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

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297), Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K), Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)

Prieinama:

MWI

INN (Tarptautinis Pavadinimas):

Neomycin Sulfate

Sudėtis:

Neomycin 3.5 mg in 1 g

Vartojimo būdas:

OPHTHALMIC

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP 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, USP is contraindicated in individuals who have shown hypersensitivity to any of its components.

Produkto santrauka:

Tube of 1/8 oz. (3.5 g) with ophthalmic tip. NDC13985-607-03 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. apexa ™ Manufactured by: Akorn Inc. Lake Forest IL 60045 Distributed by: MWI Boise, ID 83705 MWNP00N    Rev. 10/15

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC OINTMENT
MWI
----------
APEXA™
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:
Neomycin Sulfate
(equivalent to 3.5 mg neomycin base), Polymyxin B sulfate equal to
10,000 polymyxin B
units, bacitracin zinc equal to 400 bacitracin units, and white
petrolatum, q.s.
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:
Polymyxin B sulfate is the sulfate salt of polymyxin B and B , which
are produced by
the growth _of Bacillus palymyxa_ (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:
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
_lichenifoimis_ group
of _Bacillus subtilis_ var Tracy. It has a potency of not less than 40
bacitracin units per mg.
The structural formula is:
1
2
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 cell membrane by interacting with the
phospholipid
components of the m