POLYMYXIN B SULFATE AND TRIMETHOPRIM solution/ drops

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (Medzinárodný Name):

POLYMYXIN B SULFATE

Zloženie:

POLYMYXIN B 10000 [USP'U] in 1 mL

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM
SULFATE SOLUTION/ DROPS
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC SOLUTION USP
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. Trimethoprim
sulfate, a white, odorless, crystalline powder, is represented by the
following structural formula:
C
H N O S
Mol. Wt. 678.72
Chemical Name: Trimethoprim sulfate, 2,4-diamino-5-(3,4
5-trimethoxybenzyl)pyrimidine sulfate (2:1)
Polymyxin B sulfate is the sulfate salt of polymyxin B and B which are
produced by the growth of
_Bacilluspolymyxa _(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: Sodium Chloride,
Purified Water. 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 increases the permeability of
the bacterial cell membrane by
interacting with the phospholipid components o