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:

Dispensing Solutions, Inc.

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 in the following size: 10 mL – Prod. No. 03409 Store between 15° – 30° C (59°– 86° F). PROTECT FROM LIGHT. KEEP OUT OF REACH OF CHILDREN. Revised August 2007

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN - NEOMYCIN SULFATE,
POLYMYXIN B SULFATE AND GRAMICIDIN SOLUTION/ DROPS
DISPENSING SOLUTIONS, INC.
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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 ADDED: 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:
l
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 _Bacillusbrevis _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