TOBREX- tobramycin ointment

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Novartis Pharmaceuticals Corporation

Droga podania:

OPHTHALMIC

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

TOBREX® (tobramycin ophthalmic ointment) 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 TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children. TOBREX (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

Podsumowanie produktu:

TOBREX (tobramycin ophthalmic ointment) 0.3% is supplied as a 3.5 g sterile ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: 3.5 g containing tobramycin 0.3% (3 mg/g).................................................. NDC 0078-0813-01 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, TOBREX (tobramycin ophthalmic ointment) 0.3% can be used until the expiration date on the tube. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis Revised: June 2021 T2021-76

Status autoryzacji:

New Drug Application

Charakterystyka produktu

TOBREX- TOBRAMYCIN OINTMENT
NOVARTIS PHARMACEUTICALS CORPORATION
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TOBREX (TOBRAMYCIN OPHTHALMIC OINTMENT) 0.3%
DESCRIPTION
TOBREX (tobramycin ophthalmic ointment) 0.3% is a sterile topical
ophthalmic
antibiotic formulation prepared specifically for topical therapy of
external ophthalmic
infections.
EACH GRAM OF TOBREX (TOBRAMYCIN OPHTHALMIC OINTMENT) 0.3% CONTAINS:
ACTIVE: tobramycin 0.3% (3 mg). PRESERVATIVE: chlorobutanol 0.5%.
INACTIVES:
mineral oil, white petrolatum.
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:
Molecular Formula:
C
H
N O
Molecular Weight: 467.52 g/mol
Chemical Name:
0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)
}-0-{2,6-diamino-2,3,6-trideoxy-α-D-
ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.
®
®
18
37
5
9
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
TOBREX (tobramycin ophthalmic ointment) 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