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Vraylar Dosage

Generic name: CARIPRAZINE 1.5mg
Dosage form: capsule, gelatin coated
Drug class: Atypical antipsychotics

Medically reviewed by Drugs.com. Last updated on Nov 22, 2024.

2.1 General Dosing Information

VRAYLAR is given orally once daily and can be taken with or without food.

Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Prescribers should monitor patients for adverse reactions and treatment response for several weeks after starting VRAYLAR and after each dosage change.

2.2 Recommended Dosage in Schizophrenia

The starting dosage of VRAYLAR is 1.5 mg orally once daily. The recommended dosage range is 1.5 mg to 6 mg orally once daily. The dosage can be increased to 3 mg on Day 2. Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments. The maximum recommended dosage is 6 mg orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

2.3 Recommended Dosage in Manic or Mixed Episodes Associated with Bipolar I Disorder

The starting dosage of VRAYLAR is 1.5 mg orally once daily. Increase the dosage to 3 mg orally once daily on Day 2. The recommended dosage range is 3 mg to 6 mg orally once daily. Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments. The maximum recommended dosage is 6 mg orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

2.4 Recommended Dosage in Depressive Episodes Associated with Bipolar I Disorder (Bipolar Depression)

The starting dosage of VRAYLAR is 1.5 mg orally once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg orally once daily on Day 15. Maximum recommended dosage is 3 mg orally once daily.

2.5 Recommended Dosage for Adjunctive Therapy to Antidepressants for the Treatment of Major Depressive Disorder

The starting dosage of VRAYLAR is 1.5 mg orally once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg orally once daily on Day 15. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. Maximum recommended dosage is 3 mg orally once daily.

2.6 Dosage Modifications for CYP3A4 Inhibitors and Inducers

Initiating VRAYLAR While Taking a Strong or Moderate CYP3A4 Inhibitor

Dosage modifications for the starting dosage of VRAYLAR in patients taking a strong or moderate CYP3A4 inhibitor are presented in Table 1:

Table 1: Dosage Modifications for the Starting Dosage of VRAYLAR in Patients Taking a Strong or Moderate CYP3A4 Inhibitor

VRAYLAR Starting Dosage
When Taking a Strong
CYP3A4 Inhibitor
When Taking a Moderate CYP3A4 Inhibitor
Schizophrenia Start at 1.5 mg orally every 3 days; increase to 1.5 mg orally every other day, if needed* Start at 1.5 mg orally every other day; increase to 1.5 mg orally daily, if needed*
Bipolar Mania
Bipolar Depression
1.5 mg orally every 3 days 1.5 mg orally every other day
Adjunctive therapy for treatment of MDD

*Depending upon clinical response and tolerability.

Initiating a Strong or Moderate CYP3A4 Inhibitor While Taking a Stable Dosage of VRAYLAR

Dosage recommendations for patients initiating a strong or moderate CYP3A4 inhibitor while on a stable dose of VRAYLAR (see Table 2):e:

Table 2: Dosage Modifications for VRAYLAR When Initiating a Strong or Moderate CYP3A4 Inhibitor and While Taking a Stable Dose of VRAYLAR

Currently on VRAYLAR Dosage VRAYLAR Dosage When Initiating a Strong CYP3A4 Inhibitor VRAYLAR Dosage When Initiating a Moderate CYP3A4 Inhibitor
1.5 or 3 mg once daily 1.5 mg orally every 3 days 1.5 mg orally every other day
4.5 or 6 mg once daily 1.5 mg orally every other day 1.5 mg orally once daily

When the strong or moderate CYP3A4 inhibitor is discontinued, the VRAYLAR dosage may need to be increased based on clinical response and tolerability.

Dosage Modifications for Patients Concomitantly Taking VRAYLAR with CYP3A4 Inducers

Concomitant use of VRAYLAR and a CYP3A4 inducer has not been evaluated and is not recommended.

2.7 Treatment Discontinuation

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. There are no systematically collected data to specifically address switching patients from VRAYLAR to other antipsychotics or concerning concomitant administration with other antipsychotics.

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