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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: ARIPIPRAZOLE (aripiprazole) is indicated for the treatment of schizophrenia and related psychotic disorders 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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The efficacy and safety of aripiprazole, 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 ARIPIPRAZOLE.
2 Clinical Trial Adverse Reactions). Refer to DRUG INTERACTION section for dosage adjustment in patients taking 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).
ARIPIPRAZOLE Product Monograph Page 6 of 69 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.
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 8 ADVERSE REACTIONS; 14 CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia, Adolescents [13 – 17 years of age]).
Geriatric (≥ 65 years of age):
Safety and efficacy of aripiprazole in the treatment of schizophrenia in patients 65 years of age or older have not been established. 4 Geriatrics). ARIPIPRAZOLE is not indicated in elderly patients with dementia (see 3 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. 7 Drug 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). 3 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment Schizophrenia Adults Usual Dose: The recommended starting and target dose for ARIPIPRAZOLE is 10 or 15 mg/day administered on a once-a-day schedule.
). ARIPIPRAZOLE should only be prescribed to adolescents with schizophrenia by clinicians who are experienced in the diagnosis and treatment of adolescents with psychiatric illness and who are experienced in the early detection and management of the above-mentioned safety issues associated with this class of drugs.
Schizophrenia ARIPIPRAZOLE is indicated for the treatment of schizophrenia in adolescents 15 – 17 years of age. Safety and efficacy were evaluated in one 6-week clinical trial in adolescents (13 – 17 years of age) with schizophrenia.
ARIPIPRAZOLE is not indicated for the treatment of schizophrenia in adolescents less than 15 years of age due to insufficient safety and efficacy data (see 8 ADVERSE REACTIONS; and 14 CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia, Adolescents [13 – 17 years of age]).
The safety and efficacy of aripiprazole during long-term treatment have not been systematically evaluated in adolescents with schizophrenia. The physician who elects to use ARIPIPRAZOLE for extended periods in adolescents with schizophrenia should periodically re- evaluate the long-term usefulness of the drug for the individual patient.
1 Special populations, Use in Elderly Patients with Dementia). The safety and efficacy of aripiprazole in patients 65 years of age or older has not been established. 4 Geriatrics; and
, Skin 01/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ....................................................................................................................
1 Pediatric ......................................................................................................................... 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 ................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 9 7 WARNINGS AND PRECAUTIONS ......................................................................................
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 6 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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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. ARIPIPRAZOLE Product Monograph Page 7 of 69 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 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 during long-term treatment have not been systematically evaluated in adolescent patients with schizophrenia.
The physician who elects to use ARIPIPRAZOLE for extended periods in adolescent patients with schizophrenia should periodically re-evaluate the long-term usefulness of the drug for the individual patient. 3 Administration ARIPIPRAZOLE can be taken without regard to meals.
Tablets should not be crushed or cut; they should be swallowed whole. Switching from Other Antipsychotics There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to aripiprazole or concerning concomitant administration with other antipsychotics.
While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
5 Missed Dose If a patient misses a dose by a few hours, the patient should be advised to take their dose as soon as he/she remembers. If most of the day has passed, he/she should be advised to wait until the next scheduled dose. Patients should be advised to not take 2 doses of ARIPIPRAZOLE at once.
ARIPIPRAZOLE Product Monograph Page 8 of 69
1 Special Populations ...................................................................................................... 2 Breast-feeding ...............................................................................................................
3 Pediatrics ....................................................................................................................... 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 ........................................................................................................................... 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 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 Test Interactions .............................................................................
7 Drug-Lifestyle Interactions .......................................................................................... 43 10 ACTION AND CLINICAL PHARMACOLOGY ........................................................................
1 Mechanism of Action ................................................................................................... 2 Pharmacodynamics......................................................................................................
3 Pharmacokinetics......................................................................................................... 44 11 STORAGE, STABILITY AND DISPOSAL […]