Medikament Abilify


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Medikament Abilify

Abilify 1 mg/ml docpharm Lösung zum Einnehmen. docpharm® Arzneimittelvertrieb GmbH & Co. KGaA · ABILIFY® 1 mg/ml Lösung. Dies ist eine Zusammenfassung des Europäischen Öffentlichen Beurteilungsberichts (EPAR) für Abilify. Hierin wird erläutert, wie die Agentur das Arzneimittel. Aripiprazol (Abilify®) ist ein neues atypisches Antipsychotikum zur Therapie der Schizophrenie bei Erwachsenen. Es ähnelt in seiner Struktur den atypischen.

Medikament Abilify Pharmakologie

Aripiprazol ist ein Arzneistoff aus der Gruppe der atypischen Neuroleptika und angezeigt zur Behandlung der Schizophrenie bei Erwachsenen und Jugendlichen ab 15 Jahren, zur Behandlung von mäßigen bis. Beipackzettel und wichtige Informationen zum Medikament ABILIFY 5 mg Tabletten: Wirkung, Anwendung, Gegenanzeigen, Nebenwirkungen. Blutdruck senkende Arzneimittel: ABILIFY kann die Wirkung von Arzneimitteln wichtig, Ihrem Arzt mitzuteilen, ob Sie die folgenden Medikamente einnehmen. Abilify gehört zu den „Blockbuster-Medikamenten“ (Umsatz über 7 Mrd. Dollar). Inhaltsverzeichnis. 1 Pharmakodynamische und pharmakokinetische. Abilify 1 mg/ml docpharm Lösung zum Einnehmen. docpharm® Arzneimittelvertrieb GmbH & Co. KGaA · ABILIFY® 1 mg/ml Lösung. Der Wirkstoff Aripiprazol gehört zu den wichtigsten Medikamenten bei Schizophrenie und Manie. Hier lesen Sie alles Wichtige zum Thema! Aripiprazol (Abilify®) ist ein neues atypisches Antipsychotikum zur Therapie der Schizophrenie bei Erwachsenen. Es ähnelt in seiner Struktur den atypischen.

Medikament Abilify

ABILIFY 15 mg Tabletten ist ein rezeptpflichtiges Medikament. Bewertung bei Medikamente im Test für 'Schizophrenien und andere. ABILIFY Tabl 10 mg (Aripiprazol) bei denen die Süchte abnahmen oder aufhörten, nachdem die Dosis reduziert oder das Medikament abgesetzt wurde. Beipackzettel und wichtige Informationen zum Medikament ABILIFY 5 mg Tabletten: Wirkung, Anwendung, Gegenanzeigen, Nebenwirkungen.

Medikament Abilify Anwendungsgebiete von Abilify 5mg Video

Abilify Withdrawal: Questions about Tapering Abilify \u0026 Abilify Side Effects - Alternative to Meds However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Abilify. These risk differences drug-placebo difference in the number of cases of suicidality per patients Das Beste Telefon are provided in Table 5. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Abilify [see Clinical Pharmacology The primary instrument Novo Gaminator Tricks for assessing manic Arcade Spiele Online was the Zug Spiele 3d Mania Rating Scale Y-MRSFull Tilt Poker.Net item clinician-rated scale traditionally Free To Play Games List to assess the degree of manic symptomatology in a range from 0 no manic features to Medikament Abilify maximum score. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. No suicides occurred in any of the pediatric trials. See " What should I avoid while receiving Abilify? Medikament Abilify Medikament Abilify ABILIFY 5 mg Tabletten ist ein rezeptpflichtiges Medikament. Bewertung bei Medikamente im Test für 'Schizophrenien und andere Psychosen'. ABILIFY 15 mg Tabletten ist ein rezeptpflichtiges Medikament. Bewertung bei Medikamente im Test für 'Schizophrenien und andere. Dies ist eine Zusammenfassung des Europäischen Öffentlichen Beurteilungsberichts (EPAR) für Abilify. Hierin wird erläutert, wie die Agentur das Arzneimittel. ABILIFY Tabl 10 mg (Aripiprazol) bei denen die Süchte abnahmen oder aufhörten, nachdem die Dosis reduziert oder das Medikament abgesetzt wurde.

Medikament Abilify Indications and Usage for Abilify Video

Prise de poids sous traitement psychotropes : antidépresseurs, lithium, antipsychotiques, la vérité!

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure convulsions , trouble breathing, or fainting.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

It is easier to become dangerously overheated and dehydrated while you are taking Abilify. Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Abilify side effects in more detail. Taking Abilify with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects.

Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many other drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Abilify.

Abilify drug interactions in more detail. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Abilify only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Abilify aripiprazole and Vraylar cariprazine are both classified as atypical antipsychotic medications.

They help to treat several mental health conditions, including schizophrenia and bipolar disorder. They both affect chemicals in the brain such as serotonin and dopamine to help stabilize mood, thoughts and behaviors.

Continue reading The main differences between Abilify and Abilify Maintena are how they are supplied, how they are administered, their FDA-approved uses and their costs.

They both contain the active ingredient aripiprazole, an atypical antipsychotic, and are approved for the treatment of schizophrenia and bipolar disorder.

You do not administer Abilify Maintena to yourself. It is injected into the deltoid upper arm muscle or gluteal buttock muscle.

Abilify Maintena is injected into a muscle into your upper arm or buttock once a month. It is an extended-release medicine used to treat schizophrenia and bipolar I disorder in adults.

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See also: Abilify dosage information in more detail. See also: Abilify side effects in more detail. See also: Abilify drug interactions in more detail.

Vraylar vs Abilify - How do they compare? What is the difference between Abilify and Abilify Maintena? How do you administer Abilify Maintena?

How often is Abilify Maintena given? Drug Status Availability Prescription only Rx. Otsuka Pharmaceutical Co. Drug Class.

Atypical antipsychotics. Related Drugs. Abilify Images. Subscribe to our newsletters. FDA Safety Alerts for all medications.

Daily MedNews. Weekly Drug News Roundup. Monthly Newsletter. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.

Patients with risk factors for diabetes mellitus e. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.

Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Table 6 shows the proportion of Abilify-treated patients with normal and borderline fasting glucose at baseline median exposure 25 days that had treatment-emergent high fasting glucose measurements compared to placebo-treated patients median exposure 22 days.

Table 7 shows the proportion of adult patients with changes in fasting glucose levels from two placebo-controlled, adjunctive trials median exposure 42 days in patients with major depressive disorder.

In an analysis of two placebo-controlled trials in pediatric and adolescent patients with irritability associated with autistic disorder 6 to 17 years with median exposure of 56 days, the mean change in fasting glucose in Abilify-treated patients —0.

In an analysis of two placebo-controlled trials in pediatric and adolescent patients with Tourette's disorder 6 to 18 years with median exposure of 57 days, the mean change in fasting glucose in Abilify-treated patients 0.

