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ARIPIPRAZOLE OTSUKA is a brand name for Aripiprazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Aripiprazole Otsuka is indicated for maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For patients who have never taken aripiprazole, tolerability with aripiprazole must be established prior to initiating treatment with Aripiprazole Otsuka. Titration of the dose for Aripiprazole Otsuka is not required. Starting regimen The recommended starting dosing regimen when transitioning from Aripiprazole Otsuka 400 mg once monthly is Aripiprazole Otsuka 960 mg no sooner than 26 days after previous injection of Aripiprazole Otsuka 400 mg.
Aripiprazole Otsuka 960 mg should then be dosed once every 2 months (every 56 days). Initiation may also be started by following one of two additional regimens: • One injection start: On the day of initiation following oral therapy, one injection of Aripiprazole Otsuka 960 mg should be administered and treatment with 10 mg to 20 mg oral aripiprazole per day for 14 consecutive days should be continued to maintain therapeutic aripiprazole concentrations during initiation of therapy.
• Two injection start: On the day of initiation following oral therapy, one injection of Aripiprazole Otsuka 960 mg and one injection of Aripiprazole Otsuka 400 mg should be administered at two different injection sites (see method of administration), along with one 20 mg dose of oral aripiprazole.
Dosing interval and dosing adjustments After the injection start, the recommended maintenance dose is one injection of Aripiprazole Otsuka 960 mg every second month. Inject Aripiprazole Otsuka 960 mg once every two months as a single injection 56 days after the previous injection.
Patients may be given the injection up to 2 weeks before or 2 weeks after the scheduled 2- month dose. If there are adverse reactions with the Aripiprazole Otsuka 960 mg dose, reduction to Aripiprazole Otsuka 720 mg once every two months should be considered.
Missed doses If more than 8 weeks and less than 14 weeks have elapsed since the last injection, the next dose of Aripiprazole Otsuka 960 mg/720 mg should be administered as soon as possible. The once every two months schedule should then be resumed.
If more than 14 weeks have elapsed since the last injection, the next dose of Aripiprazole Otsuka 960 mg/720 mg should be administered with concomitant oral aripiprazole for 14 days or with 2 separate injections (one each of Aripiprazole Otsuka 960 mg and Aripiprazole Otsuka 400 mg or one each Aripiprazole Otsuka 720 mg and Aripiprazole Otsuka 300 mg) administered together with one 20 mg oral aripiprazole dose.
Summary of the safety profile The safety profile of Aripiprazole Otsuka 960 mg and Aripiprazole Otsuka 720 mg for the treatment of schizophrenia in adults is based on adequate and well- controlled studies of Aripiprazole Otsuka 400 mg and Aripiprazole Otsuka 300 mg.
In general, the observed adverse drug reactions (ADRs) in Aripiprazole Otsuka 960 mg/720 mg clinical trials were similar to the ADRs observed in the Aripiprazole Otsuka 400 mg/300 mg clinical trials. 8%). 1 %) were the most frequently observed ADRs.
Tabulated list of adverse reactions The incidences of the ADRs associated with Aripiprazole Otsuka 400 mg/300 mg and Aripiprazole Otsuka 960 mg/720 mg are tabulated below. The table is based on adverse reactions reported during clinical trials and/or post- marketing use.
All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The ADRs listed under the frequency “not known” were reported during post- marketing use. g. g. hypothermia, pyrexia) Chest pain Peripheral oedema System organ class Common Uncommon Not known Investigations Blood creatine phosphokinase increased Blood glucose increased Blood glucose decreased Glycosylated haemoglobin increased Waist circumference increased Blood cholesterol decreased Blood triglycerides decreased Blood glucose fluctuation a: Reported as very common in Aripiprazole Otsuka 960 mg/720 mg clinical trials.
b: Reported only in Aripiprazole Otsuka 960 mg/720 mg […]
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period. Use in patients who are in an acutely agitated or severely psychotic state Aripiprazole Otsuka should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
8). Close supervision of high-risk patients should accompany antipsychotic treatment. Cardiovascular disorders Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products. 8). QT prolongation In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo. 8).
Tardive dyskinesia In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole. 8). These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Neuroleptic malignant syndrome (NMS) NMS is a potentially fatal symptom complex associated with antipsychotics. In clinical trials, rare cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The once every two months schedule should then be resumed. 4). No recommendations on dosing can be made. 2). Hepatic impairment No dose adjustment is required for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, the data available are insufficient to establish recommendations.
In these patients dosing should be managed cautiously. 2). Known CYP2D6 poor metabolisers In patients who are known to be CYP2D6 poor metabolisers: • Patients transitioning from Aripiprazole Otsuka 300 mg once monthly: The starting dose should be one injection of Aripiprazole Otsuka 720 mg g, no sooner than 26 days after previous injection of Aripiprazole Otsuka 300 mg.
• One injection start (following transition from oral therapy): The starting dose should be one injection of Aripiprazole Otsuka 720 mg and treatment should be continued with the prescribed dose of oral aripiprazole per day for 14 consecutive days.
• Two injection start (following transition from oral therapy): The starting dose should be 2 separate injections; one Aripiprazole Otsuka 720 mg and one Aripiprazole Otsuka 300 mg injection, together with a single dose of 20 mg oral aripiprazole (see method of administration).
Thereafter, a maintenance dose of Aripiprazole Otsuka 720 mg should be administered once every two months as a single injection. Maintenance dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers Maintenance dose adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors or strong CYP2D6 inhibitors for more than 14 days.
5). In case of adverse reactions despite dose adjustments of Aripiprazole Otsuka 960 mg, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed. 5). Aripiprazole Otsuka 960 mg/720 mg should not be used in patients who are known to be CYP2D6 poor metabolisers and concomitantly use a strong CYP2D6 and/or CYP3A4 inhibitor.
g. due to adverse rections to the higher dose. Paediatric population The safety and efficacy of Aripiprazole Otsuka 960 mg/720 mg in children and adolescents aged 0 to 17 years have not been established. No data are available. Method of administration Aripiprazole Otsuka 960 mg and 720 mg is only intended for gluteal intramuscular injection and must not be administered intravenously or subcutaneously.
It must only be administered by a […]
8). Seizure In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole. 8). 4 years; range: 56 to 99 years), patients treated with aripiprazole were at an increased risk of death compared to placebo.
7 % in placebo. 8). , stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78 to 88 years). 6 % of placebo- treated patients in these trials. This difference was not statistically significant.
8). Aripiprazole is not indicated for the treatment of patients with dementia- related psychosis. Hyperglycaemia and diabetes mellitus Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with aripiprazole.
No specific studies have been conducted with Aripiprazole Otsuka in patients with hyperglycaemia or diabetes mellitus. Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
8). 8). Weight gain Weight gain is commonly seen in schizophrenic patients due to use of antipsychotics known to cause weight gain, co-morbidities, poorly managed lifestyle and might lead to severe complications. Weight gain has been reported post-marketing among patients prescribed oral aripiprazole.
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder, or pituitary […]