POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- polymyxin b sulfate, trimethoprim sulfate solution/ drops

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

A-S Medication Solutions

INN (International Name):

POLYMYXIN B SULFATE

Sammensætning:

POLYMYXIN B 10000 [USP'U] in 1 mL

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Product: 50090-2064 NDC: 50090-2064-0 10 mL in a BOTTLE, DROPPER

Autorisation status:

New Drug Application Authorized Generic

Produktets egenskaber

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- POLYMYXIN B SULFATE,
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
A-S MEDICATION SOLUTIONS
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POLYMYXIN B SULFATE AND TRIMETHOPRIM
OPHTHALMIC SOLUTION, USP
S TERILE
DESCRIPTION
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a
sterile antimicrobial solution for
topical ophthalmic use.
CHEMICAL NAMES: Trimethoprim sulfate,
2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate
(2:1), is a white, odorless, crystalline powder with a molecular
weight of 678.72 and the following
structural formula:
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:
CONTAINS: ACTIVES: polymyxin B sulfate 10,000 units/mL; trimethoprim
sulfate equivalent to 1 mg/mL.
PRESERVATIVE: benzalkonium chloride 0.04 mg/mL. INACTIVES: purified
water; sodium chloride; and
sulfuric acid. May also contain sodium hydroxide for pH adjustment. It
has pH of 4.0 to 6.2 and
osmolality of 270 to 310 mOsm/kg.
CLINICAL PHARMACOLOGY
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
1
2
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