Olanzapine ODT 20mg Tablets

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, muscarinic M1-M5 receptors, alpha-1 adrenergic receptors, and histamine H1 receptors. Its antipsychotic activity is thought to be mediated through a combination of dopamine D2 and serotonin 5-HT2A antagonism.

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
+ Drowsiness
+ 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 heart rhythms (fast or slow heartbeat)
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 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 counts, which can increase the risk of infection; if you have a history of low white blood cell counts, inform your doctor and seek medical attention if you experience:
+ Fever
+ Chills
+ Sore throat
Tardive dyskinesia, a severe muscle problem, which may cause:
+ Involuntary movements
+ Tongue sticking out
+ Puffing cheeks
+ Mouth puckering
+ Chewing problems

Other Possible Side Effects

While many people may not experience side effects or only have mild 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 have concerns about other symptoms, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems you have. This information is crucial in determining the safety of taking this medication in conjunction with your other health conditions.

To ensure your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to assess potential interactions and ensure the safe use of this medication.

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 and avoid driving or engaging in activities that require alertness until you understand how it affects you. 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 can increase the risk of developing high blood sugar or diabetes, high cholesterol, and weight gain, which may contribute to heart and brain blood vessel disease. As directed by your doctor, monitor your blood sugar levels and undergo regular blood work and other laboratory tests.

It is recommended to avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls and subsequent injuries, such as fractures.

In rare cases, a severe and potentially life-threatening reaction can occur, characterized by symptoms like fever, rash, swollen glands, and problems affecting organs such as the liver, kidney, blood, heart, muscles and joints, or lungs. If you have concerns, 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 they may have a higher risk of experiencing certain side effects.

This medication may affect fertility, but this effect is reversible once the medication is discontinued. If you have questions, consult with your doctor.

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

• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased sedation, respiratory depression.
• Anticholinergic drugs (e.g., benztropine, tricyclic antidepressants): Increased risk of anticholinergic side effects (e.g., constipation, urinary retention, dry mouth, blurred vision).
• 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.

• Antihypertensive agents: Increased risk of orthostatic hypotension.
• Levodopa and dopamine agonists: Olanzapine may antagonize their 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.

• Not available

• Excessive sedation
• Dizziness or lightheadedness (orthostatic hypotension)
• Dry mouth, blurred vision, constipation, urinary retention (anticholinergic effects)
• Muscle stiffness, tremor, restlessness (EPS)
• Uncontrolled movements (tardive dyskinesia)
• Increased thirst, urination, hunger (hyperglycemia)
• Fever, muscle rigidity, altered mental status, autonomic instability (Neuroleptic Malignant Syndrome)
• Sore throat, fever, signs of infection (agranulocytosis/neutropenia)

Category C. Use 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.

Olanzapine is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for sedation, poor feeding, and weight gain.

Not approved for use in children under 13 years of age. For adolescents (13-17 years) with schizophrenia or bipolar I mania, lower starting doses and careful titration are recommended due to higher rates of weight gain, dyslipidemia, and sedation compared to adults.

Elderly patients, particularly those with dementia-related psychosis, are at increased risk of death when treated with antipsychotics. Olanzapine is not approved for this indication. Elderly patients may be more sensitive to the anticholinergic, hypotensive, and sedative effects. Consider lower starting doses and slower titration.

• Olanzapine ODT is bioequivalent to the conventional tablet and can be taken without water, which may be beneficial for patients with dysphagia or those who may be non-adherent to traditional tablets.
• Significant weight gain and metabolic abnormalities (hyperglycemia, dyslipidemia) are common and require proactive monitoring and management.
• Orthostatic hypotension is a risk, especially at initiation and with dose increases; advise patients to rise slowly.
• Sedation is a common side effect, often leading to once-daily dosing at bedtime.
• While generally having a lower risk of EPS than first-generation antipsychotics, EPS and tardive dyskinesia can still occur.
• Smoking (due to CYP1A2 induction) can significantly reduce olanzapine levels, potentially requiring higher doses in smokers.

• Other atypical antipsychotics (e.g., Aripiprazole, Quetiapine, Risperidone, Lurasidone, Cariprazine, Brexpiprazole, Ziprasidone)
• Mood stabilizers (e.g., Lithium, Valproate, Carbamazepine, Lamotrigine) for bipolar disorder.
• First-generation antipsychotics (e.g., Haloperidol, Chlorpromazine) for schizophrenia.

If your symptoms or health issues persist or worsen, 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 patient fact sheet that provides crucial information about its use. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it was taken.