Medicinal Products

ARIPIPRAZOLE EG 15 mg

Generic drug of Abilify
Therapeutic Class: Neurology-Psychiatry
active ingredients: Aripiprazole
laboratory: EG Labo

Orodispersible tablet
box of 28
All forms

Indication

Aripiprazole is indicated for the treatment of schizophrenia in adults and adolescents up to 15 years of age and older.

Aripiprazole is indicated in the treatment of moderate episodes of manic episodes of bipolar I disorder and in the prevention of reoccurrence of manic episodes in adults who have had episodes of manic pre-dominance and for whom manic episodes have responded to treatment with aripiprazole (see Proprietary Pharmacodynamics ).

Aripiprazole is indicated in the treatment of moderate episodes of manic episodes of bipolar I disorder in adolescents aged 13 years and over for up to 12 weeks (see section 5.1 ).

Dosage ARIPIPRAZOLE EG 15 mg tablet orodispersible box of 28

Aripiprazole is indicated for the treatment of schizophrenia in adults and adolescents up to 15 years of age and older.

Aripiprazole is indicated in the treatment of moderate episodes of manic episodes of bipolar I disorder and in the prevention of reoccurrence of manic episodes in adults who have had episodes of manic pre-dominance and for whom manic episodes have responded to treatment with aripiprazole (see Proprietary Pharmacodynamics ).

Aripiprazole is indicated in the treatment of moderate episodes of manic episodes of bipolar I disorder in adolescents aged 13 years and over for up to 12 weeks (see section 5.1 ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Side effects Aripiprazole Eg

Summary of the safety profile

The most common adverse events reported during placebo-controlled clinical trials were akathisia and nausea, each occurring in more than 3% of patients treated with oral aripiprazole.

List of undesirable effects in tabular form

The following undesirable effects have been reported more frequently (≥ 1/100) than placebo, or have been identified as undesirable effects that may be clinically significant (*).

The frequencies below are defined using the following convention: Frequent (≥ 1/100, <1/10) and not very frequent (≥ 1/1000, <1/100).

Endocrine disorders

Few frequent: hyperprolactinïmie.

Psychiatric disorders

Frequent: restlessness, insomnia, anxieties.

Few frequent: depression **, hypersexuality.

Frequency indefinite: aggressiveness.

Nervous System Affections

Frequent: extrapyramidal disorders, akathisia, tremor, dizziness, somnolence, sedation, cephalitis.

Eye disorders

Frequent: blurred vision.

Few frequent: diplopia.

Heart conditions

Few frequent: tachycardia *.

Vascular disorders

Not very common: orthostatic hypotension *.

Gastrointestinal disorders

Frequent: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion.

General disorders and administration site abnormalities

Frequent: tiredness

Description of selective undesirable effects

Extrapyramidal symptoms

Schizophrenia : In a 52-week long-term controlled clinical trial, the incidence of extrapyramidal symptoms, including parkinsonism, akathisia, dystonia and dyskinesia, was overall lower in patients treated with aripiprazole (25.8%). %) compared with patients treated with halopetridol (57.3%). In a 26-week long-term placebo-controlled clinical trial, the incidence of extrapyramidal symptoms was 19% in patients treated with aripiprazole and 13.1% in patients treated with placebo. In another 26-week long-term controlled clinical trial, the incidence of extrapyramidal symptoms was 14.8% in patients treated with aripiprazole and 15.1% in patients treated with olanzapine.

Manic episodes in bipolar I disorder - in a 12-week clinical trial, the incidence of extrapyramidal symptoms was 23.5% in patients treated with aripiprazole and 53.3% in patients treated by halopèridol. In another 12-week clinical trial, the incidence of extrapyramidal symptoms was 26.6% in patients treated with aripiprazole and 17.6% in patients treated with lithium.

In the 26-week, long-term, placebo-controlled clinical study, the incidence of extrapyramidal symptoms was 18.2% in patients treated with aripiprazole and 15.7% in patients treated with aripiprazole. patients treated with placebo.

akathisia

In clinical trials versus placebo, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo. In schizophrenic patients, the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.

dystonia

Class effect: Symptoms of dystonia, prolonged abnormal contractions of a muscle group, may occur in pre-existing patients during the first days of treatment. Dystonic symptoms include spasm of the neck muscles, sometimes progressing to oppression of the throat, difficulty in swallowing, difficulty in breathing and / or protrusion of the tongue. While these symptoms may occur at low doses, they have been reported more frequently and with greater sensitivity to first-generation antipsychotics and higher doses. A high risk of acute dystonia has been observed in groups of men and young people.

Among patients with variations in standard and lipid parameters that may be clinically significant (see Proprietary Pharmacodynamics section), there was no significant difference in clinical status between the aripiprazole group and the placebo group. Mostly transient and asymptomatic CPKs (creatine phosphokinase) were observed in 3.5% of patients treated with aripiprazole and in 2.0% of patients treated with placebo.

HyperprolactinÚmie

In clinical studies of the approved indication (s) and postmarketing, there was an increase as well as a decrease in the serum prolactin initial values ​​with aripiprazole (see Proprietary Pharmacodynamics ).

Other results

The undesirable effects known to be associated with antipsychotic treatments and also reported during aripiprazole treatment include: neuroleptic malignant syndrome, tardive dyskinesias, convulsions, corticovascular undesirable effects, and increased mortality in patients with severe dementia., hyperglycemia and diabetes mellitus (see Warnings and Precautions section ).

