TOBRAMYCIN solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Somerset Therapeutics, LLC

INN (International Name):

TOBRAMYCIN

Sammensetning:

TOBRAMYCIN 3 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 0.3%. 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.

Produkt oppsummering:

Tobramycin ophthalmic solution USP, 0.3% is supplied as a 5 mL sterile solution, packaged in a 10 mL white LDPE bottle and natural LDPE nozzle and White HDPE cap as follows: 5 mL containing tobramycin 0.3% (3 mg/mL)… NDC 70069-131 -01. Storage: Store at 2° to 25°C (36° to 77°F). After opening, tobramycin ophthalmic solution 0.3% can be used until the expiration date on the bottle. For Product Inquiry call [phone] Revised: June, 2021 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 PSSO0483 ST-TBR11/P/06

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TOBRAMYCIN - TOBRAMYCIN SOLUTION/ DROPS
SOMERSET THERAPEUTICS, LLC
----------
RX ONLY
FOR TOPICAL OPHTHALMIC USE ONLY
DESCRIPTION
Tobramycin ophthalmic solution 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 water for injection.
Tobramycin ophthalmic
solution 0.3% has a pH range between 7.0 and 8.0 and an osmolality of
260-320
mOsm/kg.
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:
18
37
5
9
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.
_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 i