TOBRAMYCIN solution/ drops

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

Tobramycin (UNII: VZ8RRZ51VK) (Tobramycin - UNII:VZ8RRZ51VK)

から入手可能:

Proficient Rx LP

INN（国際名）:

Tobramycin

構図:

Tobramycin 3 mg in 1 mL

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in pediatric patients. Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

製品概要:

Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in plastic dropper bottles in two sizes: NDC 63187-902-02. . . . . . . . . . . . 2 mL NDC 63187-902-05. . . . . . . . . . . . 5 mL

認証ステータス:

Abbreviated New Drug Application

製品の特徴

TOBRAMYCIN- TOBRAMYCIN SOLUTION/ DROPS
PROFICIENT RX LP
----------
TOBRAMYCIN OPHTHALMIC SOLUTION, USP
0.3%–STERILE
RX ONLY
DESCRIPTION:
Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical
ophthalmic antibiotic formulation
prepared specifically for topical therapy of external ophthalmic
infections.
Tobramycin is a water soluble aminoglycoside antibiotic active against
a wide variety of gram-negative
and gram-positive ophthalmic pathogens. The molecular formula is C
H N O , the molecular weight
is 467.52 and the structural formula is:
CHEMICAL NAME:
O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1 →
4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-
pyranosyl-(1 → 6)}-2- deoxystreptamine.
EACH ML CONTAINS:
ACTIVE: Tobramycin 3 mg (0.3%). INACTIVES: Boric Acid, Sodium
Chloride, Sodium Sulfate, Tyloxapol,
Sodium Hydroxide and/or Sulfuric Acid to adjust pH (7.0 to 8.0), and
Purified Water USP.
PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
CLINICAL PHARMACOLOGY:
_In Vitro Data: In Vitro_ studies have demonstrated tobramycin is
active against susceptible strains of the
following microorganisms:
Staphylococci, including _S. aureus_ and _S. epidermidis_
(coagulase-positive and coagulase-negative),
including penicillin-resistant strains.
Streptococci, including some of the Group A betahemolytic species,
some nonhemolytic species, and
some _Streptococcus pneumoniae_.
_Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae,
Enterobacter aerogenes, Proteus_
_mirabilis, Morganella morganii,_ most _Proteus vulgaris_ strains,
_Haemophilus influenzae_ and _H. aegyptius,_
_Moraxella lacunata, Acinetobacter calcoaceticus_ and some _Neisseria_
species.
Bacterial susceptibility studies demonstrate that in some cases,
microorganisms resistant to gentamicin
18
37
5
9
retain susceptibility to tobramycin.
INDICATIONS AND USAGE:
Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic
indicated in the treatment of external
infections of the eye and its adnexa caused by susceptible bacteria.
Appropriate moni