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:

Pacific Pharma, Inc.

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 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.

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 60758-908-10 Storage: Store at 15°-25°C (59°-77°F) and protect from light. Rx only Revised: 12 /2018 For more information, call 1-800-678-1605 Distributed for Allergan USA, Inc. Madison, NJ 07940 © 2019 Allergan, Inc. All trademarks are the property of their respective owners v1.0USPI908

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- POLYMYXIN B SULFATE,
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
PACIFIC PHARMA, 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.
CLINICAL PHARMACOLOGY
Trimethoprim is a synthetic antibacterial drug active against a wide
variety of aerobic gram-positive and
1
2
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
foll