What are the precautions and guidelines for using Vraylar (cariprazine) with hydroxyzine in patients with schizophrenia or bipolar disorder and anxiety?

From the Guidelines

When using Vraylar (cariprazine) with hydroxyzine in patients with schizophrenia or bipolar disorder who also have anxiety, careful monitoring is essential due to potential additive central nervous system effects. These medications can generally be used together, but clinicians should start with lower doses of both medications and gradually titrate upward while monitoring for side effects. For Vraylar, the typical starting dose is 1.5 mg once daily, which can be increased to 3-6 mg daily for schizophrenia or 1.5-3 mg daily for bipolar disorder 1. Hydroxyzine is typically started at 25-50 mg three to four times daily for anxiety. Patients should be monitored for excessive sedation, dizziness, and orthostatic hypotension, particularly during the initial combination period. Both medications can prolong the QT interval, so baseline and follow-up ECG monitoring is recommended, especially in patients with cardiac risk factors 1. Patients should avoid alcohol and other CNS depressants while on this combination. The rationale for this approach is that both medications affect neurotransmitter systems in the brain, with Vraylar primarily affecting dopamine and serotonin receptors while hydroxyzine works through histamine receptor antagonism. This combination addresses both the primary psychiatric disorder and comorbid anxiety, but the overlapping side effect profiles require careful management.

Some key considerations when using this combination include:

• Monitoring for signs of serotonin syndrome, a potentially life-threatening condition caused by elevated brain serotonin levels, especially when combining serotonergic medications 1
• Assessing compliance with pharmacologic treatment and patient concerns about adverse effects on a regular basis, such as monthly 1
• Considering tapering the patient from medications prescribed for anxiety if symptoms are under control and the primary environmental sources of anxiety are no longer present 1
• Being cautious when combining two or more non-MAOI serotonergic drugs, including antidepressants, opioids, and other medications that may increase the risk of serotonin syndrome 1

Overall, the use of Vraylar with hydroxyzine in patients with schizophrenia or bipolar disorder and anxiety requires careful consideration of the potential benefits and risks, as well as close monitoring for side effects and adverse reactions.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Precautions and Guidelines for Using Vraylar (Cariprazine) with Hydroxyzine

• The use of Vraylar (cariprazine) with hydroxyzine in patients with schizophrenia or bipolar disorder and anxiety requires careful consideration of the potential interactions and side effects 2, 3.
• Cariprazine is a dopamine D3 receptor-preferring D3/D2 partial agonist antipsychotic that is approved for the treatment of schizophrenia and manic and depressive episodes associated with bipolar I disorder 4, 5.
• Hydroxyzine is an antihistamine that can be used to treat anxiety and insomnia, but it can also cause sedation and interact with other medications 6.
• When using cariprazine with hydroxyzine, patients should be monitored for increased sedation, drowsiness, and other adverse effects such as extrapyramidal symptoms, akathisia, and nausea 3, 5.
• The dosage of cariprazine should be adjusted based on the patient's response and tolerance, and the concomitant use of hydroxyzine should be taken into account when determining the optimal dose 2, 4.

Potential Interactions and Side Effects

• The concomitant use of cariprazine and hydroxyzine can increase the risk of sedation, drowsiness, and other adverse effects such as dry mouth, constipation, and urinary retention 3, 6.
• Cariprazine can also cause changes in metabolic parameters, such as increases in fasting glucose levels, which should be monitored in patients taking hydroxyzine 5.
• Hydroxyzine can interact with other medications, including antipsychotics like cariprazine, and increase the risk of adverse effects such as QT interval prolongation and cardiac arrhythmias 6.

Clinical Trials and Studies

• Clinical trials have demonstrated the efficacy and safety of cariprazine in patients with schizophrenia and bipolar disorder, but the use of hydroxyzine in these studies was not specifically evaluated 2, 4, 5.
• Post hoc investigations have supported the efficacy of cariprazine across individual symptoms and domains in schizophrenia, as well as in diverse areas of interest including cognition, functioning, negative symptoms, hostility, and global well-being 6.
• Further studies are needed to evaluate the safety and efficacy of using cariprazine with hydroxyzine in patients with schizophrenia or bipolar disorder and anxiety 3, 5.