CATAPRES clonidine hydrochloride 150 microgram/1mL injection ampoule

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

clonidine hydrochloride, Quantity: 150 microgram/mL

Tersedia dari:

Clinect Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections

Rute administrasi :

Intramuscular, Intravenous

Unit dalam paket:

5x1mL

Kelas:

Medicine Registered

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

INDICATIONS AS AT 16 May 2001: Parenteral: Acute hypertensive crisis. As an alternative to oral therapy where the oral route of administration is inappropriate.

Ringkasan produk:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1991-09-26

Selebaran informasi

CATAPRES
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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 use
Catapres? 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 do I use Catapres? 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
•
Alcohol ma

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION –
CATAPRES
® CLONIDINE HYDROCHLORIDE
TABLETS AND INJECTION AMPOULES
1.
NAME OF THE MEDICINE
clonidine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CATAPRES 150 tablets contain 150 micrograms of clonidine
hydrochloride.
CATAPRES ampoules contain 150 micrograms of clonidine hydrochloride/1
mL.
Excipients with known effect
Each CATAPRES 150 tablet contains 36.05 mg of lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
CATAPRES 150 tablets: scored, white, compressed tablets, impressed
with the symbol 15C/15C on one side
and with the Boehringer Ingelheim symbol on the reverse side. Each
tablet contains 150 micrograms of
clonidine hydrochloride.
CATAPRES ampoules: clear, colourless solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral:
All grades of essential hypertension.
Renal hypertension.
Parenteral:
Acute hypertensive crisis.
As an alternative to oral therapy where the oral route of
administration is inappropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
The dosage recommendations are as follows:
_Tablets: _75 micrograms (half a tablet) two or three times a day.
Increase the daily dosage by half-tablet
(75 micrograms) increments until desired control of blood pressure is
achieved. In those patients to whom
CATAPRES is given as sole therapy, there may be in the early months of
treatment a need to gradually
increase dosage to achieve optimal control. Dosage adjustment by small
increments is desirable up to a
maximum recommended dose of 900 micrograms per day. In the early
stages of treatment, some associated
fluid retention may be minimised by the concomitant use of a thiazide
diuretic.
_Maintenance:_ 150 micrograms (one tablet) to 300 micrograms (two
tablets) three times a day.
In impaired renal and hepatic function the half-life is prolonged and
the dosage regimen should be monitored
carefully.
The hypotensive effect of CATAPRES is dose dependent. It is usual to
titrate the dose of