Olanzapine 7.5mg Tablets

Manufacturer MACLEODS PHARMACEUTICALS Active Ingredient Olanzapine Tablets(oh LAN za peen) Pronunciation oh LAN za peen
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.
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Drug Class
Antipsychotic
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Pharmacologic Class
Atypical antipsychotic; Thienobenzodiazepine
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Pregnancy Category
Category C
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FDA Approved
Sep 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Olanzapine is a medication used to treat mental health conditions like schizophrenia and bipolar disorder. It works by helping to balance certain natural chemicals in the brain, which can improve thoughts, feelings, and behavior. It's important to take it regularly as prescribed and be aware of potential side effects like weight gain or drowsiness.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated. Be mindful of your body's needs, especially in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration. You can take this medication with or without food, but if it causes stomach upset, taking it with food may help alleviate this issue.

It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better. This will help ensure that you receive the full benefits of the treatment.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom, as the moisture and humidity can affect the medication's potency. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs, which can provide a safe and environmentally responsible way to dispose of your medication.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Take exactly as prescribed, do not stop abruptly without consulting your doctor.
  • Avoid alcohol and other CNS depressants, as they can increase drowsiness and other side effects.
  • Monitor your weight regularly and discuss any significant changes with your doctor.
  • Maintain a healthy diet and exercise routine to help manage potential weight gain and metabolic changes.
  • Be aware of symptoms of high blood sugar (increased thirst, urination, hunger) and report them to your doctor.
  • Avoid overheating and dehydration, as olanzapine can affect the body's ability to regulate temperature.
  • Use caution when driving or operating machinery until you know how this medication affects you, due to potential drowsiness or dizziness.

Dosing & Administration

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Adult Dosing

Standard Dose: Schizophrenia: 10-15 mg once daily. Bipolar I Disorder (manic/mixed episodes): 10-15 mg once daily (monotherapy) or 10-20 mg once daily (adjunctive).
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

schizophrenia: Initial: 5-10 mg/day, target: 10-15 mg/day. Max: 20 mg/day.
bipolar_manic_mixed: Initial: 10-15 mg/day (monotherapy), 10 mg/day (adjunctive). Max: 20 mg/day.
bipolar_maintenance: 10-20 mg/day.
agitation_associated_with_schizophrenia_or_bipolar_mania: IM: 10 mg (single dose), may repeat after 2 hours, max 30 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 13 years.
Adolescent: Schizophrenia (13-17 years): Initial 2.5-5 mg/day, target 10 mg/day. Max 20 mg/day. Bipolar I Disorder (13-17 years): Initial 2.5-5 mg/day, target 10 mg/day. Max 20 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally required.
Moderate: No dosage adjustment generally required.
Severe: No dosage adjustment generally required, but caution advised.
Dialysis: Not significantly removed by dialysis; no specific adjustment, but caution advised.

Hepatic Impairment:

Mild: No dosage adjustment generally required.
Moderate: Consider lower starting dose (e.g., 5 mg/day) and titrate cautiously.
Severe: Not available, use with extreme caution or avoid.

Pharmacology

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Mechanism of Action

Olanzapine is an atypical antipsychotic that exhibits antagonism at multiple receptors, including dopamine D1, D2, D3, D4, and D5 receptors, serotonin 5-HT2A, 5-HT2C, 5-HT3, and 5-HT6 receptors, alpha-1 adrenergic receptors, histamine H1 receptors, and muscarinic M1-M5 receptors. Its antipsychotic activity is thought to be mediated through a combination of dopamine and serotonin antagonism, with a higher affinity for 5-HT2A receptors than D2 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: 60-80%
Tmax: 5-8 hours
FoodEffect: Food does not affect the rate or extent of absorption.

Distribution:

Vd: 1000 L (approximately)
ProteinBinding: 93% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration: Yes

Elimination:

HalfLife: 21-54 hours (mean 33 hours)
Clearance: Approximately 25 L/hour (oral)
ExcretionRoute: Urine (57%), Feces (30%)
Unchanged: < 7% (in urine)
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Pharmacodynamics

OnsetOfAction: Within hours to days for initial symptom control; full therapeutic effect may take weeks.
PeakEffect: Peak plasma concentrations at 5-8 hours; clinical peak effect varies.
DurationOfAction: Once daily dosing due to long half-life.

