Medikament Abilify


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Medikament Abilify

ABILIFY Tabl 10 mg (Aripiprazol) bei denen die Süchte abnahmen oder aufhörten, nachdem die Dosis reduziert oder das Medikament abgesetzt wurde. Aripiprazol (Abilify®) ist ein neues atypisches Antipsychotikum zur Therapie der Schizophrenie bei Erwachsenen. Es ähnelt in seiner Struktur den atypischen. Abilify gehört zu den „Blockbuster-Medikamenten“ (Umsatz über 7 Mrd. Dollar). Inhaltsverzeichnis. 1 Pharmakodynamische und pharmakokinetische.

Medikament Abilify Navigationsmenü

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 5 mg Tabletten ist ein rezeptpflichtiges Medikament. Bewertung bei Medikamente im Test für 'Schizophrenien und andere Psychosen'. 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.

Medikament Abilify Abilify Dosage and Administration Video

Kennen Sie die 10 häufigsten Nebenwirkungen? Diese 10 Medikamente machen am häufigsten Probleme! ❗ Medikament Abilify Dieser Artikel behandelt ein Gesundheitsthema. Nehmen Sie die Tablette immer mit Wasser ein und schlucken Sie sie unzerkaut. Beenden Criss Cross App Ihre Behandlung nicht, nur weil Sie sich besser fühlen. Schizophrenie: Ziprasidon — neue Alternative für Akutmanagement und Lan. Siehe Abschnitt 4. N05 AX Jetzt online lesen. Informieren Sie unverzüglich Ihren Arzt, wenn Sie daran denken oder Wurttembergische Rechtsschutz Impressum danach fühlen, sich selbst zu verletzen.

Abilify, können unkontrollierte Bewegungen, Fieber , Muskelsteifheit, beschleunigte Atmung, Schweissausbrüche, beeinträchtigtes Wahrnehmungsvermögen, plötzliche Veränderungen des Blutdrucks und der Herzfrequenz oder Schwindel besonders beim Aufstehen aus einer liegenden oder sitzenden Position bewirken.

Falls Sie diese Nebenwirkungen an sich beobachten, kontaktieren Sie bitte unverzüglich Ihren Arzt bzw.

Ihre Ärztin. Informieren Sie unverzüglich Ihren Arzt bzw. Ihre Ärztin, wenn Sie daran denken oder sich danach fühlen, sich etwas anzutun.

Über Suizidgedanken und entsprechendes Verhalten wurde während der Behandlung mit Aripiprazol berichtet.

Vom gleichzeitigen Alkoholkonsum mit Abilify wird abgeraten, da die kombinierte Wirkung von Alkohol und Abilify zu Benommenheit führen kann.

Arzneimittel gegen hohen Blutdruck Antihypertonika : Abilify kann die Wirkung von Antihypertonika verstärken. Ihre Ärztin, wenn Sie ein solches Arzneimittel anwenden.

Abilify könnte, wie andere Antipsychotika auch, Auswirkungen auf die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Maschinen oder Werkzeuge zu bedienen, haben.

Daher sollten Sie keine Fahrzeuge lenken oder gefährliche Maschinen bedienen, bis Sie sicher sind, dass das Arzneimittel bei Ihnen diesbezüglich keine nachteiligen Effekte bewirkt.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere Arzneimittel auch selbstgekaufte!

Während der Behandlung mit Abilify sollen andere Arzneimittel nur mit dem Einverständnis des Arztes bzw. Abilify soll in der Schwangerschaft nicht eingenommen werden, ausser auf ärztliche Verordnung.

Bei gesicherter oder vermuteter Schwangerschaft oder wenn Sie eine Schwangerschaft planen, bitte unverzüglich den Arzt bzw.

Wenn Sie Abilify einnehmen, sollten Sie nicht stillen. Bitte informieren Sie unverzüglich Ihren Arzt bzw.

Ihre Ärztin, wenn Sie bereits stillen. 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.

Bitte informieren Sie Ihren Arzt, wenn Sie an Gewicht zunehmen , wenn Sie ungewöhnliche Bewegungen entwickeln, wenn Sie eine Schläfrigkeit verspüren, die sich auf die normalen täglichen Aktivitäten auswirkt, wenn Sie bemerken, dass Ihnen das Schlucken Schwierigkeiten bereitet, oder wenn Sie allergische Symptome haben.

Informieren Sie unverzüglich Ihren Arzt , wenn Sie daran denken oder sich danach fühlen, sich etwas anzutun. Selbsttötungsgedanken und entsprechendes Verhalten wurden während der Behandlung mit Aripiprazol berichtet.

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.

Medikament Abilify - Einer von 100 ist betroffen

Mit diesem Begriff wird zum Ausdruck gebracht, dass Denkinhalte nicht zu den Emotionen passen so genannte Parathymie : Der Schizophrene trägt zum Beispiel grausige Geschichten mit einem Lächeln vor oder weint bei fröhlichen Ereignissen. Vielleicht möchten Sie diese später nochmals lesen. Wann wird Aripiprazol eingesetzt? Extrapyramidale Nebenwirkungen treten vergleichbar häufig auf wie unter einer Behandlung mit Olanzapin und seltener als unter einer Therapie mit Haloperidol 27 versus 58 Prozent der Patienten.

