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

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals Inc.

Administreringssätt:

OPHTHALMIC

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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: C28 H38 N8 O10 S Mol. Wt. 678.72 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. 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

Produktsammanfattning:

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 68788-8152-1 10 mL DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. 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. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Relabeled By: Preferred Pharmaceuticals Inc. Revised: June 2023 9117804 (Folded) 9117904 (Flat)

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
PREFERRED PHARMACEUTICALS INC.
----------
POLYMYXIN B SULFATE
ANDTRIMETHOPRIM
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 phos