CLOPIXOL DEPOT zuclopenthixol decanoate 200 mg/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zuclopenthixol decanoate, Quantity: 200 mg

Available from:

Lundbeck Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: fractionated coconut oil

Administration route:

Intramuscular

Units in package:

5 x 1mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Maintenance treatment of acute psychoses, mania and exacerbation of chronic psychoses. May be an advantage in the treatment of noncompliant patients.

Product summary:

Visual Identification: Clear yellowish oil.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1993-09-20

Patient Information leaflet

CLOPIXOL
®
C
L
O
P
I
X
O
L
®
CLOPIXOL
® TABLETS 10 MG, CLOPIXOL
® ACUPHASE INJECTION 50 MG/ML, CLOPIXOL
® DEPOT INJECTION 200 MG/ML
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 CLOPIXOL?
Clopixol Tablet, Acuphase and Depot contain the active ingredient
Zuclopenthixol hydrochloride, Zuclopenthixol acetate and
Zuclopenthixol decanoate, respectively. Clopixol tablets are used for
the acute and long-term treatment of schizophrenia and
other mental illnesses, and to treat the manic phase of
manic-depressive illness. Clopixol Acuphase injection is used for the
initial
treatment of acute episodes of mental disorders and to treat mania.
Clopixol Depot injection is used to prevent further episodes of
your illness. For more information, see Section 1. Why am I using
Clopixol? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CLOPIXOL?
Do not use if you have ever had an allergic reaction to Zuclopenthixol
hydrochloride, Zuclopenthixol acetate or Zuclopenthixol
decanoate or any of the ingredients listed at the end of the CMI.
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.
For more information, see Section 2. What should I know before I use
Clopixol? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Clopixol 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 DO I USE CLOPIXOL?
•
Clopixol tablets: the usual dose is 10 to 50 mg per day; Clopixol
Acuphase injection: the usual dose is 50 to 150 mg (1 to 3 mL)
every 2 to 3 days; Clopixol Depot injection: the usual dose is 200 to
400 mg (1 to 2 mL) every second to fourth week.
•
Clopixol tablets should be swallowed whole with a full glass of water;
Clopixol injections should only be given by a doctor, nurs

Summary of Product characteristics

CLOPIXOL
®
1 of 21
AUSTRALIAN PRODUCT INFORMATION
CLOPIXOL
 (ZUCLOPENTHIXOL HYDROCHLORIDE) FILM-
COATED TABLETS
CLOPIXOL
 ACUPHASE (ZUCLOPENTHIXOL ACETATE)
INJECTION
CLOPIXOL
 DEPOT (ZUCLOPENTHIXOL DECANOATE)
INJECTION
1
NAME OF THE MEDICINE
CLOPIXOL
 TABLETS
CLOPIXOL
 ACUPHASE
INJECTION
CLOPIXOL
 DEPOT INJECTION
Zuclopenthixol hydrochloride
Zuclopenthixol acetate
Zuclopenthixol decanoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clopixol tablets _
Film-coated tablets containing 10 mg zuclopenthixol as zuclopenthixol
hydrochloride.
_Clopixol Acuphase injection _
The 1 mL solution for injection contains 50 mg zuclopenthixol acetate
equivalent to 45.25
mg zuclopenthixol.
The 2 mL solution for injection containing 100 mg zuclopenthixol
acetate equivalent to 90.50
mg zuclopenthixol.
_Clopixol Depot injection _
The 1 ml solution for injection contains 200 mg zuclopenthixol
decanoate equivalent to 144.4
mg zuclopenthixol.
Excipients with known effect in the tablets: sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_Clopixol tablets _
Film-coated tablets. Clopixol 10 mg tablets are light red brown, round
biconvex film-coated
tablets.
CLOPIXOL
®
2 of 21
_Clopixol Acuphase injection _
Solution for injection. Clopixol Acuphase injection presents as a
clear, yellowish oil.
_Clopixol Depot injection _
Solution for injection. Clopixol Depot injection presents as a clear,
yellowish oil.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Clopixol tablets _
Acute and chronic schizophrenia and other psychoses, especially those
with symptoms such
as hallucinations, delusions, thought disturbances, agitation,
restlessness, hostility or
aggressiveness.
Manic phase of manic depressive illness.
_Clopixol Acuphase injection _
Initial treatment of acute psychoses, mania and exacerbation of
chronic psychoses.
_Clopixol Depot injection _
Maintenance treatment. May be an advantage in the treatment of
noncompliant patients.
4.2
DOSE AND METHOD OF ADMINISTRAT