TOBRAMYCIN AND DEXAMETHASONE suspension/ drops

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Rebel Distributors Corp

INN (Διεθνής Όνομα):

TOBRAMYCIN

Σύνθεση:

TOBRAMYCIN 3 mg in 1 mL

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% is supplied in a plastic bottle with a controlled drop tip in the following sizes: 5 mL NDC 21695-416-05 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Store upright at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Shake well before using. Rx only Manufactured by: Alcon Laboratories Fort Worth, TX 76134 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

TOBRAMYCIN AND DEXAMETHASONE- TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/
DROPS
REBEL DISTRIBUTORS CORP
----------
TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP, 0.3%/0.1%
(STERILE)
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-FIuoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
18
37
5
9
22
29
5
EACH ML CONTAINS: ACTIVES: Tobramycin 3 mg (0.3%) and Dexamethasone 1
mg (0.1%);
INACTIVES: Sodium Sulfate, Sodium Chloride, Hydroxyethyl Cellulose,
Tyloxapol, Edetate
Disodium and Purified Water. 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, Escher