ARIPIPRAZOLE MILPHARM

Posology Adults Schizophrenia: the recommended starting dose for Aripiprazole Milpharm is 10 mg/day or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole Milpharm is effective in a dose range of 10 mg/day to 30 mg/day.

Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. 1). Some patients may benefit from a higher dose.

The maximum daily dose should not exceed 30 mg. Recurrence prevention of manic episodes in Bipolar I Disorder: for preventing recurrence of manic episodes in patients who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.

Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status. Paediatric population Schizophrenia in adolescents aged 15 years and older: the recommended dose for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals.

Treatment should be initiated at 2 mg (using aripiprazole oral solution 1 mg/ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. 1). Aripiprazole is effective in a dose range of 10mg/day to 30 mg/day.

Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated although individual patients may benefit from a higher dose. 1). Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for aripiprazole is 10 mg/day administered on a once- a-day schedule without regard to meals.

Treatment should be initiated at 2 mg (using aripiprazole oral solution 1 mg/ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks.

8). 1). Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. 1). Irritability associated with autistic disorder: the safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.

Summary of the safety profile The most commonly reported adverse reactions in placebo-controlled trials were akathisia and nausea each occurring in more than 3% of patients treated with oral aripiprazole. 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.

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. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken.

QT prolongation:

In clinical trials of 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.

Other extrapyramidal symptoms:

In paediatric clinical trials of aripiprazole akathisia and parkinsonism were observed. If signs and symptoms of other EPS appear in a patient taking aripiprazole, dose reduction and close clinical monitoring should be considered.

1.