TOBRAMYCIN AND DEXAMETHASONE suspension/ drops

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)

可用日期:

Preferred Pharmaceuticals Inc.

INN（国际名称）:

TOBRAMYCIN

组成:

TOBRAMYCIN 3 mg in 1 mL

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

TOBRAMYCIN AND DEXAMETHASONE- TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/
DROPS
PREFERRED PHARMACEUTICALS INC.
----------
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: 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,