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ARIPIPRAZOLE MYLAN is a brand name for Aripiprazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Aripiprazole Mylan is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Schizophrenia: the recommended starting dose for aripiprazole 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 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 an appropriate aripiprazole containing medicinal product) 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 10 mg/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 an appropriate aripiprazole containing medicinal product) 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.
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).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 but no recommendation on a posology can be made. Tics associated with Tourette’s disorder: the safety and efficacy of aripiprazole in children and adolescents 6 to 18 years of age have not yet been established. 1 but no recommendation on a posology can be made.
Special populations Elderly The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established. 4). Hepatic impairment Νο 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 Νο dosage adjustment is required in patients with renal impairment.
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 Aripiprazole Mylan is for oral use. 2).
1). Laboratory parameters Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically […]
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.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued. Seizure In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
8). 4 years; range: 56 to 99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo. 7 % in the placebo group.
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 atypical antipsychotics, including aripiprazole.
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes. In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Precise risk estimates for hyperglycaemia-related adverse reactions in patients treated with aripiprazole and with other atypical antipsychotics are not available to allow direct comparisons. 8). 8). Weight gain Weight gain is commonly seen in schizophrenic and bipolar mania […]