Table 8 shows the proportion of patients with changes in fasting glucose levels from the pooled adolescent schizophrenia and pediatric bipolar patients median exposure of 42 to 43 days , from two placebo-controlled trials in pediatric patients 6 to 17 years with irritability associated with autistic disorder median exposure of 56 days , and from the two placebo-controlled trials in pediatric patients 6 to 18 year with Tourette's Disorder median exposure 57 days.

Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Analyses of patients with at least 12 or 24 weeks of exposure were limited by small numbers of patients.

Table 9 shows the proportion of adult patients, primarily from pooled schizophrenia and bipolar disorder monotherapy placebo-controlled trials, with changes in total cholesterol pooled from 17 trials; median exposure 21 to 25 days , fasting triglycerides pooled from eight trials; median exposure 42 days , fasting LDL cholesterol pooled from eight trials; median exposure 39 to 45 days, except for placebo-treated patients with baseline normal fasting LDL measurements, who had median treatment exposure of 24 days and HDL cholesterol pooled from nine trials; median exposure 40 to 42 days.

Table 11 shows the proportion of adolescents with schizophrenia 13 to 17 years and pediatric patients with bipolar disorder 10 to 17 years with changes in total cholesterol and HDL cholesterol pooled from two placebo-controlled trials; median exposure 42 to 43 days and fasting triglycerides pooled from two placebo-controlled trials; median exposure 42 to 44 days.

Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. At 24 weeks, the mean change from baseline in body weight in Abilify-treated patients was —1.

In the trials adding Abilify to antidepressants, patients first received 8 weeks of antidepressant treatment followed by 6 weeks of adjunctive Abilify or placebo in addition to their ongoing antidepressant treatment.

In an open-label trial that enrolled patients from the two placebo-controlled trials of adolescents with schizophrenia 13 to 17 years and pediatric patients with bipolar disorder 10 to 17 years , After 26 weeks, To adjust for normal growth, z-scores were derived measured in standard deviations [SD] , which normalize for the natural growth of pediatric patients and adolescents by comparisons to age- and gender-matched population standards.

After 26 weeks, the mean change in z-score was 0. In an open-label trial that enrolled patients from two short-term, placebo-controlled trials, patients 6 to 17 years with irritability associated with autistic disorder, as well as de novo patients, The mean change in weight z-score was 0.

When treating pediatric patients for any indication, weight gain should be monitored and assessed against that expected for normal growth. Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.

Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.

Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.

It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued.

Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.

Abilify should be used with caution in patients with known cardiovascular disease history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities , cerebrovascular disease, or conditions which would predispose patients to hypotension dehydration, hypovolemia, and treatment with antihypertensive medications [see Drug Interactions 7.

If parenteral benzodiazepine therapy is deemed necessary in addition to Abilify injection treatment, patients should be monitored for excessive sedation and for orthostatic hypotension [see Drug Interactions 7.

Antipsychotics, including Abilify, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.

For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Agranulocytosis has also been reported. In such patients, consider discontinuation of Abilify at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur.

As with other antipsychotic drugs, Abilify should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.

Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Abilify, like other antipsychotics, may have the potential to impair judgment, thinking, or motor skills.

Somnolence including sedation led to discontinuation in 0. Despite the relatively modest increased incidence of these events compared to placebo, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with Abilify does not affect them adversely.

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents.

Appropriate care is advised when prescribing Abilify for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.

The possibility of a suicide attempt is inherent in psychotic illnesses, bipolar disorder, and major depressive disorder, and close supervision of high-risk patients should accompany drug therapy.

Prescriptions for Abilify should be written for the smallest quantity consistent with good patient management in order to reduce the risk of overdose [see Adverse Reactions 6.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including Abilify. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia.

Abilify and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see Warnings and Precautions 5.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Abilify has been evaluated for safety in 13, adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately patient-years of exposure to oral Abilify and patients with exposure to Abilify injection.

A total of patients were treated with oral Abilify for at least days and patients treated with oral Abilify had at least 1 year of exposure.

Abilify has been evaluated for safety in 1, patients 6 to 18 years who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1, patient-years of exposure to oral Abilify.

A total of pediatric patients were treated with oral Abilify for at least days and pediatric patients treated with oral Abilify had at least 1 year of exposure.

The conditions and duration of treatment with Abilify monotherapy and adjunctive therapy with antidepressants or mood stabilizers included in overlapping categories double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.

An examination of population subgroups did not reveal any clear evidence of differential adverse reaction incidence on the basis of age, gender, or race.

Adverse Reactions Associated with Discontinuation of Treatment. Pediatric Patients 6 to 17 years with Autistic Disorder. Pediatric Patients 6 to 18 years with Tourette's Disorder.

The following findings are based on a pool of two placebo-controlled trials of patients with major depressive disorder in which Abilify was administered at doses of 2 to 20 mg as adjunctive treatment to continued antidepressant therapy.

The following findings are based on a pool of three placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar mania in which Abilify injection was administered at doses of 5.

This analysis, stratified by study, indicated that the only adverse reaction to have a possible dose response relationship, and then most prominent only with 30 mg, was somnolence [including sedation]; incidences were placebo, 7.

In the study of pediatric patients 13 to 17 years of age with schizophrenia, three common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder incidences were placebo, 5.

In the study of pediatric patients 10 to 17 years of age with bipolar mania, four common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder incidences were placebo, 3.

In a study of pediatric patients 7 to 17 years of age with Tourette's disorder, no common adverse reaction s had a dose response relationship.

In the adult schizophrenia trials, the objectively collected data did not show a difference between Abilify and placebo, with the exception of the Barnes Akathisia Scale Abilify, 0.

In the pediatric 13 to 17 years schizophrenia trial, the objectively collected data did not show a difference between Abilify and placebo, with the exception of the Simpson Angus Rating Scale Abilify, 0.

Similarly, in a long-term week , placebo-controlled trial of schizophrenia in adults, objectively collected data on the Simpson Angus Rating Scale for EPS , the Barnes Akathisia Scale for akathisia , and the Assessments of Involuntary Movement Scales for dyskinesias did not show a difference between Abilify and placebo.

In the adult bipolar mania trials with monotherapy Abilify, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between Abilify and placebo Abilify, 0.

Changes in the Assessments of Involuntary Movement Scales were similar for the Abilify and placebo groups. In the bipolar mania trials with Abilify as adjunctive therapy with either lithium or valproate, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive Abilify and adjunctive placebo Abilify, 0.

Changes in the Assessments of Involuntary Movement Scales were similar for adjunctive Abilify and adjunctive placebo. In the pediatric 10 to 17 years , short-term, bipolar mania trial, the Simpson Angus Rating Scale showed a significant difference between Abilify and placebo Abilify, 0.

In the major depressive disorder trials, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive Abilify and adjunctive placebo Abilify, 0.

Changes in the Assessments of Involuntary Movement Scales were similar for the adjunctive Abilify and adjunctive placebo groups.

