POLYMYXIN B SULFATE AND TRIMETHOPRIM- polymyxin b sulfate and 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:

RPK Pharmaceuticals, 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 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.1 1 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.

Product summary:

Product: 53002-8620 NDC: 53002-8620-1 10 mL in a BOTTLE, DROPPER

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
RPK PHARMACEUTICALS, INC.
----------
POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC SOLUTION, USP
(Sterile)
RX ONLY
FOR TOPICAL APPLICATION IN THE EYE
DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a
sterile antimicrobial
solution for topical ophthalmic use. It has pH of 4.0 to 5.5 and
osmolality of 270 to 310
mOsm/kg.
CHEMICAL NAMES:
Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)
pyrimidine sulfate, is a
white, odorless, crystalline powder with a molecular weight of 678.72
and the following
structural formula:
C
H
N O
S
Mol. Wt. 678.72
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 formula is:
28
38
8
10
1
2
EACH ML CONTAINS: ACTIVES: Polymyxin B Sulfate equal to 10,000
polymyxin B units,
Trimethoprim Sulfate (equivalent to trimethoprim 1 mg); INACTIVES:
Purified Water,
Sodium Chloride. Sulfuric acid and, if necessary, sodium hydroxide may
be added to
adjust pH (4.0 – 5.5). PRESERVATIVE ADDED: Benzalkonium Chloride
0.004%.
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 p