Olanzapine 5mg Tablets
WARNING: There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia. @ COMMON USES: It is used to treat bipolar disorder. It is used to treat schizophrenia.It is used to treat depression.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antipsychotic
Pharmacologic Class
Atypical Antipsychotic; Dopamine and Serotonin Receptor Antagonist
Pregnancy Category
C
FDA Approved
Sep 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Olanzapine is a medication used to treat certain mental health conditions like schizophrenia and bipolar disorder. It works by helping to balance certain natural chemicals in the brain. It can help reduce symptoms like hallucinations, delusions, and extreme mood swings. It's important to take it regularly as prescribed, even if you feel better.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Adhere to the dosage and administration guidelines carefully.
It is essential to stay hydrated by drinking plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake. Be cautious in hot weather or during physical activity, as this can lead to fluid loss. Drink plenty of fluids to prevent dehydration.
You can take this medication with or without food. If it causes stomach upset, take it with food to help alleviate this issue.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling better.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Adhere to the dosage and administration guidelines carefully.
It is essential to stay hydrated by drinking plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake. Be cautious in hot weather or during physical activity, as this can lead to fluid loss. Drink plenty of fluids to prevent dehydration.
You can take this medication with or without food. If it causes stomach upset, take it with food to help alleviate this issue.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling better.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid alcohol and other CNS depressants, as they can increase drowsiness and other side effects.
- Be aware of the risk of weight gain and metabolic changes. Maintain a healthy diet and engage in regular physical activity.
- Monitor blood sugar and cholesterol levels regularly as advised by your doctor.
- Avoid overheating and dehydration, especially during exercise or in hot weather, as olanzapine can affect the body's ability to regulate temperature.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms or a return of your condition.
Available Forms & Alternatives
Available Strengths:
- Olanzapine ODT 20mg Tablets
- Olanzapine ODT 15mg Tablets
- Olanzapine ODT 10mg Tablets
- Olanzapine ODT 5mg Tablets
- Olanzapine 10mg Inj, 1 Vial
- Olanzapine ODT 5mg Tablets
- Olanzapine 15mg Tablets
- Olanzapine 2.5mg Tablets
- Olanzapine 20mg Tablets
- Olanzapine 10mg Tablets
- Olanzapine 5mg Tablets
- Olanzapine 7.5mg Tablets
- Olanzapine 10mg Inj, 1 Vial
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For schizophrenia, typically 10 mg once daily. For bipolar mania, 10-15 mg once daily.
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
schizophrenia:
Initial: 5-10 mg once daily; Target: 10 mg once daily; Max: 20 mg/day
bipolar_mania_monotherapy:
Initial: 10-15 mg once daily; Max: 20 mg/day
bipolar_mania_combination:
Initial: 10 mg once daily; Max: 20 mg/day
bipolar_maintenance:
10-20 mg once daily
agitation_IM:
5-10 mg IM, may repeat after 2 hours (max 3 doses/24 hours, max 30 mg/day)
treatment_resistant_depression_with_fluoxetine:
Initial: 5 mg olanzapine with 20 mg fluoxetine; Max: 18 mg olanzapine with 75 mg fluoxetine
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established for children <13 years)
Adolescent:
For schizophrenia or bipolar I disorder (manic or mixed episodes) in adolescents (13-17 years): Initial 2.5-5 mg once daily; Target 10 mg once daily; Max 20 mg/day. Lower starting doses and slower titration may be considered due to increased risk of weight gain and dyslipidemia.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally needed.
Moderate:
No dosage adjustment generally needed.
Severe:
No dosage adjustment generally needed, but caution advised due to limited experience.
Dialysis:
Not significantly removed by dialysis. No specific adjustment recommended, but monitor clinical response.
Hepatic Impairment:
Mild:
No dosage adjustment generally needed.
Moderate:
Consider lower starting dose (e.g., 5 mg) and slower titration in patients with moderate hepatic impairment (Child-Pugh B).
Severe:
Not available (limited data, use with caution).
Pharmacology
Mechanism of Action
Olanzapine is an atypical antipsychotic that exhibits high affinity for serotonin 5-HT2A, 5-HT2C, 5-HT3, 5-HT6 receptors, and dopamine D1, D2, D3, D4 receptors. It also has affinity for muscarinic M1-M5, alpha-1 adrenergic, and histamine H1 receptors. Its antipsychotic activity is thought to be mediated through a combination of dopamine D2 and serotonin 5-HT2A antagonism. The 5-HT2A antagonism is believed to contribute to a lower propensity for extrapyramidal symptoms (EPS) compared to typical antipsychotics.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated, but well absorbed orally. Food does not affect the rate or extent of absorption.
