TOBRAMYCIN AND DEXAMETHASONE suspension/ drops

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals,Inc.

Mode d'administration:

OPHTHALMIC

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Tobramycin and Dexamethasone Ophthalmic Suspension, USP 0.3%/0.1% is supplied in a plastic bottle with a controlled drop tip and pink cap in the following sizes: NDC 68071-2418-2 2.5 mL Store upright at 20° to 25°C (68° to 77°F). Shake well before using. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch & Lomb Incorporated or its affiliates Revised July 2020 9090705 (folded) 9090605 (flat)

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TOBRAMYCIN AND DEXAMETHASONE- TOBRAMYCIN AND
DEXAMETHASONE SUSPENSION/ DROPS
NUCARE PHARMACEUTICALS,INC.
----------
TOBRAMYCIN AND
DEXAMETHASONE
OPHTHALMIC
SUSPENSION, USP
0.3%/0.1%
(STERILE)
RX ONLY
FOR OPHTHALMIC USE ONLY
DESCRIPTION
Tobramycin and Dexamethasone Ophthalmic Suspension, USP 0.3%/0.1% is a
sterile,
multiple dose antibiotic and steroid combination for topical
ophthalmic use.
Tobramycin is represented by the following structural formula:
Molecular formula: C
H
N
O
Molecular weight: 467.52
Chemical Name: _0_-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-
_0_-[(2,6-diamino-2,3,6-
tridexoxy-α-D- _ribo_-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine
Dexamethasone is represented by the following structural formula:
Molecular formula: C
H
FO
Molecular weight: 392.47
Chemical Name:
9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
EACH ML CONTAINS:
ACTIVES: Tobramycin 3 mg (0.3%) and Dexamethasone 1 mg (0.1%);
INACTIVES:
Edetate Disodium, Hydroxyethyl Cellulose, Purified Water, Sodium
Chloride, Sodium
Sulfate, and Tyloxapol. Sulfuric Acid and/or Sodium Hydroxide may be
added to adjust
pH (5.0 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
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-
18
37
5
9
22
29
5
negative), including penicillin-resistant strains.
_Streptococci_, including some of the Group A-beta-hemolytic species,
some nonhemolytic
speci