The change from baseline for each VRAYLAR dose group was compared to placebo. In all three trials, Vraylar was superior to placebo.Young Mania Rating Scale (YMRS) and Clinical Global Impressions-Severity scale (CGI-S) were used as the primary and secondary efficacy measures, respectively, for assessing psychiatric signs and symptoms in each trial:In each study, the primary endpoint was decrease from baseline in YMRS total score at the end of week 3. Vraylar is not approved for the treatment of patients with dementia-related psychosis Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs. Grapefruit can decrease how quickly the body breaks down sildenafil (Viagra). Vraylar has not been evaluated in patients with a recent history of myocardial infarction or unstable cardiovascular disease. 13 years: Safety and efficacy not established >13 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals ≥24 hr to recommended dosage of 3 mg/day; dosage range: 1-6 mg/day (dosages >3 mg/day have not been proved more effective and are associated with increased incidence of adverse effects) Therefore, the maximum recommended dose is 6 mg/day.Examination of population subgroups based on age (there were few patients over 55), sex, and race did not suggest any clear evidence of differential responsiveness.The safety and efficacy of VRAYLAR as maintenance treatment in adults with schizophrenia were demonstrated in a randomized withdrawal trial that included 200 patients meeting DSM-IV criteria for schizophrenia who were clinically stable following 20 weeks of open-label cariprazine at doses of 3 to 9 mg/day. Consult your doctor before breast-feeding.Drug interactions may change how your medications work or increase your risk for serious side effects. (Source: youtube.com) When the CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased [see Concomitant use of VRAYLAR and a CYP3A4 inducer has not been evaluated and is not recommended because the net effect on active drug and metabolites is unclear [see Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms; the plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week [see VRAYLAR (cariprazine) capsules are available in four strengths.Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. The effect that symptomatic suppression has upon the long-term course of tardive dyskinesia is unknown.In six, placebo-controlled trials up to 8-weeks of adult patients with bipolar disorder (mania or depression), the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) and borderline (≥100 and <126 mg/dL) to high were similar in patients treated with Vraylar and placebo. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.Read the Medication Guide provided by your pharmacist before you start taking cariprazine and each time you get a refill. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.Studies have shown that a small number of people (especially people younger than 25) who take antidepressants may have an increased risk of suicidal thoughts or behaviors. These events led to discontinuation in 0.3% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. Cariprazine had no effect on fetal survival. Tell your doctor if you are pregnant, trying to conceive, or are breast feeding as Vraylar may be harmful to your newborn or nursing baby. The change from baseline for Vraylar and active control groups was compared to placebo. Syncope was not observed.Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and patients with cerebrovascular disease. Limit alcoholic beverages. The starting dose of VRAYLAR is 1.5 mg.