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

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
20-11-2018

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:

Putney, Inc.

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 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. NDC 26637-841-41 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Putney, Inc. Portland, ME 04101 USA 1-866-683-0660 PUTNEY Rev. April 2015 8T900 L7 J1 Ini0215

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

                                NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE, BACITRACIN ZINC OINTMENT
PUTNEY, INC.
----------
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 is a sterile antimicrobial
ointment for ophthalmic use. Each gram contains: neomycin sulfate
equivalent to 3.5 mg neomycin base,
polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin
zinc equivalent to 400 bacitracin
units in a white petrolatum and mineral oil base.
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
μg 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 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 cell membrane by interacting with the phospholipid
c
                                
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