Olanzapine ODT 5mg 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, adrenergic α1, histamine H1, and muscarinic M1, M2, M3, M4, M5 receptors. Its antipsychotic efficacy is believed to be mediated through a combination of dopamine and serotonin antagonism, particularly 5-HT2A and D2 receptor blockade.

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
+ 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 problems, 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)
Not sweating 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, such as:
+ 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
+ Fast 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 severe muscle problem, characterized by:
+ 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's 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 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.

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

Important Warnings and Precautions

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, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

Metabolic and Cardiovascular Risks
Drugs similar to 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. Therefore, it is crucial to:

Monitor your blood sugar levels as directed by your doctor
Undergo regular blood work and other laboratory tests as advised by your doctor

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

Potential Side Effects
This medication may cause dizziness, drowsiness, and impaired stability, which can increase the risk of falls, broken bones, and other health problems.

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

Special Considerations for Older Adults and Children
Older adults with dementia who take medications like this one may 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.

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

Reproductive and Pregnancy Considerations
This medication may affect fertility, but this effect is reversible when 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. You will need to discuss the benefits and risks of this medication 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.
• Drugs that prolong QT interval (e.g., quinidine, sotalol, thioridazine): Additive QT prolongation risk.
• Dopamine agonists (e.g., levodopa, bromocriptine): Olanzapine may antagonize their effects.
• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): Increased olanzapine plasma levels.
• CYP1A2 inducers (e.g., carbamazepine, rifampin, omeprazole, smoking): Decreased olanzapine plasma levels.

• Anticholinergic agents: Potentiation of anticholinergic effects (e.g., constipation, dry mouth, blurred vision, urinary retention).
• Antihypertensive agents: Additive hypotensive effects, particularly orthostatic hypotension.
• Valproate: Increased risk of neutropenia when co-administered with olanzapine.
• Lithium: No significant pharmacokinetic interaction, but monitor for adverse effects.

• Not available

• Sedation/Drowsiness
• Dizziness/Orthostatic Hypotension
• Anticholinergic effects (dry mouth, constipation, blurred vision, urinary retention)
• Weight gain
• Symptoms of hyperglycemia (polyuria, polydipsia, polyphagia)
• Symptoms of dyslipidemia
• Extrapyramidal symptoms (tremor, rigidity, akathisia, dystonia)
• Tardive dyskinesia (involuntary movements of face, tongue, limbs)
• Neuroleptic Malignant Syndrome (fever, muscle rigidity, altered mental status, autonomic instability)
• Suicidal ideation or worsening of depression (especially in children, adolescents, young adults)
• Seizures
• Rash or allergic reactions

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 of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Olanzapine is excreted into breast milk. The American Academy of Pediatrics considers it to be of unknown effect on the nursing infant but may be of concern. Monitor breastfed infants for sedation, irritability, poor feeding, and weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.

Safety and efficacy not established in children under 13 years of age. Use in adolescents (13-17 years) for schizophrenia and bipolar I disorder is established, but with a Black Box Warning regarding increased risk of suicidal thoughts and behaviors. Monitor closely for metabolic side effects (weight gain, dyslipidemia, hyperglycemia) which may be more pronounced in this population.

Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death (Black Box Warning). Olanzapine is not approved for this indication. Elderly patients may be more susceptible to orthostatic hypotension, anticholinergic effects, and metabolic side effects. Use lower initial doses and titrate slowly, monitoring closely for adverse effects.

• Olanzapine ODT (Orally Disintegrating Tablet) should be administered immediately upon removal from the blister pack. Do not chew or crush the tablet; allow it to dissolve on the tongue and then swallow with saliva.
• Due to the risk of significant weight gain and metabolic abnormalities (hyperglycemia, dyslipidemia), thorough baseline and ongoing monitoring of weight, BMI, fasting glucose, and lipid profiles is crucial.
• Patients should be educated on the importance of healthy lifestyle choices (diet, exercise) to mitigate metabolic risks.
• Olanzapine can cause sedation; advise patients to take it at bedtime if possible, and to avoid activities requiring mental alertness until they know how the medication affects them.
• The Black Box Warning for increased mortality in elderly patients with dementia-related psychosis is critical; olanzapine should not be used for this indication.
• Monitor for extrapyramidal symptoms (EPS) and tardive dyskinesia, especially with long-term use. Consider using AIMS scale regularly.

• 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, Lamotrigine) for bipolar disorder
• Antidepressants (for depressive episodes in bipolar disorder, often with a mood stabilizer or antipsychotic)
• Psychotherapy (e.g., Cognitive Behavioral Therapy, Family-Focused Therapy)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, 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 and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with 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 amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.