Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
DIRECT RX
HYDROCORTISONE
HYDROCORTISONE 10 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
- For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics. For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is supplied in a white plastic dropper bottle in the following size: 10 mL bottles - NDC 24208-635-62 Storage: Store at 15°-25°C (59°-77°F). FOR OTIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS DIRECT RX ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE DESCRIPTION SECTION Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is a sterile antibacterial and anti-inflammatory suspension for otic use. 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 of not less than 600 micrograms of neomycin standard per milligram, calculated on an anhydrous basis. The structural formulae are: [Neomycin Sulfate (structural formula)] Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2, 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: [Polymyxin B Sulfate (structural formula)] Hydrocortisone 11β,17, 21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory hormone. Its structural formula is: [Hydrocortisone (structural formula)] C21H30O5 Mol. Wt. 362.47 Each mL Contains: ACTIVES: Hydrocortisone, 10 mg (1%), Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate, equal to 10,000 polymyxin B units; 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%. CLINICAL PHARMACOLOGY SECTION 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 sul Прочитать полный документ