PREXAL 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Schizophrenia; treatment of moderate to severe manic episode; prevention of recurrence in bipolar disorder in patients whose manic episode has responded to olanzapine.

Off-Label Uses

Common off‑label uses include adjunctive treatment for treatment‑resistant depression (often with fluoxetine), acute agitation (including in emergency settings), and delirium (selected cases); use for dementia‑related psychosis/agitation is off‑label and carries increased mortality risk warnings in older adults.

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; usual target ~10 mg/day; adjust within 5-20 mg/day (max 20 mg/day). Acute mania (bipolar): 15 mg once daily (monotherapy) or 10 mg once daily with lithium/valproate; adjust within 5-20 mg/day (max 20 mg/day). Bipolar maintenance/relapse prevention: continue at the effective dose, typically 5-20 mg once daily (max 20 mg/day).

Initial Dose

Schizophrenia: 5-10mg once daily. Bipolar Mania: 10-15mg once daily. [9, 11, 31]

Maintenance Dose

10mg once daily (range 5-20mg/day)

Maximum Dose

20mg per day. [6, 31]

Children's Dosage

Schizophrenia (13-17 years): Start with 2.5-5mg once daily, target dose is 10mg/day, max dose is 20mg/day. Bipolar I Mania (13-17 years): Start with 2.5-5mg once daily, target dose is 10mg/day, max dose is 20mg/day. [6, 31]

Dose Adjustment Notes

Consider a lower starting dose (e.g., 5 mg once daily) in elderly/frail patients, those with hepatic impairment, or those predisposed to hypotension; titrate cautiously in 5 mg steps; smokers may need higher doses and dose reduction may be needed if smoking stops.

How to Take

Swallow the film‑coated tablet whole with water once daily; may be taken with or without food; take at the same time each day (evening dosing may be preferred if sedation occurs).

Side Effects

Common Side Effects

Weight gain, somnolence (drowsiness), increased appetite, dizziness, dry mouth, constipation, orthostatic hypotension; metabolic changes such as increased glucose and lipids can occur.

Side Effect Frequency

Very common (>10%): weight gain, somnolence; commonly also increased appetite and metabolic changes (e.g., increased glucose and lipids). Common (1-10%): dizziness, akathisia/parkinsonism, orthostatic hypotension, constipation, dry mouth, fatigue, peripheral edema, and prolactin increase.

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine or any component of the product.

Warnings & Precautions

Boxed warning: increased mortality in elderly with dementia-related psychosis (not approved). Monitor for metabolic changes (weight, glucose, lipids); risk of NMS and tardive dyskinesia; orthostatic hypotension (especially during titration); sedation/CNS depression; seizure risk/lowered threshold; leukopenia/neutropenia; use caution in hepatic impairment and in cardiovascular/cerebrovascular disease.

Age Restriction

Not approved for use in children <13 years (schizophrenia) and <10 years (bipolar I mania); safety/efficacy not established below these ages.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Key interactions: CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) ↑ olanzapine; CYP1A2 inducers (e.g., carbamazepine, rifampin, smoking) ↓ olanzapine; additive CNS depression with alcohol/benzodiazepines/opioids; antagonism with levodopa/dopamine agonists; additive hypotension with antihypertensives; additive anticholinergic effects with anticholinergics.

Interaction Severity

MAJOR: Concomitant parenteral benzodiazepines with IM olanzapine (risk of excessive sedation/cardiorespiratory depression-avoid); strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can markedly increase olanzapine levels-consider dose reduction/monitoring. MODERATE: CYP1A2 inducers (e.g., smoking, carbamazepine, rifampin) can reduce levels-may require dose increase/monitoring; additive hypotension with antihypertensives; antagonism of levodopa/dopamine agonists; additive CNS depression with alcohol/other sedatives.

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Schizophrenia (13-17 years): Start with 2.5-5mg once daily, target dose is 10mg/day, max dose is 20mg/day. Bipolar I Mania (13-17 years): Start with 2.5-5mg once daily, target dose is 10mg/day, max dose is 20mg/day. [6, 31]

Elderly

Start at 5mg once daily; titrate slowly with careful monitoring for orthostatic hypotension, sedation, and metabolic effects. Not recommended for elderly patients with dementia-related psychosis

Liver Impairment

No fixed adjustment, but consider a lower starting dose (e.g., 5 mg/day) and cautious titration in hepatic impairment.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original packaging to protect from light and moisture

Missed Dose

Take as soon as remembered on the same day; skip the missed dose if it is almost time for the next dose. Do not double the dose

Stopping the Medicine

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

Overdose

Symptoms: somnolence/sedation, agitation, tachycardia, hypotension, anticholinergic effects, dysarthria, extrapyramidal symptoms; severe cases may include respiratory depression, coma, and arrhythmias/QT changes. Management: emergency care with airway/ventilation support, activated charcoal if appropriate, continuous cardiovascular/respiratory monitoring, and supportive treatment; no specific antidote.

Patient Counseling

Take once daily as prescribed (with/without food) and do not stop abruptly without medical advice; may cause drowsiness-avoid driving until effects are known and avoid alcohol/other sedatives; monitor weight and follow diet/exercise advice; attend scheduled checks for blood sugar and lipids; stand up slowly to reduce dizziness; seek urgent care for fever/rigidity/confusion (possible NMS) or uncontrolled movements; tell the prescriber about smoking status or changes.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting plasma glucose or HbA1c, fasting lipid panel; assess for extrapyramidal symptoms/tardive dyskinesia and sedation; consider LFTs and CBC if clinically indicated.

Pharmacology

Mechanism of Action

Atypical antipsychotic with antagonism at dopamine D2 and serotonin 5‑HT2A receptors, with additional activity at 5‑HT2C, H1, muscarinic, and α1‑adrenergic receptors.

Onset of Action

Sedation may occur within hours after the first dose; improvement in agitation/psychotic symptoms may begin within several days to 1-2 weeks, with fuller effect often taking 4-6 weeks.

Duration of Effect

Sedative effects may last several hours; antipsychotic effect is maintained with once-daily dosing (approximately 24 hours), with sustained clinical benefit requiring continued daily therapy over weeks.

Half-Life

Approximately 30 hours on average (reported range about 21-54 hours).

Bioavailability

Oral bioavailability is approximately 60% (variable) due to first‑pass metabolism.

Metabolism

Extensive hepatic metabolism primarily via CYP1A2, with a lesser contribution from CYP2D6, plus direct glucuronidation; metabolites are largely inactive (e.g., 10-N-glucuronide and 4′-N-desmethyl olanzapine).

Product Information

Available Dosage Forms

For PREXAL specifically: oral film‑coated tablet (5 mg) in blister pack of 30 tablets.

Composition per Dose

Each film-coated tablet: 5mg olanzapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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