Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Table 2). ARISTADA INITIO 7 Days of Oral Aripiprazole a Re-initiate with a Single Dose of ARISTADA INITIO and a Single Dose of Oral Aripiprazole 30 mg OR supplement with 21 Days of Oral Aripiprazole a a The patient should supplement with the same dose of oral aripiprazole as when the patient began ARISTADA (see .
The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Aristada and any potential adverse effects on the breastfed infant from Aristada or from the underlying maternal condition.Safety and effectiveness of Aristada in patients <18 years of age have not been evaluated.Safety and effectiveness of Aristada in patients >65 years of age have not been evaluated.Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that is known to respond to antipsychotic drugs. Select one or more newsletters to continue. Why Are Dementia Patients Getting Risky Psychiatric Drugs? Following intramuscular injection, aripiprazole lauroxil is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. However, epidemiological studies suggest an increased risk of hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics.Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Store all materials at room temperature.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.Aristada, like other antipsychotics, has the potential to impair judgment, thinking or motor skills. In conjunction with the first ARISTADA injection, administer a single injection of ARISTADA INITIO and one dose of oral aripiprazole 30 mg, or continue treatment with oral aripiprazole for 21 consecutive days [see Recommended Dosage]. The intramuscular (IM) injections were administered on Days 1, 29 and 57.Efficacy was assessed using Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression Improvement Scale (CGI-I):Eligible patients were 18 to 70 years of age with PANSS total score of 70 to 120 and a score of ≥4 for at least 2 of the selected Positive Scale items. Injection-Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection-site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA. The mechanism of action of aripiprazole in schizophrenia is unknown. All materials should be stored at room temperature.A | 5 mL syringe containing ARISTADA sterile aqueous extended-release injectable suspensionC | 20 gauge needle, 1½-inch with yellow needle hubAlways consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
Aristada and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.The following are discussed in more details in other sections of the labeling: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.Aristada has been evaluated for safety in 1180 adult patients in clinical trials in schizophrenia.The most common adverse reaction (incidence ≥5% and at least twice the rate of placebo in patients treated with Aristada) was akathisia.Adverse reactions associated with the use of Aristada (incidence of 2% or greater, rounded to the nearest percent and Aristada incidence greater than placebo) that occurred are shown in In an open label pharmacokinetic study, the adverse reactions associated with the use of 441 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months were similar across the dose groups.Injection site reactions were reported by 4% of patients treated with 441 mg Aristada and 5% of patients treated with 882 mg Aristada compared to 2% of patients treated with placebo.