Betaxolol 0.5% eye drops

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Betaxolol hydrochloride

Prieinama:

A A H Pharmaceuticals Ltd

ATC kodas:

S01ED02

INN (Tarptautinis Pavadinimas):

Betaxolol hydrochloride

Dozė:

5mg/1ml

Vaisto forma:

Eye drops

Vartojimo būdas:

Ocular

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 11060000

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betaxolol 0.5% Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Betaxolol
5.0 mg/ml
(as Betaxolol hydrochloride
5.6 mg/ml)
Excipient(s) with known effect
Benzalkonium chloride 0.01%w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in conditions such as
ocular
hypertension and chronic open-angle glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly): recommended therapy is one drop of_
_Betaxolol
0.5% Eye Drops to be instilled into the affected eye(s) twice a day.
Children: No clinical studies have been performed to establish safety
and
efficacy in children. Therefore, this product is currently not
recommended for
use in children.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the
systemic absorption is reduced. This may result in a decrease in
systemic side
effects and an increase in local activity.
Intraocular pressure should be reassessed approximately four weeks
after
starting treatment because response to Betaxolol 0.5% Eye Drops may
take a
few weeks to stabilise.
If necessary, concomitant treatment with miotics, adrenaline and/or
carbonic
anhydrase
inhibitors
can
be
instituted.
In
order
to
prevent
the
active
substance(s) from being washed out when additional ophthalmic
medication is
used,
an
interval
of
at
least
10
minutes
between
each
application
is
recommended.
The
use
of
two
topical
beta-adrenergic
agents
is
not
recommended.
Transfer from a single antiglaucoma agent: Continue the agent and add
one
drop of Betaxolol 0.5% Eye Drops_ _in each affected eye twice daily.
On the
following day, discontinue the previous agent completely, and continue
with
Betaxolol 0.5% Eye Drops_._
When several antiglaucoma agents are being used, the patient should be
assessed on an individual basis. Adjustment should involve one agent
at a
time at int