APO-ARIPIPRAZOLE 2 mg aripiprazole tablets blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

aripiprazole, Quantity: 2 mg

Verfügbar ab:

Arrotex Pharmaceuticals Pty Ltd

INN (Internationale Bezeichnung):

aripiprazole

Darreichungsform:

Tablet, uncoated

Zusammensetzung:

Excipient Ingredients: indigo carmine aluminium lake; tartaric acid; iron oxide yellow; croscarmellose sodium; microcrystalline cellulose; magnesium stearate

Verabreichungsweg:

Oral

Einheiten im Paket:

30 and 100

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,Acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate;,Maintenance treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.

Produktbesonderheiten:

Visual Identification: 2 mg tablets are green, rectangular, slightly biconvex tablets, engraved "2" on one side, "A" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2009-07-09

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION -
APO- ARIPIPRAZOLE (ARIPIPRAZOLE) TABLETS
1
NAME OF THE MEDICINE
Aripiprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg, 5mg, 10mg, 15mg, 20mg and 30mg aripiprazole
as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
2 MG TABLETS
Green, rectangular, slightly biconvex tablets, engraved “2” on one
side, “A” on the other side.
5 MG TABLETS
Blue, rectangular, slightly biconvex tablets, engraved “5” on one
side, “A” on the other side.
10 MG TABLETS
Pink, rectangular, slightly biconvex tablets, engraved “10” on one
side, “A” on the other side.
15 MG TABLETS
Yellow, round, slightly biconvex tablets, engraved “ARI” over
“15” on one side, “APO” on the other
side.
20 MG TABLETS
White to off-white, round, slightly biconvex tablets, engraved
“ARI” over “20” on one side, “APO”
on the other side.
30 MG TABLETS
Pink, round, slightly biconvex tablets, engraved “ARI” over
“30” on one side, “APO” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole is indicated for the treatment of schizophrenia including
maintenance of clinical
improvement during continuation therapy.
Although this document refers to the results of studies of
aripiprazole in conditions other than
schizophrenia, the APO- Aripiprazole tablets are not indicated for use
in the treatment of
conditions other than schizophrenia.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Aripiprazole tablets are intended for oral administration.
DOSAGE
ADULTS
Recommended Dosage – Schizophrenia
The recommended starting dose for aripiprazole
is 10 or 15 mg/day administered on a once-a-
day schedule without regard to meals. In clinical trial, doses in the
range of 10 to 30 mg/day have
been effective. Daily dosage may be adjusted with regard to individual
clinical status within the
range of 10-30 mg daily. Dosage increases should not be made prior to
the time needed to
achieve ste