POLYMYXIN B SULFATE AND TRIMETHOPRIM solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Trimethoprim sulfate (UNII: E377MF8EQ8) (Trimethoprim - UNII:AN164J8Y0X), Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)

제공처:

Akorn

INN (International Name):

Trimethoprim sulfate

구성:

Trimethoprim 1 mg in 1 mL

관리 경로:

OPHTHALMIC

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 influenza 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.

제품 요약:

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is supplied as a sterile solution in plastic dropper bottles in the following size: 10 mL in a 10 mL bottle NDC 17478-703-11 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. WARNING – KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Akorn Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 ATP00N Rev. 03/22

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SOLUTION
AKORN
----------
POLYMYXIN B SULFATE AND TRIMETHOPRIM OPHTHALMIC SOLUTION
RX ONLY
DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile
antimicrobial
solution for topical ophthalmic use. Trimethoprim sulfate,
2,4-diamino-5-(3,4,5-
trimethoxybenzyl)pyrimidine sulfate (2:1), occurs as a white,
odorless, crystalline
powder with a molecular weight of 678.72. The structural formula is as
follows:
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 as follows:
EACH ML CONTAINS:
ACTIVES: Trimethoprim Sulfate equivalent to Trimethoprim 1 mg (0.1%)
and Polymyxin B
Sulfate 10,000 units. Preservative: Benzalkonium Chloride 0.04 mg
(0.004%). INACTIVES:
Sodium Chloride, Sulfuric Acid and Sodium Hydroxide may be added to
adjust pH (3.0 to
5.5), and Water for Injection.
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. For
that reason,
trimethoprim 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.
When used topically, trimethoprim and polymyxin B absorption through
intact skin and
mucous membranes is insignificant.
Bloo