TOBRAMYCIN solution/ drops

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

RPK Pharmaceuticals, Inc.

Toedieningsweg:

OPHTHALMIC

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

Product: 53002-9231 NDC: 53002-9231-1 5 mL in a BOTTLE, DROPPER

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TOBRAMYCIN- TOBRAMYCIN SOLUTION/ DROPS
RPK PHARMACEUTICALS, INC.
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TOBRAMYCIN OPHTHALMIC SOLUTION, USP 0.3%
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 0.3% (3 mg). INACTIVES: boric acid, sodium
chloride, sodium
sulfate, tyloxapol, sodium hydroxide and/or sulfuric acid to adjust pH
(7.0 to 8.0), and
water for injection. PRESERVATIVE: benzalkonium chloride 0.01% (0.1
mg).
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 Weight = 467.52
Molecular Formula: C
H
N O
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.
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
18
37
5
9
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 caused by susceptible
bacteria. Appropriate
monitoring of bacterial res