TOBRAMYCIN solution/ drops

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Gland Pharma Limited

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

5 mL sterile solution supplied in opaque white low density polyethylene bottle which is closed with natural low density polyethylene nozzle and then with Tan colored high density polyethylene cap as follows: 5 mL containing tobramycin 0.3% (3 mg/mL)…. NDC 68083-374-01 Storage:   Store at 2°C to 25°C (36°F to 77°F). After opening, Tobramycin Ophthalmic Solution, USP 0.3% can be used until the expiration date on the bottle. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad -500043, India Issued: 07/2021

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

TOBRAMYCIN - TOBRAMYCIN SOLUTION/ DROPS
GLAND PHARMA LIMITED
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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 decahydrate, sodium chloride,
tyloxapol, sodium
hydroxide and/or sulfuric acid (to adjust pH) and water for injection.
Tobramycin
ophthalmic solution USP, 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:
O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-
hexopyranosyl-(1→6)]-2-deoxy-L-streptamine.
CLINICAL PHARMACOLOGY
_In Vitro Data: In vitro _studies
have demonstrated tobramycin is active against susceptible strains of
the following
18
37
5
9
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 topic