In the pediatric 6 to 17 years short-term autistic disorder trials, the Simpson Angus Rating Scale showed a significant difference between Abilify and placebo Abilify, 0.

In the pediatric 6 to 18 years short-term Tourette's disorder trials, changes in the Simpson Angus Rating Scale, Barnes Akathisia Scale and Assessments of Involuntary Movement Scale were not clinically meaningfully different for Abilify and placebo.

Agitation Associated with Schizophrenia or Bipolar Mania. Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.

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 drugs.

An elevated risk of acute dystonia is observed in males and younger age groups. A similar profile was observed in a long-term monotherapy study and a long-term adjunctive study with lithium and valproate in bipolar disorder.

The following listing does not include reactions: 1 already listed in previous tables or elsewhere in labeling, 2 for which a drug cause was remote, 3 which were so general as to be uninformative, 4 which were not considered to have significant clinical implications, or 5 which occurred at a rate equal to or less than placebo.

Most adverse events observed in the pooled database of 1, pediatric patients, aged 6 to 18 years, were also observed in the adult population.

Additional adverse reactions observed in the pediatric population are listed below. Most adverse reactions observed in the pooled database of adult patients treated with Abilify injection, were also observed in the adult population treated with oral Abilify.

Additional adverse reactions observed in the Abilify injection population are listed below. The following adverse reactions have been identified during post-approval use of Abilify.

Based on pharmacokinetic studies, no dosage adjustment of Abilify is required when administered concomitantly with famotidine, valproate, lithium, lorazepam.

In addition, no dosage adjustment is necessary for substrates of CYP2D6 e. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Abilify [see Clinical Pharmacology There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Abilify, during pregnancy.

Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes see Data.

There are risks to the mother associated with untreated schizophrenia, bipolar I disorder, or major depressive disorder, and with exposure to antipsychotics, including Abilify, during pregnancy see Clinical Considerations.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.

There is a risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide.

Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth.

It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.

Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.

Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects.

A retrospective study from a Medicaid database of women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects.

In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.

Delayed skeletal ossification was observed at 3 and 10 times the MRHD. Delivered offspring had increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed at 10 times the MRHD the other dose groups were not examined for these findings.

Postnatally, delayed vaginal opening was seen at 3 and 10 times the MRHD. Impaired reproductive performance decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring were observed at 10 times the MRHD; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity.

Decreased fetal weight and increased incidence of fused sternebrae were observed at 19 and 65 times the MRHD. An increase in stillbirths and, decreases in pup weight persisting into adulthood and survival were also seen at this dose.

There were no effects on postnatal behavioral and reproductive development. Limited data from published literature report the presence of aripiprazole in human breast milk, at relative infant doses ranging between 0.

There are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating women taking aripiprazole.

The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Abilify and any potential adverse effects on the breastfed infant from Abilify or from the underlying maternal condition.

Safety and effectiveness in pediatric patients with major depressive disorder or agitation associated with schizophrenia or bipolar mania have not been established.

The pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see Clinical Pharmacology Safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in pediatric patients aged 13 to 17 years [see Dosage and Administration 2.

Although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients.

Safety and effectiveness in pediatric patients with bipolar mania were established in a 4-week, placebo-controlled clinical trial in pediatric patients aged 10 to 17 years [see Dosage and Administration 2.

The efficacy of adjunctive Abilify with concomitant lithium or valproate in the treatment of manic or mixed episodes in pediatric patients has not been systematically evaluated.

However, such efficacy and lack of pharmacokinetic interaction between aripiprazole and lithium or valproate can be extrapolated from adult data, along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients.

Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two 8-week, placebo-controlled clinical trials in pediatric patients aged 6 to 17 years [see Indications and Usage 1 , Dosage and Administration 2.

A maintenance trial was conducted in pediatric patients 6 to 17 years of age with irritability associated with autistic disorder.

Overall, 85 patients were stabilized and entered the second, week, double-blind phase where they were randomized to either continue Abilify treatment or switch to placebo.

In this trial, the efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder was not established.

Safety and effectiveness of aripiprazole in pediatric patients with Tourette's Disorder were established in one 8-week aged 7 to 17 years and one week trial aged 6 to 18 years in pediatric patients [see Dosage and Administration 2.

Maintenance efficacy in pediatric patients has not been systematically evaluated. In addition, delayed sexual maturation was observed in males.

At all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary atrophy , adrenals adrenocortical hypertrophy , mammary glands hyperplasia and increased secretion , and female reproductive organs vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea were observed.

The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. All drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies.

All drug-related effects were reversible after a 2-month recovery period. No dosage adjustment is recommended for elderly patients [see Boxed Warning , Warnings and Precautions 5.

Placebo-controlled studies of oral Abilify in schizophrenia, bipolar mania, or major depressive disorder did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Placebo-controlled studies of Abilify injection in patients with agitation associated with schizophrenia or bipolar mania did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Abilify is not approved for the treatment of patients with psychosis associated with Alzheimer's disease [see Boxed Warning and Warnings and Precautions 5.

Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. No dosage adjustment for Abilify is required on the basis of a patient's sex, race, or smoking status [see Clinical Pharmacology Abilify has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence.

Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of Abilify misuse or abuse e.

In physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral Abilify have been reported worldwide.

These include overdoses with oral Abilify alone and in combination with other substances. No fatality was reported with Abilify alone.

The largest known dose with a known outcome involved acute ingestion of mg of oral Abilify 42 times the maximum recommended daily dose by a patient who fully recovered.

Deliberate or accidental overdosage was also reported in children age 12 years and younger involving oral Abilify ingestions up to mg with no fatalities.

Other clinically important signs and symptoms observed in one or more patients with Abilify overdoses alone or with other substances include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

No specific information is available on the treatment of overdose with Abilify. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted.

Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.

Close medical supervision and monitoring should continue until the patient recovers. Charcoal: In the event of an overdose of Abilify, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole.

Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with Abilify, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.

Aripiprazole is 7-[4-[4- 2,3-dichlorophenyl piperazinyl]butoxy]-3,4-dihydrocarbostyril. The chemical structure is:. Abilify Tablets are available in 2, 5, 10, 15, 20, and 30 mg strengths.

Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water.

The oral solution is flavored with natural orange cream and other natural flavors. Abilify Injection is available in single-dose vials as a ready-to-use, 9.

Inactive ingredients for this solution include The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear.

However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

The mean elimination half-lives are about 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively. Steady-state concentrations are attained within 14 days of dosing for both active moieties.

Aripiprazole accumulation is predictable from single-dose pharmacokinetics. At steady-state, the pharmacokinetics of aripiprazole is dose-proportional.

For CYP2D6 poor metabolizers, the mean elimination half-life for aripiprazole is about hours. Abilify can be administered with or without food.

