TOBRAMYCIN- tobramycin solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

tobramycin (UNII: VZ8RRZ51VK) (tobramycin - UNII:VZ8RRZ51VK)

Tilgjengelig fra:

Lake Erie Medical DBA Quaity Care Products LLC

INN (International Name):

tobramycin

Sammensetning:

tobramycin 3 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 children. Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Produkt oppsummering:

5 mL sterile solution is packaged in a 5 mL white plastic DROP-TAINER* bottle with a plastic dispensing plug and white plastic closure (NDC 49999-0148-05) containing tobramycin 0.3% (3 mg/mL). Storage: Store at 2° - 25°C (36° - 77°F). Rx Only *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd. Dist. by: FALCON Pharmaceuticals, Ltd Fort Worth, TX 76134 Mfd. by: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TOBRAMYCIN- TOBRAMYCIN SOLUTION
LAKE ERIE MEDICAL DBA QUAITY CARE PRODUCTS LLC
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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 of Tobramycin Ophthalmic Solution USP, 0.3% contains: ACTIVE:
tobramycin 0.3% (3 mg).
PRESERVATIVE: benzalkonium chloride 0.01% (0.1 mg). INACTIVES: boric
acid, sodium sulfate, sodium
chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust
pH) and purified water.
Tobramycin Ophthalmic Solution USP, 0.3% has a pH range between 7.0
and 8.0.
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:
MW=467.2
Molecular Formula
C
H N O
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.
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.
18
37
5
9
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 USP, 0.3% is a topical antibiotic
indicated in the treatment of external