TOBRAMYCIN AND DEXAMETHASONE suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

Sandoz Inc

INN (International Name):

TOBRAMYCIN

Composition:

TOBRAMYCIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye

Product summary:

Sterile ophthalmic suspension in 2.5 mL (NDC61314-647-25), 5 mL (NDC61314-647-05) and 10 mL (NDC61314-647-10) dispensers. STORAGE Store at 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well before using. After opening, tobramycin and dexamethasone ophthalmic suspension can be used until the expiration date on the bottle. Distributed by Sandoz Inc. Princeton, NJ 08540 May 2021 T2021-123 775950 US

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TOBRAMYCIN AND DEXAMETHASONE- TOBRAMYCIN AND
DEXAMETHASONE SUSPENSION/ DROPS
SANDOZ INC
----------
TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION
STERILE
DESCRIPTION
Tobramycin and dexamethasone ophthalmic suspension is a sterile,
multiple dose
antibiotic and steroid combination for topical ophthalmic use.
The chemical structures for tobramycin and dexamethasone are presented
below:
Tobramycin Empirical 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
Molecular Weight: 467.52
Dexamethasone Empirical Formula: C
H
FO
Chemical Name:
9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
18
37
5
9
22
29
5
Molecular Weight: 392.47
EACH ML OF TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION
CONTAINS:
ACTIVES: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg).
PRESERVATIVE:
benzalkonium chloride 0.01%. INACTIVES: edetate disodium, hydroxyethyl
cellulose,
purified water, sodium chloride, sodium sulfate, sulfuric acid and/or
sodium hydroxide
(to adjust pH), and tyloxapol.
CLINICAL PHARMACOLOGY
Corticoids suppress the inflammatory response to a variety of agents
and they probably
delay or slow healing. Since corticoids may inhibit the body's defense
mechanism against
infection, a concomitant antimicrobial drug may be used when this
inhibition is
considered to be clinically significant. Dexamethasone is a potent
corticoid.
The antibiotic component in the combination (tobramycin) is included
to provide action
against susceptible organisms. _In vitro _studies have demonstrated
that 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, Kl