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AG-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: AG-Aripiprazole (aripiprazole tablets) is indicated for: • the treatment of schizophrenia and related psychotic disorders in adults. In controlled clinical trials, aripiprazole tablets was found to improve both positive and negative symptoms. Aripiprazole tablets has been shown to be more effective than placebo in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The efficacy and safety of aripiprazole tablets, at doses greater than 30 mg/day, have not been established. Pediatric and adolescent patients are at greater risk of experiencing certain adverse events related to the use of atypical antipsychotics including AG-Aripiprazole.
Some of these adverse events appear to be dose related (see WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS, Serious Warnings and Precautions Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in the death rate in the drug-treated patients. , pneumonia) in nature (see WARNINGS AND PRECAUTIONS - Special Populations, Use in Elderly Patients with Dementia). AG-Aripiprazole (Aripiprazole Tablets) Product Monograph Page 7 of 94 Clinical Trial Adverse Reactions).
Refer to DRUG INTERACTION section for dosage adjustment in patients taking AG-Aripiprazole concomitantly with strong CYP3A4 inhibitors (such as ketoconazole or clarithromycin), with potential CYP2D6 inhibitors (such as quinidine, fluoxetine, or paroxetine) or with potential CYP3A4 inducers (such as carbamazepine).
Dosing Considerations in Special Populations Pediatrics (< 18 years of age):
Safety and efficacy were evaluated in adolescent (13-17 years of age) patients with schizophrenia in one 6-week clinical trial. AG-Aripiprazole is not indicated for the treatment of schizophrenia in adolescent patients under 15 years of age due to insufficient safety and efficacy data (see ADVERSE REACTIONS, CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia-Adolescents).
Safety and efficacy in pediatric and adolescent patients (10-17 years of age) with bipolar I disorder have been evaluated in one 4-week clinical trial. AG-Aripiprazole is not indicated for the treatment of bipolar I disorder in patients under 13 years of age due to insufficient safety and efficacy data (see ADVERSE REACTIONS, CLINICAL TRIALS, Trial Design and Study Demographics, Bipolar–Pediatric and Adolescent).
The safety and efficacy of AG-Aripiprazole in patients with major depressive disorder (MDD) under the age of 18 years have not been established and its use is not recommended (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
1 Adverse Reaction Overview Aripiprazole was evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, dementia of the Alzheimer's type, Parkinson’s disease, and alcoholism, and who 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 (monotherapy or adjunctive therapy with antidepressants or mood stabilizers) 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 AG-Aripiprazole (Aripiprazole Tablets) Product Monograph Page 25 of 94 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. Aripiprazole was evaluated for safety in 233 pediatric and adolescent patients (10 -17 years) who participated in multiple-dose, clinical trials in bipolar I disorder.
A total of 103 pediatric and adolescent patients with bipolar I disorder were treated with oral aripiprazole for more than 26 weeks. Treatment emergent adverse frequencies are reported for pediatric and adolescent patients, 10 - 17 years of age in a manic or mixed episode of bipolar I disorder, but the majority of patients were 13 - 17 years of age.
4 Geriatrics .............................................................................................................. 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 ............................................................................................................. 24 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 Quantitative Data .............................................................................................................. 5 Clinical Trial Adverse Reactions (Pediatrics) ............................................................
6 Post-Market Adverse Reactions .............................................................................. 55 9 DRUG INTERACTIONS ................................................................................................ 1 Serious Drug Interactions Box .................................................................................
AG-Aripiprazole (aripiprazole tablets) 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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Geriatric (≥ 65 years of age):
Safety and efficacy of aripiprazole tablets in the treatment of schizophrenia and bipolar I disorder in patients 65 years of age or older have not been established. Given the greater sensitivity of this population, a lower starting dose may be considered when clinical factors warrant (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
AG-Aripiprazole is not indicated in elderly patients with dementia (see SERIOUS WARNINGS AND PRECAUTIONS BOX).
Patients with hepatic impairment:
No dosage adjustment is required for patients with hepatic impairment.
Patients with renal impairment:
No dosage adjustment is required in patients with renal impairment.
Gender:
No dosage adjustment is required for female patients as compared to male patients.
Smoking status:
No dosage adjustment is required for smokers (see DRUG INTERACTIONS, Drug- AG-Aripiprazole (Aripiprazole Tablets) Product Monograph Page 8 of 94 Lifestyle Interaction).
CYP2D6 poor metabolizers:
Approximately 8% of Caucasians lack the capacity to metabolize CYP2D6 substrates and are classified as poor metabolizers (PM), whereas the rest are extensive metabolizers (EM). CYP2D6 metabolizing capacity should be considered when aripiprazole is co- administered with drugs that inhibit CYP2D6 (see DRUG INTERACTIONS, Drug-Drug Interactions).
