry external auditory canal with a sterile cotton applicator

Use calibrated dropper to administer

The patient should lie with the affected ear upward and then the drops should be instilled; maintain this position for 5 minutes to facilitate penetration of the drops into the ear canal

If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension; the wick should be kept moist by adding further solution q4hr; replace wick at least once q24hr

Dosage Forms & Strengths

colistin/hydrocortisone/neomycin/thonzonium

otic suspension

  • (3mg/10mg/3.3mg/0.5mg)/mL

Bacterial Otitis Externa

<1 year: safety and efficacy not established

Instill 4 gtt into affected ear TID/QID; not to exceed 10 days of therapy

Administration

Thoroughly clean and dry external auditory canal with a sterile cotton applicator

Use calibrated dropper to administer

The patient should lie with the affected ear upward and then the drops should be instilled; maintain this position for 5 minutes to facilitate penetration of the drops into the ear canal

If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension; the wick should be kept moist by adding further solution q4hr; replace wick at least once q24hr

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Adverse Effects

Frequency Not Defined

Neomycin

  • Skin sensitization
  • Ototoxicity
  • Nephrotoxicity

Hydrocortisone

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Skin maceration
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
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Warnings

Contraindications

Hypersensitivity

Do not use if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (eg, herpes simplex virus, varicella zoster virus)

Cautions

Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti; risk increased with prolonged use (not to exceed 10 days)

Prolonged treatment may result in overgrowth of nonsusceptible organisms and fungi; if infection not improved after 1 week, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed

Cross-allergenicity reported with aminoglycosides

Use cautiously with perforated tympanic membrane

Neomycin may cause cutaneous sensitization

For otic use only

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk following otic application

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Colistin: Polypeptide antibiotic; penetrates into and disrupts the bacterial cell membrane

Hydrocortisone: Corticosteroid; thought to act by regulating the rate of protein synthesis; it controls inflammation, edema, pruritus, and other dermal reactions

Neomycin: Aminoglycoside antibiotic; inhibits protein synthesis, disrupting the normal cycle of ribosomal function

Thonzonium: Surface-active agent that promotes tissue contact by dispersion and penetration of cellular debris and exudate

Microbiology

  • Together, colistin and neomycin elicit bactericidal activity against most strains of the following organisms in vitro
  • Aerobic gram-positive microorganisms: Staphylococcus aureus
  • Aerobic gram-negative microorganisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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