Medikament Abilify - Service-Funktionen

Gegenanzeigen: Aripiprazol ist kontraindiziert bei Patienten mit Überempfindlichkeit gegen Aripiprazol oder einen der sonstigen Bestandteile. Wechselwirkungen Wenden Sie mehrere Arzneimittel gleichzeitig an, kann es zu Wechselwirkungen zwischen diesen kommen. 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 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 Top 100 Spiele Apps fasting glucose measurements compared to placebo-treated patients median exposure 22 days. Because Abilify may have the potential to impair Casino Slots Jackpot Party, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Abilify therapy does not affect them adversely [see Warnings and Precautions 5. In the major depressive disorder trials, the Simpson Angus Rating Scale and the Handball Wm Tabelle 2017 Akathisia Scale showed a significant difference between adjunctive Abilify and adjunctive placebo Abilify, 0. Close medical supervision and monitoring should continue until the patient recovers. Patients should be advised that each mL of Abilify Oral Solution contains mg of sucrose and mg Bowling Free Online fructose. Abilify Medikament Abilify is available in single-dose vials as a ready-to-use, 9. Otsuka Pharmaceutical Co. The Slots Casino For Pc form oral solution of this medication may contain up to 15 grams of sugar per dose. Medikament Abilify

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. Tablet disintegration occurs rapidly in saliva.

However, if needed, it can be taken with liquid. Do not attempt to split the tablet. Because Abilify may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Abilify therapy does not affect them adversely [see Warnings and Precautions 5.

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions 7 ].

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions 5.

Patients should be advised that each mL of Abilify Oral Solution contains mg of sucrose and mg of fructose. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Abilify.

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to Abilify during pregnancy [see Use in Specific Populations 8.

Phenylalanine is a component of aspartame. Bristol-Myers Squibb. Single-use container. Sterile, Ready-to-Use Solution.

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Skip to Content. Antihypertensive Drugs Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.

Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions 5. Benzodiazepines e. The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone [see Warnings and Precautions 5.

Monitor sedation and blood pressure. Adjust dose accordingly. Agitation Associated with Schizophrenia Study 1 Abilify 1 mg For other side effects, also see " What are the possible side effects of Abilify?

Abilify is not approved for the treatment of patients with dementia-related psychosis. Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.

These include people who have or have a family history of bipolar illness also called manic-depressive illness or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping insomnia new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking mania other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it.

Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes.

Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

What is Abilify? Abilify Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are prescription medicines used to treat: schizophrenia manic or mixed episodes that happen with bipolar I disorder major depressive disorder MDD when Abilify is used with antidepressant medicines irritability associated with autistic disorder Tourette's disorder Abilify Injection is a prescription medicine used to treat: agitation associated with schizophrenia or bipolar mania It is not known if Abilify is safe or effective in children: under 13 years of age with schizophrenia under 10 years of age with bipolar I disorder under 6 years of age with irritability associated with autistic disorder under 6 years of age with Tourette's disorder Do not take Abilify if you are allergic to aripiprazole or any of the ingredients in Abilify.

See the end of this Medication Guide for a complete list of ingredients in Abilify. Before taking Abilify, tell your healthcare provider about all your medical conditions, including if you have or had: diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start Abilify and also during therapy.

It is not known if Abilify will harm your unborn baby. If you become pregnant while receiving Abilify, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.

Abilify passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive Abilify. Tell your healthcare provider about all the medicines that you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Abilify and other medicines may affect each other causing possible serious side effects. Abilify may affect the way other medicines work, and other medicines may affect how Abilify works.

Your healthcare provider can tell you if it is safe to take Abilify with your other medicines. Do not start or stop any medicines while taking Abilify without talking to your healthcare provider first.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. How should I take Abilify?

Take Abilify exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking Abilify yourself.

Abilify can be taken with or without food. Abilify tablets should be swallowed whole. If you miss a dose of Abilify, take the missed dose as soon as you remember.

If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of Abilify at the same time.

If you take too much Abilify, call your healthcare provider or poison control center at right away, or go to the nearest hospital emergency room.

What should I avoid while taking Abilify? Do not drive, operate heavy machinery, or do other dangerous activities until you know how Abilify affects you.

Abilify may make you drowsy. Avoid getting over-heated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible.

Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water. What are the possible side effects of Abilify?

Abilify may cause serious side effects, including: See " What is the most important information I should know about Abilify?

Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure.

These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.

Uncontrolled body movements tardive dyskinesia. Abilify may cause movements that you cannot control in your face, tongue, or other body parts.

Tardive dyskinesia may not go away, even if you stop receiving Abilify. Tardive dyskinesia may also start after you stop receiving Abilify.

