POLYMYXIN B SULFATE AND TRIMETHOPRIM solution/ drops

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Доступно од:

Preferred Pharmaceuticals Inc.

INN (Међународно име):

POLYMYXIN B SULFATE

Састав:

POLYMYXIN B 10000 [USP'U] in 1 mL

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM
SULFATE SOLUTION/ DROPS
PREFERRED PHARMACEUTICALS INC.
----------
POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC SOLUTION, USP*
(Sterile)
RX ONLY
FOR TOPICAL APPLICATION IN THE EYE
*Does not meet USP packaging specification for light resistance.
DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP* 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:
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:
EACH ML CONTAINS: ACTIVES: Polymyxin B Sulfate equal to 10,000
polymyxin B units, Trimethoprim
28
38
8
10
1
2
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 –
6.2). PRESERVATIVE ADDED:
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 incr