Iopidine

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Apraclonidine hydrochloride 5.75 mg/mL equivalent to 5 mg Apraclonidine

Dostupno od:

Clinect NZ Pty Limited

INN (International ime):

Apraclonidine hydrochloride 5.75 mg/mL (= 5 mg Apraclonidine)

Doziranje:

0.5 %

Farmaceutski oblik:

Eye drops, solution

Sastav:

Active: Apraclonidine hydrochloride 5.75 mg/mL equivalent to 5 mg Apraclonidine Excipient: Benzalkonium chloride Hydrochloric acid Purified water Sodium acetate trihydrate Sodium chloride Sodium hydroxide

Jedinice u paketu:

Bottle, plastic, 1 x 5.0 mL, 5 mL

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Rohner AG

Terapijske indikacije:

IOPIDINE Eye Drops 0.5% are indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional intraocular pressure reduction. Patients on maximally tolerated medical therapy who are treated with IOPIDINE Eye Drops 0.5% to delay surgery should have frequent follow up examinations and treatment should be discontinued if the intraocular pressure rises significantly.

Proizvod sažetak:

Package - Contents - Shelf Life: Bottle, plastic, - 5 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 10 mL - 36 months from date of manufacture stored at or below 25°C

Datum autorizacije:

1993-10-28

Uputa o lijeku

Iopidine
®
1
IOPIDINE®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IOPIDINE?
Iopidine contains the active ingredient apraclonidine hydrochloride.
Iopidine is used to lower raised pressure in the eye and to
treat glaucoma.
For more information, see Section 1. Why am I using Iopidine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IOPIDINE?
Do not use if you have ever had an allergic reaction to Iopidine,
clonidine, pilocarpine or any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Iopidine?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Iopidine and affect how it works or
may be affected by Iopidine.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE IOPIDINE?
•
The usual dose of Iopidine is one drop in the affected eye(s) three
times each day.
•
Follow the instructions provided on ‘How to use’ the Iopidine, and
use Iopidine until your doctor tells you to stop.
More instructions can be found in Section 4. How do I use Iopidine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IOPIDINE?
THINGS YOU
SHOULD DO
•
Remind any doctor or pharmacist you visit that you are using Iopidine.
•
Keep all your doctor's appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or lower the dose without first asking
your doctor. If you stop using
your medicine your condition may worsen.
DRIVING OR USING
MACHINES
•
You should not drive, operate machinery or perform tasks requiring
mental alertness and/or
physical coordination as you may feel dizzy or tired after using
Iopidine.
ADDICTION
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Svojstava lijeka

1
NEW ZEALAND DATA SHEET
1.
IOPIDINE 0.5% EYE DROPS
IOPIDINE
®
(apraclonidine hydrochloride) Eye Drops 0.5%.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
mL
of
Iopidine
Eye
Drops
0.5%
contains
apraclonidine
hydrochloride
5.75
mg,
equivalent
to
apraclonidine base 5 mg.
Excipient with known effect
Benzalkonium chloride 0.1 mg per 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution, sterile, isotonic.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Iopidine Eye Drops 0.5% are indicated for short-term adjunctive
therapy in patients on maximally tolerated
medical therapy who require additional IOP reduction.
Patients on maximally tolerated medical therapy who are treated with
Iopidine Eye Drops 0.5% to delay surgery
should have frequent follow up examinations and treatment should be
discontinued if the intraocular pressure
rises significantly.
The addition of Iopidine Eye Drops 0.5% to patients already using two
aqueous suppressing drugs (i.e. beta-
blocker plus carbonic anhydrase inhibitor) as part of their maximally
tolerated medical therapy may not provide
additional benefit. This is because apraclonidine is an
aqueous-suppressing drug and the addition of a third
aqueous suppressant may not significantly reduce IOP.
The IOP-lowering efficacy of Iopidine Eye Drops 0.5% diminishes over
time in some patients. This loss of
effect, or tachyphylaxis, appears to be an individual occurrence with
a variable time of onset and should be
closely monitored. The benefit for most patients is less than one
month.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
_DOSE _
One drop of Iopidine Eye Drops 0.5% should be instilled into the
affected eye(s) three times per day.
Since Iopidine Eye Drops 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.
PAEDIATRIC POPULATION
Clinical studies to establish safety and efficacy in children ha