Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Unit Dose Services
HYDROCORTISONE
HYDROCORTISONE 10 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION/ DROPS UNIT DOSE SERVICES ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION, USP (STERILE) RX ONLY DESCRIPTION Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP, is a sterile antibacterial and anti-inflammatory suspension for otic use. EACH ML CONTAINS: _ACTIVES:_Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate, equal to 10,000 polymyxin B units, and Hydrocortisone, 10 mg (1%); _INACTIVES:_Cetyl Alcohol (0.9%), Polysorbate 80, Propylene Glycol, Purified Water. Sulfuric Acid may be added to adjust pH (3.0 - 7.0). _PRESERVATIVE ADDED:_Thimerosal 0.01%. 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 standard per milligram, calculated on an anhydrous basis. The structural formulae are: 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 formulae are: 1 2 Hydrocortisone 11β, 17, 21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory hormone. Its structural formula is: C H O Mol. Wt. 362.46 CLINICAL PHARMACOLOGY Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids 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. The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate together are considered active against the Aqra d-dokument sħiħ