Страна: Египет
Язык: английский
Источник: EDA (Egyptian Drug Authority)
OTSUKA PHARMACEUTICAL-JAPAN
15 mg
tablet
10 tablets
OTSUKA EGYPT
2005-03-22
Page 73 of 81 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 Прочитать полный документ
Page 1 of 81 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)]_ Page 2 of 81 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 Прочитать полный документ