POLYMYXIN B SULFATE AND TRIMETHOPRIM solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

STAT RX LLC USA

INN（国际名称）:

POLYMYXIN B SULFATE

组成:

POLYMYXIN B SULFATE 10000 in 1 mL

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution 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 is contraindicated in patients with known hypersensitivity to any of its components.

產品總結:

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile solution. Each mL contains trimethoprim sulfate equivalent to 1 mg trimethoprim and polymyxin B sulfate 10,000 units in a plastic dropper bottle of 10 mL (NDC 61314-628-10). Storage: Store at 15° - 25°C (59° - 77°F) and protect from light. Rx Only Dist. by: FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Rev: January 2003 Printed in USA 340176-0103

授权状态:

Abbreviated New Drug Application

产品特点

POLYMYXIN B SULFATE AND TRIMETHOPRIM - POLYMYXIN B SULFATE AND
TRIMETHOPRIM SOLUTION
STAT RX LLC USA
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DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile
antimicrobial solution for
topical ophthalmic use. It has a pH of 4.0 to 6.2 and osmolality of
270 to 310 mOsm/kg.
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 formula are:
CONTAINS: ACTIVES: polymyxin B sulfate 10,000 units/mL; trimethoprim
sulfate equivalent to
trimethoprim 1mg/mL. PRESERVATIVE: benzalkonium chloride 0.04 mg/mL.
INACTIVES: sodium chloride;
sulfuric acid and purified water. May also contain sodium hydroxide
for pH adjustment.
1
2
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 very much 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 rapidly 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 containi