Clonidine Transdermal System, USP

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clonidine 7.56mg equivalent to 0.3mg/24hr

Available from:

Viatris Limited

INN (International Name):

Clonidine 7.56 mg (equivalent to 0.3mg/24hr)

Dosage:

0.3 mg/24h

Pharmaceutical form:

Transdermal patch

Composition:

Active: Clonidine 7.56mg equivalent to 0.3mg/24hr Excipient: Adhesive 8400E/000 Colloidal silicon dioxide Durotak 87-613A Ethylenevinylacetate copolymer Heptane Light liquid paraffin No Tox ink brown- FGN4476

Prescription type:

Prescription

Manufactured by:

PCAS Finland Oy

Therapeutic indications:

Clonidine transdermal system USP is indicated for the treatment of mild to moderate hypertension. It can be used as monotherapy or concomitantly with other antihypertensive agents if required to enhance hypotensive effect.

Product summary:

Package - Contents - Shelf Life: Individual wrap, Individual wrap Paper/LDPE/Aluminium foil/Adhesive/Sealant film with 4 adhesive covers - 4 patches - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2011-12-16

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CLONIDINE TRANSDERMAL SYSTEM USP
_CLONIDINE TRANSDERMAL PATCH _
_0.1 MG/DAY, 0.2 MG/DAY, 0.3 MG/DAY_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clonidine
Transdermal System USP.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Clonidine
Transdermal System USP against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT CLONIDINE
TRANSDERMAL SYSTEM
USP IS USED FOR
Clonidine Transdermal System USP
lowers high blood pressure. The
patch contains a medicine called
clonidine, which belongs to a group
of medicines called antiadrenergic
agents.
It works by slowing your heart rate,
and widening your blood vessels
making it easier for your blood to
flow which results in lower blood
pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this medicine
in children or adolescents.
BEFORE YOU USE
CLONIDINE
TRANSDERMAL SYSTEM
USP
_WHEN YOU MUST NOT USE _
_IT_
DO NOT USE CLONIDINE
TRANSDERMAL SYSTEM USP IF YOU
HAVE AN ALLERGY TO:

any medicine containing
clonidine

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ABNORMALLY SLOW OR
IRREGULAR HEARTBEAT.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF T

Summary of Product characteristics

Page 1 of 11
NEW ZEALAND DATA SHEET
CLONIDINE TRANSDERMAL SYSTEM USP
1. PRODUCT NAME
CLONIDINE TRANSDERMAL SYSTEM USP, 0.1 mg/day, 0.2 mg/day or 0.3
mg/day, transdermal
patch.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CLONIDINE TRANSDERMAL SYSTEM USP contains 0.1 mg/day, 0.2 mg/day
or 0.3 mg/day
of clonidine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CLONIDINE TRANSDERMAL SYSTEM USP 0.1 mg/day:
(
2.52 mg/3.33 cm
2
). A rectangular patch
with rounded corners consisting of a peach-coloured backing labelled
with ‘Mylan
®
Clonidine
0.1 mg/day’ in brown ink, a solid matrix drug reservoir layer, an
adhesive formulation layer, and an
oversized removable release liner.
CLONIDINE TRANSDERMAL SYSTEM USP 0.2 mg/day:
(
5.04 mg/6.67 cm
2
). A rectangular patch
with rounded corners consisting of a peach-coloured backing labelled
with ‘Mylan
®
Clonidine
0.2 mg/day’ in brown ink, a solid matrix drug reservoir layer, an
adhesive formulation layer, and an
oversized removable release liner.
CLONIDINE TRANSDERMAL SYSTEM USP 0.3 mg/day:
(
7.56 mg/10.0 cm
2
). A rectangular patch
with rounded corners consisting of a peach-coloured backing labelled
with ‘Mylan
®
Clonidine
0.3 mg/day’ in brown ink, a solid matrix drug reservoir layer, an
adhesive formulation layer, and an
oversized removable release liner.
The rate of release of clonidine and content of clonidine in each
system is given in the table below:
Programmed Delivery
_In vivo _/ day
Over 1 week
Clonidine content
(mg)
Size
(cm
2
)
Clonidine
Transdermal
System
USP, 0.1 mg/day
0.1 mg
2.52
3.33
Clonidine
Transdermal
System
USP, 0.2 mg/day
0.2 mg
5.04
6.67
Clonidine
Transdermal
System
USP, 0.3 mg/day
0.3 mg
7.56
10.0
Page 2 of 11
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
CLONIDINE TRANSDERMAL SYSTEM USP is indicated for the treatment of
mild to moderate
hypertension. It can be used as monotherapy or concomitantly with
other antihypertensive agents if
required to enhance hypotensive effect.
_4.2_
_DOSE AND METHOD OF