Administration of a 15 mg Abilify Tablet with a standard high-fat meal did not significantly affect the C ma x or AUC of aripiprazole or its active metabolite, dehydro-aripiprazole, but delayed T max by 3 hours for aripiprazole and 12 hours for dehydro-aripiprazole.

Oral Solution: Aripiprazole is well absorbed when administered orally as the solution. At equivalent doses, the plasma concentrations of aripiprazole from the solution were higher than that from the tablet formulation.

The single-dose pharmacokinetics of aripiprazole were linear and dose-proportional between the doses of 5 to 30 mg.

The steady-state volume of distribution of aripiprazole following intravenous administration is high L or 4.

In healthy human volunteers administered 0. Aripiprazole is metabolized primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.

Aripiprazole is the predominant drug moiety in the systemic circulation. Effects of other drugs on the exposures of aripiprazole and dehydro-aripiprazole are summarized in Figure 1 and Figure 2, respectively.

Based on simulation, a 4. The effects of Abilify on the exposures of other drugs are summarized in Figure 3. The steady-state plasma concentrations of sertraline and desmethylsertraline were not substantially changed when these antidepressant therapies were coadministered with aripiprazole.

Exposures of aripiprazole and dehydro-aripiprazole in specific populations are summarized in Figure 4 and Figure 5, respectively. In addition, in pediatric patients 10 to 17 years of age administered with Abilify 20 mg to 30 mg , the body weight corrected aripiprazole clearance was similar to the adults.

In two pharmacokinetic studies of aripiprazole injection administered intramuscularly to healthy subjects, the median times to the peak plasma concentrations were at 1 hour and 3 hours.

In stable patients with schizophrenia or schizoaffective disorder, the pharmacokinetics of aripiprazole after intramuscular administration were linear over a dose range of 1 mg to 45 mg.

Although the metabolism of aripiprazole injection was not systematically evaluated, the intramuscular route of administration would not be expected to alter the metabolic pathways.

Aripiprazole did not induce tumors in male mice or male rats. An increase in mammary, pituitary, and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be mediated by prolonged dopamine D 2 -receptor antagonism and hyperprolactinemia.

Serum prolactin was not measured in the aripiprazole carcinogenicity studies. However, increases in serum prolactin levels were observed in female mice in a week dietary study at the doses associated with mammary gland and pituitary tumors.

Serum prolactin was not increased in female rats in 4-week and week dietary studies at the dose associated with mammary gland tumors.

The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unclear.

The mutagenic potential of aripiprazole was tested in the in vitro bacterial reverse-mutation assay, the in vitro bacterial DNA repair assay, the in vitro forward gene mutation assay in mouse lymphoma cells, the in vitro chromosomal aberration assay in Chinese hamster lung CHL cells, the in vivo micronucleus assay in mice, and the unscheduled DNA synthesis assay in rats.

Aripiprazole and a metabolite 2,3-DCPP were clastogenic in the in vitro chromosomal aberration assay in CHL cells with and without metabolic activation.

A positive response was obtained in the in vivo micronucleus assay in mice; however, the response was due to a mechanism not considered relevant to humans.

Estrus cycle irregularities and increased corpora lutea were seen at all doses, but no impairment of fertility was seen. Disturbances in spermatogenesis were seen at 19 times the MRHD and prostate atrophy was seen at 13 and 19 times the MRHD without impairment of fertility.

Evaluation of the retinas of albino mice and of monkeys did not reveal evidence of retinal degeneration. Additional studies to further evaluate the mechanism have not been performed.

The relevance of this finding to human risk is unknown. Efficacy of the oral formulations of Abilify aripiprazole was established in the following adequate and well-controlled trials:.

Efficacy of the injectable formulation of Abilify aripiprazole was established in the following adequate and well-controlled trials:.

Four of the five trials were able to distinguish Abilify from placebo, but one study, the smallest, did not. Three of these studies also included an active control group consisting of either risperidone one trial or haloperidol two trials , but they were not designed to allow for a comparison of Abilify and the active comparators.

In the four positive trials for Abilify, four primary measures were used for assessing psychiatric signs and symptoms. The PANSS is a item scale that measures positive symptoms of schizophrenia 7 items , negative symptoms of schizophrenia 7 items , and general psychopathology 16 items , each rated on a scale of 1 absent to 7 extreme ; total PANSS scores range from 30 to The Clinical Global Impression CGI assessment reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient.

The 2 and 5 mg doses did not demonstrate superiority to placebo on the primary outcome measure. Thus, the efficacy of 10, 15, 20, and 30 mg daily doses was established in two studies for each dose.

Among these doses, there was no evidence that the higher dose groups offered any advantage over the lowest dose group of these studies.

An examination of population subgroups did not reveal any clear evidence of differential responsiveness on the basis of age, gender, or race. A longer-term trial enrolled inpatients or outpatients meeting DSM-IV criteria for schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer.

The efficacy of Abilify as monotherapy in the acute treatment of manic episodes was established in four 3-week, placebo-controlled trials in hospitalized patients who met the DSM-IV criteria for bipolar I disorder with manic or mixed episodes.

These studies included patients with or without psychotic features and two of the studies also included patients with or without a rapid-cycling course.

The primary instrument used for assessing manic symptoms was the Young Mania Rating Scale Y-MRS , an item clinician-rated scale traditionally used to assess the degree of manic symptomatology in a range from 0 no manic features to 60 maximum score.

This study included patients with manic or mixed episodes and with or without psychotic features. Patients were initiated on open-label lithium 0.

A maintenance trial was conducted in adult patients meeting DSM-IV criteria for bipolar I disorder with a recent manic or mixed episode who had been stabilized on open-label Abilify and who had maintained a clinical response for at least 6 weeks.

One hundred sixty-one outpatients were then randomized in a double-blind fashion, to either the same dose of Abilify they were on at the end of the stabilization and maintenance period or placebo and were then monitored for manic or depressive relapse.

During the randomization phase, Abilify was superior to placebo on time to the number of combined affective relapses manic plus depressive , the primary outcome measure for this study Study 7 in Figure 7.

A total of 55 mood events were observed during the double-blind treatment phase. Nineteen were from the Abilify group and 36 were from the placebo group.

The number of observed manic episodes in the Abilify group 6 were fewer than that in the placebo group 19 , while the number of depressive episodes in the Abilify group 9 was similar to that in the placebo group An examination of population subgroups did not reveal any clear evidence of differential responsiveness on the basis of age and gender; however, there were insufficient numbers of patients in each of the ethnic groups to adequately assess inter-group differences.

An adjunctive maintenance trial was conducted in adult patients meeting DSM-IV criteria for bipolar I disorder with a recent manic or mixed episode.

Three hundred thirty-seven patients were then randomized in a double-blind fashion, to either the same dose of Abilify they were on at the end of the stabilization period or placebo plus lithium or valproate and were then monitored for manic, mixed, or depressive relapse for a maximum of 52 weeks.

Abilify was superior to placebo on the primary endpoint, time from randomization to relapse to any mood event Study 8 in Figure 8.