2 Recommended Dose and Dosage Adjustment Schizophrenia Adults Usual Dose: The recommended starting and target dose for AG-Aripiprazole is 10 or 15 mg/day administered on a once-a-day schedule. Doses in the range of 10 to 30 mg/day have been established as effective in clinical trials.
However, greater efficacy has not been demonstrated at doses higher than 10 mg/day. Dosage increases, if needed, should only be made after 2 weeks, the time needed to achieve steady state. The maximum daily dose should not exceed 30 mg/day.
Patients should be maintained on the lowest effective dose that provides optimal clinical response and tolerability and should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (15 -17 years of age) Usual dose:
The recommended target dose of AG-Aripiprazole is 10 mg/day administered on a once-a- day schedule. The recommended starting daily dose is 2 mg/day, titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days.
Subsequent dose increases should be administered, if needed and as tolerated, in 5 mg/day increments. Both the 10 mg/day and 30 mg/day doses have been shown to be effective in a double-blind, placebo- controlled clinical trial; however, the 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose.
The maximum daily dose should not exceed 30 mg/day. Patients should be maintained on the lowest effective dose that provides optimal clinical response and tolerability. The safety and efficacy of aripiprazole tablets during long term treatment have not been systematically evaluated in adolescent patients with schizophrenia.
The physician who elects to use AG-Aripiprazole for extended periods in adolescent patients with schizophrenia should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Bipolar Disorder Adults:
Monotherapy The recommended starting dose for AG-Aripiprazole as acute monotherapy is 15 mg given once […]
AG-AripiprazoleAG-Aripiprazole is not indicated for the treatment of schizophrenia in adolescent patients under 15 years or for the treatment of manic or mixed episodes of bipolar I disorder in patients under 13 years of age due to insufficient safety and efficacy data (see ADVERSE REACTIONS, CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia- Adolescents and Bipolar Disorder-Pediatric and Adolescent).
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 following baseline evaluation.
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 AG-Aripiprazole (Aripiprazole Tablets) Product Monograph Page 26 of 94 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%).
Short-Term, Placebo-Controlled Trials of Aripiprazole in Adult Patients with Bipolar Mania The following findings are based on a pool of 3-week, placebo-controlled, bipolar mania trials in which aripiprazole was administered orally at doses of 15 or 30 mg/day.
Adverse Events Associated with Discontinuation of Treatment Overall, in patients with bipolar mania, there was little difference in the incidence of discontinuation due to adverse events between aripiprazole-treated (11%) and placebo-treated (10%) patients.
The types of adverse events that led to discontinuation were similar between the aripiprazole and placebo-treated patients. 3% of patients on placebo. Commonly Reported Adverse Events Commonly reported adverse events associated with the use of aripiprazole in patients with bipolar mania (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) are shown in Table 2.
AG-Aripiprazole […]
2 Overview .................................................................................................................. 3 Drug-Drug Interactions ............................................................................................
4 Drug-Food Interactions ............................................................................................ 5 Drug-Herb Interactions ............................................................................................
6 Drug-Laboratory Test Interactions........................................................................... 7 Drug-Lifestyle Interactions....................................................................................... 60 10 ACTION AND CLINICAL PHARMACOLOGY ...................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
61 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 63 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 63 13 PHARMACEUTICAL INFORMATION .............................................................................
64 14 CLINICAL TRIALS ........................................................................................................ 1 Trial Design and Study Demographics.................................................................. 2 Study Results ........................................................................................................
3 Comparative Bioavailability Studies ..................................................................... 70 15 MICROBIOLOGY ........................................................................................................ 72 16 NON-CLINICAL TOXICOLOGY ......................................................................................
72 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 82 PATIENT MEDICATION INFORMATION .................................................................................. 83 AG-Aripiprazole (Aripiprazole Tablets) Product Monograph Page 4 of 94 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AG-Aripiprazole (aripiprazole tablets) is indicated for: • the treatment of schizophrenia and related psychotic disorders in adults.
In controlled clinical trials, aripiprazole tablets was found to improve both positive and negative symptoms. Aripiprazole tablets has been shown to be more effective than placebo in maintaining clinical improvement for up to 26 weeks in adults.
• the treatment of manic or mixed episodes in bipolar I disorder in adults. AG-Aripiprazole may be used as acute monotherapy or cotherapy with lithium or divalproex sodium when there is an insufficient acute response to these agents alone.
Aripiprazole tablets as cotherapy with lithium or divalproex sodium has been shown to be more effective than placebo plus mood stabilizer in maintaining clinical improvement for up to 1 year in adult patients with manic or mixed episodes associated with bipolar I disorder (see CLINICAL TRIALS, Trial Design and Study Demographics, Bipolar Disorder).
The physician who elects to use AG-Aripiprazole for extended periods […]