POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE solution/ drops

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), TRIMETHOPRIM SULFATE (UNII: E377MF8EQ8) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Disponível em:

DIRECT RX

DCI (Denominação Comum Internacional):

POLYMYXIN B SULFATE

Composição:

POLYMYXIN B 10000 [USP'U] in 1 mL

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.* *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is contraindicated in patients with known hypersensivitity to any of its components.

Resumo do produto:

Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with white high impact polystyrene (HIPS) caps as follows: 10 mL in 10 mL bottle - NDC 60758-908-10 Storage: Store at 15°-25°C (59°-77°F) and protect from light. Revised: 11/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A.

Status de autorização:

New Drug Application Authorized Generic

Características técnicas

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- POLYMYXIN B SULFATE
AND TRIMETHOPRIM SULFATE SOLUTION/ DROPS
DIRECT RX
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POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
CLINICAL PHARMACOLOGY SECTION
Trimethoprim is a synthetic antibacterial drug active against a wide
variety of aerobic
gram-positive and gram-negative ophthalmic pathogens. Trimethoprim
blocks the
production of tetrahydrofolic acid from dihydrofolic acid by binding
to and reversibly
inhibiting the enzyme dihydrofolate reductase. This binding is
stronger for the bacterial
enzyme than for the corresponding mammalian enzyme, and therefore,
selectively
interferes with bacterial biosynthesis of nucleic acids and proteins.
Polymyxin B, a cyclic lipopeptide antibiotic, is bactericidal for a
variety of gram-negative
organisms, especially Pseudomonas aeruginosa. It increases the
permeability of the
bacterial cell membrane by interacting with the phospholipid
components of the
membrane.
Blood samples were obtained from 11 human volunteers at 20 minutes, 1
hour and 3
hours following instillation in the eye of 2 drops of ophthalmic
solution containing 1 mg
trimethoprim and 10,000 units polymyxin B per mL. Peak serum
concentrations were
approximately 0.03 mcg/mL trimethoprim and 1 unit/mL polymyxin B.
Microbiology
In vitro studies have demonstrated that the anti-infective components
of polymyxin B
sulfate and trimethoprim ophthalmic solution, USP are active against
the following
bacterial pathogens that are capable of causing external infections of
the eye:
Trimethoprim: Staphylococcus aureus and Staphylococcus epidermidis,
Streptococcus
pyogenes, Streptococcus faecalis, Streptococcus pneumoniae,
Haemophilus influenzae,
Haemophilus aegyptius, Escherichia coli, Klebsiella pneumoniae,
Proteus mirabilis (indole-
negative), Proteus vulgaris (indole-positive), Enterobacter aerogenes
and Serratia
marcescens.
Polymyxin B: Pseudomonas aeruginosa, Escherichia coli, Klebsiella
pneumoniae,
Enterobacter aerogenes and Haemophilus influenzae.
INDICATIONS & USAGE SECTION