Neomycin Polymyxin B Sulfates And Dexamethasone also known as Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone is a human prescription drug labeled by 'Medsource Pharmaceuticals'. National Drug Code (NDC) number for Neomycin Polymyxin B Sulfates And Dexamethasone is 45865-796. This drug is available in dosage form of Suspension/ Drops. The names of the active, medicinal ingredients in Neomycin Polymyxin B Sulfates And Dexamethasone drug includes Dexamethasone - 1 mg/mL Neomycin Sulfate - 3.5 mg/mL Polymyxin B Sulfate - 10000 [USP'U]/mL . The currest status of Neomycin Polymyxin B Sulfates And Dexamethasone drug is Active.

Neomycin polymyxin b sulfates and dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone sodium chloride hypromelloses polysorbate 20 water hydrochloric acid sodium hydroxide benzalkonium chloride neomycin sulfate neomycin polymyxin b sulfate polymyxin b dexamethasone dexamethasone

Indications and usage: for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular 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 corticosteroids 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. the particular anti-infective drug in this product is active against the following common bacterial eye pathogens: staphylococcus aureus, esche Read more...

Warnings: prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. if this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. steroids should be used with caution in the presence of glaucoma. intraocular pressure should be checked frequently. the use of steroids after cataract surgery may delay Read more...

General the initial prescription and renewal of the medication order beyond 20 ml of neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension 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. as fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. fungal cultures should be taken when appropriate. if this product is used for 10 days or longer, intraocular pressure should be monitored (see warnings ). prolonged use of topical antibacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.

Dosage and administration: one or two drops in the conjunctival sac(s). in severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. in mild disease, drops may be used up to four to six times daily. not more than 20 ml should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in precautions above. for topical ophthalmic use only. shake well before using.

Contraindications: neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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. exact incidence figures are not available since no denominator of treated patients is available. reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. the reactions due to the corticosteroid component are: elevation of intraocular pressure (iop) with possible development of glaucoma and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. corticosteroid-containing preparations have also been reported to cause perforation of the globe. keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following local use of steroids. to report suspected adverse reactions, contact bausch + lomb, a division of valeant pharmaceuticals north ameri Read more...

Pregnancy teratogenic effects pregnancy category c. dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. in the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. in the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. there are no adequate or well-controlled studies in pregnant women. neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Pediatric use safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Description: neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension, usp is a multiple dose anti-infective steroid combination in a sterile suspension for topical application. the active ingredient, dexamethasone, is represented by the following structural formula: c 22 h 29 fo 5 mol. wt. 392.47 chemical name: pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. 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 to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. the structural formula is: polymyxin b sulfate is the sulfate salt of polymyxin b 1 and b 2 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 milligram, calculated on an anhydrous basis. the structural formula is: each ml contains: actives: neomycin sulfate (equivalent to 3.5 mg neomycin), polymyxin b sulfate equal to 10,000 polymyxin b units, dexamethasone 1 mg (0.1%); inactives: sodium chloride, hypromellose, polysorbate 20, purified water. hydrochloric acid and/or sodium hydroxide may be added to adjust ph (3.5 – 6.0). preservative added: benzalkonium chloride 0.004% dexamethasone (structural formula) neomycin sulfate (structural formula) polymyxin b sulfate (structural formula)

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, a concomitant antimicrobial drug 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 an antimicrobial 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 both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that 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.

Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin b sulfate. treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 µg/ml) tested. however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. polymyxin b has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

How supplied: neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension, usp is supplied in a controlled drop tip bottle with a white cap in the following size: 5 ml - ndc 24208-830-60 do not use if imprinted neckband is not intact. storage: store between 15°-25° c (59°-77° f). store upright. keep out of reach of children. bausch + lomb, a division of valeant pharmaceuticals north america llc, bridgewater, nj 08807 usa ©bausch & lomb incorporated rev. 06/2016 9114203 (folded) 9114303 (flat)

Information for patients if inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. this product is sterile when packaged. to prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. the use of this bottle by more than one person may spread infection. keep bottle tightly closed when not in use. keep out of the reach of children.

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