TOBRAMYCIN AND DEXAMETHASONE suspension/ drops

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticasl,Inc.

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

INDICATIONS AND USAGE: 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 followi

Ringkasan produk:

HOW SUPPLIED: Tobramycin and dexamethasone ophthalmic suspension, USP is sterile ophthalmic suspension supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 5 mL, 10 mL or 10 mL natural polyethylene bottle respectively with a natural polyethylene controlled drop tip and a white polypropylene cap. NDC 68071-2772-2: 2.5 mL 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. Rx Only

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

TOBRAMYCIN AND DEXAMETHASONE- TOBRAMYCIN AND
DEXAMETHASONE SUSPENSION/ DROPS
NUCARE PHARMACEUTICASL,INC.
----------
TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION, USP
STERILE
DESCRIPTION: Tobramycin and dexamethasone ophthalmic suspension USP is
a
sterile, multiple dose antibiotic and steroid combination for topical
ophthalmic use with a
pH of approximately 5.5 and an osmolality of approximately 300
mOsm/kg.
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
MW: 467.52
18
37
5
9
Dexamethasone
Empirical Formula: C
H
FO
Chemical Name:
9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
MW: 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 dihydrate,
hydroxyethyl
cellulose, sodium chloride, sodium sulfate anhydrous, sulfuric acid
and/or sodium
hydroxide (to adjust pH), tyloxapol, and water for injection.
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 nonhemoly