Tmax:
5-8 hours
FoodEffect:
Absorption is not affected by food.
Distribution:
Vd:
1000 L (high volume of distribution)
ProteinBinding:
Approximately 93% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
21-54 hours (mean 33 hours)
Clearance:
Approximately 27 L/hr (oral clearance)
ExcretionRoute:
Approximately 57% in urine (primarily as metabolites), 30% in feces (primarily as metabolites).
Unchanged:
Approximately 7% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within hours for sedation/agitation; several days to weeks for full antipsychotic effect.
PeakEffect:
Not precisely defined for therapeutic effect, but plasma concentrations peak at 5-8 hours.
DurationOfAction:
Once daily dosing due to long half-life.
Safety & Warnings
BLACK BOX WARNING
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. Increased risk of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in elderly patients with dementia-related psychosis.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Movement problems, such as:
+ Trouble controlling body movements
+ Twitching
+ Changes in balance
+ Difficulty swallowing or speaking
New or worsening mental, mood, or behavioral changes, including:
+ Thoughts of self-harm or suicide
Severe dizziness or fainting
Abnormal heartbeat (fast or slow)
Inability to sweat during physical activity or in warm temperatures
Seizures
Drooling
Changes in vision
Memory problems or loss
Chest pain
Swelling
Abnormal sensations, such as burning, numbness, or tingling
Difficulty urinating
Hormonal changes, including:
+ Enlarged breasts
+ Nipple discharge
+ Erectile dysfunction
+ Menstrual changes
Swollen glands
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Rapid heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Low white blood cell count, which can increase the risk of infection; if you have a history of low white blood cell count, inform your doctor and seek medical attention immediately if you experience:
+ Fever
+ Chills
+ Sore throat
Tardive dyskinesia, a rare but potentially irreversible movement disorder, characterized by:
+ Involuntary movements, such as tongue sticking out, puffing cheeks, mouth puckering, or chewing
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dizziness
Drowsiness
Fatigue
Weakness
Restlessness
Shakiness
Headache
Constipation
Dry mouth
Upset stomach
Weight gain
Increased appetite
Back pain
Joint pain
* Sleep disturbances
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Movement problems, such as:
+ Trouble controlling body movements
+ Twitching
+ Changes in balance
+ Difficulty swallowing or speaking
New or worsening mental, mood, or behavioral changes, including:
+ Thoughts of self-harm or suicide
Severe dizziness or fainting
Abnormal heartbeat (fast or slow)
Inability to sweat during physical activity or in warm temperatures
Seizures
Drooling
Changes in vision
Memory problems or loss
Chest pain
Swelling
Abnormal sensations, such as burning, numbness, or tingling
Difficulty urinating
Hormonal changes, including:
+ Enlarged breasts
+ Nipple discharge
+ Erectile dysfunction
+ Menstrual changes
Swollen glands
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Rapid heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Low white blood cell count, which can increase the risk of infection; if you have a history of low white blood cell count, inform your doctor and seek medical attention immediately if you experience:
+ Fever
+ Chills
+ Sore throat
Tardive dyskinesia, a rare but potentially irreversible movement disorder, characterized by:
+ Involuntary movements, such as tongue sticking out, puffing cheeks, mouth puckering, or chewing
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dizziness
Drowsiness
Fatigue
Weakness
Restlessness
Shakiness
Headache
Constipation
Dry mouth
Upset stomach
Weight gain
Increased appetite
Back pain
Joint pain
* Sleep disturbances
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unexplained fever, muscle stiffness, confusion, sweating, or fast heart rate (signs of Neuroleptic Malignant Syndrome - NMS). Seek immediate medical attention.
- Uncontrolled movements of the face, tongue, or other body parts (signs of tardive dyskinesia). Report to your doctor.
- Excessive thirst, frequent urination, increased hunger, or unusual weakness (signs of high blood sugar). Report to your doctor.
- Dizziness or lightheadedness when standing up (orthostatic hypotension).
- Severe skin rash, fever, swollen lymph nodes, or swelling of the face (signs of DRESS syndrome). Seek immediate medical attention.
- Sore throat, fever, or other signs of infection (may indicate low white blood cell count).
- Difficulty swallowing or breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Potential Health Risks
Drugs like this one have been associated with increased risks of high blood sugar or diabetes, high cholesterol, and weight gain, which may contribute to heart and brain blood vessel disease. To monitor your condition, follow your doctor's instructions for checking your blood sugar levels and scheduling blood work and other laboratory tests.