Safety & Warnings

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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.
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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 or seek medical attention immediately:

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
+ Trouble 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
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking
New or worsening mental, mood, or behavior changes, including thoughts of hurting yourself or suicide
Severe dizziness or passing out
Fast or slow heartbeat
Not sweating during activities or in warm temperatures
Seizures
Drooling
Changes in eyesight
Memory problems or loss
Chest pain
Swelling
Burning, numbness, or tingling feelings that are not normal
Trouble passing urine
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
Swollen glands
Neuroleptic malignant syndrome (NMS), a potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Low white blood cell counts, which can increase the risk of infection, particularly if you have a history of low white blood cell counts; seek medical attention if you experience:
+ Fever
+ Chills
+ Sore throat
Tardive dyskinesia, a severe muscle problem, which may be more likely to occur in people with diabetes, older adults, especially older females, and those taking higher doses or using the medication for an extended period; seek medical attention if you experience:
+ Trouble controlling body movements
+ Problems with your tongue, face, mouth, or jaw, such as tongue sticking out, puffing cheeks, mouth puckering, or chewing

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following potential side effects. If you experience any of these symptoms or if they bother you or do not go away, contact your doctor or seek medical attention:

Feeling dizzy, sleepy, tired, or weak
Restlessness
Shakiness
Headache
Constipation
Dry mouth
Upset stomach
Weight gain
Increased appetite
Back pain
Joint pain
Trouble sleeping

Reporting Side Effects

If you have questions about side effects or want to report any side effects, you can:

Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
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Seek Immediate Medical Attention If You Experience:

  • Uncontrolled muscle movements (especially of the face, tongue, or limbs)
  • High fever, stiff muscles, confusion, sweating, fast or irregular heartbeat (signs of NMS)
  • Severe dizziness or fainting when standing up
  • Signs of high blood sugar (increased thirst, increased urination, increased hunger, weakness)
  • Signs of infection (fever, sore throat, chills)
  • Yellowing of skin or eyes (jaundice)
  • Unusual bleeding or bruising
  • Thoughts of self-harm or suicide (especially in young adults)
  • Difficulty swallowing
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all prescription and over-the-counter (OTC) medications, natural products, and vitamins you are taking to both your doctor and pharmacist.
* All existing health problems, as they may affect the safety of taking this medication.

Remember, it is crucial to verify the safety of taking this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.

Be aware that medications like this one have been associated with increased risks of high blood sugar, diabetes, high cholesterol, and weight gain, which may contribute to the development of heart and brain blood vessel disease. As directed by your doctor, monitor your blood sugar levels and undergo regular blood work and laboratory tests.

Avoid consuming alcohol while taking this medication, and consult your doctor before using marijuana, cannabis, or prescription and over-the-counter medications that may cause drowsiness. This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and related injuries, such as fractures.

In rare cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms such as fever, rash, swollen glands, and organ dysfunction (e.g., liver, kidney, blood, heart, muscles, joints, or lungs). If you have any concerns or questions, discuss them with your doctor.

Elderly patients with dementia who take medications like this one have a higher risk of experiencing strokes, which can be fatal. This medication is not approved for treating dementia-related mental health issues. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population. This medication may affect fertility, but this effect is reversible upon discontinuation of the medication. If you have questions or concerns, consult your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks to you and your baby. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Slurred speech
  • Agitation
  • Tachycardia (fast heart rate)
  • Extrapyramidal symptoms (tremor, rigidity)
  • Coma
  • Respiratory depression
  • Hypotension
  • Seizures

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased sedation, respiratory depression.
  • Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Increased risk of arrhythmias.
  • Dopamine agonists (e.g., levodopa, bromocriptine): Olanzapine may antagonize their effects.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): Significantly increase olanzapine levels.
  • Strong CYP1A2 inducers (e.g., carbamazepine, rifampin, omeprazole, smoking): Significantly decrease olanzapine levels.
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Moderate Interactions

  • Anticholinergic drugs: Potentiation of anticholinergic effects (e.g., constipation, dry mouth, blurred vision).
  • Antihypertensive agents: Additive hypotensive effects.
  • Drugs causing orthostatic hypotension.
  • Valproate: Increased risk of neutropenia/leukopenia when co-administered with olanzapine.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Weight/BMI

Rationale: Risk of significant weight gain and metabolic changes.

Timing: Before initiation

Fasting Plasma Glucose (FPG) or HbA1c

Rationale: Risk of hyperglycemia and new-onset diabetes.

Timing: Before initiation

Lipid Panel (Fasting)

Rationale: Risk of dyslipidemia.

Timing: Before initiation

Blood Pressure

Rationale: Risk of orthostatic hypotension.

Timing: Before initiation

Personal/Family History of Diabetes, Dyslipidemia, Cardiovascular Disease

Rationale: To assess baseline risk factors.

