OLAZINE 5/MG FC TAB 28/FC TAB

Indications

Approved Uses

Schizophrenia (acute and maintenance) in adults; Bipolar I disorder: acute manic or mixed episodes (monotherapy or adjunct to lithium/valproate) and maintenance (monotherapy).

Off-Label Uses

Common off-label uses include delirium-related agitation (especially in medically ill), behavioral/psychological symptoms of dementia (not recommended routinely; significant safety warnings), chemotherapy-induced nausea/vomiting (antiemetic regimens), and augmentation in treatment-resistant depression (distinct from the approved olanzapine/fluoxetine product).

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; usual target 10 mg/day; maintenance typically 10-20 mg/day; max 20 mg/day. Bipolar I acute mania/mixed (adults): start 10-15 mg once daily (monotherapy) or 10 mg once daily (adjunct to lithium/valproate); maintenance 5-20 mg/day; max 20 mg/day.

Initial Dose

5-10mg once daily for Schizophrenia; 10-15mg once daily for Bipolar Mania.

Maintenance Dose

5-20mg once daily.

Maximum Dose

20mg per day.

Children's Dosage

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

Dose Adjustment Notes

Consider lower starting dose (e.g., 5 mg once daily) in elderly, debilitated, hypotension-prone patients, and in hepatic impairment; titrate cautiously (typically in 5 mg steps at intervals of at least several days to 1 week). Smoking (CYP1A2 induction) can lower exposure; CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) increase exposure-consider dose reduction and monitoring.

How to Take

Swallow whole with water. Can be taken with or without food. Administer once daily, preferably at the same time each day.

Side Effects

Common Side Effects

Weight gain, increased appetite, somnolence/sedation, dizziness, dry mouth, constipation, orthostatic hypotension, peripheral edema, akathisia/restlessness, tremor, headache; metabolic abnormalities (hyperglycemia/diabetes risk, increased triglycerides and cholesterol).

Side Effect Frequency

Very common (>10%): somnolence/sedation, weight gain, increased appetite; metabolic changes such as increased glucose and lipid abnormalities are also common to very common depending on study/population. Common (1-10%): dizziness, orthostatic hypotension, constipation, dry mouth, akathisia/tremor, fatigue, peripheral edema, increased liver enzymes. Uncommon/rare (<1%): seizures, tardive dyskinesia, neuroleptic malignant syndrome, blood dyscrasias (e.g., leukopenia/neutropenia), QT prolongation/bradycardia.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to olanzapine or any excipients; narrow-angle glaucoma is a precaution/caution (not a strict contraindication).

Warnings & Precautions

Warnings/precautions: not approved for dementia-related psychosis (↑ mortality); metabolic monitoring (weight/BMI, glucose, lipids); risk of NMS and tardive dyskinesia; orthostatic hypotension (caution in cardiovascular disease/dehydration/antihypertensives); seizure risk; leukopenia/neutropenia (monitor CBC if history/low baseline); anticholinergic effects (caution in narrow-angle glaucoma, BPH, ileus); hepatic impairment (caution/monitor); taper to discontinue.

Age Restriction

Not approved for use in children <13 years (for schizophrenia/bipolar indications); adolescent use (≥13 years) may be permitted for specific indications per local labeling.

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MAJOR: Concomitant IM olanzapine with parenteral benzodiazepines (e.g., IM/IV lorazepam) due to risk of excessive sedation/cardiorespiratory depression; additive CNS depression with alcohol/benzodiazepines/opioids (clinically significant). MODERATE: CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) increase levels; CYP1A2 inducers (smoking, carbamazepine, rifampin) decrease levels; antihypertensives (additive hypotension); dopamine agonists/levodopa (pharmacodynamic antagonism). MINOR/OTHER: Activated charcoal reduces absorption if given close in time.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

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

Elderly

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

Liver Impairment

Hepatic impairment: consider a lower starting dose (e.g., 5 mg) and titrate cautiously; monitor LFTs, especially in moderate impairment and when risk factors for hepatic dysfunction exist.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Overdose

Overdose: symptoms include marked sedation, anticholinergic effects, tachycardia, agitation, dysarthria, EPS, hypotension, respiratory depression, coma (± QT changes); management is supportive with airway/ventilation, cardiovascular monitoring, consider activated charcoal if early, and avoid epinephrine for hypotension (use norepinephrine/fluids).

Patient Counseling

Take once daily exactly as prescribed, with or without food, at the same time each day; do not stop abruptly without prescriber advice. May cause significant drowsiness/dizziness-avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives. Rise slowly to reduce orthostatic dizziness/falls. Monitor and manage metabolic effects (weight gain, increased appetite, increased blood sugar and lipids)-keep follow-up appointments for weight/BMI, glucose/HbA1c, and lipid checks. Seek urgent care for high fever/rigidity/confusion (neuroleptic malignant syndrome), new or worsening involuntary movements (tardive dyskinesia), severe rash/swelling, or symptoms of hyperglycemia (excessive thirst/urination). Tell your clinician if you start/stop smoking (can reduce olanzapine levels via CYP1A2 induction). Store below 30°C and keep out of reach of children.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, fasting lipid panel; assess for EPS/tardive dyskinesia; consider LFTs and CBC when clinically indicated; monitor for sedation/orthostasis and metabolic syndrome.

Pharmacology

Onset of Action

Sedation can occur within hours; peak plasma concentration occurs ~5-8 hours after an oral dose; antipsychotic symptom improvement typically begins within 1-2 weeks with fuller response over ~4-6 weeks.

Duration of Effect

Once-daily clinical effect is typical; elimination half-life is approximately 21-54 hours (variable), supporting 24-hour dosing intervals.

Half-Life

Approximately 21-54 hours; mean about 30 hours (can be longer in some patients, e.g., elderly or non-smokers).

Bioavailability

Oral bioavailability is not reliably established/commonly reported; olanzapine is well absorbed with extensive first-pass metabolism (food has no clinically meaningful effect).

Metabolism

Extensive hepatic metabolism mainly via CYP1A2 and direct glucuronidation (UGT1A4); CYP2D6 is a minor pathway; metabolites are largely inactive.

Protein Binding

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

Product Information

Available Dosage Forms

For this product: Film-coated tablet (oral). In general, olanzapine is also available as orodispersible/orally disintegrating tablets and as intramuscular injection (short-acting); long-acting depot exists in some markets as olanzapine pamoate.

Composition per Dose

Each film-coated tablet: Olanzapine 5mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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