Some side effects, such as tardive dyskinesia, can cause permanent injury even after a person stops taking the drug. This warning applies to antidepressants in general.The label advises patients to monitor for the emergence or worsening of suicidal thoughts and behaviors. provider for the most current information.The recipient will receive more details and instructions to access this offer.By clicking send, you acknowledge that you have permission to email the recipient with this information.The recipient will receive more details and instructions to access this offer.By clicking send, you acknowledge that you have permission to email the recipient with this information. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including Abilify) during the third trimester of pregnancy. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)] 5.

The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. 2001
Patients <50 kg in the low dose Abilify group started at 2 mg per day with a target dose of 5 mg per day after 2 days. 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 Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. The Kaplan-Meier curves of the time from randomization to relapse to any mood event during the 52-week, double-blind treatment phase for Abilify and placebo groups are shown in Figure 8.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.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). It might be people starting to spend $300 a week on lottery tickets, and in other cases people will gamble away tens of thousands of dollars.”Hypersexual activity is another compulsive behavior associated with Abilify. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.

Both doses of Abilify were superior to placebo in the PANSS total score (Study 6 in Table 26), the primary outcome measure of the study. Abilify has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalyzed by CYP3A4. Data sources include IBM Watson Micromedex (updated 2 Sep 2020), Cerner Multum™ (updated 1 Sep 2020), … Prior results do not predict a similar outcome. At steady-state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.Effects of other drugs on the exposures of aripiprazole and dehydro-aripiprazole are summarized in Figure 1 and Figure 2, respectively. A retrospective study from a Medicaid database of 9258 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.In pregnant rats treated orally with aripiprazole during organogenesis at doses of 3, 10, and 30 mg/kg/day, which are approximately 1, 3 and 10 times the MRHD of 30 mg/day based on mg/mIn pregnant rats injected intravenously with aripiprazole during organogenesis at doses of 3, 9, and 27 mg/kg/day, which are 1, 3, and 9 times the MRHD of 30 mg/day based on mg/mIn pregnant rabbits treated orally with aripiprazole during organogenesis at doses of 10, 30, and 100 mg/kg/day which are 6, 19, and 65 times the MRHD of 30 mg/day based on mg/mIn pregnant rabbits injected intravenously with aripiprazole during organogenesis at doses of 3, 10, and 30 mg/kg/day, which are 2, 6, and 19 times the MRHD of 30 mg/day based on mg/mIn rats treated orally with aripiprazole peri- and post-natally from gestation Day 17 through postpartum Day 21 at doses of 3, 10, and 30 mg/kg/day which are 1, 3, and 10 times the MRHD of 30 mg/day based on mg/mIn rats injected intravenously with aripiprazole from gestation Day 6 through lactation Day 20 at doses of 3, 8, and 20 mg/kg/day, which are 1, 3, and 6 times the MRHD of 30 mg/day based on mg/mLimited data from published literature report the presence of aripiprazole in human breast milk, at relative infant doses ranging between 0.7% to 8.3% of the maternal weight-adjusted dosage. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.