দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Sandoz Inc
NEOMYCIN SULFATE
NEOMYCIN 3.5 mg in 1 g
OPHTHALMIC
PRESCRIPTION DRUG
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 steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is supplied as a STERILE ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment can be used until the expiration date on the tube. Distributed by: Sandoz Inc. Princeton, NJ 08540 T2021-98 May 2021 450573 US
New Drug Application Authorized Generic
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT SANDOZ INC ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC OINTMENT STERILE DESCRIPTION Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is: Neomycin B (R =H, R =CH NH ) Neomycin C (R =CH NH , R =H) The chemical structure for the active ingredient Polymyxin B Sulfate is: 1 2 2 2 1 2 2 2 The chemical structure for the active ingredient Dexamethasone is: C H FO MOLECULAR WEIGHT = 392.47 G/MOL ESTABLISHED NAME: dexamethasone CHEMICAL NAME: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16- methyl-, (11β, 16α)-. EACH GRAM OF NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC OINTMENT CONTAINS: ACTIVE: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. PRESERVATIVES: methylparaben 0.05%, propylparaben 0.01%. INACTIVES: anhydrous liquid lanolin and white petrolatum. 22 29 5 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 m সম্পূর্ণ নথি পড়ুন