TOBRAMYCIN solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MWI

INN (International Name):

Tobramycin

Composition:

Tobramycin 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in white low-density polyethylene (LDPE) plastic dropper bottle: NDC 13985-604-05            5 mL

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOBRAMYCIN- TOBRAMYCIN SOLUTION/ DROPS
MWI
----------
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 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-β-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_
18
37
5
9
_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 caused by susceptible
bacteria. Appropriate
monitoring of bacterial response to topical antibiotic therapy should
accompany t