Kraj: Stany Zjednoczone
Język: angielski
Źródło: 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)
Preferred Pharmaceuticals, Inc.
AURICULAR (OTIC)
PRESCRIPTION DRUG
INDICATIONS AND USAGE: 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. CONTRAINDICATIONS: This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.
How Supplied: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is available in a DROP-TAINER* bottle containing 10mL NDC 68788-7684-01. * DROP-TAINER is a Registered trademark of Alcon Research, Ltd. Store at 15° to 25°C (59° to 77°F). Rx Only Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP bottle of 10 mL with sterilized dropper.
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION PREFERRED PHARMACEUTICALS, INC. ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION, USP STERILE 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: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, glacial acetic acid and Water for Injection. 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 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formula are: Neomycin B (R =H, R =CH NH ) Neomycin C (R =CH NH , R =H) 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 formula are: 1 2 2 2 1 2 2 2 1 2 Hydrocortisone, 11β,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is: 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 ar Przeczytaj cały dokument