ARIPILIN Oral tablet 15

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Aripiprazole

Available from:

Lincoln Pharmaceuticals Limited, INDIA

ATC code:

Antipsychotic drugs

INN (International Name):

Aripiprazole

Dosage:

15

Pharmaceutical form:

Oral tablet

Manufactured by:

Lincoln Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Off white to pink colour with small specks, round shaped, biconvex, plain on both sides of Uncoates tablets.; Local technical representative: Heko Pharmacy Limited (7718)

Authorization status:

Registered/Compliant

Authorization date:

2022-05-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Tablets USP 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE DECLARATION
Aripiprazole USP
QUANTITATIVE DECLARATION
Each tablet contains 68.350 mg of Lactose Monohydrate.
For full list of Excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Tablet
Off white to pink colour with small specks, round shaped, biconvex,
plain on both sides
of Uncoated tablets.
The breakline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
4.
CLINICAL PARTICULARS
1.
THERAPEUTIC INDICATIONS
It is indicated for the treatment of schizophrenia in adults and in
adolescents aged 15
years, older, and moderate to severe manic episodes in bipolar I
disorder and for the
prevention of a new manic episode in adults who experienced
predominantly manic
episodes and whose manic episodes responded to aripiprazole treatment.
It is also
indicated for the treatment up to 12 weeks of moderate to severe manic
episodes in bipolar
I disorder in adolescents aged 13 years and older.
2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS _
•
_SCHIZOPHRENIA:_ starting recommended dose is 10-15 mg/day with a
maintenance
dose of 15 mg/day. Improved efficacy at doses higher than a daily dose
has not
been proved although individual patients may benefit from a higher
dose. The
maximum daily dose should not exceed 30 mg. It is effective in a dose
range of 10
mg/day to 30 mg/day
•
MANIC EPISODES IN BIPOLAR I DISORDER: Initially starting dose 15 mg
once daily,
some patients may benefit from a higher dose. The maximum daily dose
should not
exceed 30 mg.
•
RECURRENCE PREVENTION OF MANIC EPISODES IN BIPOLAR I DISORDER: for
preventing
recurrence of manic episodes in patients, who have been receiving
aripiprazole as
monotherapy
or
combination
therapy,
continue
therapy
at
the
same
dose.
Adjustments
of
daily
dosage,
including
dose
reduction
should
be
considered
because of clinical status.
_SPECIAL POPULATIONS _
•
HEPATIC IMPAIRMENT: No dosa