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:

Bausch & Lomb Incorporated

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 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 a natural high density polyethylene (HDPE) cannula and a white HDPE cap. NDC 24208-780-55 – 3.5 g tube Caution: Federal law prohibits dispensing without a prescription. FOR TOPICAL OPHTHALMIC USE Storage: Store between 15°C to 25°C (59°F to 77°F). Keep tightly closed when not in use. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: 06/2023 9796800 (Folded) 9796900 (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
BAUSCH & LOMB INCORPORATED
----------
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 topical 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 and 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
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:
1
2
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 a potency of not less than 40
bacitracin units per mg.
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