Cortisporin
 Cortisporin Cream

drug-information.ru

|Cortisporin Cortisporin Cream

Drugs search, click the first letter of a drug name:


| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9  Home

Cortisporin


Generic Name: neomycin sulfate, polymyxin B sulfate, bacitracin zinc and hydrocortisone
Dosage Form: Ophthalmic ointment

Description

Cortisporin® Ophthalmic Ointment (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment) is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and white petrolatum, q.s.

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 µg 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:

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

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

Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

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

Microbiology: The anti-infective components in Cortisporin Ophthalmic Ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens (see INDICATIONS AND USAGE).

Indications and Usage

Cortisporin Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus , streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseria species, and Pseudomonas aeruginosa.

The product does not provide adequate coverage against Serratia marcescens.

Contraindications

Cortisporin Ophthalmic Ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Cortisporin Ophthalmic Ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

Warnings

NOT FOR INJECTION INTO THE EYE. Cortisporin Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Use of the ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

Precautions

General

The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

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.

Information for Patients

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentrations (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size, or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Corticosteroids have been found 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. Cortisporin Ophthalmic Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from Cortisporin Ophthalmic Ointment, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of the secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Local irritation on installation has been reported.

Dosage and Administration

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

How Supplied

Tube of 1/8 oz. (3.5 g) with ophthalmic tip (NDC 61570-035-35).

Rx only.

Store at 15° to 25°C (59° to 77°F).

Rev. 9/98

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Draxis Pharma, Inc., Kirkland, Quebec H9H 4J4


Cortisporin (neomycin sulfate, polymyxin B sulfate, bacitracin zinc and hydrocortisone)
PRODUCT INFO
Product Code 61570-035 Dosage Form OINTMENT
Route Of Administration OPHTHALMIC DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
neomycin sulfate (neomycin) Active 3.5 MILLIGRAM  In 1 GRAM
polymyxin B sulfate (polymyxin B) Active 10000 UNITS  In 1 GRAM
bacitracin zinc (bacitracin) Active 400 UNITS  In 1 GRAM
hydrocortisone (hydrocortisone) Active 10 MILLIGRAM  In 1 GRAM
petrolatum Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 61570-035-35 3.5 GRAM In 1 TUBE None

Revised: 10/2006





Where can I get more information about Cortisporin Cortisporin Cream ? We recommend to use www.Drugs.com

