Casporyn

What is Casporyn HC and how is it used?

Casporyn is a prescription medicine used to treat the symptoms of Steroid Responsive Dermatoses with Infection. Casporyn may be used alone or with other medications.

Casporyn belongs to a class of drugs called Antibacterials, Topicals.

It is not known if Casporyn is safe and effective in children.

What are the possible side effects of Casporyn?

Casporyn may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• hearing problems,
• ringing in your ears,
• feeling of fullness in the ears,
• spinning sensation,
• nausea,
• lightheadedness,
• loss of balance or coordination,
• trouble walking,
• numbness or tingly feeling under your skin,
• muscle twitching,
• seizure,
• little or no urination,
• drowsiness,
• confusion,
• mood changes,
• increased thirst,
• loss of appetite,
• vomiting,
• swelling,
• weight gain,
• shortness of breath,
• weak or shallow breathing,
• severe stomach cramps, and
• diarrhea that is watery or bloody

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Casporyn include:

• mild nausea,
• vomiting, and
• mild diarrhea

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Casporyn. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

CASPORYN HC Optic 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:

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:

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

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 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

10 mL bottle (NDC 70199-011-10). Store at 15° to 25°C (59° to 77°F).

Manufactured for: Casper Pharma LLC East Brunswick, NJ 08816. Revised: Apr 2019

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. CASPORYN HC 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.

Treatment 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.

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

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 CASPORYN HC is used by a nursing woman.

Pediatric Use

The safety and effectiveness of CASPORYN HC in otitis externa have been established in pediatric patients.

Geriatric Use

Clinical studies of CASPORYN HC 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 identified differences in responses between the elderly and younger patients.

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.

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.

PATIENT INFORMATION

Avoid contaminating the bottle tip 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.

SHAKE WELL BEFORE USING.