Country: United States
Language: English
Source: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
Aidarex Pharmaceuticals LLC
DEXAMETHASONE
DEXAMETHASONE 1 mg in 1 g
OPHTHALMIC
PRESCRIPTION DRUG
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or 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 conjunctivitises 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 drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus , Escherichia coli, Haemophilus influenzae , Klebsiella / Enterob
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment USP is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. 3.5 GRAM in a TUBE/1 TUBE in a CARTON (53217-289-01) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE OINTMENT AIDAREX PHARMACEUTICALS LLC ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC OINTMENT USP STERILE RX ONLY DESCRIPTION: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is a multiple dose anti-infective steroid combination in a sterile ointment for topical application. The active ingredient dexamethasone, is represented by the following structural formula: C H FO Mol. Wt. 392.47 Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11, 17,21-trihydroxy-16-methyl-, (11ß, 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 are: 22 29 5 Polymyxin B Sulfate is the sulfate salt of polymyxin B and B 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 are: Each gram of ointment contains: ACTIVES: Dexamethasone 1 mg (0.1%), Neomycin Sulfate equivalent to Neomycin 3.5 mg base, Polymyxin B Sulfate 10,000 units in a base containing INACTIVES: White Petrolatum and Mineral Oil. CLINICAL PHARMACOLOGY: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infections, 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 corticoid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and 1 2 convenience, with the added assurance that the appropriate do Read the complete document