ARIPRIP 15 TABLET 15MG

IND-SWIFT LABORATORIES LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Sep 6, 2022
Approval ID: 93daccb4fef040b8
Company: IND-SWIFT LABORATORIES LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 93daccb4fef040b8
Drug Name: ARIPRIP 15 TABLET 15MG
Product Name: ARIPRIP 15 TABLET 15MG
Approval Number: SIN16595P
Approval Date: 2022-09-06
Registrant: GOLDPLUS UNIVERSAL PTE LTD
Licence Holder: GOLDPLUS UNIVERSAL PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET
Dosage: DOSAGE AND ADMINISTRATION 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 without regard to meals. Aripiprazole has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady state [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Maintenance Therapy While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, systematic evaluation of patients with schizophrenia who had been symptomatically stable on other antipsychotic medication, for periods of 3 months or longer, were discontinued from those medications, and were then administered Aripiprazole 15 mg/day and observed for relapse during a period of up to 26 weeks, demonstrated a benefit of such maintenance treatment [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Patients should be periodically reassessed to determine the need for maintenance treatment. Adolescents Usual Dose The recommended target dose of Aripiprazole is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with Schizophrenia at daily doses of 10 mg and 30mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose and was associated with a higher incidence of significant adverse reactions including extrapyramidal disorder, somnolence and tremor [see SIDE EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Aripiprazole can be administered without regard to meals [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Maintenance Therapy The efficacy of Aripiprazole for the maintenance treatment of schizophrenia in the adolescent population has not been evaluated. While there is no body of evidence available to answer the question of how long the adolescent patient treated with Aripiprazole should be maintained on the drug, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and paediatric patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment. 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. Bipolar Disorder Acute Treatment of Manic and Mixed Episodes Adults The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 to 15 mg given once daily as adjunctive therapy with lithium or valproate. Aripiprazole can be given without regard to meals. The recommended target dose of Aripiprazole is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials. Adolescents The recommended starting dose in adolescent patients as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. Aripiprazole can be given without regard to meals. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion. Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring [see WARNINGS AND PRECAUTIONS, SIDE EFFECTS, and CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. Therefore, Aripiprazole is not recommended for use in patients below 13 years of age [see SIDE EFFECTS and CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Maintenance Therapy The recommended dose for maintenance treatment is the same dose needed to stabilize patients during acute treatment, both for adult and paediatric patients. Systematic evaluation of adult patients with Bipolar I Disorder experiencing a manic or mixed episode, who had been symptomatically stable on Aripiprazole Tablets (15 mg/day or 30 mg/day with a starting dose of 30 mg/day) for 6 consecutive weeks and then randomized to Aripiprazole Tablets (15 mg/day or 30 mg/day) or placebo for at least 6 months and up to an additional 17 months of observation for relapse, demonstrated a benefit of such maintenance treatment [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Patient should be periodically reassessed to determine the need for maintenance treatment. Adjunctive Treatment of Major Depressive Disorder The recommended starting dose for Aripriprazole as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Patients should be periodically reassessed to determine the continued need for maintenance treatment. Irritability Associated with Autistic Disorder Paediatric Patients (6 to 17 years) The recommended dosage range for the treatment of paediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day. Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Patients should be periodically reassessed to determine the continued need for maintenance treatment. Tourette’s Disorder Paediatric Patients (6 to 18 years) The recommended dosage range for Tourette’s Disorder is 5 to 20 mg/day. For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than 1 week. For patients weighing 50 kg or more, dosing should be initiated at 2 mg/day for 2 days, and then increased to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8. The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Patients should be periodically reassessed to determine the continued need for maintenance treatment. Dosage Adjustments for Cytochrome P450 Considerations Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 1). When the co-administered drug is withdrawn from the combination therapy, Aripiprazole dosage should then be adjusted to its original level. When the co-administered CYP3A4 inducer is withdrawn, Aripiprazole dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favourable clinical response. <img src="/TGIF/Ariprip-Table1_130324.png" alt="Ariprip Dosage Table 1" /> Special population Hepatic and Renal Impairment: No dosage adjustment for Aripiprazole is required on the basis of a patient’s hepatic function (mild to severe hepatic impairment, Child-Pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute). Geriatric Use: No dosage adjustment is recommended for elderly patients. Of the 13,543 patients treated with oral Aripiprazole in clinical trials, 1,073 (8%) were ≥ 65 years old and 799 (6%) were ≥ 75 years old. Placebo-controlled studies of oral Aripiprazole in schizophrenia, bipolar mania, or major depressive disorder did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Aripiprazole is not approved for treatment of patients with psychosis associated with Alzheimer's disease Other Specific Populations: No dosage adjustment for Aripiprazole is required on the basis of a patient's sex, race, or smoking status. Method of administration: Aripiprazole tablets are for oral use without regard to meals.
Route Of Administration: ORAL
Indication Info: INDICATIONS AND USAGE Schizophrenia Aripiprazole is indicated for the treatment of schizophrenia. The efficacy of Aripiprazole in the treatment of schizophrenia was established in four short-term (4- and 6-week) controlled trials in adults and one 6-week trial in paediatrics (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to paediatrics [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. The physician who elects to use Aripiprazole for extended periods should periodically re-evaluate the long- term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION]. Bipolar I Disorder Aripriprazole is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder and for maintaining stability or preventing recurrence, as monotherapy in adults and in adolescents aged 13 years and older, and as an adjunct to lithium or valproate in adults. The efficacy of Aripiprazole as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in paediatric patients. Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Physicians who elect to use Aripiprazole for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION]. Adjunctive Treatment of Major Depressive Disorder Aripriprazole is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in three 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Irritability Associated with Autistic Disorder Aripriprazole is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in paediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. The efficacy of Aripriprazole for the maintenance treatment of irritability associated with autistic disorder was not established. Tourette’s Disorder Aripriprazole is indicated for the treatment of Tourette’s disorder. Efficacy was established in one 8-week (aged 7 to 17 years) and one 10-week (aged 6 to 18 years) placebo-controlled trial in paediatric patients with Tourette’s disorder [see CLINICAL STUDIES) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Contraindications: CONTRAINDICATION Hypersensitivity to the active substance or to any of the excipients.
Atc Code: N05AX12
Atc Item Name: aripiprazole
Pharma Manufacturer Name: GOLDPLUS UNIVERSAL PTE LTD
Company Detail Path: /organization/goldplus-universal-pte-ltd

Active Ingredients

Aripiprazole

15.00mg

ARIPIPRAZOLE

15 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 6, 2022

Approval ID

93daccb4fef040b8

Type

Therapeutic

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