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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K), trimethoprim sulfate (UNII: E377MF8EQ8) (trimethoprim - UNII:AN164J8Y0X)

Disponible des:

H.J. Harkins Company, Inc.

Designació comuna internacional (DCI):

polymyxin B sulfate

Composición:

polymyxin B sulfate 10000 [USP'U] in 1 mL

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 viridans, 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 hypersensivitity to any of its components.

Resumen del producto:

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: 10 mL in 10 mL bottle - NDC 60758-908-10 Note: Store at 15° - 25°C (59° - 77°F) and protect from light. Rx only Revised August 2004 © 2004 PACIFIC PHARMA Irvine, CA 92612 U.S.A. Printed in U.S.A. 71756PY10P Repacked by: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE - POLYMYXIN B SULFATE,
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
H.J. HARKINS COMPANY, 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 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.
1
2
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