ARIPDON Tablets 5mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Aripiprazole

Available from:

MANSA HEALTHCARE PTE. LTD.

ATC code:

N05AX12

Pharmaceutical form:

TABLET

Composition:

Aripiprazole 5.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PHARMATHEN INTERNATIONAL S.A

Authorization status:

ACTIVE

Authorization date:

2023-02-13

Summary of Product characteristics

1
PACKAGE INSERT
1. ARIPDON TABLETS 5MG
2 COMPOSITION
Each tablet contains 5 mg of aripiprazole.
3 PHARMACEUTICAL FORM
Blue round and biconvex tablets of 6.1 mm in diameter, engraved with
“5” on one side
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
ARIPDON is indicated for the treatment of schizophrenia. The efficacy
of aripiprazole in the
treatment of schizophrenia was established in four short-term (4- and
6-week) controlled trials
in adults. Maintenance efficacy was demonstrated in one trial in
adults.The physician who
elects to use aripiprazole for extended periods should periodically
re-evaluate the long- term
usefulness of the drug for the individual patient.
ARIPDON is indicated for the treatment of acute manic and mixed
episodes associated with
Bipolar I Disorder and for maintaining stability or preventing
recurrence, as monotherapy in
adults,and as an adjunct to lithium or valproate in adults.
The efficacy of aripiprazole as monotherapy was established in four
3-week monotherapy
trials in adults.Efficacy as adjunctive therapy was established in one
6-week adjunctive trial
in adults.
Maintenance efficacy was demonstrated in one monotherapy maintenance
trial and in one
adjunctive maintenance trial in adults. Physicians who elect to use
ARIPDON for extended
periods, should periodically re-evaluate the long-term usefulness of
the drug for the individual
patient.
4.2 Posology and method of administration
Schizophrenia
Usual dose
The recommended starting and target dose for aripiprazole is 10 or 15
mg/day administered
on a once-a-day schedule without regard to meals. Aripiprazole has
been systematically
evaluated and shown to be effective in a dose range of 10 to 30
mg/day, however, doses
higher than 10 or 15 mg/day were not more effective than 10 or 15
mg/day. Dosage increases
should generally not be made before 2 weeks, the time needed to
achieve steady state.
Maintenance Therapy
While there is no body of evidence available to answer the question of
how long a patient
treated with aripiprazole shou