TOBRAMYCIN AND DEXAMETHASONE suspension/ drops

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

NuCare Pharmaceuticals,Inc.

Администрация маршрут:

OPHTHALMIC

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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 68071-4203-5 Box of 5mL DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Store upright at 20°-25°C (68°-77°F). Shake well before using. Rx only Revised: June 2016 Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated 9090703 (folded) 9090603 (flat)

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

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:
C
H
N
O
Mol. Wt. 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:
C
H
FO
Mol. Wt. 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
species, and some _Streptococcus pneumoniae._
_Pseudomonas aeru