Substance Interactions
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor to discuss potential interactions.
Dizziness and Falling Risks
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and related injuries, such as fractures. Be cautious to prevent accidents.
Severe Reaction Warning
In rare cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms such as fever, rash, swollen glands, and organ problems (e.g., liver, kidney, blood, heart, muscles, joints, or lungs). If you have concerns, consult your doctor.
Special Considerations
Older Adults with Dementia: Drugs like this one have been linked to a higher risk of strokes, including fatal cases, in older adults with dementia. This medication is not approved for treating dementia-related mental health issues.
Age-Related Precautions: If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pediatric Use: When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population.
Reproductive Considerations: This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have questions, consult your doctor.
* Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Discuss the benefits and risks of this medication with your doctor, as taking it during the third trimester may lead to side effects or withdrawal symptoms in the newborn.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Potential Health Risks
Drugs like this one have been associated with increased risks of high blood sugar or diabetes, high cholesterol, and weight gain, which may contribute to heart and brain blood vessel disease. To monitor your condition, follow your doctor's instructions for checking your blood sugar levels and scheduling blood work and other laboratory tests.
Substance Interactions
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor to discuss potential interactions.
Dizziness and Falling Risks
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and related injuries, such as fractures. Be cautious to prevent accidents.
Severe Reaction Warning
In rare cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms such as fever, rash, swollen glands, and organ problems (e.g., liver, kidney, blood, heart, muscles, joints, or lungs). If you have concerns, consult your doctor.
Special Considerations
Older Adults with Dementia: Drugs like this one have been linked to a higher risk of strokes, including fatal cases, in older adults with dementia. This medication is not approved for treating dementia-related mental health issues.
Age-Related Precautions: If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pediatric Use: When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population.
Reproductive Considerations: This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have questions, consult your doctor.
* Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Discuss the benefits and risks of this medication with your doctor, as taking it during the third trimester may lead to side effects or withdrawal symptoms in the newborn.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Slurred speech
- Agitation
- Tachycardia (fast heart rate)
- Extrapyramidal symptoms (e.g., tremor, muscle stiffness)
- Coma
- Respiratory depression
- Hypotension
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Management is supportive, including maintaining an open airway, oxygenation, and ventilation. Activated charcoal may be considered if ingested recently. Monitor cardiovascular function and vital signs.
Drug Interactions
Major Interactions
- CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased sedation and respiratory depression.
- Anticholinergic drugs (e.g., benztropine, tricyclic antidepressants): Potentiation of anticholinergic effects (e.g., severe constipation, urinary retention, heat intolerance).
- Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Increased risk of arrhythmias.
- CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): Increased olanzapine levels.
- CYP1A2 inducers (e.g., carbamazepine, rifampin, omeprazole, smoking): Decreased olanzapine levels.
Moderate Interactions
- Antihypertensives: Additive hypotensive effects.
- Dopamine agonists (e.g., levodopa): Olanzapine may antagonize effects.
- Valproate: Increased risk of neutropenia when co-administered with olanzapine.
- Lithium: Increased risk of adverse events (e.g., tremor, sedation) when co-administered with olanzapine.
Minor Interactions
- Cimetidine, antacids: No significant effect on olanzapine absorption.
Monitoring
Baseline Monitoring
Weight, BMI, Waist Circumference
Rationale: Risk of significant weight gain and metabolic syndrome.
Timing: Before starting treatment
Fasting Plasma Glucose (FPG) or HbA1c
Rationale: Risk of hyperglycemia and new-onset diabetes mellitus.
Timing: Before starting treatment
Fasting Lipid Panel (Total Cholesterol, LDL, HDL, Triglycerides)
Rationale: Risk of dyslipidemia.
Timing: Before starting treatment
Blood Pressure
Rationale: Risk of orthostatic hypotension.
Timing: Before starting treatment
Personal and Family History of Cardiovascular Disease, Diabetes, Dyslipidemia
Rationale: Identify individuals at higher risk for metabolic adverse effects.
Timing: Before starting treatment
Movement Disorder Assessment (e.g., AIMS)
Rationale: Assess for baseline dyskinesias.
Timing: Before starting treatment
Routine Monitoring
Weight, BMI, Waist Circumference
Frequency: Monthly for first few months, then quarterly
Target: Maintain within healthy range
Action Threshold: Significant weight gain (e.g., >5% of baseline) warrants intervention (diet, exercise, consider alternative).
