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:

Aidarex Pharmaceuticals LLC

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*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size: 10 MILLILITER in a BOTTLE, DROPPER/1 CARTON in a CARTON (53217-244-01) DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance.  RETAIN IN CARTON UNTIL TIME OF USE. Relabeled by  Aidarex Pharmaceuticals,LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM
SULFATE SOLUTION/ DROPS
AIDAREX PHARMACEUTICALS LLC
----------
POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC SOLUTION, USP*
(Sterile)
RX ONLY
FOR TOPICAL APPLICATION IN THE EYE
*Does not meet USP packaging specification for light resistance.
DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP* 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:
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 –
6.2). 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 increas