Aripiprazole 1 mg/mL
Aripiprazole oral · SOLUTION · Camber Pharmaceuticals, Inc.
Aripiprazole is a solution containing aripiprazole oral at 1 mg/mL, taken oral. Manufactured by Camber Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Aripiprazole
- Generic Name
- Aripiprazole oral
- NDC Code (Product)
31722-684- Manufacturer
- Camber Pharmaceuticals, Inc.
- Strength
- 1 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216150
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 11/01/2023
Recall History
The Harvard Drug Group
Superpotent Drug; out of specification results for assay (manufacturer)
Apotex Corp.
Failed Dissolution Specifications: Out of specification for dissolution.
Apotex Inc.
Superpotent Drug: Product may not meet specifications throughout shelf life.
Hetero Labs, Ltd. - Unit III
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Golden State Medical Supply Inc.
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Aidapak Services, LLC
Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD464
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
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 Aripiprazole is indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: • Schizophrenia (14.1) • Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 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 •Oral formulations: Administer once daily without regard to meals (2) •Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) 2.1 Schizophrenia Adults The recommended starting and target dose for aripiprazole is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole 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 more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see Clinical Studies (14.1)] . Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial invo…
Contraindications
4 CONTRAINDICATIONS Aripiprazole 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 aripiprazole (4)
Drug Interactions
7 DRUG INTERACTIONS Dosage adjustment due to drug interactions (7.1): Factors Dosage Adjustments for Aripiprazole 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 Aripiprazole Table 25: Clinically Important Drug Interactions with Aripiprazole: 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) The concomitant use of aripiprazole with strong CYP 3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of aripiprazole alone [see Clinical Pharmacology (12.3)]. With concomitant use of aripiprazole with a strong CYP3A4 inhibitor or CYP2D6 inhibitor, reduce the aripiprazole dosage [see Dosage and Administration (2.7)]. Strong CYP3A4 Inducers (e.g., carb…
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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.…
Frequently Asked Questions
What is Aripiprazole used for?
Aripiprazole contains Aripiprazole oral. It is a solution taken oral. Consult your doctor for specific uses.
Is Aripiprazole a controlled substance?
Aripiprazole is not classified as a controlled substance by the DEA.
What is the generic name for Aripiprazole?
The generic name for Aripiprazole is Aripiprazole oral. There are no other listed brand versions of Aripiprazole oral.
What is the NDC code for Aripiprazole 1 mg/mL?
The NDC (National Drug Code) for Aripiprazole 1 mg/mL is 31722-684, listed by Camber Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)