Fasting Plasma Glucose (FPG) or HbA1c
Frequency: At 3 months, then annually (or more frequently if risk factors present)
Target: FPG <100 mg/dL, HbA1c <5.7%
Action Threshold: FPG âĨ126 mg/dL or HbA1c âĨ6.5% (diabetes diagnosis); FPG 100-125 mg/dL or HbA1c 5.7-6.4% (prediabetes) warrants intervention.
Fasting Lipid Panel
Frequency: At 3 months, then annually (or more frequently if risk factors present)
Target: LDL <100 mg/dL, HDL >40 mg/dL (men), >50 mg/dL (women), Triglycerides <150 mg/dL
Action Threshold: Significant dyslipidemia warrants intervention.
Blood Pressure
Frequency: At each visit, especially during titration
Target: Normal range
Action Threshold: Orthostatic hypotension (drop >20 mmHg systolic or >10 mmHg diastolic) or sustained hypertension.
Movement Disorder Assessment (e.g., AIMS)
Frequency: Every 6-12 months
Target: No abnormal involuntary movements
Action Threshold: Emergence or worsening of tardive dyskinesia.
Mental Status and Clinical Response
Frequency: At each visit
Target: Symptom control, improved functioning
Action Threshold: Worsening of symptoms, emergence of new symptoms, or lack of efficacy.
Symptom Monitoring
- Sedation/drowsiness
- Dizziness/lightheadedness (especially upon standing)
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Tremor
- Akathisia (restlessness)
- Dystonia (muscle spasms)
- Tardive dyskinesia (involuntary movements, especially of face/mouth)
- Changes in appetite or thirst
- Excessive urination
- Unusual fatigue or weakness
- Signs of neuroleptic malignant syndrome (fever, muscle rigidity, altered mental status, autonomic instability)
- Signs of drug reaction with eosinophilia and systemic symptoms (DRESS) (rash, fever, lymphadenopathy, organ involvement)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
Trimester-Specific Risks:
First Trimester:
Limited data, but no clear evidence of increased major congenital malformations.
Second Trimester:
No specific increased risks identified.
Third Trimester:
Risk of extrapyramidal and/or withdrawal symptoms in the neonate (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder). Monitor neonates for these symptoms.
Lactation
L3 (Moderately Safe). Olanzapine is excreted into breast milk. The relative infant dose (RID) is estimated to be 1-5%. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones. Weigh benefits of breastfeeding against potential risks to the infant.
Infant Risk:
Low to moderate risk. Potential for sedation, lethargy, poor feeding, and weight gain in the infant. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Safety and efficacy not established for children under 13 years of age. In adolescents (13-17 years), there is a higher incidence of weight gain, increases in lipids, and increases in liver transaminases compared to adults. Close monitoring of metabolic parameters is crucial.
Geriatric Use
Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death and cerebrovascular adverse events. Olanzapine is not approved for this indication. In general, elderly patients may be more sensitive to the effects of olanzapine, particularly orthostatic hypotension and anticholinergic effects. Consider lower starting doses and slower titration.
Clinical Information
Clinical Pearls
- Olanzapine is highly effective but associated with significant metabolic side effects (weight gain, hyperglycemia, dyslipidemia). Proactive monitoring and patient education on lifestyle modifications are critical.
- Consider the orally disintegrating tablet (Zyprexa Zydis) for patients who have difficulty swallowing or may be non-adherent.
- IM olanzapine is used for acute agitation and has a rapid onset of action.
- Smoking (due to CYP1A2 induction) can significantly reduce olanzapine plasma levels, potentially leading to reduced efficacy. Dosage adjustments may be needed if a patient starts or stops smoking.
- Orthostatic hypotension is a common side effect, especially during initiation and dose titration. Advise patients to rise slowly from sitting or lying positions.
- Olanzapine has a relatively low risk of EPS compared to typical antipsychotics, but tardive dyskinesia can still occur. Regular AIMS assessments are important.
Alternative Therapies
- Other atypical antipsychotics (e.g., risperidone, quetiapine, aripiprazole, ziprasidone, lurasidone, cariprazine, brexpiprazole)
- Typical antipsychotics (e.g., haloperidol, chlorpromazine) (less common due to higher EPS risk)
- Mood stabilizers (e.g., lithium, valproate, lamotrigine) for bipolar disorder
- Antidepressants (for depression, often in combination with an antipsychotic for bipolar depression or treatment-resistant depression)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (5mg)
Generic Available:
Yes
Insurance Coverage:
Most insurance plans cover generic olanzapine, often as a Tier 1 or Tier 2 medication. Brand name Zyprexa may require prior authorization or be on a higher tier.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.