ABILIFY Injection: Acute Treatment for Agitation in Schizophrenia and Bipolar Disorder

ABILIFY Injection is an intramuscular formulation of aripiprazole indicated for the short-term management of acute agitation in adults with schizophrenia or bipolar I disorder, manic or mixed episodes. It is used to rapidly control psychomotor agitation, a condition characterized by excessive motor activity linked to inner tension that interferes with diagnosis and care.

ABILIFY Injection is approved for:

• The acute treatment of agitation associated with schizophrenia or bipolar I disorder (manic or mixed episodes) in adults.

The injectable form is specifically intended for intramuscular use to provide rapid control of agitation when immediate symptom management is required.

Acetaminophen

ABILIFY Injection works as an atypical antipsychotic by modulating dopamine and serotonin receptor activity. This action helps to regulate neurotransmitter imbalances in the brain associated with schizophrenia and bipolar disorder, reducing symptoms like agitation and psychomotor hyperactivity.

Adults (acute agitation):

• Recommended dose: 9.75 mg (1.3 mL) intramuscularly
• Doses between 5.25 mg to 15 mg have been studied, with 9.75 mg generally effective; 5.25 mg may be used when clinically warranted.
• If agitation persists after the initial dose, additional intramuscular doses may be given with at least 2 hours between injections, up to a maximum of 30 mg per day.
• Do not administer intravenously or subcutaneously; inject deeply and slowly into muscle.
• After stabilization with injection, switch to oral aripiprazole 10–30 mg/day as soon as clinically appropriate.

Administration instructions:

• Draw the required volume of solution per dosing table; discard any unused portion.
• Inspect solution for particles or discoloration before administration.

Adjustments: Dosage adjustments based on age, gender, race, renal or hepatic impairment are not routinely required.

Drug interaction dose adjustments:

• Reduce dose by half when given with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) or CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine).
• Increase dose when given with CYP3A4 inducers (e.g., carbamazepine).

Increased mortality in elderly patients with dementia-related psychosis: Elderly patients with dementia-related psychosis treated with antipsychotics, including aripiprazole, are at increased risk of death, mostly due to cardiovascular or infectious causes. ABILIFY Injection is not approved for this population.

Suicidality risk with antidepressants in youth: Antidepressants increase suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. Close monitoring is required when using adjunctive therapies with aripiprazole in these populations.

Concomitant use of certain drugs requires dose adjustment of aripiprazole:

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): reduce aripiprazole dose by 50%; restore dose after inhibitor withdrawal.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): reduce aripiprazole dose by at least 50%; restore dose after inhibitor withdrawal.
• CYP3A4 inducers (e.g., carbamazepine): increase aripiprazole dose; reduce dose when inducer withdrawn.