Typical mistypes for Cortisporin Cortisporin Cream
xortisporin cortisporin cream, vortisporin cortisporin cream, fortisporin cortisporin cream, dortisporin cortisporin cream, cirtisporin cortisporin cream, ckrtisporin cortisporin cream, clrtisporin cortisporin cream, cprtisporin cortisporin cream, c0rtisporin cortisporin cream, c9rtisporin cortisporin cream, coetisporin cortisporin cream, codtisporin cortisporin cream, coftisporin cortisporin cream, cottisporin cortisporin cream, co5tisporin cortisporin cream, co4tisporin cortisporin cream, corrisporin cortisporin cream, corfisporin cortisporin cream, corgisporin cortisporin cream, coryisporin cortisporin cream, cor6isporin cortisporin cream, cor5isporin cortisporin cream, cortusporin cortisporin cream, cortjsporin cortisporin cream, cortksporin cortisporin cream, cortosporin cortisporin cream, cort9sporin cortisporin cream, cort8sporin cortisporin cream, cortiaporin cortisporin cream, cortizporin cortisporin cream, cortixporin cortisporin cream, cortidporin cortisporin cream, cortieporin cortisporin cream, cortiwporin cortisporin cream, cortisoorin cortisporin cream, cortislorin cortisporin cream, cortis-orin cortisporin cream, cortis0orin cortisporin cream, cortispirin cortisporin cream, cortispkrin cortisporin cream, cortisplrin cortisporin cream, cortispprin cortisporin cream, cortisp0rin cortisporin cream, cortisp9rin cortisporin cream, cortispoein cortisporin cream, cortispodin cortisporin cream, cortispofin cortisporin cream, cortispotin cortisporin cream, cortispo5in cortisporin cream, cortispo4in cortisporin cream, cortisporun cortisporin cream, cortisporjn cortisporin cream, cortisporkn cortisporin cream, cortisporon cortisporin cream, cortispor9n cortisporin cream, cortispor8n cortisporin cream, cortisporib cortisporin cream, cortisporim cortisporin cream, cortisporij cortisporin cream, cortisporih cortisporin cream, cortisporin xortisporin cream, cortisporin vortisporin cream, cortisporin fortisporin cream, cortisporin dortisporin cream, cortisporin cirtisporin cream, cortisporin ckrtisporin cream, cortisporin clrtisporin cream, cortisporin cprtisporin cream, cortisporin c0rtisporin cream, cortisporin c9rtisporin cream, cortisporin coetisporin cream, cortisporin codtisporin cream, cortisporin coftisporin cream, cortisporin cottisporin cream, cortisporin co5tisporin cream, cortisporin co4tisporin cream, cortisporin corrisporin cream, cortisporin corfisporin cream, cortisporin corgisporin cream, cortisporin coryisporin cream, cortisporin cor6isporin cream, cortisporin cor5isporin cream, cortisporin cortusporin cream, cortisporin cortjsporin cream, cortisporin cortksporin cream, cortisporin cortosporin cream, cortisporin cort9sporin cream, cortisporin cort8sporin cream, cortisporin cortiaporin cream, cortisporin cortizporin cream, cortisporin cortixporin cream, cortisporin cortidporin cream, cortisporin cortieporin cream, cortisporin cortiwporin cream, cortisporin cortisoorin cream, cortisporin cortislorin cream, cortisporin cortis-orin cream, cortisporin cortis0orin cream, cortisporin cortispirin cream, cortisporin cortispkrin cream, cortisporin cortisplrin cream, cortisporin cortispprin cream, cortisporin cortisp0rin cream, cortisporin cortisp9rin cream, cortisporin cortispoein cream, cortisporin cortispodin cream, cortisporin cortispofin cream, cortisporin cortispotin cream, cortisporin cortispo5in cream, cortisporin cortispo4in cream, cortisporin cortisporun cream, cortisporin cortisporjn cream, cortisporin cortisporkn cream, cortisporin cortisporon cream, cortisporin cortispor9n cream, cortisporin cortispor8n cream, cortisporin cortisporib cream, cortisporin cortisporim cream, cortisporin cortisporij cream, cortisporin cortisporih cream, cortisporin cortisporin xream, cortisporin cortisporin vream, cortisporin cortisporin fream, cortisporin cortisporin dream, cortisporin cortisporin ceeam, cortisporin cortisporin cdeam, cortisporin cortisporin cfeam, cortisporin cortisporin cteam, cortisporin cortisporin c5eam, cortisporin cortisporin c4eam, cortisporin cortisporin crwam, cortisporin cortisporin crsam, cortisporin cortisporin crdam, cortisporin cortisporin crram, cortisporin cortisporin cr4am, cortisporin cortisporin cr3am, cortisporin cortisporin crezm, cortisporin cortisporin cresm, cortisporin cortisporin crewm, cortisporin cortisporin creqm, cortisporin cortisporin crean, cortisporin cortisporin creak, cortisporin cortisporin creaj, ortisporin cortisporin cream, crtisporin cortisporin cream, cotisporin cortisporin cream, corisporin cortisporin cream, cortsporin cortisporin cream, cortiporin cortisporin cream, cortisorin cortisporin cream, cortisprin cortisporin cream, cortispoin cortisporin cream, cortisporn cortisporin cream, cortispori cortisporin cream, cortisporin cortisporin cream, cortisporin cortisporin cream, cortisporin ortisporin cream, cortisporin crtisporin cream, cortisporin cotisporin cream, cortisporin corisporin cream, cortisporin cortsporin cream, cortisporin cortiporin cream, cortisporin cortisorin cream, cortisporin cortisprin cream, cortisporin cortispoin cream, cortisporin cortisporn cream, cortisporin cortispori cream, cortisporin cortisporincream, cortisporin cortisporin ream, cortisporin cortisporin ceam, cortisporin cortisporin cram, cortisporin cortisporin crem, cortisporin cortisporin crea, ocrtisporin cortisporin cream, crotisporin cortisporin cream, cotrisporin cortisporin cream, coritsporin cortisporin cream, cortsiporin cortisporin cream, cortipsorin cortisporin cream, cortisoprin cortisporin cream, cortisproin cortisporin cream, cortispoirn cortisporin cream, cortisporni cortisporin cream, cortispori n cortisporin cream, cortisporin cortisporin cream, cortisporin c ortisporin cream, cortisporin ocrtisporin cream, cortisporin crotisporin cream, cortisporin cotrisporin cream, cortisporin coritsporin cream, cortisporin cortsiporin cream, cortisporin cortipsorin cream, cortisporin cortisoprin cream, cortisporin cortisproin cream, cortisporin cortispoirn cream, cortisporin cortisporni cream, cortisporin cortispori ncream, cortisporin cortisporinc ream, cortisporin cortisporin rceam, cortisporin cortisporin ceram, cortisporin cortisporin craem, cortisporin cortisporin crema, ccortisporin cortisporin cream, coortisporin cortisporin cream, corrtisporin cortisporin cream, corttisporin cortisporin cream, cortiisporin cortisporin cream, cortissporin cortisporin cream, cortispporin cortisporin cream, cortispoorin cortisporin cream, cortisporrin cortisporin cream, cortisporiin cortisporin cream, cortisporinn cortisporin cream, cortisporin cortisporin cream, cortisporin cortisporin cream, cortisporin ccortisporin cream, cortisporin coortisporin cream, cortisporin corrtisporin cream, cortisporin corttisporin cream, cortisporin cortiisporin cream, cortisporin cortissporin cream, cortisporin cortispporin cream, cortisporin cortispoorin cream, cortisporin cortisporrin cream, cortisporin cortisporiin cream, cortisporin cortisporinn cream, cortisporin cortisporin cream, cortisporin cortisporin ccream, cortisporin cortisporin crream, cortisporin cortisporin creeam, cortisporin cortisporin creaam, cortisporin cortisporin creamm, etc.



© Copyright by drug-information.ru 2001-2019. All rights reserved