TOBRAMYCIN AND DEXAMETHASONE- tobramycin and dexamethasone suspension/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

INN (International Name):

TOBRAMYCIN

Sammensetning:

TOBRAMYCIN 3 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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 68071-1655-5 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)

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

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
18
37
5
9
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-negative),
including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species,
some nonhemolytic species, and
some _Streptococcus pneumoniae._
_Pseudomonas aeruginosa, E