ZOLINDA 1/MG/ML ORAL SOLUTION 150ML

Indications

Approved Uses

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

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 (acute): start 15 mg once daily (mono- or adjunct); max 30 mg/day. Adjunctive MDD: start 2-5 mg/day; target 5-10 mg/day; max 15 mg/day. Pediatrics (where approved): Schizophrenia (13-17) and Bipolar I mania (10-17): start 2 mg/day, increase to 5 mg after 2 days, then 10 mg after 2 more days; max 30 mg/day. Autism irritability (6-17): start 2 mg/day; target 5-10 mg/day; max 15 mg/day. Tourette’s (6-18): start 2 mg/day; 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

10-15 mg once daily (adults, schizophrenia)

Maintenance Dose

10-30 mg once daily depending on indication and response

Maximum Dose

30 mg/day.

Children's Dosage

Schizophrenia (≥13 years): 10 mg/day (max 30 mg/day). Bipolar I mania (≥10 years): 10 mg/day (max 30 mg/day). Autism irritability (≥6 years): 5-15 mg/day (max 15 mg/day). Tourette's disorder (≥6 years): 5-20 mg/day based on weight.

Dose Adjustment Notes

Adjust for CYP interactions: with strong CYP2D6 inhibitors or strong CYP3A4 inhibitors, reduce aripiprazole dose by ~50%; if both strong CYP2D6 and CYP3A4 inhibitors are used, reduce to ~25% of usual dose. With strong CYP3A4 inducers, increase (often double) the dose over 1-2 weeks and reduce back when the inducer is stopped. Poor CYP2D6 metabolizers: use ~50% of usual dose (and ~25% if also on a strong CYP3A4 inhibitor). No adjustment is generally required for renal impairment; mild-moderate hepatic impairment usually none, while severe hepatic impairment: use caution/individualize.

How to Take

Administer orally once daily with or without food; measure the dose with a calibrated oral measuring device (oral syringe/cup). The oral solution may be taken directly; if mixing is needed, mix only with a compatible non‑alcoholic beverage and take immediately.

How to Prepare

N/A - ready-to-use aripiprazole oral solution (1 mg/mL); no reconstitution or dilution required. Shake well before each dose and measure with an oral syringe/marked measuring device.

Side Effects

Common Side Effects

Headache, akathisia (restlessness), anxiety, insomnia, nausea, vomiting, constipation, lightheadedness, drowsiness, blurred vision, weight gain, increased salivation.

Side Effect Frequency

Very common (>10%): akathisia, headache, insomnia, nausea. Common (1-10%): anxiety/agitation, restlessness, somnolence/sedation, dizziness, extrapyramidal symptoms (including tremor), vomiting, constipation, fatigue, blurred vision, weight gain.

Safety & Warnings

Contraindications

Contraindication: known hypersensitivity to aripiprazole or any component/excipients (including reactions such as anaphylaxis/angioedema).

Warnings & Precautions

Key warnings/precautions: increased mortality in elderly with dementia-related psychosis (not approved); suicidality risk in children/adolescents/young adults; NMS; tardive dyskinesia; metabolic changes (glucose/lipids/weight); orthostatic hypotension/cardiovascular caution; seizure risk; leukopenia/neutropenia monitoring in at-risk patients; impulse-control/compulsive behaviors.

Age Restriction

Approved for certain indications in pediatric patients ≥6 years; not approved <6 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: strong CYP3A4 inhibitors and strong CYP2D6 inhibitors increase aripiprazole exposure (dose reduction often needed); strong CYP3A4 inducers decrease exposure (dose increase often needed); additive hypotension with antihypertensives and additive CNS effects with alcohol/CNS depressants.

Interaction Severity

MAJOR/clinically significant: strong CYP3A4 inducers (e.g., carbamazepine, rifampin) ↓ aripiprazole levels-often require dose increase; strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole) and strong CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) ↑ levels-require dose reduction. MODERATE: additive CNS depression with alcohol/benzodiazepines/opioids; enhanced orthostatic hypotension with antihypertensives. QT-prolongation risk is generally low with aripiprazole but use caution with other QT-prolonging drugs in high-risk patients.

Food Interaction

No restriction.

Special Populations

Children

Schizophrenia (≥13 years): 10 mg/day (max 30 mg/day). Bipolar I mania (≥10 years): 10 mg/day (max 30 mg/day). Autism irritability (≥6 years): 5-15 mg/day (max 15 mg/day). Tourette's disorder (≥6 years): 5-20 mg/day based on weight.

Elderly

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

Kidney Impairment

No adjustment needed

Liver Impairment

No dosage adjustment required for hepatic impairment, including severe impairment; use clinical caution and monitor.

Storage & Patient Advice

Preparation Instructions

N/A - ready-to-use aripiprazole oral solution (1 mg/mL); no reconstitution or dilution required. Shake well before each dose and measure with an oral syringe/marked measuring device.

Overdose

Symptoms may include somnolence/lethargy, vomiting, tremor, tachycardia and blood pressure changes; severe cases can include QT/QRS changes, seizures, and loss of consciousness; management is supportive (airway/ventilation, cardiac monitoring, consider activated charcoal if early) with no specific antidote-seek emergency care.

Patient Counseling

Take once daily at the same time with or without food; measure doses with a calibrated device. Avoid alcohol and use caution with driving until effects are known. Do not stop abruptly without prescriber advice. Report new/worsening mood or suicidal thoughts, extrapyramidal symptoms/akathisia, signs of hyperglycemia, and any impulse-control problems (e.g., gambling, binge eating, shopping, hypersexuality). Store below 30°C (SFDA).

Monitoring Requirements

Baseline and periodic: weight/BMI (and ideally waist circumference), blood pressure, fasting glucose or HbA1c, fasting lipid panel; assess for extrapyramidal symptoms/tardive dyskinesia, akathisia, and clinical response/suicidality. CBC only if clinically indicated (e.g., history of low WBC or infection symptoms).

Pharmacology

Half-Life

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

Metabolism

Extensive hepatic metabolism primarily via CYP2D6 and CYP3A4 to an active metabolite (dehydro-aripiprazole).

Product Information

Available Dosage Forms

Oral tablet, oral solution, intramuscular injection (immediate-release), extended-release intramuscular injectable suspension

Composition per Dose

Each 1ml of oral solution contains 1mg of aripiprazole.

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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