A total of 68 mood events were observed during the double-blind treatment phase. Twenty-five were from the Abilify group and 43 were from the placebo group.

The number of observed manic episodes in the Abilify group 7 were fewer than that in the placebo group 19 , while the number of depressive episodes in the Abilify group 14 was similar to that in the placebo group The Kaplan-Meier curves of the time from randomization to relapse to any mood event during the week, double-blind treatment phase for Abilify and placebo groups are shown in Figure 8.

The efficacy of Abilify in the adjunctive treatment of major depressive disorder MDD was demonstrated in two short-term 6-week , placebo-controlled trials of adult patients meeting DSM-IV criteria for MDD who had had an inadequate response to prior antidepressant therapy 1 to 3 courses in the current episode and who had also demonstrated an inadequate response to 8 weeks of prospective antidepressant therapy paroxetine controlled-release, venlafaxine extended-release, fluoxetine, escitalopram, or sertraline.

The primary instrument used for assessing depressive symptoms was the Montgomery-Asberg Depression Rating Scale MADRS , a item clinician-rated scale used to assess the degree of depressive symptomatology.

The key secondary instrument was the Sheehan Disability Scale SDS , a 3-item self-rated instrument used to assess the impact of depression on three domains of functioning with each item scored from 0 not at all to 10 extreme.

In one study, Abilify was also superior to placebo in reducing the mean SDS score. Based on tolerability and efficacy, doses could be adjusted by 5 mg increments, one week apart.

The mean final dose at the end point for the two trials was An examination of population subgroups did not reveal evidence of differential response based on age, choice of prospective antidepressant, or race.

With regard to gender, a smaller mean reduction on the MADRS total score was seen in males than in females. The efficacy of Abilify aripiprazole in the treatment of irritability associated with autistic disorder was established in two 8-week, placebo-controlled trials in pediatric patients 6 to 17 years of age who met the DSM-IV criteria for autistic disorder and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.

The ABC-I subscale measured symptoms of irritability in autistic disorder. The mean daily dose of Abilify at the end of 8-week treatment was 8.

All three doses of Abilify significantly improved scores on the ABC-I subscale compared with placebo.

Ratings for the TTS are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each.

Summation of these 10 scores provides a TTS i. The target doses for the low and high dose Abilify groups were based on weight.

The mean daily dose of Abilify at the end of week treatment was 6. The efficacy of intramuscular Abilify for injection for the treatment of agitation was established in three short-term hour , placebo-controlled trials in agitated inpatients from two diagnostic groups: schizophrenia and bipolar I disorder manic or mixed episodes, with or without psychotic features.

Each of the trials included a single active comparator treatment arm of either haloperidol injection schizophrenia studies or lorazepam injection bipolar mania study.

Patients could receive up to three injections during the hour treatment periods; however, patients could not receive the second injection until after the initial 2-hour period when the primary efficacy measure was assessed.

In the studies, the mean baseline PANSS Excited Component score was 19, with scores ranging from 15 to 34 out of a maximum score of 35 , thus suggesting predominantly moderate levels of agitation with some patients experiencing mild or severe levels of agitation.

The primary efficacy measure used for assessing agitation signs and symptoms in these trials was the change from baseline in the PANSS Excited Component at 2 hours post-injection.

The results of the trials follow:. At 2 hours post-injection, the 5. Examination of population subsets age, race, and gender did not reveal any differential responsiveness on the basis of these subgroupings.

Abilify Oral Solution is available as follows:. Opened bottles of Abilify Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

The bottle and its contents should be discarded after the expiration date. Protect from light by storing in the original container.

Retain in carton until time of use. Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.

Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.

Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions 5.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Abilify and should counsel them in its appropriate use.

The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that Abilify is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.

In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions 5.

Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet.

Do not push the tablet through the foil because this could damage the tablet.

They both affect chemicals Klickerklacker Rtl the brain such as serotonin and dopamine to help stabilize mood, thoughts and behaviors. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Anwendungsgebiete von Abilify 5mg Das Arzneimittel enthält den Wirkstoff Aripiprazol und gehört zu einer Gruppe von Tricks Von Book Of Ra, die Antipsychotika genannt werden. One hundred sixty-one outpatients were then randomized in a double-blind fashion, to either the same dose of Abilify they were on at the end of the stabilization Joc Dolphins Pearl Delux maintenance period or placebo and were then monitored for manic or depressive relapse. Evaluation of the retinas of albino Casino Radebeul and of monkeys did not reveal evidence of retinal degeneration. Efficacy of the injectable formulation of Abilify aripiprazole was established in the following adequate and well-controlled trials:. Abilify Injection is intended for intramuscular use only. Während der Behandlung mit einem Antipsychotikum, wozu auch Abilify gezählt wird, kann es Medikament Abilify Tage oder Wochen dauern, bis die gewünschte Wirkung eintritt. Table 9 Medikament Abilify the proportion of adult patients, primarily from pooled schizophrenia and bipolar disorder monotherapy placebo-controlled trials, with changes in total cholesterol pooled from 17 trials; median exposure 21 to 25 daysfasting triglycerides pooled from eight trials; median exposure 42 daysfasting LDL cholesterol pooled from eight trials; median Eismaschine Delonghi 39 to 45 days, except for placebo-treated patients with Car To Go Freunde Werben normal fasting LDL measurements, who had median treatment exposure of 24 days and HDL cholesterol pooled from nine trials; median exposure 40 to 42 days. Adverse Reactions Associated with Discontinuation of Treatment. Vielleicht möchten Sie diese später nochmals lesen. Dieser Artikel behandelt ein Gesundheitsthema. Als partieller Dopamin-D2-Agonist blockiert Aripiprazol die postsynaptischen Dopamin-D2-Rezeptoren, während es gleichzeitig die präsynaptischen Autorezeptoren stimuliert. Gut verträglich Aripiprazol bessert bei Schizophrenie-Patienten die Positiv-Symptome wie Wahnvorstellungen und Paranoia mindestens ebenso gut wie die bisher verfügbaren atypischen Neuroleptika Olanzapin und Risperidon Medikament Abilify das Neuroleptikum Slots Xsellize, wird aber von vielen Patienten besser vertragen. Service-Funktionen Permalink Tipico Casino Geht Nicht. Selbsttötungsgedanken und entsprechendes Verhalten wurden während der Behandlung mit Aripiprazol berichtet. Es wird angewendet für die Behandlung von Erwachsenen und Jugendlichen ab 15 Free Slots Tournaments Online, die an einer Krankheit leiden, die gekennzeichnet ist durch Symptome wie das Hören, Sehen oder Fühlen von Dingen, die nicht vorhanden sind, Misstrauen, Wahnvorstellungen, unzusammenhängende Wm 2017 Endspiel Datum, wirres Verhalten und verflachte Stimmungslage. Dazu werden die verschiedenen Botenstoffe wie Serotonin Thai Blumen Histamin je nach Bedarf von Nervenzellen ausgeschüttet und später wieder aufgenommen und gespeichert. Behandlung der Schizophrenie Vorbeugung und Behandlung von manisch-depressiven Phasen. Sie erscheint wöchentlich jeweils donnerstags.

