TOBRAMYCIN OPHTHALMIC SOLUTION solution/ drops

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Alembic Pharmaceuticals Inc.

प्रशासन का मार्ग:

OPHTHALMIC

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Tobramycin ophthalmic solution USP, 0.3 % is 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  containing tobramycin 0.3% (3 mg/mL). 5 mL in a 5 mL bottle (NDC 62332-518-05). Storage :  Store at 2 to 25°C (36 to 77°F). After opening, Tobramycin ophthalmic solution USP, 0.3 % can be used until the expiration date on the bottle. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921 USA Made in India Manufactured by: Gland Pharma Limited D.P. Pally, Dundigal Post, Hyderabad-500 043, India (IND) Revised: July, 2021 

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

TOBRAMYCIN OPHTHALMIC SOLUTION - TOBRAMYCIN OPHTHALMIC
SOLUTION SOLUTION/ DROPS
ALEMBIC PHARMACEUTICALS INC.
----------
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 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 to
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:
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. a_ureus_
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 mirabillis, Morganella morganii_, most Proteus
vulgaris strains,
_Haemophilus influenzea 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
Tobr