ABILIFY

3 mL), administered as a single intramuscular injection. 25 mg to 15 mg as a single injection. 5). A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status and no more than three injections should be given in any 24-hour period.

The maximum daily dose of aripiprazole is 30 mg (including all formulations of ABILIFY). If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution.

Special populations Paediatric population The safety and efficacy of ABILIFY solution for injection in children and adolescents aged 0 to 17 years have not been established. No data are available. Hepatic impairment No dosage adjustment is required for patients with mild to 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). Renal impairment No dosage adjustment is required in patients with renal impairment.

Elderly The safety and efficacy of ABILIFY in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established. 4). 2). 5). Dose adjustments due to interactions When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.

5). When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased. 5). Method of administration ABILIFY solution for injection is for intramuscular use. To enhance absorption and minimise variability, injection into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions, is recommended.

ABILIFY solution for injection should not be administered intravenously or subcutaneously. 1).

Summary of the safety profile The most commonly reported adverse reactions in placebo-controlled trials were nausea, dizziness and somnolence each occurring in more than 3 % of patients treated with aripiprazole solution for injection.

Tabulated list of adverse reactions The incidences of the Adverse Drug Reactions (ADRs) associated with aripiprazole therapy are tabulated below. The table is based on adverse events 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 frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

Consequently, the frequency of these adverse events is qualified as "not known". g. g. 3 %). 1 % for placebo-treated patients. 1 % for olanzapine- treated patients. 3 % for haloperidol-treated patients. 6 % for those treated with lithium.

7 % for placebo-treated patients. 2 % with placebo. 0 % with placebo.

Dystonia Class effect:

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue.

While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products. An elevated risk of acute dystonia is observed in males and younger age groups.

The efficacy of ABILIFY solution for injection in patients with agitation and disturbed behaviours has not been established related to conditions other than schizophrenia and manic episodes in Bipolar I Disorder. Simultaneous administration of injectable antipsychotics and parenteral benzodiazepine may be associated with excessive sedation and cardiorespiratory depression.

5). Patients receiving ABILIFY solution for injection should be observed for orthostatic hypotension. Blood pressure, pulse, respiratory rate and level of consciousness should be monitored regularly. The safety and efficacy of ABILIFY solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).

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. 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.

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