TOBRAMYCIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

TOBRAMYCIN

Composition:

TOBRAMYCIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tobramycin Ophthalmic Solution 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 is contraindicated in patients with known hypersensitivity to any of its components.

Product summary:

Tobramycin Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip in the following size: 5 mL bottle - Prod. No. 24207 Store at 2°-30°C (36°-86°F). Avoid excessive heat. KEEP OUT OF REACH OF CHILDREN. Revised August 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9116800 (Folded) 9116900 (Flat) Relabeled by: H.J. Harkins Company, Inc. Nipomo, CA 93444

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOBRAMYCIN - TOBRAMYCIN SOLUTION
H.J. HARKINS COMPANY, INC.
----------
TOBRAMYCIN
OPHTHALMIC SOLUTION USP,
0.3% (STERILE)
RX ONLY
DESCRIPTION:
Tobramycin ophthalmic solution is a sterile topical ophthalmic
antibiotic formulation prepared
specifically for topical therapy of external infections.
EACH ML CONTAINS:
ACTIVE: Tobramycin 3 mg (0.3%). INACTIVES: Boric Acid, Sodium Sulfate,
Sodium Chloride,
Tyloxapol and Purified Water. Sodium Hydroxide and/or Sulfuric Acid
may be added to adjust pH (7.0 -
8.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.1 mg (0.01%).
The structural formula of tobramycin is
Molecular formula: C
H N O
Molecular weight: 467.52
Chemical name:
O-[3-amino-3-deoxy—α-D-gluco-pyranosyl-(1 →
4)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-
pyranosyl- (1 → 6)]-2-deoxystreptamine.
Tobramycin is a water-soluble aminoglycoside antibiotic active against
a wide variety of gram-negative
and gram-positive ophthalmic pathogens.
CLINICAL PHARMACOLOGY:
_In Vitro Data: In vitro _studies have demonstrated tobramycin is
active against susceptible strains of the
18
37
5
9
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-betahemolytic 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, _and _Acinetobacter calcoaceticus _and some
_Neisseria _species. Bacterial susceptibility
studies demonstrate that in some cases, microorganisms resistant to
gentamicin retain susceptibility to
tobramycin. A significant bacterial population resistant to tobramycin
has not yet emerged; however,
bacterial resistance may develop upon prolonged use.
INDICATIONS AND USAGE:
Tobramycin Ophthalmic Solution is a topical anti