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

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NuCare Pharmaceuticals,Inc.

INN (Algemene Internationale Benaming):

POLYMYXIN B SULFATE

Samenstelling:

POLYMYXIN B 10000 [USP'U] in 1 mL

Toedieningsweg:

OPHTHALMIC

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

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: NDC 68071-1651-5 Box of 10mL 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. Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated Revised: June 2016 9117802 (Folded) 9117902 (Flat)

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SULFATE SOLUTION/ DROPS
NUCARE PHARMACEUTICALS,INC.
----------
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 increa