IOPIDINE 0.5 %

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

APRACLONIDINE AS HYDROCHLORIDE

Tersedia dari:

NOVARTIS ISRAEL LTD

Kode ATC:

S01EA03

Bentuk farmasi:

OPHTHALMIC SOLUTION

Komposisi:

APRACLONIDINE AS HYDROCHLORIDE 5 MG/ML

Rute administrasi :

OCULAR

Jenis Resep:

Required

Diproduksi oleh:

ALCON COUVREUR, BELGIUM

Kelompok Terapi:

APRACLONIDINE

Area terapi:

APRACLONIDINE

Indikasi Terapi:

Short term adjunctive therapy of chronic glaucoma in patients on maximally tolerated medical therapy who require additional intraocular pressure (IOP) reduction to delay laser treatment or glaucoma surgery.

Tanggal Otorisasi:

2020-07-31

Selebaran informasi

KAPVORM
140 x 210 / 140 x 22 mm
AANTAL KLEUREN : 1
KT
16-09-2011
IL
recto-verso
Iopidine 0,5%
44480-5
BELGIUM
V4
068 60 28209 00
068 60 28209 00
PMS ZWART
à 100%
44480-5
APPROVAL
BESOP-00326
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Karakteristik produk

IOP API NOV23 V3
1.
NAME OF THE MEDICINAL PRODUCT
IOPIDINE 0.5%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains apraclonidine 5 mg (as hydrochloride).
Excipients with known effect:
1 ml of solution contains 0.1 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic, solution.
A colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
IOPIDINE 0.5% is indicated for short‐term adjunctive therapy of
chronic glaucoma in patients
on maximally
tolerated medical therapy who require additional intraocular pressure
(IOP) reduction to delay laser treatment
or glaucoma surgery.
The IOP lowering efficacy of IOPIDINE 0.5% diminishes over time in
most patients. Although some patients have
received successful treatment with IOPIDINE 0.5% for longer periods,
the benefit for most patients is
less than
one month.
The addition of IOPIDINE 0.5% to patients already using two aqueous
suppressing drugs (i.e. beta‐blockers plus
carbonic anhydrase inhibitor) as part of their maximally tolerated
medical therapy may not provide additional
benefit. This is because IOPIDINE 0.5% is an aqueous suppressing drug
and the addition
of a third aqueous
suppressant may not significantly reduce IOP.
4.2
Posology and method of administration
Posology
One drop of IOPIDINE 0.5% should be instilled into the affected eye(s)
three times per day (t.i.d.). Since
IOPIDINE 0.5% will be used with other ocular glaucoma therapies, an
approximate five minute interval
between instillation of each medication should be observed to prevent
washout of the previous dose. Eye
ointments should be administered last. If, for any reason, the drop of
IOPIDINE 0.5% does not remain in the
eye, then the patient should repeat the dose by placing another drop
in the eye. The maximum
recommended duration of therapy is one month due to loss of effect
over time (tachyphylaxis). However,
some patients may benefit from treatment with IOPIDINE 0.5% for longer
periods.
There are