POLYMYXIN B SULFATE AND TRIMETHOPRIM solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

NuCare Pharmaceuticals,Inc.

INN (Kansainvälinen yleisnimi):

POLYMYXIN B SULFATE

Koostumus:

POLYMYXIN B 10000 [USP'U] in 1 mL

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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 68071-4103-5) Storage: Store at 15° - 25°C (59° - 77°F) and protect from light. Rx Only

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

POLYMYXIN B SULFATE AND TRIMETHOPRIM- POLYMYXIN B SULFATE AND
TRIMETHOPRIM SOLUTION
NUCARE PHARMACEUTICALS,INC.
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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:
1
2
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 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