NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC- neomycin sulfate, polymyxin b sulfate and bacitracin zinc ointment

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)

Tilgængelig fra:

MWI

INN (International Name):

NEOMYCIN SULFATE

Sammensætning:

NEOMYCIN 3.5 mg in 1 g

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Produkt oversigt:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip. NDC 13985-746-35 – 3.5 g tube DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY Store between 15° - 25°C (59°- 77°F). Keep tightly closed when not in use. KEEP OUT OF REACH OF CHILDREN. Revised 10/2016 Manufactured by: Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Distributed by: MWI Boise, ID 83705 9563900 (Folded) 9562700 (Flat)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND BACITRACIN ZINC OINTMENT
MWI
----------
NEOMYCIN AND POLYMYXIN B SULFATES
AND BACITRACIN ZINC OPHTHALMIC
OINTMENT, USP (STERILE)
RX ONLY
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic
Ointment USP is a sterile
antimicrobial ointment for ophthalmic use.
EACH GRAM CONTAINS
ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg neomycin base),
Polymyxin B Sulfate equivalent to
10,000 polymyxin B units, and Bacitracin Zinc equivalent to 400
bacitracin units; INACTIVES: White
Petrolatum, Mineral Oil.
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:
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:
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related
cyclic polypeptides (mainly bacitracin
A) produced by the growth of an organism of the _licheniformis _group
of _Bacillus subtilis _var Tracy. It has
1
2
a potency of not less than 40 bacitracin units per milligram.
The structural formula for bacitracin A is:
CLINICAL PHARMACOLOGY
A wide range of antibacterial action is provided by the overlapping
spectra of neomycin, polymyxin B
sulfate, and bacitracin.
Neomycin is bactericidal for many gram-positive and gram-negative
organisms. It is an aminoglycoside
antibiotic which inhibits protein synthesis by binding with ribosomal
RNA and causing misreading of
the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms.
It increases the permeability of
the bacterial c