ZOLINDA 5/MG TAB 30/TAB

Indications

Approved Uses

Schizophrenia; acute treatment of manic and mixed episodes associated with Bipolar I disorder; adjunctive treatment of Major Depressive Disorder (with antidepressants); irritability associated with autistic disorder; Tourette’s disorder.

Off-Label Uses

Common off-label uses include augmentation in OCD and PTSD, behavioral symptoms/agitation in dementia (not recommended routinely due to boxed warning), and other anxiety-spectrum conditions; other proposed uses (e.g., eating disorders, substance use disorders) have variable/limited evidence.

Dosage & Administration

Dosing by Condition

Adults-Schizophrenia: start 10-15 mg once daily, target/maintenance 10-15 mg/day, max 30 mg/day; Bipolar I mania/mixed: start 15 mg once daily (mono- or adjunct), maintenance 15 mg/day, max 30 mg/day; MDD adjunct: start 2-5 mg/day, target 5-10 mg/day, max 15 mg/day. Pediatric indications (where approved in labeling): schizophrenia (13-17), bipolar mania (10-17), autism irritability (6-17), Tourette’s (6-18) use lower starting doses (often 2 mg/day) with titration to age/weight-based targets.

Initial Dose

10-15 mg once daily for schizophrenia; 2-5 mg once daily for MDD adjunct

Maintenance Dose

10-30 mg once daily depending on indication and response

Maximum Dose

30 mg/day.

Children's Dosage

Schizophrenia (13-17 years): Start 2 mg/day, target 10 mg/day, max 30 mg/day. Bipolar I (10-17 years): Start 2 mg/day, target 10 mg/day, max 30 mg/day. Autism-related irritability (6-17 years): Start 2 mg/day, target 5-15 mg/day, max 15 mg/day. Tourette's (6-18 years): Start 2 mg/day, max 20 mg/day.

Dose Adjustment Notes

With strong CYP2D6 inhibitors OR strong CYP3A4 inhibitors: reduce aripiprazole dose to 50%; with BOTH strong CYP2D6 and strong CYP3A4 inhibitors: reduce to 25% of usual dose; with strong CYP3A4 inducers: increase dose (typically double) over 1-2 weeks and reduce back when inducer stopped; no routine adjustment for renal impairment or mild-moderate hepatic impairment.

How to Take

Swallow tablet whole with water. Can be taken with or without food. Take at the same time each day.

Side Effects

Common Side Effects

Akathisia/restlessness, headache, insomnia or somnolence, anxiety, nausea/vomiting, constipation, dizziness/lightheadedness, weight gain, fatigue; increased salivation can occur.

Safety & Warnings

Contraindications

Known hypersensitivity to aripiprazole or any component/excipient of the formulation.

Warnings & Precautions

Key warnings/precautions: increased mortality in elderly with dementia-related psychosis (not approved); suicidality risk in children/adolescents/young adults when used with antidepressants for MDD; monitor for NMS and tardive dyskinesia; monitor weight, glucose and lipids; orthostatic hypotension (caution in cardiovascular disease/dehydration); seizures (caution in predisposed); leukopenia/neutropenia (monitor CBC if history/low WBC); impulse-control/compulsive behaviors; caution with dysphagia/aspiration risk; avoid abrupt discontinuation.

Age Restriction

Pediatric use is indication-specific: approved in children/adolescents for certain indications with minimum ages (e.g., ≥6 years for irritability associated with autistic disorder; ≥10 years for bipolar I manic/mixed episodes; ≥13 years for schizophrenia). Not established/approved below these ages.

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MAJOR: strong CYP3A4 inducers (e.g., carbamazepine, rifampin) ↓ levels-may require dose increase; strong CYP3A4 inhibitors (e.g., ketoconazole) and strong CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) ↑ levels-require dose reduction. MODERATE: additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives. Other interactions (e.g., lithium) are generally not major but require clinical monitoring.

Food Interaction

No restriction.

Special Populations

Pregnancy

Category C

Children

Schizophrenia (13-17 years): Start 2 mg/day, target 10 mg/day, max 30 mg/day. Bipolar I (10-17 years): Start 2 mg/day, target 10 mg/day, max 30 mg/day. Autism-related irritability (6-17 years): Start 2 mg/day, target 5-15 mg/day, max 15 mg/day. Tourette's (6-18 years): Start 2 mg/day, max 20 mg/day.

Elderly

Start at lower doses, titrate slowly. Not approved for dementia-related psychosis. Monitor for orthostatic hypotension and falls. Standard adult dosing applies otherwise.

Kidney Impairment

No adjustment needed

Liver Impairment

No dosage adjustment is generally required in mild-to-severe hepatic impairment, but use clinical caution in severe impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually under medical supervision when discontinuing.

Patient Counseling

Take once daily at the same time with or without food; avoid alcohol and use caution driving until effects known; rise slowly to reduce dizziness; do not stop abruptly without prescriber advice; report akathisia/EPS, signs of neuroleptic malignant syndrome, new/worsening mood or suicidality, and impulse-control problems (e.g., gambling/binge eating); attend metabolic monitoring; store below 30°C (per SFDA).

Monitoring Requirements

Baseline and periodic: weight/BMI (and waist circumference if used), blood pressure, fasting glucose/HbA1c, fasting lipids; assess for EPS/akathisia and tardive dyskinesia (e.g., AIMS), sedation/orthostasis; monitor for suicidality/mood changes (especially in younger patients); CBC if history of low WBC/neutropenia.

Pharmacology

Mechanism of Action

Dopamine-serotonin system stabilizer: partial agonist at dopamine D2 (and D3) and serotonin 5‑HT1A receptors, and antagonist at serotonin 5‑HT2A receptors.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

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

Metabolism

Extensive hepatic metabolism mainly via CYP2D6 and CYP3A4 to the active metabolite dehydro-aripiprazole.

Product Information

Available Dosage Forms

For aripiprazole (active ingredient): oral tablet; orally disintegrating tablet; oral solution; short-acting IM injection; long-acting IM injectable suspension (extended-release). For ZOLINDA specifically (per SFDA API): oral tablet only.

Composition per Dose

Each tablet: 5 mg aripiprazole

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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