MZ Clonidine HCl Injection clonidine hydrochloride 150 microgram/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clonidine hydrochloride, Quantity: 150 microgram/mL

Available from:

Medsurge Pharma Pty Ltd

INN (International Name):

Clonidine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intramuscular, Subcutaneous

Units in package:

5 pack, 10 pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MZ Clonidine HCl Injection is indicated for acute hypertensive crisis and as an alternative to oral therapy where the oral route of administration is inappropriate.

Product summary:

Visual Identification: Colourless, clear solution in a Type I neutral glass ampoules with 1 ml nominal volume; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-11-24

Patient Information leaflet

_MZ _CLONIDINE HCL INJECTION CMI V3.0 (OCTOBER 2018)
1
_MZ CLONIDINE HCL _
_INJECTION_
_ _
_CLONIDINE HYDROCHLORIDE _
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS LEAFLET _
This leaflet answers some
common questions about
_MZ_
Clonidine HCl Injection.
It does not contain all the
available information
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you using the
_MZ_
Clonidine HCl Injection against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH _MZ_
CLONIDINE HCL INJECTION, ASK
YOUR DOCTOR OR PHARMACIST.
This leaflet was last updated on
the date at the end of this leaflet.
More recent information may be
available. The latest Consumer
Medicine Information is
available from your pharmacist,
doctor, or from www.tga.gov.au
and may contain important
information about the medicine
and its use of which you should
be aware.
KEEP THIS LEAFLET
.
You may need to read it again.
_WHAT MZ CLONIDINE HCL _
_INJECTION IS USED FOR _
_MZ_
Clonidine HCl Injection
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).
_HOW MZ CLONIDINE HCL _
_INJECTION WORKS _
_MZ_
Clonidine HCl Injection
works by relaxing and widening
blood vessels and so helps to
lower your blood pressure.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE IS BEING GIVEN TO
YOU.
Your doctor may have
prescribed it for another reason.
_BEFORE YOU USE MZ _
_CLO

Summary of Product characteristics

_MZ_ CLONIDINE HCL INJECTION
_ _
PRODUCT INFORMATION
Edition 3.0 – February 2021
Page
1
AUSTRALIAN PRODUCT INFORMATION – _MZ_ CLONIDINE HCL
INJECTION (CLONIDINE HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
CLONIDINE HYDROCHLORIDE
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clonidine Hydrochloride 150 microgram/1 mL
_MZ _Clonidine HCl Injection 1mL ampoules contain 150 microgram of
clonidine hydrochloride, 9 mg
of sodium chloride, hydrochloric acid (qs) and water for injections
(qs).
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_MZ _Clonidine HCl Injection_ _is indicated for acute hypertensive
crisis and as an alternative to oral
therapy where the oral route of administration is inappropriate.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Subcutaneous or intramuscular injection of _MZ_ Clonidine HCl
Injection should only be
administered to patients in a lying position. Product is for single
use in one patient only. Discard
any residue.
One to two ampoules (150-300 micrograms) by intramuscular injection
undiluted, or given
intravenously in 10 mL of normal saline over five minutes. May be
repeated at intervals of 3 to 6
hours as necessary. Following intravenous injection, an initial
pressor phase of 5-10 mm Hg
lasting approximately 5 minutes may occur. This effect can be lessened
by slow administration.
As clonidine is metabolised in the liver and excreted mainly by the
kidneys, any hepatic or renal
impairment may require a reduction in dosage. Clonidine HCl Injection
may be given in
combination with guanethidine, alpha methyldopa or other
antihypertensives to provide
effective control of blood pressure in refractory cases. In this way
the dose of each individual
drug may be reduced and side effects minimised.
_MZ_ Clonidine HCl Injection contain 0.154 mmol sodium (3.5 mg) per
ampoule.
Renal insufficiency
Dosage must be adjusted:
•
according to the individual antihypertensive response which can show
high variability
in pat