POLYMYXIN B SULFATE AND TRIMETHOPRIM- polymyxin b sulfate and trimethoprim sulfate solution/ drops

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Proficient Rx LP

INN (Alþjóðlegt nafn):

POLYMYXIN B SULFATE

Samsetning:

POLYMYXIN B 10000 [USP'U] in 1 mL

Stjórnsýsluleið:

OPHTHALMIC

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 Pseudomonasaeruginosa .** **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.

Vörulýsing:

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 in the following size: 10 mL - NDC 63187-631-10 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. Revised: November 2012     Bausch & Lomb Incorporated Tampa, Florida 33637 ©Bausch & Lomb Incorporated 9117801 (Folded) 9117901(Flat) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
PROFICIENT RX LP
----------
POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC SOLUTION USP*
(Sterile)
Rx only
FOR USE IN THE EYES ONLY
*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. Trimethoprim sulfate, a white, odorless, crystalline
powder, is
represented by the following structural formula:
C
H
N O
S
Mol. Wt. 678.72
Chemical Name: Trimethoprim sulfate, 2,4-diamino-5-(3,4
5-trimethoxybenzyl)pyrimidine
sulfate (2:1)
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 increases the
permeability of t