NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- neomycin sulfate, polymyxin b sulfate and hydrocortisone suspension

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Disponível em:

Sandoz Inc

DCI (Denominação Comum Internacional):

NEOMYCIN SULFATE

Composição:

NEOMYCIN 3.5 mg in 1 mL

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye [see Clinical Pharmacology: Microbiology ]. The particular anti-infective drugs in this product are act

Resumo do produto:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a bottle containing 7.5 mL. NDC 61314-641-75 SHAKE WELL BEFORE USING. Store at 20° to 25°C (68° to 77°F).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION
SANDOZ INC
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
OPHTHALMIC SUSPENSION, USP
RX ONLY
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is a
sterile antimicrobial and anti-inflammatory suspension for ophthalmic
use.
EACH ML CONTAINS: ACTIVES: neomycin sulfate (equivalent to 3.5 mg
neomycin base),
polymyxin B sulfate equivalent to 10,000 polymyxin B units, and
hydrocortisone 10 mg
(1%). PRESERVATIVE: thimerosal 0.001%. INACTIVES: cetyl alcohol,
glyceryl
monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol,
sulfuric acid (to adjust
pH) and water for injection.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are
produced by the
growth of _Streptomyces fradiae _Waksman (Fam. Streptomycetacae). It
has a potency
equivalent to not less than 600 μg of neomycin standard per mg,
calculated on an
anhydrous basis. Its structural formula are:
Neomycin B (R =H, R =CH NH )
Neomycin C (R =CH NH , R =H)
Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, 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. Its
structural formula are:
1
2
2
2
1
2
2
2
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an
anti-inflammatory
hormone. Its structural formula is:
CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to a variety of
agents, and they
probably delay or slow healing. Since corticosteroids may inhibit the
body's defense
mechanism against infection, concomitant antimicrobial drugs may be
used when this
inhibition is considered to be clinically significant in a particular
case.
When a decision to administer both a corticosteroid and antimicrobials
is made, the
administration of such drugs in combination has the advantage of
greater