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:

DIRECT RX

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 61314-628-10). Storage: Store at 15° - 25°C (59° - 77°F) and protect from light. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SOLUTION
DIRECT RX
----------
POLYMYXIN B SULFATE AND TRIMETHOPRIM
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile
antimicrobial solution for
topical ophthalmic use. It has a 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:
[trimethoprim-chemical]
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 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:
[polymyxin-chemical]
[polymyxin-text]
Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim
sulfate equivalent to trimethoprim
1mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives:
sodium chloride; sulfuric acid and
purified water. May also contain sodium hydroxide for pH adjustment.
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 very much 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 rapidly 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 following
instillation i