ABILIFY TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ARIPIPRAZOLE

Available from:

OTSUKA PHARMACEUTICALS (SINGAPORE) PTE. LTD.

ATC code:

N05AX12

Dosage:

5.0 mg

Pharmaceutical form:

TABLET

Composition:

ARIPIPRAZOLE 5.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

OTSUKA PHARMACEUTICAL CO. LTD.

Authorization status:

ACTIVE

Authorization date:

2004-04-14

Patient Information leaflet

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ABILIFY
®
(
ARIPIPRAZOLE)
TABLETS
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
AND SUICIDAL THOUGHTS AND BEHAVIOURS WITH ANTIDEPRESSANT DRUGS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC
DRUGS ARE AT AN INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN
PLACEBO-CONTROLLED
TRIALS (MODAL DURATION OF 10 WEEKS
),
LARGELY IN PATIENTS TAKING ATYPICAL
ANTIPSYCHOTIC DRUGS, REVEALED A RISK OF DEATH IN DRUG-TREATED PATIENTS
OF BETWEEN
1.6 TO 1.7 TIMES THE RISK OF DEATH IN PLACEBO-TREATED PATIENTS. OVER
THE COURSE OF A
TYPICAL 10-WEEK CONTROLLED TRIAL, THE RATE OF DEATH IN DRUG-TREATED
PATIENTS WAS
ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN THE PLACEBO GROUP.
ALTHOUGH THE
CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED TO BE EITHER
CARDIOVASCULAR (EG, HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS (EG,
PNEUMONIA) IN
NATURE. OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL
ANTIPSYCHOTIC DRUGS,
TREATMENT WITH CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE
MORTALITY. THE
EXTENT TO WHICH THE FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL
STUDIES MAY BE
ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME
CHARACTERISTIC(S) OF THE
PATIENTS IS NOT CLEAR. ABILIFY IS NOT APPROVED FOR THE TREATMENT OF
PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS [SEE WARNINGS AND PRECAUTIONS (4.1)].
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOUR
IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES. THESE STUDIES DID
NOT SHOW AN
INCREASE IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOUR WITH
ANTIDEPRESSANT USE IN
PATIENTS OVER AGE 24; THERE WAS A REDUCTION IN RISK WITH
ANTIDEPRESSANT USE IN PATIENTS
AGED 65 AND OLDER [SEE WARNINGS AND PRECAUTIONS (4.3)].
IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY,
MONITOR CLOSELY FOR
WORSENING, AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIOURS.
ADVISE FAMILIES
AND CAREGIVERS OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION
WITH THE
PRESCRIBER [SEE WARNINGS AND PRECA

Summary of Product characteristics

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ABILIFY
®
(
ARIPIPRAZOLE)
TABLETS
ORAL SOLUTION
1. INDICATIONS AND USAGE
SCHIZOPHRENIA
ABILIFY is indicated for the treatment of schizophrenia. The efficacy
of ABILIFY in the treatment of
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL
THOUGHTS AND BEHAVIOURS WITH ANTIDEPRESSANT DRUGS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED
TRIALS (MODAL DURATION OF
10 WEEKS
),
LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS, REVEALED A
RISK OF DEATH IN
DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN
PLACEBO-TREATED
PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE
RATE OF DEATH IN DRUG-
TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN
THE PLACEBO GROUP.
ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED
TO BE EITHER
CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS
(E.G., PNEUMONIA) IN NATURE.
OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC
DRUGS, TREATMENT WITH
CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO
WHICH THE FINDINGS
OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO
THE ANTIPSYCHOTIC DRUG
AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR.
ABILIFY IS NOT APPROVED
FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS [_SEE _
_WARNINGS AND _
_PRECAUTIONS (4.1)_].
ANTIDEPRESSANTS
INCREASED
THE
RISK
OF
SUICIDAL
THOUGHTS
AND
BEHAVIOUR
IN
CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES. THESE STUDIES DID
NOT SHOW AN INCREASE
IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOUR WITH ANTIDEPRESSANT USE
IN PATIENTS OVER AGE
24 YEARS; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANT USE IN
PATIENTS AGED 65 YEARS AND
OLDER [_SEE _
_WARNINGS AND PRECAUTIONS (4.3)_].
IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY,
MONITOR CLOSELY FOR
WORSENIN