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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products LLC

INN (International Name):

polymyxin B sulfate

Composition:

polymyxin B 10000 [USP'U] in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 55700-105-10 Storage: Store at 15°-25°C (59°-77°F) and protect from light. Revised: 11/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A. 71756PY11

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- POLYMYXIN B SULFATE,
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
QUALITY CARE PRODUCTS LLC
----------
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.
CLINICAL PHARMACOLOGY
1
2
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