ABILIRAZOLE 15/MG TAB 30/TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder (acute manic/mixed episodes and maintenance); Adjunctive treatment of major depressive disorder (adults); Irritability associated with autistic disorder (pediatric); Tourette’s disorder (pediatric).

Off-Label Uses

Common off-label uses include augmentation in OCD, PTSD, and anxiety disorders; behavioral symptoms/agitation in dementia (not recommended routinely due to boxed warning and risk); borderline personality disorder symptoms; substance-related disorders in select cases.

Dosage & Administration

Dosing by Condition

Adults-Schizophrenia: 10-15 mg PO once daily (target 15 mg), max 30 mg/day. Bipolar I (acute mania/mixed): 15 mg once daily (mono- or adjunct), may increase, max 30 mg/day. Adjunct MDD: start 2-5 mg once daily, target 5-10 mg/day, max 15 mg/day. Pediatrics-Schizophrenia (13-17): start 2 mg/day, titrate to 10 mg/day (target), max 30 mg/day. Bipolar I mania (10-17): start 2 mg/day, titrate to 10 mg/day, max 30 mg/day. Autism irritability (6-17): start 2 mg/day, usual 5-15 mg/day, max 15 mg/day. Tourette’s (6-18): weight-based; typical target 5 mg/day (<50 kg) or 10 mg/day (≥50 kg), max 10 mg/day (<50 kg) or 20 mg/day (≥50 kg).

Initial Dose

10-15mg once daily for schizophrenia and bipolar mania in adults

Maintenance Dose

15mg once daily (range 10-30mg/day depending on indication and response)

Maximum Dose

30 mg per day.

Children's Dosage

Schizophrenia (13-17 years): 10mg/day target, max 30mg/day. Bipolar I mania (10-17 years): 10mg/day target, max 30mg/day. Autism irritability (6-17 years): 5-15mg/day, max 15mg/day. Tourette's disorder (6-18 years): <50kg: 2mg/day initial, target 5mg/day, max 10mg/day; ≥50kg: 2mg/day initial, target 10mg/day, max 20mg/day.

Dose Adjustment Notes

Reduce aripiprazole dose by 50% with strong CYP2D6 inhibitors or strong CYP3A4 inhibitors; if both strong CYP2D6 and CYP3A4 inhibitors are used, reduce to 25% of usual dose. For strong CYP3A4 inducers, generally double the dose (do not exceed recommended max) and reduce back when the inducer is stopped. CYP2D6 poor metabolizers: use ~50% of usual dose; if also on a strong CYP3A4 inhibitor, use ~25%.

How to Take

Swallow the 15 mg tablet whole with water; may be taken with or without food; take once daily at the same time each day. Do not crush/chew unless specifically instructed (this product is a standard tablet, not an ODT).

Side Effects

Common Side Effects

Akathisia/restlessness, insomnia or somnolence, anxiety, headache, nausea/vomiting, constipation, dizziness, fatigue; weight gain can occur (generally less than some other SGAs).

Side Effect Frequency

Common (≥1% to <10%): akathisia, headache, insomnia, anxiety, nausea, vomiting, constipation, dizziness/lightheadedness, somnolence/sedation, fatigue, tremor, blurred vision; frequency of some effects varies by indication and age group (e.g., akathisia can be very common in some adult trials).

Safety & Warnings

Contraindications

Contraindication: known hypersensitivity to aripiprazole or any component of the formulation.

Warnings & Precautions

Key warnings/precautions: boxed warnings (dementia-related psychosis mortality; suicidality in young people with antidepressant-treated conditions), NMS, tardive dyskinesia, metabolic monitoring (glucose/lipids/weight), orthostatic hypotension/falls (caution with cardiovascular/cerebrovascular disease and dehydration), seizures (caution with seizure history), leukopenia/neutropenia (CBC if risk factors), dysphagia/aspiration risk, and monitor for impulse-control disorders and akathisia.

