देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
Unit Dose Services
NEOMYCIN SULFATE
NEOMYCIN 3.5 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPS UNIT DOSE SERVICES ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC SUSPENSION, USP (STERILE) RX ONLY 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 H FO 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 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 is: 22 29 5 1 2 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% 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 antimicr पूरा दस्तावेज़ पढ़ें