NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN- neomycin sulfate, polymyxin b sulfate and gramicidin solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), GRAMICIDIN (UNII: 5IE62321P4) (GRAMICIDIN - UNII:5IE62321P4)

Tilgjengelig fra:

Bausch & Lomb Incorporated

INN (International Name):

NEOMYCIN SULFATE

Sammensetning:

NEOMYCIN 1.75 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution 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. This product is contraindicated in those persons who have shown hypersensitivity to any of its components.

Produkt oppsummering:

Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is supplied in a plastic squeeze bottle with a controlled drop tip and a natural cap in the following size: NDC 24208-790-62 - 10 mL Store between 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. Keep out of reach of children.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN OPHTHALMIC SOLUTION,
USP
(Sterile)
RX ONLY
DESCRIPTION
Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution,
USP is a sterile
antimicrobial solution for ophthalmic use.
EACH ML CONTAINS: ACTIVES: neomycin sulfate, (equivalent to 1.75 mg
neomycin
base), polymyxin B sulfate equal to 10,000 polymyxin B units,
gramicidin, 0.025 mg;
INACTIVES: sodium chloride, alcohol (0.5%), Poloxamer 188, propylene
glycol, purified
water. Hydrochloric acid and/or ammonium hydroxide may be added to
adjust pH (4.7-
6.0).
PRESERVATIVE: thimerosal 0.001%.
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 base 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:
1
2
Gramicidin (also called gramicidin D) is a mixture of three pairs of
antibacterial
substances (Gramicidin A, B and C) produced by the growth of _Bacillus
brevis _Dubos
(Fam. Bacillaceae). It has a potency of not less than 900 mcg of
standard gramicidin per
mg. The structural formulae are:
CLINICAL PHARMACOLOGY
A wide range of antibacterial action is provided by the overlapping
spectra of neomycin,
polymyxin B sulfate, and gramicidin.
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 bac