If parenteral benzodiazepine therapy is deemed necessary in addition to Abilify injection treatment, patients should be monitored for excessive sedation and for orthostatic hypotension [see Drug Interactions 7.

Antipsychotics, including Abilify, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.

For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Agranulocytosis has also been reported. In such patients, consider discontinuation of Abilify at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur.

As with other antipsychotic drugs, Abilify should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.

Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Abilify, like other antipsychotics, may have the potential to impair judgment, thinking, or motor skills.

Somnolence including sedation led to discontinuation in 0. Despite the relatively modest increased incidence of these events compared to placebo, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with Abilify does not affect them adversely.

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Abilify for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.

The possibility of a suicide attempt is inherent in psychotic illnesses, bipolar disorder, and major depressive disorder, and close supervision of high-risk patients should accompany drug therapy.

Prescriptions for Abilify should be written for the smallest quantity consistent with good patient management in order to reduce the risk of overdose [see Adverse Reactions 6.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including Abilify. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia.

Abilify and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see Warnings and Precautions 5.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Abilify has been evaluated for safety in 13, adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately patient-years of exposure to oral Abilify and patients with exposure to Abilify injection.

A total of patients were treated with oral Abilify for at least days and patients treated with oral Abilify had at least 1 year of exposure.

Abilify has been evaluated for safety in 1, patients 6 to 18 years who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1, patient-years of exposure to oral Abilify.

A total of pediatric patients were treated with oral Abilify for at least days and pediatric patients treated with oral Abilify had at least 1 year of exposure.

The conditions and duration of treatment with Abilify monotherapy and adjunctive therapy with antidepressants or mood stabilizers included in overlapping categories double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.

An examination of population subgroups did not reveal any clear evidence of differential adverse reaction incidence on the basis of age, gender, or race.

Adverse Reactions Associated with Discontinuation of Treatment. Pediatric Patients 6 to 17 years with Autistic Disorder.

Pediatric Patients 6 to 18 years with Tourette's Disorder. The following findings are based on a pool of two placebo-controlled trials of patients with major depressive disorder in which Abilify was administered at doses of 2 to 20 mg as adjunctive treatment to continued antidepressant therapy.

The following findings are based on a pool of three placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar mania in which Abilify injection was administered at doses of 5.

This analysis, stratified by study, indicated that the only adverse reaction to have a possible dose response relationship, and then most prominent only with 30 mg, was somnolence [including sedation]; incidences were placebo, 7.

In the study of pediatric patients 13 to 17 years of age with schizophrenia, three common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder incidences were placebo, 5.

In the study of pediatric patients 10 to 17 years of age with bipolar mania, four common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder incidences were placebo, 3.

In a study of pediatric patients 7 to 17 years of age with Tourette's disorder, no common adverse reaction s had a dose response relationship.

In the adult schizophrenia trials, the objectively collected data did not show a difference between Abilify and placebo, with the exception of the Barnes Akathisia Scale Abilify, 0.

In the pediatric 13 to 17 years schizophrenia trial, the objectively collected data did not show a difference between Abilify and placebo, with the exception of the Simpson Angus Rating Scale Abilify, 0.

Similarly, in a long-term week , placebo-controlled trial of schizophrenia in adults, objectively collected data on the Simpson Angus Rating Scale for EPS , the Barnes Akathisia Scale for akathisia , and the Assessments of Involuntary Movement Scales for dyskinesias did not show a difference between Abilify and placebo.

In the adult bipolar mania trials with monotherapy Abilify, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between Abilify and placebo Abilify, 0.

Changes in the Assessments of Involuntary Movement Scales were similar for the Abilify and placebo groups. In the bipolar mania trials with Abilify as adjunctive therapy with either lithium or valproate, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive Abilify and adjunctive placebo Abilify, 0.

Changes in the Assessments of Involuntary Movement Scales were similar for adjunctive Abilify and adjunctive placebo. In the pediatric 10 to 17 years , short-term, bipolar mania trial, the Simpson Angus Rating Scale showed a significant difference between Abilify and placebo Abilify, 0.

In the major depressive disorder trials, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive Abilify and adjunctive placebo Abilify, 0.

Changes in the Assessments of Involuntary Movement Scales were similar for the adjunctive Abilify and adjunctive placebo groups. In the pediatric 6 to 17 years short-term autistic disorder trials, the Simpson Angus Rating Scale showed a significant difference between Abilify and placebo Abilify, 0.

In the pediatric 6 to 18 years short-term Tourette's disorder trials, changes in the Simpson Angus Rating Scale, Barnes Akathisia Scale and Assessments of Involuntary Movement Scale were not clinically meaningfully different for Abilify and placebo.

Agitation Associated with Schizophrenia or Bipolar Mania. Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.

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 drugs.

An elevated risk of acute dystonia is observed in males and younger age groups. A similar profile was observed in a long-term monotherapy study and a long-term adjunctive study with lithium and valproate in bipolar disorder.

The following listing does not include reactions: 1 already listed in previous tables or elsewhere in labeling, 2 for which a drug cause was remote, 3 which were so general as to be uninformative, 4 which were not considered to have significant clinical implications, or 5 which occurred at a rate equal to or less than placebo.

Most adverse events observed in the pooled database of 1, pediatric patients, aged 6 to 18 years, were also observed in the adult population.

Additional adverse reactions observed in the pediatric population are listed below. Most adverse reactions observed in the pooled database of adult patients treated with Abilify injection, were also observed in the adult population treated with oral Abilify.

Additional adverse reactions observed in the Abilify injection population are listed below. The following adverse reactions have been identified during post-approval use of Abilify.

Based on pharmacokinetic studies, no dosage adjustment of Abilify is required when administered concomitantly with famotidine, valproate, lithium, lorazepam.

In addition, no dosage adjustment is necessary for substrates of CYP2D6 e. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Abilify [see Clinical Pharmacology There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Abilify, during pregnancy.

Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes see Data.

There are risks to the mother associated with untreated schizophrenia, bipolar I disorder, or major depressive disorder, and with exposure to antipsychotics, including Abilify, during pregnancy see Clinical Considerations.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U. There is a risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide.

Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth.

It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.

Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.

Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects.

A retrospective study from a Medicaid database of women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects.

In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.

Delayed skeletal ossification was observed at 3 and 10 times the MRHD. Delivered offspring had increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed at 10 times the MRHD the other dose groups were not examined for these findings.

Postnatally, delayed vaginal opening was seen at 3 and 10 times the MRHD. Impaired reproductive performance decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring were observed at 10 times the MRHD; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity.

Decreased fetal weight and increased incidence of fused sternebrae were observed at 19 and 65 times the MRHD. An increase in stillbirths and, decreases in pup weight persisting into adulthood and survival were also seen at this dose.