Timing: Before initiation

Mental Status Examination

Rationale: To establish baseline psychiatric symptoms and cognitive function.

Timing: Before initiation

Movement Disorder Assessment (e.g., AIMS)

Rationale: To establish baseline for extrapyramidal symptoms (EPS) and tardive dyskinesia.

Timing: Before initiation

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Routine Monitoring

Weight/BMI

Frequency: Monthly for first few months, then quarterly

Target: Maintain healthy BMI

Action Threshold: Significant weight gain (e.g., >5% baseline) warrants intervention.

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 β‰₯100 mg/dL or HbA1c β‰₯5.7% warrants further evaluation/intervention.

Lipid Panel (Fasting)

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: Abnormal lipid levels warrant intervention.

Blood Pressure

Frequency: Monthly for first few months, then quarterly

Target: <120/80 mmHg

Action Threshold: Sustained hypertension or symptomatic orthostatic hypotension.

Mental Status Examination

Frequency: Regularly, as clinically indicated

Target: Improvement or stabilization of psychiatric symptoms

Action Threshold: Worsening symptoms, emergence of new symptoms, or lack of response.

Movement Disorder Assessment (e.g., AIMS)

Frequency: Every 6-12 months, or as clinically indicated

Target: Absence of abnormal involuntary movements

Action Threshold: Emergence or worsening of EPS or tardive dyskinesia.

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Symptom Monitoring

  • Sedation/Drowsiness
  • Dizziness/Orthostatic Hypotension
  • Dry mouth
  • Constipation
  • Weight gain
  • Increased appetite
  • Hyperglycemia symptoms (polydipsia, polyuria, polyphagia)
  • Extrapyramidal symptoms (akathisia, dystonia, parkinsonism)
  • Tardive dyskinesia (involuntary movements, especially of face/mouth)
  • Neuroleptic Malignant Syndrome (NMS) symptoms (fever, muscle rigidity, altered mental status, autonomic instability)
  • Seizures
  • Suicidal ideation (especially in children, adolescents, young adults)
  • Signs of agranulocytosis (fever, sore throat, infection)

Special Patient Groups

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Pregnancy

Olanzapine is a Pregnancy Category C drug. 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 malformation risk.
Second Trimester: Limited data.
Third Trimester: Risk of extrapyramidal and/or withdrawal symptoms in neonates (e.g., agitation, tremor, hypertonia, hypotonia, respiratory distress, feeding disorder). Monitor neonates for these symptoms.
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Lactation

Olanzapine is excreted into breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for olanzapine, and any potential adverse effects on the breastfed infant from olanzapine or from the underlying maternal condition. Monitor infants for sedation, irritability, poor feeding, and weight gain.

Infant Risk: L3 (Moderate risk) - Potential for infant sedation, poor feeding, and weight gain. Monitor infant closely.
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Pediatric Use

Approved for schizophrenia and bipolar I disorder in adolescents (13-17 years). Not recommended for children under 13 years due to lack of established efficacy and safety. Higher rates of weight gain, lipid abnormalities, and elevated prolactin levels observed in pediatric patients compared to adults.

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Geriatric Use

Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death. Olanzapine is not approved for this indication. Use lower starting doses and slower titration in elderly patients due to increased sensitivity to anticholinergic and hypotensive effects. Monitor closely for orthostatic hypotension and sedation.

Clinical Information

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Clinical Pearls

  • Olanzapine is associated with a high risk of weight gain and metabolic abnormalities (hyperglycemia, dyslipidemia). Regular monitoring of weight, glucose, and lipids is crucial.
  • Sedation is a common side effect, especially at the start of treatment. Dosing at bedtime can help mitigate this.
  • Consider the long half-life when adjusting doses; steady state is reached in about a week.
  • Smoking can significantly reduce olanzapine levels due to CYP1A2 induction; dose adjustments may be needed if a patient starts or stops smoking.
  • While effective, its metabolic side effect profile often leads to it being a second-line choice for some patients, especially those with pre-existing metabolic risk factors.
  • Oral disintegrating tablets (Zyprexa Zydis) are available for patients who have difficulty swallowing or may be non-adherent.
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Alternative Therapies

  • Other atypical antipsychotics (e.g., Risperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine)
  • Typical antipsychotics (e.g., Haloperidol, Chlorpromazine) - generally less preferred due to higher EPS risk.
  • Mood stabilizers (e.g., Lithium, Valproate, Carbamazepine) for bipolar disorder.
  • Antidepressants (often adjunctive for bipolar depression, but not monotherapy for mania/psychosis).
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (7.5mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.