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ARIPIPRAZOLE SANDOZ is a brand name for Aripiprazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Aripiprazole Sandoz is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For patients who have never taken aripiprazole, tolerability with oral Aripiprazole must occur prior to initiating treatment with Aripiprazole. Titration of the dose for Aripiprazole is not required. The starting dose can be administered by following the below regimen: • One injection start: On the day of initiation, one injection of Aripiprazole 400 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.
After the injection start, the recommended maintenance dose of Aripiprazole is 400 mg. Aripiprazole should be administered once monthly as a single injection (no sooner than 26 days after the previous injection). If there are adverse reactions with the 300 and 400 mg dose, reduction of the dose to 300 mg once monthly should be considered.
Missed doses Missed doses Timing of missed dose Action If 2nd or 3rd dose is missed and time since last injection is: > 4 weeks and < 5 weeks The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
> 5 weeks Concomitant oral Aripiprazole should be restarted for 14 days with next administered injection. Monthly injection schedule should then resume. , after attainment of steady state) and time since last injection is: > 4 weeks and < 6 weeks The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
> 6 weeks Concomitant oral Aripiprazole should be restarted for 14 days with next administered injection. Monthly injection schedule should then resume. 4). 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: One injection start: The starting dose should be 300 mg Aripiprazole and continue treatment with the prescribed dose of oral Aripiprazole per day for 14 consecutive days.
The maintenance dose should be 300 mg Aripiprazole once monthly. 5) and treatment should be continued with the prescribed dose of oral Aripiprazole per day for 14 consecutive days. After the injection start, see table below for the recommended maintenance dose of Aripiprazole.
1 %). Tabulated list of adverse reactions The incidences of the ADRs associated with Aripiprazole therapy 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 Investigations Blood creatine phosphokinas e increased Blood glucose increased Blood glucose decreased Glycosylated haemoglobin increased Waist circumference increased Blood cholesterol decreased Blood triglycerides decreased Blood glucose fluctuation Description of selected adverse reactions Injection site reactions During the double-blind, controlled phases of the two long-term trials, injection site reactions were observed; those seen were generally mild to moderate in severity, and resolved over time.
1 %), had a median onset on day 2 after the injection and a median duration of 4 days. In an open-label study comparing bioavailability of Aripiprazole 300 mg administered in the deltoid or gluteal muscle, injection site related reactions were slightly more frequent in the deltoid muscle.
The majority were mild and improved on subsequent injections. When compared to studies where Aripiprazole 300 mg was injected in the gluteal muscle, repeated occurrence of injection site pain was more frequent in the deltoid muscle.
Neutropenia Neutropenia has been reported in the clinical program with Aripiprazole 300 mg and typically started around day 16 after first injection, and lasted a median of 18 days. […]
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 300 mg 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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Aripiprazole 400 mg and 300 mg should be administered once monthly as a single injection (no sooner than 26 days after the previous 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 Sandoz, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed. 5). Maintenance dose adjustments of Aripiprazole in patients who are taking concomitant strong CYP2D6 inhibitors, strong CYP3A4 inhibitors, and/or CYP3A4 inducers for more than 14 days Adjusted monthly dose Patients taking 400 mg of Aripiprazole Strong CYP2D6 or strong CYP3A4 inhibitors 300 mg Strong CYP2D6 and strong CYP3A4 inhibitors 200 mg* CYP3A4 inducers Avoid use Patients taking 300 mg of Aripiprazole Strong CYP2D6 or strong CYP3A4 inhibitors 200 mg* Strong CYP2D6 and strong CYP3A4 inhibitors 160 mg* CYP3A4 inducers Avoid use * 200 mg and 160 mg can be achieved via adjustment of the injection volume only by using Aripiprazolepowder and solvent for prolonged-release suspension for injection.
Paediatric population The safety and efficacy of Aripiprazole 300 mg in children and adolescents aged 0 to 17 years have not been established. No data is available. Method of administration Aripiprazole 300 mg is only intended for intramuscular use and must not be administered intravenously or subcutaneously.
It should only be administered by a healthcare professional. The suspension must be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle. Care should be taken to avoid inadvertent injection into a blood vessel.
Full instructions for use and handling of Aripiprazole 400 mg and 300 mg are provided in the package leaflet (information intended for healthcare professionals). 6.
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. g. g. 8). g. 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.
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 life-style 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 adenoma. 8). […]