NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC ointment

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Rising Pharma Holdings, Inc.

Կառավարման երթուղին:

OPHTHALMIC

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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.

Ապրանքի ամփոփագիր:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is supplied in a tube of 1/8 oz (3.5 g) with an ophthalmic tip (NDC 16571-754-53). Caution: Federal law prohibits dispensing without a prescription. Store at 15°C to 25°C (59°F to 77°F). FOR TOPICAL OPHTHALMIC USE Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 02/2021 PIA75453-00 Made in Canada

Լիազորման կարգավիճակը:

New Drug Application Authorized Generic

Ապրանքի հատկությունները

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC - NEOMYCIN
AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT
RISING PHARMA HOLDINGS, INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OPHTHALMIC
OINTMENT,
USP STERILE
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic
Ointment, USP is a
sterile antimicrobial ointment for topical ophthalmic use. Each gram
contains: 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 and 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 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 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