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ODAN-ARIPIPRAZOLE is a brand name for Aripiprazole, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ODAN-ARIPIPRAZOLE SOLUTION (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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Oral solution doses can be substituted for the tablet doses on a mg-per-mg basis up to 25 mg of the tablet. 3 Comparative Bioavailability Studies). 3 Comparative Bioavailability Studies) • 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 ODAN-ARIPIPRAZOLE SOLUTION. 3 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics; 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions).
• Refer to 9 DRUG INTERACTIONS, Drug-Drug Interactions 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 of aripiprazole were evaluated in adolescent (13-17 years of age) patients with schizophrenia in one 6-week clinical trial. ODAN- ARIPIPRAZOLE SOLUTION 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).
Safety and efficacy of aripiprazole in pediatric and adolescent patients (10-17 years of age) with bipolar I disorder have been evaluated in one 4-week clinical trial. ODAN-ARIPIPRAZOLE SOLUTION is not indicated for the treatment of bipolar I disorder in patients under 13 years of 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. 4 WARNINGS AND PRECAUTIONS - Special Populations, Use in Elderly Patients with Dementia). Odan-Aripiprazole Solution Product Monograph Page 7 of 77 age due to insufficient safety and efficacy data (see 8 ADVERSE REACTIONS, 14 CLINICAL TRIALS, Trial Design and Study Demographics, Bipolar–Pediatric and Adolescent).
). ODAN-ARIPIPRAZOLE SOLUTION should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the early detection and management of the safety issues associated with this class of drugs.
The safety and efficacy of aripiprazole as adjunctive treatment in MDD have not been systematically evaluated beyond 6 weeks. Therefore, the required length of adjunctive treatment with ODAN-ARIPIPRAZOLE SOLUTION is unknown. When prescribed as an adjunct to antidepressants in the treatment of MDD, ODAN-ARIPIPRAZOLE SOLUTION should be used for the shortest period of time that is clinically indicated.
Clinical trials evaluating aripiprazole in MDD did not include aripiprazole monotherapy treatment arms. It is therefore unknown whether efficacy in adjunct treatment is due to aripiprazole alone or from combined treatment with an antidepressant.
1 Pediatrics Pediatrics (< 18 years of age): When prescribing to adolescents with schizophrenia (15- 17 years of age) or with a manic or mixed episode of bipolar I disorder (13-17 years of age), clinicians must take into account the safety concerns associated with all antipsychotic drugs which include: weight gain; hyperlipidemia; hyperglycemia; and, extrapyramidal effects which can be more frequent or more severe in this patient population than in adults (see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS).
ODAN-ARIPIPRAZOLE SOLUTION should only be prescribed to adolescents with schizophrenia or bipolar I disorder 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.
Odan-Aripiprazole Solution Product Monograph Page 5 of 77 Schizophrenia ODAN-ARIPIPRAZOLE SOLUTION is indicated for the treatment of schizophrenia in adolescents 15 – 17 years of age. Safety and efficacy of aripiprazole were evaluated in one 6-week clinical trial in adolescents (13-17 years of age) with schizophrenia.
ODAN-ARIPIPRAZOLE SOLUTION (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.
Odan-Aripiprazole Solution Product Monograph Page 6 of 77
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
Geriatric (≥ 65 years of age):
Safety and efficacy of aripiprazole in the treatment of schizophrenia and bipolar I disorder in patients 65 years of age or older have not been established. 4 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics). ODAN-ARIPIPRAZOLE SOLUTION 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.
Smoking status:
No dosage adjustment is required for smokers (see 9 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 9 DRUG INTERACTIONS, Drug-Drug Interactions).
e. 10 or 15 mL solution/day) administered on a once-a-day schedule. Aripiprazole 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. 3 Pharmacokinetics, Oral Solution). 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.
e. 10 mL solution/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 […]
ODAN-ARIPIPRAZOLE SOLUTION 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, 14 CLINICAL TRIALS, Trial Design and Study Demographics, Schizophrenia-Adolescents).
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 ODAN- ARIPIPRAZOLE SOLUTION for extended periods in adolescents with schizophrenia should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Bipolar disorder ODAN-ARIPIPRAZOLE SOLUTION is indicated for the acute treatment of manic or mixed episodes in bipolar I disorder as monotherapy in adolescent patients 13 - 17 years of age. Safety and efficacy of aripiprazole were evaluated in one 4-week clinical trial in pediatric and adolescent patients (10-17 years of age) in a current manic or mixed episode as part of bipolar I disorder.
ODAN-ARIPIPRAZOLE SOLUTION is not indicated for the treatment of manic or mixed episodes in bipolar I disorder in adolescents less than 13 years of age due to insufficient safety and efficacy data (see 8 ADVERSE REACTIONS, 14 CLINICAL TRIALS, Trial Design and Study Demographics, Bipolar Disorder-Pediatric and Adolescent).
The efficacy and safety of aripiprazole for the maintenance treatment of bipolar I disorder in the pediatric and adolescent populations have not been systematically evaluated. 3 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
2 Geriatrics Geriatrics (≥ 65 years of age): ODAN-ARIPIPRAZOLE SOLUTION is not indicated in elderly patients with dementia. 4 WARNINGS AND PRECAUTIONS, 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.
Caution should be used when treating geriatric patients. 3 Pharmacokinetic, Special Populations and Conditions). 2 CONTRAINDICATIONS ODAN-ARIPIPRAZOLE SOLUTION (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. 1 Dosing Considerations • Oral solution doses can be substituted for the tablet doses on a mg-per-mg basis up to 25 mg of the tablet. 3 Comparative Bioavailability Studies).
3 Comparative Bioavailability Studies) • 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 ODAN-ARIPIPRAZOLE SOLUTION.
3 WARNINGS AND PRECAUTIONS, Special […]