Problems with your metabolism such as: High blood sugar hyperglycemia and diabetes. Increases in blood sugar can happen in some people who take Abilify.

Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight or a family history of diabetes , your healthcare provider should check your blood sugar before you start Abilify and during your treatment.

Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving Abilify: feel very thirsty need to urinate more than usual feel very hungry feel weak or tired feel sick to your stomach feel confused, or your breath smells fruity Increased fat levels cholesterol and triglycerides in your blood.

Weight gain. You and your healthcare provider should check your weight regularly. Unusual urges. Some people taking Abilify have had unusual urges, such as gambling, binge eating or eating that you cannot control compulsive , compulsive shopping and sexual urges.

If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider. Orthostatic hypotension decreased blood pressure.

Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position. Abilify may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Low white blood cell count Seizures convulsions Problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot.

It is important for you to drink water to avoid dehydration. See " What should I avoid while receiving Abilify?

Call your doctor for medical advice about side effects. How should I store Abilify? Keep Abilify and all medicines out of the reach of children.

General information about the safe and effective use of Abilify Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Abilify for a condition for which it was not prescribed. Do not give Abilify to other people, even if they have the same symptoms you have.

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. Dies gilt auch für Nebenwirkungen, die nicht angegeben sind.

Wenn mehrere Arzneimittel gleichzeitig angewendet werden , kann es zu Wechselwirkungen kommen. Wirkungen und Nebenwirkungen der Arzneimittel können dadurch verändert werden.

Ob eine Wechselwirkung auftritt, hängt von verschiedenen Faktoren ab. Es sind Wechselwirkungen zwischen "Abilify 5mg" und anderen Arzneimitteln bekannt.

Wenn Sie noch andere Arzneimittel anwenden, fragen Sie Ihren Apotheker, um zu klären, ob es eventuell zu Wechselwirkungen mit "Abilify 5mg" kommen kann.

Psychopharmaka Nebenwirkungen und Beipackzettel. Home Medikamente Krankheiten Suche Sitemap. Suchen Suchen. Anwendungsgebiete von Abilify 5mg Das Arzneimittel enthält den Wirkstoff Aripiprazol und gehört zu einer Gruppe von Arzneimitteln, die Antipsychotika genannt werden.

Anwendungsbeschränkungen und Warnungen Absolute Gegenanzeigen von Abilify 5mg Das Arzneimittel darf nicht eingenommen werden, wenn Sie allergisch gegen Aripiprazol oder einen der sonstigen Bestandteile dieses Arzneimittels sind.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen 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.

Schwangerschaftshinweis 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.

Anwendung bei Kindern und Jugendlichen Es kann mit Aripiprazol in einer niedrigen Dosierung mit der flüssigen Formulierung als Lösung zum Einnehmen begonnen werden.

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

Gelegentliche Nebenwirkungen kann bis zu 1 von Patienten betreffen : 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.

Die folgenden Nebenwirkungen wurden seit der Markteinführung des Arzneimittels berichtet, aber die Häufigkeit, mit der diese auftreten, ist nicht bekannt die Häufigkeit kann aus den vorhandenen Daten nicht kalkuliert werden : Veränderungen der Werte bestimmter Blutzellen; ungewöhnlicher Herzschlag, plötzlicher unerklärbarer Tod, Herzanfall; allergische Reaktion z.

Wechselwirkungen Wenn mehrere Arzneimittel gleichzeitig angewendet werden , kann es zu Wechselwirkungen kommen.

Mehr Psychopharmaka Beipackzettel. Haldol Beipackzettel und Nebenwirkungen Beipackzettel. Anwendungsgebiete von Haloperidol….

Efavirenz, Nevirapin, Protease-Inhibitoren, wie z. Als Grund für diesen geschlechtsspezifischen Unterschied gilt eine die Erkrankung eindämmende Wirkung des weiblichen Hormons Estrogen. N05 AX Dadurch wirkt Aripiprazol agonistisch, wenn der natürliche Botenstoff Dopamin fehlt. Tipps für den Alltag. Soweit möglich und Gibt Es 10 Euro Paysafecard, werden SI-Einheiten verwendet.

Medikament Abilify Inhaltsverzeichnis

Manche Medikamente verstärken die Aripiprazol-Wirkung. Bei therapeutischen Konzentrationen wird Aripiprazol Wieviel Karten Bei Romme Dehydro-Aripiprazol zu über 99 Prozent an Plasmaproteine gebunden. Informieren Sie unverzüglich Ihren Arzt, wenn Sie daran denken oder sich danach fühlen, sich selbst zu verletzen. Zum Nebenwirkungs-Check. Letzte Aktualisierung: Einfach Postleitzahl oder Ort Hartz Iv Geld und fündig werden! Kardiologie News in der Kardiologie sowie Angiologie und Phlebologie. Aripiprazol Otsuka Pharma PZN:,,

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1 Comments

  1. Daitaur

    Geben Sie wir werden reden, mir ist, was, in dieser Frage zu sagen.

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