Olanzapine ODT 15mg Tablets

Olanzapine is an atypical antipsychotic that exhibits antagonism at multiple receptors, including dopamine D1, D2, D3, D4, D5, serotonin 5-HT2A, 5-HT2B, 5-HT2C, 5-HT3, 5-HT6, muscarinic M1-M5, alpha1-adrenergic, 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 or seek immediate 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
+ 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
Neurological symptoms, such as:
+ Trouble controlling body movements
+ Twitching
+ Change in balance
+ Trouble swallowing or speaking
Mental, mood, or behavior changes that are new or worsening, including:
+ Thoughts of hurting yourself or suicide
Severe dizziness or passing out
Abnormal heartbeat (fast or slow)
Inability to sweat during activities or in warm temperatures
Seizures
Drooling
Changes in eyesight
Memory problems or loss
Chest pain
Swelling
Burning, numbness, or tingling sensations that are not normal
Trouble passing urine
Hormonal changes, including:
+ Enlarged breasts
+ Nipple discharge
+ Erectile dysfunction
+ Menstrual changes
Swollen glands
Neuroleptic malignant syndrome (NMS), a rare but potentially deadly 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; 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:
+ Trouble controlling body movements
+ Problems with your tongue, face, mouth, or jaw, such as:
- Tongue sticking out
- Puffing cheeks
- Mouth puckering
- Chewing

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:

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

If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.

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 assess 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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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 activities that require you to be alert. 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
Medications 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 health, follow your doctor's instructions for checking your blood sugar levels and undergoing blood work and other laboratory tests.

Substance Interactions
Avoid consuming alcohol while taking this medication. Before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor.

Common Side Effects
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and related injuries, such as broken bones. Be cautious to prevent accidents.

Severe Allergic Reaction
In rare cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms like fever, rash, swollen glands, and problems with organs such as the liver, kidney, blood, heart, muscles and joints, or lungs. If you have concerns, discuss them with your doctor.

Special Considerations for Older Adults
Older adults with dementia who take medications like this one have a higher risk of stroke, 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.

Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in this population.

Reproductive Health
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have questions or concerns, consult with your doctor.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of this medication for 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 risk of sedation, respiratory depression, hypotension.
• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase olanzapine plasma concentrations, requiring dose reduction.
• CYP1A2 inducers (e.g., carbamazepine, rifampin, omeprazole, smoking): May decrease olanzapine plasma concentrations, requiring dose increase.
• Anticholinergic agents: Potentiation of anticholinergic effects (e.g., severe constipation, urinary retention, heat intolerance).

• Antihypertensive agents: Increased risk of orthostatic hypotension.
• Dopamine agonists (e.g., bromocriptine, levodopa): Olanzapine may antagonize their effects.
• Drugs that prolong QT interval: Additive risk of QT prolongation (use with caution).

• Lithium or Valproate: No significant pharmacokinetic interaction, but monitor for additive CNS effects.

• Sedation/Drowsiness
• Dizziness/Orthostatic Hypotension
• Extrapyramidal Symptoms (EPS) including akathisia, dystonia, parkinsonism
• Tardive Dyskinesia (involuntary movements, especially of face and tongue)
• Neuroleptic Malignant Syndrome (NMS) - fever, muscle rigidity, altered mental status, autonomic instability
• Anticholinergic effects (e.g., dry mouth, constipation, blurred vision, urinary retention)
• Signs of hyperglycemia (e.g., polyuria, polydipsia, polyphagia, weakness)
• Signs of dyslipidemia
• Seizures
• Changes in mental status or behavior

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Olanzapine is excreted into human breast milk. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.

Approved for adolescents (13-17 years) for schizophrenia and bipolar I disorder. Not established for children younger than 13 years. Adolescents may be at higher risk for weight gain and metabolic adverse effects compared to adults.

Elderly patients, especially those with dementia-related psychosis, are at increased risk of death and cerebrovascular adverse events (e.g., stroke, TIA) when treated with olanzapine. Olanzapine is not approved for this indication. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation, falls).

• Olanzapine ODT should be administered immediately upon removal from the blister pack. Do not push the tablet through the foil. Peel back the foil and gently remove the tablet.
• Place the ODT on the tongue; it will rapidly disintegrate and can be swallowed with or without liquid.
• Significant weight gain and metabolic abnormalities (hyperglycemia, dyslipidemia) are common with olanzapine. Regular monitoring of weight, blood glucose, and lipids is crucial.
• Risk of orthostatic hypotension, especially during initial titration. Advise patients to rise slowly.
• Monitor for tardive dyskinesia, particularly with long-term use. Consider dose reduction or discontinuation if it develops.
• Neuroleptic Malignant Syndrome (NMS) is a rare but potentially fatal adverse effect; discontinue olanzapine immediately if NMS is suspected.
• Olanzapine has significant anticholinergic activity, which can lead to side effects like dry mouth, constipation, and blurred vision.

• Other atypical antipsychotics (e.g., Aripiprazole, Quetiapine, Risperidone, Ziprasidone, Lurasidone, Cariprazine, Brexpiprazole)
• First-generation antipsychotics (e.g., Haloperidol, Chlorpromazine) - generally less preferred due to higher EPS risk.
• Mood stabilizers (e.g., Lithium, Valproate, Carbamazepine, Lamotrigine) for bipolar disorder.

If your symptoms or health issues persist or worsen, it is 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 for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other 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.