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

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:

REMEDYREPACK INC.

INN（国际名称）:

POLYMYXIN B SULFATE

组成:

POLYMYXIN B 10000 [USP'U] 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, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 5.5 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate, is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula: C 28 H 38 N 8 O 10 S Mol. Wt. 678.72 Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 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 is: Each mL contains: Actives: polymyxin B sulfate equal to 10,000 polymyxin B units, trimethoprim sulfate (equivalent to trimethoprim 1 mg); Inactives: purified water, sodium chloride. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 5.5). Preservative: benzalkonium chloride 0.004%

產品總結:

Polymyxin B sulfate and trimethoprim ophthalmic solution, USP* containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size: NDC: 70518-0271-00 PACKAGING: 1 in 1 CARTON, 10 mL in 1 BOTTLE DROPPER TYPE 0 Storage: Store at 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

授权状态:

Abbreviated New Drug Application

产品特点

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
REMEDYREPACK INC.
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POLYMYXIN B SULFATE
AND TRIMETHOPRIM
OPHTHALMIC SOLUTION, USP
(STERILE)
RX ONLY
FOR TOPICAL APPLICATION IN THE EYE
DESCRIPTION
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a
sterile antimicrobial
solution for topical ophthalmic use. It has pH of 4.0 to 5.5 and
osmolality of 270 to 310
mOsm/kg.
CHEMICAL NAMES:
Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)
pyrimidine sulfate, is a
white, odorless, crystalline powder with a molecular weight of 678.72
and the following
structural formula:
C
H
N
O
S Mol. Wt. 678.72
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 is:
28
38
8
10
1
2
EACH ML CONTAINS:Actives: polymyxin B sulfate equal to 10,000
polymyxin B units,
trimethoprim sulfate (equivalent to trimethoprim 1 mg); Inactives:
purified water, sodium
chloride. Sulfuric acid and, if necessary, sodium hydroxide may be
added to adjust pH
(4.0 – 5.5). Preservative: benzalkonium chloride 0.004%
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 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
compo