Olanzapine ODT 10mg Tablets

Olanzapine is an atypical antipsychotic with affinity for a number of neurotransmitter receptors. Its antipsychotic activity is thought to be mediated through a combination of antagonism at dopamine D2 and serotonin 5-HT2A receptors. It also has affinity for 5-HT2C, 5-HT3, 5-HT6, D1, D3, D4, muscarinic M1-M5, alpha-1 adrenergic, and histamine H1 receptors.

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
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)
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, 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
+ 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 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, or 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 any of these side effects bother you or do not go away, 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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

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 engaging in activities 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.

This medication may increase your risk of developing high blood sugar, diabetes, high cholesterol, and weight gain, which can contribute to heart and brain blood vessel disease. Monitor your blood sugar levels as instructed by your doctor, and undergo regular blood tests and other laboratory evaluations as recommended.

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

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

In rare cases, this medication can cause a severe and potentially life-threatening reaction, 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, discuss them with your doctor.

Elderly patients with dementia who take this type of medication 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 be at a higher risk of experiencing certain side effects.

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

If you are pregnant, planning to become pregnant, or 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.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased risk of sedation, respiratory depression, hypotension.
• Anticholinergic drugs (e.g., benztropine, tricyclic antidepressants): Potentiation of anticholinergic effects (e.g., severe constipation, urinary retention, heat intolerance).
• Dopamine agonists (e.g., levodopa, bromocriptine): Olanzapine may antagonize their effects.
• Drugs that prolong QT interval (e.g., quinidine, sotalol, certain antipsychotics): Additive risk of QT prolongation, though olanzapine's effect is minimal.

• 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.
• Antihypertensive agents: Additive hypotensive effects, especially orthostatic hypotension.
• Valproate: Increased incidence of weight gain, neutropenia, and tremor when co-administered with olanzapine.

• Lithium: No significant pharmacokinetic interaction, but monitor for additive CNS effects.
• Cimetidine, antacids: No significant effect on olanzapine absorption.

• Excessive sedation or somnolence
• Dizziness or lightheadedness (orthostatic hypotension)
• Unusual weight gain or increased appetite
• Increased thirst or urination (signs of hyperglycemia)
• Muscle stiffness, tremors, restlessness (EPS)
• Involuntary movements of face, tongue, or limbs (TD)
• Constipation or urinary retention (anticholinergic effects)
• Changes in mood or behavior (worsening of symptoms or emergence of new ones)
• Signs of neuroleptic malignant syndrome (fever, muscle rigidity, altered mental status, autonomic instability)

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.

L3 (Moderately safe). Olanzapine is excreted into breast milk. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones. Consider risks vs. benefits; alternative agents with lower milk transfer or formula feeding may be considered.

Approved for schizophrenia and bipolar I disorder (manic or mixed episodes) in adolescents (13-17 years). Higher incidence of weight gain, increased lipids, and sedation compared to adults. Careful monitoring of metabolic parameters is crucial.

Increased risk of death in elderly patients with dementia-related psychosis (Black Box Warning). Increased susceptibility to orthostatic hypotension, sedation, and anticholinergic effects. Use lower initial doses and titrate slowly. Monitor for falls and cognitive impairment.

• Olanzapine ODT should be administered immediately upon removal from the blister pack. Do not store it outside the blister pack.
• The ODT formulation is beneficial for patients who have difficulty swallowing pills or who may be non-adherent with conventional tablets.
• Significant metabolic side effects (weight gain, dyslipidemia, hyperglycemia) are common with olanzapine. Proactive monitoring and lifestyle interventions are essential.
• Orthostatic hypotension is a common side effect, especially during initial titration. Advise patients to rise slowly from a sitting or lying position.
• Smoking can significantly reduce olanzapine levels due to CYP1A2 induction, potentially requiring higher doses in smokers.
• Consider the risk of tardive dyskinesia with long-term use; periodically assess for abnormal involuntary movements using a standardized scale (e.g., AIMS).

• Other atypical antipsychotics (e.g., risperidone, quetiapine, aripiprazole, 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 bipolar depression, often in combination with a mood stabilizer or antipsychotic)

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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this 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, and the time it occurred.