TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIMETHOPRIM SULFATE (UNII: E377MF8EQ8) (TRIMETHOPRIM - UNII:AN164J8Y0X), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

TRIMETHOPRIM SULFATE

Composition:

TRIMETHOPRIM 1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trimethoprim Sulfate and Polymyxin B Sulfate 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 influenza and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

Product summary:

Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is supplied as a sterile solution in plastic dropper bottles in the following size: 10 mL in a 10 mL bottle NDC 68788-0536-1 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. WARNING – KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 ATP00N Rev. 10/16 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE- TRIMETHOPRIM SULFATE AND
POLYMYXIN B SULFATE SOLUTION
PREFERRED PHARMACEUTICALS INC.
----------
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE OPHTHALMIC SOLUTION
RX ONLY
DESCRIPTION
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is a
sterile antimicrobial solution
for topical ophthalmic use. Trimethoprim sulfate,
2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine
sulfate (2:1), occurs as a white, odorless, crystalline powder with a
molecular weight of 678.72. The
structural formula is as follows:
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 is as follows:
EACH ML CONTAINS:
ACTIVES: Trimethoprim Sulfate equivalent to Trimethoprim 1 mg (0.1%)
and Polymyxin B Sulfate
10,000 units. Preservative: Benzalkonium Chloride 0.04 mg (0.004%).
INACTIVES: Sodium Chloride,
Sulfuric Acid and Sodium Hydroxide may be added to adjust pH (3.0 to
5.5), and Water for Injection.
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 very much stronger for the bacterial enzyme than for the
corresponding mammalian enzyme.
For that reason, trimethoprim 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.
When used topically, trimethoprim and polymyxin B absorption through