Pediatric population

Schizophrenia in adolescents aged 15 years and over

In a short-term placebo-controlled clinical trial in 302 schizophrenic adolescents (aged 13 to 17 years), the frequency and nature of undesirable effects were similar to those of adults, with the exception of reactions. reported more frequently in adolescents taking aripiprazole than in adults taking aripiprazole (and more frequently than in placebo): drowsiness / sedation and extrapyramidal disorder were very commonly reported (≥ 1/10), and drought in the mouth, increased appetite and orthostatic hypotension have been reported frequently (≥ 1/100, <1/10). The tolerance profile in an open-label 26-week extension trial was similar to the one observed in the short-term, placebo-controlled trial.

The pooled analysis of a population of adolescents (aged 13 to 17 years) with schizophrenia, exposed to the drug for periods up to 2 years, revealed an incidence of low plasma prolactin in girls (<3 ng / ml) and boys (<2 ng / ml) by 29.5% and 48.3%, respectively. Within the population of adolescents (aged 13 to 17 years) with schizophrenia, exposed to a dosage ranging from 5 mg to 30 mg of aripiprazole for a period of up to 72 months, the incidence of serum prolactin in girls (<3 ng / ml) and boys (<2 ng / ml) was 25.6% and 45.0%, respectively.

Manic episodes in bipolar I disorder in adolescents aged 13 years and over

The frequency and nature of adverse effects in adolescents with bipolar I disorder were similar to those observed in adults, except for the following reactions: very often (≥ 1/10): somnolence (23, 0%), extrapyramidal disorders (18.4%), akathisia (16.0%) and fatigue (11.8%); and frequently (≥ 1/100, <1/10) upper abdominal pain, increased heart rate, weight gain, increased appetite, muscle contractions and dyskinesia.

The following undesirable effects had a possible dose-effect relationship: extrapyramidal disorders (the incidence was 9.1% at a dosage of 10 mg, 28.8% at a dosage of 30 mg and 1.7% for the placebo); and akathisia (the incidence was 12.1% at a dosage of 10 mg, 20.3% at a dosage of 30 mg and 1.7% for placebo).

Mean weight variations in adolescents with bipolar I disorder after 12 and 30 weeks of treatment were 2.4 kg and 5.8 kg with aripiprazole and 0.2 kg and 2.3 kg, respectively with the placebo.

In the pediatric population, drowsiness and fatigue have been observed more frequently in patients with bipolar disorder compared with those with schizophrenia.

In the pediatric population with bipolar disorder (age 10 to 17 years), exposed to the product for periods up to 30 weeks, the incidence of low plasma prolactin levels was 28.0% in girls (<3 ng / ml) and 53.3% in boys (<2 ng / ml).

After the marketing

The following undesirable effects have been reported after the marketing of the drug. The frequency of these effects is considered indeterminate (can not be estimated from the available data).

Hematological and lymphatic system disorders

Leukopenia, neutropenia, thrombocytopenia.

Immune system disorders

Allergic reaction (eg, anaphylactic reaction, angioedema including swelling of the tongue, oedematous tongue, facial oedema, pruritus or urticaria).

Endocrine disorders

Hyperglycemia, diabetes mellitus, acidocetabolic diabetes, hyperosmolar diabetic coma.

Metabolism and nutrition disorders

Weight gain, weight loss, anorexia, hyponatremia.

Psychiatric disorders

Agitation, nervousness, pathological gambling; suicide attempt, suicidal ideation, and completed suicide (see Warnings and Precautions section ).

Nervous System Affections

Impairment disorders, Neuroleptic Malignant Syndrome (NMS), Severe Epileptic Disease, Serotonin Syndrome.

Heart conditions

QT prolongation, ventricular arrhythmia, unexplained sudden death, cardiac arrest, torsades de pointes, bradycardia.

Vascular disorders

Syncope, hypertension, thromboembolic events (including pulmonary embolism and deep vein thrombosis).

Respiratory, thoracic and mediastinal disorders

Oropharyngeal spasm, laryngeal spasm, deglutition pneumonia.

Gastrointestinal disorders

Pancreasitis, dysphagia, abdomen gnosis, stomach gnosis, diarrhea.

Hospital diseases

Hepatic insufficiency, jaundice, hepatitis, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (ASAT), increased gamma glutamyl transferase (GGT), increased alkaline phosphatase.

Skin and subcutaneous tissue disorders

Eruption, photosensitivity reaction, alopecia, hyperhidrosis.

Musculoskeletal and systemic disorders

Rhabdomyolysis, myalgia, stiffness.

Renal and urinary disorders

Urinary incontinence, urinary retention.

Pregnancy, Puerperal and Perinatal Disorders

Medication withdrawal syndrome neonatal (see section Pregnancy and breastfeeding ).

Disorders of reproductive organs and breast

Priapism.

General disorders and administration site abnormalities

Temperature regulation disorder (eg hypothermia, pyrexia), chest pain, peripheral oedematous.

investigations

Increase of Cretatin Phosphokinase, increase of glycemia, variation of glycemia, increase of glycosylated hemoglobin.

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

Popular Posts

Category Medicinal Products, Next Article