POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- polymyxin b sulfate, 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.

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Polymyxin B sulfate and trimethoprim ophthalmic solution, USP 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 virida ns, Haemophilus influenzae 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, USP is contraindicated in patients with known hypersensitivity to any of its components.

產品總結:

Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with white high impact polystyrene (HIPS) caps as follows: NDC: 70518-3206-00 PACKAGING: 1 in 1 CARTON, 10 mL in 1 BOTTLE DROPPER, TYPE 0 Storage: Store at 15°-25°C (59°-77°F) and protect from light.. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

授权状态:

New Drug Application Authorized Generic

产品特点

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- POLYMYXIN B SULFATE,
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
REMEDYREPACK INC.
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POLYMYXIN B SULFATE AND TRIMETHOPRIM
OPHTHALMIC SOLUTION, USP
STERILE
DESCRIPTION
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a
sterile antimicrobial
solution for topical ophthalmic use.
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:
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 formulae are:
CONTAINS: ACTIVES: polymyxin B sulfate 10,000 units/mL; trimethoprim
sulfate
equivalent to 1 mg/mL.
PRESERVATIVE: benzalkonium chloride 0.04 mg/mL. INACTIVES: purified
water; sodium
1
2
chloride; and sulfuric acid. May also contain sodium hydroxide for pH
adjustment. It has
pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg.
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 of the
membrane.
Blood samples were obtained from 11 human volunteers at 20 minutes, 1
hour and 3
hours followi