ZYPREXA 10/MG 28/FC TAB

Indications

Approved Uses

Schizophrenia (acute and maintenance), Bipolar I disorder (acute manic or mixed episodes as monotherapy or adjunct to lithium/valproate), Bipolar I disorder maintenance, Treatment-resistant depression (in combination with fluoxetine as Symbyax)

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; usual target/maintenance 10 mg daily; max 20 mg/day. Bipolar I acute mania (adults): start 10-15 mg once daily (monotherapy) or 10 mg once daily (adjunct); maintenance typically 5-20 mg/day; max 20 mg/day. Olanzapine/fluoxetine combination (where available) is used for bipolar depression and treatment-resistant depression with evening dosing per product labeling.

Initial Dose

5-10mg once daily (schizophrenia); 10-15mg once daily (acute mania)

Maintenance Dose

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

Maximum Dose

20 mg per day.

Children's Dosage

Adolescents 13-17 years (schizophrenia and bipolar mania): Initial 2.5-5mg once daily, target 10mg once daily, max 20mg/day. Not approved for children under 13 years.

Dose Adjustment Notes

Typical adult initiation is 5-10 mg once daily with cautious titration; consider a lower starting dose (e.g., 5 mg) in elderly/debilitated patients, those with hepatic impairment, or those predisposed to hypotension; dose changes should generally occur no more frequently than about weekly; smoking status changes can alter exposure (smoking induces CYP1A2 and lowers levels; stopping smoking may increase levels).

How to Take

Swallow the 10 mg 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

Common adverse effects include somnolence/drowsiness, weight gain and increased appetite, dizziness, constipation, dry mouth, orthostatic hypotension, fatigue, and tremor/akathisia; metabolic changes (hyperglycemia and dyslipidemia) are also common/clinically important.

Side Effect Frequency

Very common (≥10%): weight gain, somnolence/sedation, increased appetite; metabolic changes such as increased glucose and lipid parameters are common and may be very common depending on population/definition. Common (1-10%): dizziness, constipation, dry mouth, orthostatic hypotension, akathisia/tremor, increased prolactin, elevated liver enzymes. Serious but uncommon/rare: NMS, seizures, tardive dyskinesia, severe hyperglycemia/DKA, blood dyscrasias.

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine or to any component of the formulation (including prior serious hypersensitivity reactions such as anaphylaxis/angioedema).

Warnings & Precautions

Boxed warning: increased mortality in elderly with dementia-related psychosis (not approved). Major precautions: metabolic changes (hyperglycemia/diabetes, dyslipidemia, significant weight gain-monitor glucose/lipids/weight), NMS, tardive dyskinesia, orthostatic hypotension, leukopenia/neutropenia (CBC if risk factors), seizure risk, anticholinergic effects, and hepatic impairment caution.

Age Restriction

Schizophrenia and bipolar I mania: approved in adolescents ≥13 years (not approved <13). Bipolar I maintenance: adults only. Treatment-resistant depression (with fluoxetine) and depressive episodes in bipolar I: adults only (not approved in pediatrics).

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MAJOR: Concomitant IM olanzapine with parenteral benzodiazepines (risk of excessive sedation/respiratory depression); strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can markedly increase olanzapine exposure requiring close monitoring/dose adjustment. MODERATE: CYP1A2 inducers (e.g., carbamazepine, rifampin, tobacco smoking) can reduce levels; other CNS depressants (alcohol, opioids, benzodiazepines) increase sedation; antihypertensives increase hypotension risk; dopamine agonists/levodopa may have reduced efficacy. QTc-prolonging agents: additive QT risk is possible but olanzapine has relatively low QT liability compared with several other antipsychotics (use caution rather than categorizing as universally 'major').

Food Interaction

No food restriction; may be taken with or without food.

Special Populations

Pregnancy

Not assigned a pregnancy category (Risk Summary: Limited human data; animal studies show adverse effects

Children

Adolescents 13-17 years (schizophrenia and bipolar mania): Initial 2.5-5mg once daily, target 10mg once daily, max 20mg/day. Not approved for children under 13 years.

Elderly

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

Liver Impairment

Use with caution; consider a lower starting dose (e.g., 5 mg/day) and titrate cautiously in hepatic impairment.

Storage & Patient Advice

Overdose

Symptoms: somnolence/sedation, tachycardia, agitation, dysarthria, anticholinergic effects, hypotension, extrapyramidal symptoms; severe cases may include respiratory depression, seizures, coma and possible QT prolongation/arrhythmias. Management: no specific antidote-supportive care with airway/ventilation and cardiovascular monitoring; consider activated charcoal if early; treat hypotension with IV fluids/vasopressors and avoid epinephrine due to potential paradoxical hypotension (alpha-blockade).

Patient Counseling

Take once daily as prescribed (with or without food) and avoid abrupt discontinuation without clinician advice; may cause drowsiness-avoid driving/alcohol until effects are known; stand up slowly to reduce dizziness/orthostasis; monitor weight and report symptoms of high blood sugar; inform clinicians about smoking status changes and before starting new medicines; seek urgent care for severe muscle stiffness/fever/confusion (possible NMS) or uncontrolled abnormal movements.

Monitoring Requirements

Monitor metabolic parameters at baseline and periodically: weight/BMI (and waist circumference if used), blood pressure, fasting glucose or HbA1c, and fasting lipid profile; assess for extrapyramidal symptoms/tardive dyskinesia; consider LFTs and CBC when clinically indicated (e.g., hepatic disease, infection risk, prior blood dyscrasia).

Pharmacology

Half-Life

Elimination half-life ranges ~21-54 hours (mean ~33 hours).

Bioavailability

Oral bioavailability is approximately 60% (variable due to first-pass metabolism); peak plasma concentrations typically occur about 5-8 hours after an oral dose.

Metabolism

Hepatic metabolism via direct glucuronidation (primarily UGT1A4) and oxidative metabolism (primarily CYP1A2; minor CYP2D6); metabolites include 10-N-glucuronide and 4′-N-desmethyl olanzapine (generally inactive).

Protein Binding

Approximately 93% (primarily to albumin and alpha-1-acid glycoprotein)

Product Information

Available Dosage Forms

Olanzapine is available as: oral film-coated tablets (this product), orally disintegrating tablets, short-acting intramuscular injection, and long-acting intramuscular depot injection (olanzapine pamoate).

Composition per Dose

Each film-coated tablet: 10mg olanzapine.

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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