Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: 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)
NuCare Pharmaceuticals,Inc.
HYDROCORTISONE
HYDROCORTISONE 10 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
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: NDC 68071-4229-1 Bottles of 10 mL Store at 15°-25°C (59°-77°F). Rx only FOR USE IN EARS 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 SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION/ DROPS NUCARE PHARMACEUTICALS,INC. ---------- 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 1 2 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: 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 aga Baca dokumen lengkap