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:

Rebel Distributors Corp

INN (International Name):

polymyxin B sulfate

Composition:

polymyxin B sulfate 10000 mL 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 21695-335-10). Storage: Store at 15° - 25°C (59° - 77°F) and protect from light. Rx Only Dist. by: FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Rev: January 2003 Printed in USA 340176-0103 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SOLUTION
REBEL DISTRIBUTORS CORP
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POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC SOLUTION, USP
STERILE
DESCRIPTION
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:
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:
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.
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
1
2
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