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NRA-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: NRA-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 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 NRA-ARIPIPRAZOLE.
Some of these adverse events appear to be dose related (see WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS, 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).
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 ADVERSE REACTIONS, CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia - Adolescents).
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. 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).
NRA-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. 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). NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 6 of 74 Patients with renal impairment: No dosage adjustment is required in patients with renal impairment.
1 Adverse Reaction Overview NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 19 of 74 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. NRA-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 De sign and Study Demographics, Schizophrenia-Adolescents [13-17 years of age]).
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.
05/2023 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 .................................................................................................... 4 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................................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 8 7 WARNINGS AND PRECAUTIONS .....................................................................................
NRA-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.
NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 5 of 74
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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-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 NRA-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 NRA-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 NRA-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 NRA-ARIPIPRAZOLE can be taken without regard to meals.
Tablets should not be crushed or cut; they should be swallowed whole. NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 7 of 74 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 […]
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 NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 20 of 74 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) Eye Disorders Blurred Vision 3 1 Gastrointestinal Disorders Nausea 15 11 Constipation 11 7 Vomiting 11 6 Dyspepsia 9 7 NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 21 of 74 Percentage of Patients Reporting Event System Organ Class Aripiprazole Placebo Preferred Term (n=1843) (n=1166) 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 NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 22 of 74 […]
1 Special Populations ................................................................................................. 1 Pregnant Women ....................................................................................................
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 ....................................................................................................................
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 .............................................................................. 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 ......................................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 45 11 STORAGE, STABILITY AND DISPOSAL […]