There were no effects on postnatal behavioral and reproductive development. Limited data from published literature report the presence of aripiprazole in human breast milk, at relative infant doses ranging between 0.

There are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating women taking aripiprazole.

The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Abilify and any potential adverse effects on the breastfed infant from Abilify or from the underlying maternal condition.

Safety and effectiveness in pediatric patients with major depressive disorder or agitation associated with schizophrenia or bipolar mania have not been established.

The pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see Clinical Pharmacology Safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in pediatric patients aged 13 to 17 years [see Dosage and Administration 2.

Although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients.

Safety and effectiveness in pediatric patients with bipolar mania were established in a 4-week, placebo-controlled clinical trial in pediatric patients aged 10 to 17 years [see Dosage and Administration 2.

The efficacy of adjunctive Abilify with concomitant lithium or valproate in the treatment of manic or mixed episodes in pediatric patients has not been systematically evaluated.

However, such efficacy and lack of pharmacokinetic interaction between aripiprazole and lithium or valproate can be extrapolated from adult data, along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients.

Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two 8-week, placebo-controlled clinical trials in pediatric patients aged 6 to 17 years [see Indications and Usage 1 , Dosage and Administration 2.

A maintenance trial was conducted in pediatric patients 6 to 17 years of age with irritability associated with autistic disorder. Overall, 85 patients were stabilized and entered the second, week, double-blind phase where they were randomized to either continue Abilify treatment or switch to placebo.

In this trial, the efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder was not established.

Safety and effectiveness of aripiprazole in pediatric patients with Tourette's Disorder were established in one 8-week aged 7 to 17 years and one week trial aged 6 to 18 years in pediatric patients [see Dosage and Administration 2.

Maintenance efficacy in pediatric patients has not been systematically evaluated. In addition, delayed sexual maturation was observed in males.

At all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary atrophy , adrenals adrenocortical hypertrophy , mammary glands hyperplasia and increased secretion , and female reproductive organs vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea were observed.

The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. All drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies.

All drug-related effects were reversible after a 2-month recovery period. No dosage adjustment is recommended for elderly patients [see Boxed Warning , Warnings and Precautions 5.

Placebo-controlled studies of oral Abilify in schizophrenia, bipolar mania, or major depressive disorder did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Placebo-controlled studies of Abilify injection in patients with agitation associated with schizophrenia or bipolar mania did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Abilify is not approved for the treatment of patients with psychosis associated with Alzheimer's disease [see Boxed Warning and Warnings and Precautions 5.

Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. No dosage adjustment for Abilify is required on the basis of a patient's sex, race, or smoking status [see Clinical Pharmacology Abilify has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence.

Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of Abilify misuse or abuse e.

In physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral Abilify have been reported worldwide.

These include overdoses with oral Abilify alone and in combination with other substances. No fatality was reported with Abilify alone. The largest known dose with a known outcome involved acute ingestion of mg of oral Abilify 42 times the maximum recommended daily dose by a patient who fully recovered.

Deliberate or accidental overdosage was also reported in children age 12 years and younger involving oral Abilify ingestions up to mg with no fatalities.

Other clinically important signs and symptoms observed in one or more patients with Abilify overdoses alone or with other substances include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

No specific information is available on the treatment of overdose with Abilify. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted.

Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.

Close medical supervision and monitoring should continue until the patient recovers. Charcoal: In the event of an overdose of Abilify, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole.

Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with Abilify, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.

Aripiprazole is 7-[4-[4- 2,3-dichlorophenyl piperazinyl]butoxy]-3,4-dihydrocarbostyril. The chemical structure is:. Abilify Tablets are available in 2, 5, 10, 15, 20, and 30 mg strengths.

Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water.

The oral solution is flavored with natural orange cream and other natural flavors. Abilify Injection is available in single-dose vials as a ready-to-use, 9.

Inactive ingredients for this solution include The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear.

However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

The mean elimination half-lives are about 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively.

Steady-state concentrations are attained within 14 days of dosing for both active moieties. Aripiprazole accumulation is predictable from single-dose pharmacokinetics.

At steady-state, the pharmacokinetics of aripiprazole is dose-proportional. For CYP2D6 poor metabolizers, the mean elimination half-life for aripiprazole is about hours.

Abilify can be administered with or without food. Administration of a 15 mg Abilify Tablet with a standard high-fat meal did not significantly affect the C ma x or AUC of aripiprazole or its active metabolite, dehydro-aripiprazole, but delayed T max by 3 hours for aripiprazole and 12 hours for dehydro-aripiprazole.

Oral Solution: Aripiprazole is well absorbed when administered orally as the solution. At equivalent doses, the plasma concentrations of aripiprazole from the solution were higher than that from the tablet formulation.

The single-dose pharmacokinetics of aripiprazole were linear and dose-proportional between the doses of 5 to 30 mg. The steady-state volume of distribution of aripiprazole following intravenous administration is high L or 4.

In healthy human volunteers administered 0. Aripiprazole is metabolized primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.

Aripiprazole is the predominant drug moiety in the systemic circulation. Effects of other drugs on the exposures of aripiprazole and dehydro-aripiprazole are summarized in Figure 1 and Figure 2, respectively.

Based on simulation, a 4. The effects of Abilify on the exposures of other drugs are summarized in Figure 3. The steady-state plasma concentrations of sertraline and desmethylsertraline were not substantially changed when these antidepressant therapies were coadministered with aripiprazole.

Exposures of aripiprazole and dehydro-aripiprazole in specific populations are summarized in Figure 4 and Figure 5, respectively.

In addition, in pediatric patients 10 to 17 years of age administered with Abilify 20 mg to 30 mg , the body weight corrected aripiprazole clearance was similar to the adults.

In two pharmacokinetic studies of aripiprazole injection administered intramuscularly to healthy subjects, the median times to the peak plasma concentrations were at 1 hour and 3 hours.

In stable patients with schizophrenia or schizoaffective disorder, the pharmacokinetics of aripiprazole after intramuscular administration were linear over a dose range of 1 mg to 45 mg.

Although the metabolism of aripiprazole injection was not systematically evaluated, the intramuscular route of administration would not be expected to alter the metabolic pathways.

Aripiprazole did not induce tumors in male mice or male rats. An increase in mammary, pituitary, and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be mediated by prolonged dopamine D 2 -receptor antagonism and hyperprolactinemia.

Serum prolactin was not measured in the aripiprazole carcinogenicity studies. However, increases in serum prolactin levels were observed in female mice in a week dietary study at the doses associated with mammary gland and pituitary tumors.

Serum prolactin was not increased in female rats in 4-week and week dietary studies at the dose associated with mammary gland tumors.

