TOBRAMYCIN solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)

Tersedia dari:

Preferred Pharmaceuticals Inc.

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Tobramycin ophthalmic solution, 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. Clinical studies have shown tobramycin to be safe and effective for use in children. Tobramycin ophthalmic solution, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Ringkasan produk:

Tobramycin Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following size: NDC 68788-8248-5 - 5 mL fill in a 10 mL bottle Storage Store at 2° to 25°C (36° to 77°F). Avoid excessive heat. After opening, Tobramycin Ophthalmic Solution USP, 0.3% can be used until the expiration date on the bottle. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2021 Bausch & Lomb Incorporated or its affiliates Revised: June 2021 Relabeled By: Preferred Pharmaceuticals Inc.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

TOBRAMYCIN- TOBRAMYCIN SOLUTION
PREFERRED PHARMACEUTICALS INC.
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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.
EACH ML CONTAINS:
ACTIVE: tobramycin 3 mg (0.3%). INACTIVES: boric acid, sodium sulfate,
sodium
chloride, tyloxapol and purified water. Sodium hydroxide and/or
sulfuric acid (to adjust
pH). Tobramycin ophthalmic solution, 0.3% has a pH range between 7.0
and 8.0.
PRESERVATIVE ADDED: benzalkonium chloride 0.1 mg (0.01%).
Tobramycin is a water-soluble aminoglycoside antibiotic active against
a wide variety of
gram-negative and gram-positive ophthalmic pathogens.
The chemical structure of tobramycin is:
Chemical name:
(2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-
(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-
(hydroxymethyl)oxane-3,5-diol
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-beta-hemolytic 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 retain
susceptibility to
tobramycin.
INDICATIONS AND USAGE
Tobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated
in the treatment of
external infections of the eye and its adnexa caus