ABILIFY 10 mg/1
ARIPIPRAZOLE · TABLET · Otsuka America Pharmaceutical, Inc.
ABILIFY is a tablet containing aripiprazole at 10 mg/1, taken oral. Manufactured by Otsuka America Pharmaceutical, Inc..
Key Facts
- Brand Name
- ABILIFY
- Generic Name
- ARIPIPRAZOLE
- NDC Code (Product)
59148-008- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021436
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 11/15/2002
Recall History
Bristol Myers Squibb Manufacturing Company
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Cross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Cross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Cross Contamination with Other Products
Otsuka Pharmaceutical Development & Commercialization, Inc.
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Cross Contamination with Other Products
Otsuka Pharmaceutical Development & Commercialization, Inc.
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer once daily without regard to meals ( 2 ) Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults ( 2.1 ) 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents ( 2.1 ) 2 mg/day 10 mg/day 30 mg/day Bipolar mania – adults: monotherapy ( 2.2 ) 15 mg/day 15 mg/day 30 mg/day Bipolar mania – adults: adjunct to lithium or valproate ( 2.2 ) 10 to 15 mg/day 15 mg/day 30 mg/day Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate ( 2.2 ) 2 mg/day 10 mg/day 30 mg/day Major Depressive Disorder – adults: adjunct to antidepressants ( 2.3 ) 2 to 5 mg/day 5 to 10 mg/day 15 mg/day Irritability associated with autistic disorder – pediatric patients ( 2.4 ) 2 mg/day 5 to 10 mg/day 15 mg/day Tourette's Disorder – ( 2.5 ) Patients <50 kg 2 mg/day 5 mg/day 10 mg/day Patients ≥50 kg 2 mg/day 10 mg/day 20 mg/day Known CYP2D6 poor metabolizers: Half of the usual dose ( 2.6 ) 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…
Contraindications
4 CONTRAINDICATIONS ABILIFY is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2) ] . Known hypersensitivity to ABILIFY ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Dosage adjustment due to drug interactions ( 7.1 ): Factors Dosage Adjustments for ABILIFY Known CYP2D6 Poor Metabolizers Administer half of usual dose Known CYP2D6 Poor Metabolizers and strong CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP2D6 or CYP3A4 inhibitors Administer half of usual dose Strong CYP2D6 and CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP3A4 inducers Double usual dose over 1 to 2 weeks 7.1 Drugs Having Clinically Important Interactions with ABILIFY Table 22: Clinically Important Drug Interactions with ABILIFY: Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) Concomitant use of ABILIFY with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of ABILIFY alone [see Clinical Pharmacology (12.3) ]. Reduce the ABILIFY dosage when administered concomitantly with a strong CYP3A4 inhibitor or a strong CYP2D6 inhibitor [see Dosage and Administration (2.6) ] . Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin) Concom…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Orthostatic Hypotension [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10) ] Seizures/Convulsions [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12) ] Body Temperature Regulation [see Warnings and Precautions (5.13) ] Suicide [see Warnings and Precautions (5.14) ] Dysphagia […
Frequently Asked Questions
What is ABILIFY used for?
ABILIFY contains ARIPIPRAZOLE. It is a tablet taken oral. Consult your doctor for specific uses.
Is ABILIFY a controlled substance?
ABILIFY is not classified as a controlled substance by the DEA.
What is the generic name for ABILIFY?
The generic name for ABILIFY is ARIPIPRAZOLE. There are 12 other brand versions of ARIPIPRAZOLE.
What is the NDC code for ABILIFY 10 mg/1?
The NDC (National Drug Code) for ABILIFY 10 mg/1 is 59148-008, listed by Otsuka America Pharmaceutical, Inc..