Catapres

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Clonidine hydrochloride 150 µg/mL

から入手可能:

Clinect NZ Pty Limited

INN（国際名）:

Clonidine hydrochloride 150 µg/mL

投薬量:

150 mcg/mL

医薬品形態:

Solution for injection

構図:

Active: Clonidine hydrochloride 150 µg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

パッケージ内のユニット:

Ampoule, glass, 5 x 1mL, 5 mL

クラス:

Prescription

処方タイプ:

Prescription

製:

Boehringer Ingelheim Pharma GmbH & Co KG

適応症:

Parenteral Catapres is indicated for the treatment of hypertensive crises, slow parenteral administration is especially suitable due to the rapid onset of action.

製品概要:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 1mL - 5 mL - 36 months from date of manufacture stored at or below 30°C

承認日:

1973-01-18

情報リーフレット

CATAPRES® AMPOULES
1
CATAPRES® AMPOULES
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 CATAPRES?
Catapres contains the active ingredient clonidine hydrochloride.
Catapres is used to lower high blood pressure, also called
hypertension. Catapres works by relaxing and widening blood vessels
and so helps to lower your blood pressure.
For more information, see Section 1. Why am I using Catapres? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN CATAPRES AMPOULES?
You should not be given Catapres if you have ever had an allergic
reaction to clonidine hydrochloride or any of the ingredients
listed at the end of the CMI.
CATAPRES SHOULD NOT BE GIVEN TO YOU IF YOU HAVE CERTAIN HEART
PROBLEMS, SUCH AS IRREGULAR/SLOW HEARTBEAT. 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.
THIS MEDICINE SHOULD NOT BE GIVEN TO A CHILD UNDER THE AGE OF 18
YEARS.
For more information, see Section 2. What should I know before I am
given
Catapres Ampoules? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Catapres and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN CATAPRES AMPOULES?

Your doctor will tell you what dose of Catapres Ampoules you will
receive. Catapres Ampoules can be given as an injection
into a muscle or as a slow injection into a vein.
More instructions can be found in Section 4. How are Catapres Ampoules
given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE I AM BEING GIVEN CATAPRES AMPOULES?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit
that you are using Catapres.
DRIVING OR
USING
MACHINES

Be careful before you drive or use any machines or
tools until you know how Catapres affects you.
DRINKING
ALCOHOL

A

製品の特徴

1
NEW ZEALAND DATA SHEET
1.
CATAPRES
CATAPRES 150 mcg tablets
CATAPRES 150 mcg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CATAPRES 150 mcg tablets
One tablet contains 150 mcg clonidine hydrochloride
Excipient with known effect: One tablet contains 36.05 mg lactose
monohydrate
CATAPRES 150 mcg/mL solution for injection
Each 1 mL ampoule contains 150 mcg clonidine hydrochloride
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
CATAPRES 150 mcg tablets
White, round, flat tablets with bevelled edges, one side marked with
“15C / break-line/ 15C”
CATAPRES 150 mcg/mL solution for injection
150 mcg/mL clear, colourless solution
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral
CATAPRES
is
indicated
in
the
treatment
of
hypertension.
CATAPRES
may
be
employed
alone
or
concomitantly with other antihypertensive agents.
Parenteral
For the treatment of hypertensive crises, slow parental administration
is especially suitable due to the rapid
onset of action.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Tablets
It is recommended to slowly titrate the oral dose of CATAPRES to
satisfy the requirements of individual
patients.
_Initially _
Commence on 75 mcg (half a tablet) at night. At successive
consultations (2-4 week intervals) the daily dose
should be increased by half a tablet (75 mcg), until adequate blood
pressure control is attained. The total daily
dose is recommended to be taken once daily at night if the optimal
dose is 1 tablet or less. If the total daily
2
dose is greater than 1 tablet then dosage should be taken twice daily
in evenly divided doses. Where the
dosage is uneven the larger dose should be taken at night. Usually
doses above 600 mcg per day do not result
in a further marked drop in blood pressure.
_Maintenance _
Most patients with mild to moderate hypertension will be controlled on
a dose of 150-450 mcg daily.
In more severe cases, higher doses of up to 900 mcg daily have been
utilised on a 300 mcg (2 tablets), twice
to three times daily dosage regimen.
Inj