POLYMYXIN B SULFATE AND TRIMETHOPRIM solution

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:

Preferred Pharmacetucials 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. * *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:

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile solution. Each mL contains trimethoprim sulfate equivalent to 1 mg trimethoprim and polymyxin B sulfate 10,000 units in a plastic dropper bottle of 10 mL NDC 68788-6927-1 Storage: Store at 15° to 25°C (59° to 77°F) and protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SOLUTION
PREFERRED PHARMACETUCIALS INC.
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POLYMYXIN B SULFATE AND TRIMETHOPRIM OPHTHALMIC SOLUTION, USP
STERILE
RX ONLY
DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile
antimicrobial
solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and
osmolality of 270 to 310
mOsm/kg.
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 formula are:
1
2
CONTAINS: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim
sulfate equivalent
to trimethoprim 1 mg/mL. PRESERVATIVE: benzalkonium chloride 0.04
mg/mL.
INACTIVES: sodium chloride; sulfuric acid; and purified water. May
also contain sodium
hydroxide for pH adjustment.
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 f