Age Restriction

Indication-specific pediatric use; generally not for children <6 years. Approved from age 6 years for irritability associated with autistic disorder; from age 10 years for bipolar I mania; from age 13 years for schizophrenia (and Tourette’s disorder is also approved from age 6 years in some jurisdictions).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: strong CYP3A4 inducers (e.g., carbamazepine, rifampin) ↓ aripiprazole exposure; strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) and strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) ↑ exposure-dose adjustment is typically required; additive CNS depression/orthostatic hypotension with alcohol, benzodiazepines/opioids and antihypertensives; lithium/valproate generally do not require dose adjustment but monitor clinically.

Interaction Severity

MAJOR: Strong CYP3A4 inducers (e.g., carbamazepine, rifampin) ↓ levels-dose increase usually required; strong CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine) and strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) ↑ levels-dose reduction required. MODERATE: Additive CNS depression/impairment with alcohol, benzodiazepines, opioids; additive hypotension with antihypertensives. OTHER/CAUTION: Dopamine agonists/antagonists may counteract effects; QT risk is generally low but consider additive risk with other QT-prolonging drugs in susceptible patients.

Food Interaction

No clinically meaningful food effect; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Schizophrenia (13-17 years): 10mg/day target, max 30mg/day. Bipolar I mania (10-17 years): 10mg/day target, max 30mg/day. Autism irritability (6-17 years): 5-15mg/day, max 15mg/day. Tourette's disorder (6-18 years): <50kg: 2mg/day initial, target 5mg/day, max 10mg/day; ≥50kg: 2mg/day initial, target 10mg/day, max 20mg/day.

Elderly

No specific dose adjustment required; however, start at lower end of dosing range, monitor for orthostatic hypotension and sedation. Not approved for dementia-related psychosis in elderly patients.

Kidney Impairment

No adjustment needed

Liver Impairment

No dosage adjustment needed for mild-to-severe hepatic impairment (including severe); use clinical caution and monitor tolerability.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular schedule. Do not double the dose.

Stopping the Medicine

Do not stop abruptly - taper gradually under medical supervision to avoid withdrawal symptoms and relapse of psychiatric condition

Overdose

Symptoms may include somnolence, vomiting/nausea, tremor, tachycardia, hypotension, agitation, and rarely QT prolongation/arrhythmias, seizures, or respiratory depression; management is supportive (airway/ventilation, cardiovascular monitoring, consider activated charcoal if early, treat hypotension/arrhythmias as needed) and there is no specific antidote-seek emergency care/poison center.

Patient Counseling

Take once daily at the same time, with or without food; do not stop without prescriber advice. May cause dizziness/somnolence or akathisia-use caution with driving and avoid alcohol/other sedatives. Report new/worsening mood or suicidal thoughts, severe restlessness, or signs of NMS (fever, rigidity, confusion). Report impulse-control problems (e.g., gambling, shopping, hypersexuality, binge eating). Keep follow-ups for weight and metabolic monitoring.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, fasting lipids; assess for EPS/akathisia and tardive dyskinesia, sedation/orthostasis, and suicidality/clinical worsening. Consider CBC if history of leukopenia/neutropenia; monitor for impulse-control problems and metabolic changes.

Pharmacology

Mechanism of Action

Partial agonist at dopamine D2 (and D3) and serotonin 5-HT1A receptors, and antagonist at serotonin 5-HT2A receptors (with additional receptor activity), producing a dopamine-serotonin stabilizing effect.

Onset of Action

Initial clinical improvement may be seen within several days to 2 weeks; full therapeutic effect may take 4-6 weeks.

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); clinical symptom control is maintained with continued daily administration, with full therapeutic benefit typically requiring 4-6 weeks.

Half-Life

Aripiprazole: approximately 75 hours. Active metabolite (dehydro-aripiprazole): approximately 94 hours.

Bioavailability

Approximately 87% (oral bioavailability).

Metabolism

Extensively hepatic metabolism primarily via CYP2D6 and CYP3A4; major active metabolite is dehydro-aripiprazole.

Excretion

Approximately 25-27% recovered in urine and ~55-60% recovered in feces; <1% excreted unchanged in urine.

Protein Binding

>99% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

Immediate-release oral tablet; orally disintegrating tablet (ODT); oral solution; short-acting IM injection (for acute agitation); long-acting IM injectable suspension (aripiprazole LAI products).

Composition per Dose

Each tablet: 15mg aripiprazole

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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