A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tobradex Indications, Dosage, Storage, Stability - Tobramycin and Dexamethasone
Tobradex Indications, Dosage, Storage, Stability - Tobramycin and Dexamethasone
INDICATIONS
Dexamethasone and tobramycin
ophthalmic suspension
and ointment are indicated
for steroid-responsive inflammatory ocular
conditions for which a corticosteroid
is indicated and where superficial
bacterial ocular infection
or a risk of bacterial
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 conjunctivides 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
pathogens:
Staphylococci, including S. aureus and S. epidermis
(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, Escherichia
coli, Klebsiella
pneumoniae, Enterobacter aerogenes, Proteus
mirabilis, Morganella morganii, most Proteus
vulgaris strains Haemophilus
influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus
and some Neisseria
species.
DOSAGE AND ADMINISTRATION
Suspension: One or two drops
instilled into the conjunctival sac(s) every four to six hours.
During the initial 24
to 48 hours, the dosage may be increased to one or two drops
every two (2) hours. Frequency should be decreased gradually as
warranted by improvement in clinical
signs. Care should be taken not to discontinue therapy prematurely.
Not more than 20 ml should
be prescribed initially and the prescription should not be refilled
without further evaluation
as outlined in PRECAUTIONS
Ointment: Apply a small amount (approximately ½
inch ribbon) into the conjunctival sac(s) up to three or four times
daily.
How to apply dexamethasone
and tobramycin opthalmic
ointment:
1. Tilt your head
back.
2. Place a finger
on your cheek just under
your eye and gently pull
down until a "V"
pocket is formed between
your eyeball and your
lower lid.
3. Place a small amount (about ½ inch) of dexamethasone
and tobramycin ophthalmic
ointment in the "V"
pocket. Do not let the tip
of the tube touch
your eye.
4. Look downward before closing your eye.
Not more than 8 g should be prescribed initially and the prescription
should not be refilled without further evaluation
as outlined in PRECAUTIONS.
HOW SUPPLIED
Suspension Storage: Store at 8° to 27°C (46°
to 80°F). Store suspension
upright and shake well before using.
Ointment Storage: Store at 8° to 27°C (46°
to 80°F).
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