Catapres-TTS

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clonidine 5mg

Available from:

CARSL Consulting

INN (International Name):

Clonidine 5 mg

Dosage:

5 mg

Pharmaceutical form:

Transdermal patch

Composition:

Active: Clonidine 5mg Excipient: Calcium stearate

Units in package:

Sachet, 4 patches

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Therapeutic indications:

CATAPRES-TTS 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: Sachet, - 4 patches - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1984-12-12

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
CATAPRES
 TTS
_CLONIDINE HYDROCHLORIDE _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CATAPRES TTS. It does
not
contain all available information. It does not take the place of
talking to your doctor or
pharmacist. Keep this information with your CATAPRES TTS. You may need
to read
it again later.
_TO FIND OUT MORE ABOUT CATAPRES _
Ask your doctor or pharmacist if you have any questions about your
medicine or if
you have any trouble before, during or after using CATAPRES.
WHAT CATAPRES IS USED FOR
CATAPRES lowers high blood pressure, also called hypertension.
Everyone has blood pressure. This pressure helps your blood move
around your
body. Your blood pressure may be different at different times of the
day. You have
hypertension when your blood pressure stays higher than normal, even
when you are
calm or relaxed.
There are usually no signs of hypertension. The only way of knowing
that you have
hypertension is to have your blood pressure checked on a regular
basis. You may
feel fine and have no symptoms, but if high blood pressure is not
treated, it can lead
to serious health problems (such as heart disease).
CATAPRES works by relaxing and widening blood vessels and so helps to
lower
your blood pressure.
Your doctor may prescribe CATAPRES for other reasons. Ask your doctor
if you
have any questions about why CATAPRES has been prescribed for you.
BEFORE YOU USE CATAPRES
_WHEN YOU MUST NOT USE CATAPRES _
Only use CATAPRES if it has been prescribed for you by a doctor. Never
give it to
someone else even if their symptoms seem to be the same as yours. Do
not use
CATAPRES if you have certain heart problems, such as irregular/slow
heart beat.
Do not use CATAPRES after the EXPIRY DATE on the carton has passed. Do
not
use CATAPRES if the packaging is torn or shows signs of tampering.
_BEFORE YOU START TO USE CATAPRES _
Before using CATAPRES, you must tell your doctor if you have, or have
had, any of
the following conditions:
•
heart failure or any h

Summary of Product characteristics

NEW ZEALAND DATASHEET
1 PRODUCT NAME
CATAPRES
®
- TTS
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clonidine
3 PHARMACEUTICAL FORM
TRANSDERMAL THERAPEUTIC SYSTEM NO. 1 (PATCH): 2.5mg/3.5cm², printed
with Company symbol
and BI 31.
TRANSDERMAL THERAPEUTIC SYSTEM NO. 2 (PATCH): 5mg/7.0cm², printed
with Company symbol
and BI 32.
TRANSDERMAL THERAPEUTIC SYSTEM NO. 3 (PATCH): 7.5mg/10.5cm², printed
with Company symbol
and BI 33.
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
(cm²)
CATAPRES-TTS-1
0.1mg
2.5
3.5
CATAPRES-TTS-2
0.2mg
5.0
7.0
CATAPRES-TTS-3
0.3mg
7.5
10.5
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
CATAPRES-TTS 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 administration
CATAPRES-TTS
dosage
should
be
titrated
according
to
individual
patient's
therapeutic
requirements. Commence with one CATAPRES-TTS-1 applied weekly to a
freshly cleaned,
hairless area of the upper outer arm or chest. A new site should be
used each week when
applying new patches. If the system loosens during 7-day wearing, the
adhesive cover should be
applied directly over the system to ensure good adhesion. There have
been rare reports of the
need for patch changes prior to 7 days to maintain blood pressure
control.
If after one to two weeks the desired reduction in blood pressure is
not achieved, increase the
weekly dosage by changing to CATAPRES-TTS-2. If this dosage is still
not satisfactory after 1-2
weeks
therapy
then
increase
the
weekly
dosage
by
changing
to
CATAPRES-TTS-3.
Most patients with mild to moderate hypertension will be controlled on
one CATAPRES-TTS-3 or
less. In more resistant cases where blood pressure is not
satisfactorily controlled on one
CATAPRES-TTS-3, it is recommended that a diuretic and/or other
antihypertensive