Dosing & Uses
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
Adverse Effects
Frequency Not Defined
To report suspected adverse reactions, contact Endo Pharmaceuticals Inc. at 1-800-462-3636 or MEDWATCH at 1-800-FDA-1088 or http://www.fda.gov/medwatch/
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
Warnings
Contraindications
Hypersensitivity
Do not use if external auditory canal disorder is suspected or known to be due to cutaneous viral infection (eg, herpes simplex virus, varicella-zoster virus)
Cautions
For otic use only
Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in organ of Corti; the risk is greater with prolonged use
Therapy should be limited to 10 consecutive days; patients being treated with eardrops containing neomycin should be under close clinical observation
Should be used cautiously in any patient with a perforated tympanic membrane
Neomycin sulfate may cause cutaneous sensitization; a precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known; discontinue promptly if sensitivity or irritation occurs
When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin
The manifestation of sensitization to neomycin is usually alow-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal
Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed; these symptoms regress quickly on withdrawing the medication; neomycin containing applications should be avoided for the patient thereafter
As with any other antibiotic preparation, prolonged treatment may result in overgrowth of nonsusceptible organisms and fungi; if the infection is not improved after one week, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed
Treatment should not be continued for longer than ten days
Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for treatment of future infections
Not for use in eyes
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies of this drug in pregnant women; not known whether therapy can cause fetal harm when administered to a pregnant woman
Administer during pregnancy only if potential benefit justifies potential risk to the fetus
Colistimethate sodium, the methanesulfonate salt of colistin, was not teratogenic in rats or rabbits given intramuscular doses up to 20 mg/kg (equivalent to 9.3 mg/kg of colisitin base, approximately 30 times (rats) or 55 times (rabbits) clinical daily dose based on body surface area and assuming 100% absorption from the ear)
Colistin has not been shown to have any adverse effects on developing embryo or fetus at doses relevant to amount that will be delivered ototopically at recommended clinical doses
Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, significant systemic levels of neomycin would not be anticipated when the drug is used as directed
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels; the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals
Lactation
Hydrocortisone and colistin sulfate appears in human milk following oral administration of the drugs; since systemic absorption of these drugs may occur when they are used topically, use caution when drug is used by a nursing woman
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.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
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Cortisporin-TC otic (ear) - | 3.3-3-10-0.5 mg/mL drops | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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