ABILIFY 10mg tab.

מדינה: מצרים

שפה: אנגלית

מקור: EDA (Egyptian Drug Authority)

זמין מ:

OTSUKA PHARMACEUTICAL-JAPAN

כמות:

10 mg

טופס פרצבטיות:

tablet

יחידות באריזה:

10 tablets

תוצרת:

OTSUKA EGYPT

תאריך אישור:

2005-03-22

עלון מידע

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MEDICATION GUIDE
ABILIFY
® (A BIL Ĭ FĪ) (ARIPIPRAZOLE) TABLETS

NOT ALL ANTIDEPRESSANT MEDICINES PRESCRIBED FOR CHILDREN ARE FDA
APPROVED FOR USE IN CHILDREN.
Talk to your child’s healthcare provider for more information.
WHAT IS ABILIFY?

ABILIFY ORAL TABLETS IS PRESCRIPTION MEDICINE USED TO TREAT:
o
Schizophrenia
o
manic or mixed episodes that happen with bipolar I disorder
o
major depressive disorder (MDD) when ABILIFY is used with
antidepressant medicines
o
irritability associated with autistic disorder
o
Tourette’s disorder
IT IS NOT KNOWN IF ABILIFY IS SAFE OR EFFECTIVE IN CHILDREN:

under 13 years of age with schizophrenia

under 10 years of age with bipolar I disorder

under 6 years of age with irritability associated with autistic
disorder

under 6 years of age with Tourette’s disorder
DO NOT TAKE ABILIFY IF YOU are allergic to aripiprazole or any of the
ingredients in ABILIFY. See the end of
this Medication Guide for a complete list of ingredients in ABILIFY.
Abilify tablets contain lactose. Patients with rare hereditary
problems of galactose intolerance, the lapp
lactase deficiency or glucose-galactose malabsorption should not take
this medicinal product.
BEFORE TAKING ABILIFY, TELL YOUR HEALTHCARE PROVIDER ABOUT ALL YOUR
MEDICAL CONDITIONS, INCLUDING IF
YOU HAVE OR HAD:

diabetes or high blood sugar in you or your family; your healthcare
provider should check your blood
sugar before you start ABILIFY and also during therapy.

seizures (convulsions).

low or high blood pressure.

heart problems or stroke.

pregnancy or plans to become pregnant. It is not known if ABILIFY will
harm your unborn baby.
o
If you become pregnant while receiving ABILIFY, talk to your
healthcare provider

breast-feeding or plans to breast-feed. ABILIFY passes into your
breast milk. Talk to your healthcare
provider about the best way to feed your baby if you receive ABILIFY.

low white blood cell count.

rare hereditary problems of galactose intolerance, the lapp

מאפייני מוצר

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ABILIFY ® TABLETS
(Aripiprazole)
FULL PRESCRIBING INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL
THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE
AT AN INCREASED RISK OF DEATH. ABILIFY IS NOT APPROVED FOR THE
TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS _[SEE WARNINGS AND PRECAUTIONS
(5.1)]_.
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR
IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES. THESE STUDIES DID
NOT SHOW AN
INCREASE IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR 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 (5.3)]_.
IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY,
MONITOR CLOSELY FOR
WORSENING, AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS.
ADVISE FAMILIES AND
CAREGIVERS OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH
THE PRESCRIBER _[SEE _
_WARNINGS AND PRECAUTIONS (5.3)]_.
1 INDICATIONS AND USAGE
ABILIFY Oral Tablets, are indicated for the treatment of:

Schizophrenia
_[see Clinical Studies (14.1)]_

Acute Treatment of Manic and Mixed Episodes associated with Bipolar I
Disorder
_[see _
_Clinical Studies (14.2)]_

Adjunctive Treatment of Major Depressive Disorder
_[see Clinical Studies (14.3)]_

Irritability Associated with Autistic Disorder
_[see Clinical Studies (14.4)]_

Treatment of Tourette’s Disorder
_[see Clinical Studies (14.5)]_
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2 DOSAGE AND ADMINISTRATION
2.1 SCHIZOPHRENIA
ADULTS
The recommended starting and target dose for ABILIFY is 10 or 15
mg/day
administered on a once-a-day schedule without regard to meals. ABILIFY
has
been systematically evaluated and shown to be effective in a dose
range of 10 to
30 mg/day, when administered as the tablet formulation; however, doses
higher
than 10 or 15 mg/day were not mor