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AURO-ARIPIPRAZOLE is a brand name for Aripiprazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AURO-ARIPIPRAZOLE (aripiprazole) is indicated for: the treatment of schizophrenia in adults. In controlled clinical trials, aripiprazole was found to improve both positive and negative symptoms. Aripiprazole has been shown to be more effective than placebo in maintaining clinical improvement for up to 26 weeks in…
Verbatim from this product's HC label. Tap a section to expand.
1 Adverse Reaction Overview Aripiprazole was evaluated for safety in 13,543 adult patients who participated in multiple- dose, clinical trials of schizophrenia several other non-schizophrenia psychiatric disorders, and had approximately 7619 patient-years of exposure to oral aripiprazole and 749 patients with exposure to aripiprazole injection.
A total of 3390 patients were treated with oral aripiprazole for at least 180 days and 1933 patients treated with oral aripiprazole had at least 1 year of exposure. The conditions and duration of treatment with aripiprazole included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short-and longer-term exposure.
Aripiprazole was evaluated for safety in 202 adolescent patients (13 - 17 years of age) with schizophrenia in a 6-week placebo controlled clinical trial. Adolescent patients from this study were also treated with oral aripiprazole in uncontrolled, open label studies for more than 26 weeks (n=178) and more than 52 weeks (n=79).
Treatment emergent adverse event frequencies are reported for adolescent patients, 13 - 17 years of age, with schizophrenia that were included in these studies, but the majority of patients were 15 - 17 years of age. AURO-ARIPIPRAZOLE is not indicated for the treatment of schizophrenia in patients under 15 years due to insufficient safety and efficacy data (see ADVERSE REACTIONS, CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia-Adolescents).
Adverse events during exposure were obtained by collecting volunteered adverse events, as well as results of physical examinations, vital signs, weights, laboratory analyses, and ECG. Adverse events were recorded by clinical investigators using terminology of their own choosing.
In the tables and tabulations that follow, MedDRA dictionary terminology has been used to classify reported adverse events into a smaller number of standardized event categories, in order to provide a meaningful estimate of the proportion of individuals reporting adverse events.
The stated frequencies of adverse events represent the proportion of individuals who reported at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy Page 21 of 71 following baseline evaluation.
03/2022 Table of Contents RECENT MAJOR LABEL CHANGES ................................................................................................. 2 Table of Contents..........................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................... 4 1 INDICATIONS ..............................................................................................................................
1 Pediatrics .................................................................................................................... 2 Geriatrics.....................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..........................................................................
5 4. DOSAGE AND ADMINISTRATION .............................................................................................. 1 Dosing Considerations ................................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 3 Administration ............................................................................................................ 4 Reconstitution ............................................................................................................
5 Missed Dose ................................................................................................................ 7 5 OVERDOSAGE ............................................................................................................................
AURO-ARIPIPRAZOLE (aripiprazole) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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e. all events meeting the defined criteria, regardless of investigator causality are included. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Short-Term, Placebo-Controlled Trials of Adult Patients with Schizophrenia The following findings are based on a pool of five placebo-controlled trials (four 4-week and one 6-week) in which aripiprazole was administered orally in doses ranging from 2 to 30 mg/day.
Adverse Events Associated with Discontinuation of Treatment Overall, there was little difference in the incidence of discontinuation due to adverse events between aripiprazole-treated (7%) and placebo-treated (9%) patients. The types of adverse events that led to discontinuation were similar between the aripiprazole and placebo-treated patients.
Commonly Reported Adverse Events The only commonly observed adverse event associated with the use of aripiprazole in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (placebo 4%; aripiprazole 8%).
Adverse Events Reported at an Incidence of 2% or More Among Adult Aripiprazole-Treated Patients and Greater than Placebo in Short-Term, Placebo-Controlled Trials of Schizophrenia or another non-schizophrenia psychiatric disorder. Table 2 enumerates the pooled incidence, rounded to the nearest percent, of treatment- emergent adverse events that were reported during acute therapy of up to 6 weeks in duration in schizophrenia and another non-schizophrenia psychiatric disorder.
These events that were reported in 2% or more of patients treated with aripiprazole (doses ≥2 mg/day) and the incidence in patients treated with aripiprazole was greater than the incidence in patients treated with placebo in the combined dataset.
Table 2:
Treatment-emergent adverse events in adult patients treated with oral aripiprazole in short-term, placebo-controlled trials of schizophrenia or another non- schizophrenia psychiatric disorder. Events are reported by at least 2% of patients treated with oral aripiprazole, except events which had an incidence equal to or less than placebo.
Percentage of Patients Reporting Event System Organ Class Aripiprazole Placebo Preferred Term (n=1843) (n=1166) Page 22 of 71 Percentage of Patients Reporting Event Eye Disorders Blurred Vision 3 1 Gastrointestinal Disorders Nausea 15 11 Constipation 11 7 Vomiting 11 6 Dyspepsia 9 7 Dry Mouth 5 4 Toothache 4 3 Abdominal Discomfort 3 2 Stomach Discomfort 3 2 General Disorders and Administration Site Conditions Fatigue 6 4 Pain 3 2 Musculoskeletal and Connective Tissue Disorders Musculoskeletal Stiffness 4 3 Pain in Extremity 4 2 Myalgia 2 1 Muscle Spasms 2 1 Nervous System Disorders Headache 27 23 Dizziness 10 7 Akathisia 10 4 Sedation 7 4 Extrapyramidal Disorder 5 3 Tremor 5 3 Somnolence 5 3 Psychiatric Disorders Agitation 19 17 Insomnia 18 13 Anxiety 17 13 Restlessness 5 3 Respiratory, Thoracic, and Mediastinal Disorders Pharyngolaryngeal Pain 3 2 Cough 3 2 An examination of population subgroups did not demonstrate a difference in the incidence of adverse events based on age, […]
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................. 8 7 WARNINGS AND PRECAUTIONS ................................................................................................ 1 Special Populations ...................................................................................................
1 Pregnant Women................................................................................................... 2 Breast-feeding .......................................................................................................
3 Pediatrics ............................................................................................................... 4 Geriatrics (≥ 65 years of age) .................................................................................
5 Use in Patients with Renal Impairment ................................................................. 6 Use in Patients with Hepatic Impairment ............................................................. 7 Use in Patients with Concomitant Illness ..............................................................
8 Gender ................................................................................................................... 9 Race .......................................................................................................................
10 Lactose ................................................................................................................. 20 8 ADVERSE REACTIONS ...............................................................................................................
1 Adverse Reaction Overview...................................................................................... 2 Clinical Trial Adverse Reactions ................................................................................ 3 Less Common Clinical Trial Adverse Reactions.........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Page 3 of 71 Quantitative Data ................................................................................................. 5 Clinical Trial Adverse Reactions (Pediatrics) .............................................................
6 Post-Market Adverse Reactions ............................................................................... 38 9 DRUG INTERACTIONS...............................................................................................................
1 Serious Drug Interactions Box .................................................................................. 2 Overview ...................................................................................................................
3 Drug-Drug Interactions ............................................................................................. 4 Drug-Food Interactions.............................................................................................
5 Drug-Herb Interactions ............................................................................................. 6 Drug-Laboratory Tests ..............................................................................................
7 Drug-Lifestyle Interactions ....................................................................................... 43 10 ACTION AND CLINICAL PHARMACOLOGY..............................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics.................................................................................................
3 Pharmacokinetics ................................................................................................... 44 11 STORAGE, STABILITY AND […]