País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Bausch & Lomb Incoporated
NEOMYCIN SULFATE
NEOMYCIN 3.5 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. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).
Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is supplied in a white plastic dropper bottle in the following size: 10 mL - NDC 24208-631-10 Storage: Store between 15°C to 25°C (59°F to 77°F). Securely tighten cap between uses. Keep out of reach of children.
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE SOLUTION/ DROPS BAUSCH & LOMB INCOPORATED ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION, USP (STERILE) RX ONLY FOR USE IN EARS ONLY DESCRIPTION Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is a sterile antibacterial and anti-inflammatory solution for otic use. EACH ML CONTAINS: ACTIVES:neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%); INACTIVES: propylene glycol, hydrochloric acid, potassium metabisulfite, cupric sulfate, glycerin, purified water. The pH range is 2.0 to 4.5. 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 mg, 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 mg, calculated on an anhydrous basis. The structural formulae are: Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is an anti- inflammatory hormone. Its structural formula is: 1 2 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 following microorganisms: _Staphylococcus_ _a Leer el documento completo