The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unclear. The mutagenic potential of aripiprazole was tested in the in vitro bacterial reverse-mutation assay, the in vitro bacterial DNA repair assay, the in vitro forward gene mutation assay in mouse lymphoma cells, the in vitro chromosomal aberration assay in Chinese hamster lung CHL cells, the in vivo micronucleus assay in mice, and the unscheduled DNA synthesis assay in rats.

Aripiprazole and a metabolite 2,3-DCPP were clastogenic in the in vitro chromosomal aberration assay in CHL cells with and without metabolic activation.

A positive response was obtained in the in vivo micronucleus assay in mice; however, the response was due to a mechanism not considered relevant to humans.

Estrus cycle irregularities and increased corpora lutea were seen at all doses, but no impairment of fertility was seen. Disturbances in spermatogenesis were seen at 19 times the MRHD and prostate atrophy was seen at 13 and 19 times the MRHD without impairment of fertility.

Evaluation of the retinas of albino mice and of monkeys did not reveal evidence of retinal degeneration. Additional studies to further evaluate the mechanism have not been performed.

The relevance of this finding to human risk is unknown. Efficacy of the oral formulations of Abilify aripiprazole was established in the following adequate and well-controlled trials:.

Efficacy of the injectable formulation of Abilify aripiprazole was established in the following adequate and well-controlled trials:. Four of the five trials were able to distinguish Abilify from placebo, but one study, the smallest, did not.

Three of these studies also included an active control group consisting of either risperidone one trial or haloperidol two trials , but they were not designed to allow for a comparison of Abilify and the active comparators.

In the four positive trials for Abilify, four primary measures were used for assessing psychiatric signs and symptoms.

The PANSS is a item scale that measures positive symptoms of schizophrenia 7 items , negative symptoms of schizophrenia 7 items , and general psychopathology 16 items , each rated on a scale of 1 absent to 7 extreme ; total PANSS scores range from 30 to The Clinical Global Impression CGI assessment reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient.

The 2 and 5 mg doses did not demonstrate superiority to placebo on the primary outcome measure.

Thus, the efficacy of 10, 15, 20, and 30 mg daily doses was established in two studies for each dose. Among these doses, there was no evidence that the higher dose groups offered any advantage over the lowest dose group of these studies.

An examination of population subgroups did not reveal any clear evidence of differential responsiveness on the basis of age, gender, or race.

A longer-term trial enrolled inpatients or outpatients meeting DSM-IV criteria for schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer.

Sie dürfen sich nicht an das Steuer eines Fahrzeugs setzen und keine Werkzeuge oder Maschinen bedienen, bis Sie wissen, wie das Arzneimittel bei Ihnen wirkt.

Wenn Sie schwanger sind oder stillen , oder wenn Sie vermuten, schwanger zu sein oder beabsichtigen, schwanger zu werden, fragen Sie vor der Einnahme dieses Arzneimittels Ihren Arzt um Rat.

Informieren Sie Ihren Arzt umgehend, wenn Sie stillen. Wenn Sie das Arzneimittel einnehmen, sollten Sie nicht stillen. Die empfohlene Dosis für Erwachsene beträgt 15 mg einmal täglich.

Ihr Arzt kann Ihnen jedoch eine niedrigere oder höhere Dosis bis zu maximal 30 mg einmal täglich verschreiben. Es kann mit Aripiprazol in einer niedrigen Dosierung mit der flüssigen Formulierung als Lösung zum Einnehmen begonnen werden.

Die Dosis kann allmählich auf die empfohlene Dosis für Jugendliche von 10 mg einmal täglich gesteigert werden. Auch wenn Sie sich besser fühlen, verändern oder setzen Sie die tägliche Dosis des Arzneimittels nicht ab, ohne Ihren Arzt vorher zu fragen.

Wenn Sie feststellen, dass Sie mehr Tabletten eingenommen haben als von Ihrem Arzt empfohlen oder wenn jemand anders einige Ihrer Tabletten eingenommen hat , kontaktieren Sie umgehend Ihren Arzt.

Wenn Sie eine Dosis vergessen haben, nehmen Sie die vergessene Dosis ein, sobald Sie daran denken, nehmen Sie jedoch nicht an einem Tag die doppelte Dosis ein.

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben , die aber nicht bei jedem auftreten müssen.

Einige Personen können sich schwindelig fühlen, besonders wenn sie aus einer liegenden oder sitzenden Position aufstehen, oder sie können einen beschleunigten Puls feststellen oder doppeltsehen.

Einige Patienten können sich deprimiert fühlen. Veränderungen der Werte bestimmter Blutzellen; ungewöhnlicher Herzschlag, plötzlicher unerklärbarer Tod, Herzanfall; allergische Reaktion z.

Bei älteren Patienten mit Demenz wurden während der Einnahme von Aripiprazol mehr Todesfälle berichtet.

Ihre Ärztin oder Apothekerin informieren. Das Arzneimittel muss bei Raumtemperatur 15? Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.

Quick Links Was ist es und wofür wird es verwendet? Was müssen Sie vor dem Gebrauch beachten? Wie wird es angewendet? Was sind mögliche Nebenwirkungen?

Wie soll es aufbewahrt werden? Weitere Informationen. Autor Bristol-Myers Squibb. Was ist es und wofür wird es verwendet?

Patienten bzw. Patientinnen unter 13 Jahren sollten Abilify nicht einnehmen. Schwangerschaft Abilify soll in der Schwangerschaft nicht eingenommen werden, ausser auf ärztliche Verordnung.

Stillzeit Wenn Sie Abilify einnehmen, sollten Sie nicht stillen. Weitere Informationen Wirkstoff: Tabletten zu 5 mg, 10 mg, 15 mg bzw. Hersteller: Janssen-Cilag.

ATC Code:.

Medikament Abilify Informieren Sie unverzüglich Steve Wynn Casino Arzt, wenn Sie daran denken oder sich danach fühlen, sich etwas anzutun. Schizophrenie Forsaken Symbol Anfangsdosis: Erwachsene Einzeldosis: Tabletten Gesamtdosis: 1-mal täglich Zeitpunkt: unabhängig von den Mahlzeiten. Vielleicht möchten Sie diese später nochmals lesen. Weiterhin sollen bei der neueren Generation - im Gegensatz zu den älteren Medikamenten - die Medikament Abilify Negativsymptome der Schizophrenie wie veränderte Selbstwahrnehmung, Depression und verlangsamte Motorik deutlich verbessert werden. Ist dessen Aktivität erhöht, wirkt Aripiprazol antagonistisch. Der Erfahrungsumfang zur Anwendung von Aripiprazol in Schwangerschaft und Stillzeit ist nicht sehr hoch. Stargames Gewinner älteren Patienten mit Demenz wurden während der Einnahme von Aripiprazol mehr Todesfälle berichtet. Trotz des neuartigen Wirkmechanismus wirkt Aripiprazol bei Schizophrenie nicht besser als bisherige Neuroleptika, und nur wenige Daten aus klinischen Studien sind der öffentlichen Beurteilung zugänglich.

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