Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension (Cortisporin Otic Suspension)
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Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension (Cortisporin Otic Suspension)

CORTISPORIN® Otic Suspension
(neomycin and polymyxin B sulfates and hydrocortisone) Otic Suspension, USP

DRUG DESCRIPTION

CORTISPORIN® Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, and Water for Injection. Sulfuric acid may be added to adjust pH.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Neomycin sulfate structural formula illustration

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate structural formula illustration

Hydrocortisone, 11b,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

Hydrocortisone structural formula illustration

What are the precautions when taking neomycin and polymyxin b sulfates and hydrocortisone otic suspension (Cortisporin Otic Suspension)?

Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin), or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like sulfites, thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an ear infection caused by a virus (e.g., herpes simplex, varicella).

Before using...

Read All Potential Precautions of Cortisporin Otic Suspension »

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

DOSAGE AND ADMINISTRATION

Therapy with this product should be limited to 10 consecutive days.

The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.

For adults, 4 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal.

The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours. The wick should be replaced at least once every 24 hours.

SHAKE WELL BEFORE USING.

HOW SUPPLIED

Bottle of 10 mL with sterilized dropper. (NDC 61570-033-10).

Store at 15° to 25°C (59° to 77°F).

Also Available: CORTISPORIN® Otic Solution bottle of 10 mL with sterilized dropper. PEDIOTIC® Suspension bottle of 7.5 mL with sterilized dropper.

Prescribing Information as of November 2003. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834. FDA Rev date: 8/10/2000

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population.2 In another study, the incidence was found to be approximately 1%.3

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Stinging and burning have been reported rarely when this drug has gained access to the middle ear.

Read the Cortisporin Otic Suspension (neomycin and polymyxin b sulfates and hydrocortisone otic suspension) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

REFERENCES

2. Leyden JJ, Kligman AM. Contact dermatitis to neomycin sulfate. JAMA. 1979;242:1276-1278.

3. Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odom RB, Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and ben- zocaine: relationship between age, sex, history of exposure, and reactivity to standard patch and use tests in a general population. Arch Dermatol. 1979;115:959-962.

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be limited to 10 consecutive days (see PRECAUTIONS-General). Patients being treated with eardrops containing neomycin should be under close clinical observation. CORTISPORIN® Otic Suspension (neomycin and polymyxin b sulfates and hydrocortisone otic suspension) should not be used in any patient with a perforated tympanic membrane. Discontinue promptly if sensitization or irritation occurs. Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. 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 a low-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.

PRECAUTIONS

General: As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed. Tr eatment should not be continued for longer than 10 days. Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Laboratory Tests: Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when CORTISPORIN® Otic Suspension is used by a nursing woman.

Pediatric Use: The safety and effectiveness of CORTISPORIN® Otic Suspension in otitis extema have been established in the pediatric age group 2 years to 16 years of age. There is inadequate data to establish safety and effectiveness in otitis extema for pediatric patients under 2 years of age.1

Geriatric Use: Clinical studies of CORTISPORIN® Otic Suspension (neomycin and polymyxin b sulfates and hydrocortisone otic suspension) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identi- fied differences in responses between the elderly and younger patients.

REFERENCES

1. Jones RN, Milazzo J, Seidlin M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surgery 1997; 123:1193-1200.

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella- Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Avoid contaminating the dropper with material from the ear, fingers, or other source. This caution is necessary if the sterility of the drops is to be preserved. If sensitization or irritation occurs, discontinue use immediately and contact your physician.

Do not use in the eyes.

SHAKE WELL BEFORE USING.

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Avoid contaminating the dropper with material from the ear, fingers, or other source. This caution is necessary if the sterility of the drops is to be preserved. If sensitization or irritation occurs, discontinue use immediately and contact your physician.

Do not use in the eyes.

SHAKE WELL BEFORE USING.

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Cortisporin Otic Suspension Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NEOMYCIN/POLYMYXIN/HYDROCORTISONE SUSPENSION - OTIC

(nee-oh-MY-sin/paw-lee-MIX-in/hi-dro-KOR-tih-sown)

COMMON BRAND NAME(S): Cortisporin, Otimar, Pediotic

USES: This ear drop is used to treat outer ear infections caused by bacteria (also known as swimmer's ear). This medication contains neomycin and polymyxin, which are antibiotics that work by stopping the growth of bacteria. It also contains hydrocortisone, which is an anti-inflammatory corticosteroid that works by reducing ear swelling and discomfort.

This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: This medication is usually used 3 or 4 times a day or as directed by your doctor. The ear canal should be clean and dry before using this medication.

For accuracy and to avoid contamination, have another person insert the drops if possible. Before using, hold the container in your hand for a few minutes in order to warm it. This will minimize dizziness.

To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Shake the container well before using.

Lie on your side with the treated ear upward. Hold the dropper directly over the ear and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. For children, hold the earlobe down and back. Keep the head tilted with the treated ear upward for 5 minutes or insert a soft cotton plug if so directed. Another way to give this medication is to place a cotton wick in the ear canal and moisten it with the prescribed number of drops as often as directed. The wick should be replaced at least once a day.

Repeat the above steps for the other ear if so directed. Do not rinse the dropper. Replace the cap after use.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed, even if symptoms disappear after a few days. Stopping this medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Do not use this medication more often than prescribed or continue to use it for longer than 10 days.

Inform your doctor if your condition persists or worsens.

Do not use in the eye.

Disclaimer

Cortisporin Otic Suspension Consumer (continued)

SIDE EFFECTS: This medication may temporarily sting or burn your ear for a minute or two when applied. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this rare but very serious side effect occurs: hearing problems (e.g., hearing loss).

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), redness of the ears, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Cortisporin Otic Suspension (neomycin and polymyxin b sulfates and hydrocortisone otic suspension) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin), or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like sulfites, thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an ear infection caused by a virus (e.g., herpes simplex, varicella).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Cortisporin Otic Suspension Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

It is important to keep the infected ear(s) clean and dry. Try not to get the infected ear(s) wet when bathing. Avoid swimming unless your doctor tells you otherwise.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: This medication may be stored in the refrigerator or at room temperature between 59-86 degrees F (15-30 degrees C) away from heat and light. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2010. Copyright(c) 2010 First Databank, Inc.

CORTISPORIN® Otic Suspension
(neomycin and polymyxin B sulfates and hydrocortisone) Otic Suspension, USP

DRUG DESCRIPTION

CORTISPORIN® Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, and Water for Injection. Sulfuric acid may be added to adjust pH.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Neomycin sulfate structural formula illustration

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate structural formula illustration

Hydrocortisone, 11b,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

Hydrocortisone structural formula illustration

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CORTISPORIN® Otic Suspension
(neomycin and polymyxin B sulfates and hydrocortisone) Otic Suspension, USP

DRUG DESCRIPTION

CORTISPORIN® Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, and Water for Injection. Sulfuric acid may be added to adjust pH.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Neomycin sulfate structural formula illustration

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate structural formula illustration

Hydrocortisone, 11b,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

Hydrocortisone structural formula illustration

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CORTISPORIN® Otic Suspension
(neomycin and polymyxin B sulfates and hydrocortisone) Otic Suspension, USP

DRUG DESCRIPTION

CORTISPORIN® Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, and Water for Injection. Sulfuric acid may be added to adjust pH.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Neomycin sulfate structural formula illustration

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate structural formula illustration

Hydrocortisone, 11b,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

Hydrocortisone structural formula illustration

Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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