Olanzapine 10mg 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, M2, M3, M4, 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 experience any of the following symptoms, contact your doctor or seek medical help 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 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, including:
+ Enlarged breasts
+ Nipple discharge
+ Erectile dysfunction
+ Menstrual changes
Swollen glands
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS), which may cause:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Low white blood cell counts, which may increase the risk of infection; if you have a history of low white blood cell counts, inform your doctor and seek medical help immediately if you experience:
+ Fever
+ Chills
+ Sore throat
Tardive dyskinesia, a severe muscle problem that may cause:
+ 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 possible 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 or other side effects bother you or do not go away, contact your doctor or seek medical help. 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.

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 alertness, as it may affect your ability to stay alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.

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 and undergo regular blood tests and other laboratory evaluations as recommended.

Avoid consuming alcohol while taking this medication, and consult your doctor before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness. This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls, which can result in fractures or other health issues.

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

Older adults 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, planning to become pregnant, or 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): Potentiation of anticholinergic effects (e.g., severe constipation, urinary retention, heat intolerance).
• Drugs that prolong QT interval (e.g., quinidine, sotalol, thioridazine): Increased risk of arrhythmias.
• Dopamine agonists (e.g., levodopa, bromocriptine): Olanzapine may antagonize their effects.
• Fluvoxamine (CYP1A2 inhibitor): Significantly increases olanzapine levels.
• Carbamazepine (CYP1A2 inducer): Significantly decreases olanzapine levels.
• Smoking (CYP1A2 inducer): Decreases olanzapine levels.

• Antihypertensives: Increased risk of orthostatic hypotension.
• Diazepam: Increased orthostatic hypotension.
• Ethanol: Enhanced sedative effect.
• Omeprazole, Rifampin (CYP1A2 inducers): May decrease olanzapine levels.
• Ciprofloxacin (CYP1A2 inhibitor): May increase olanzapine levels.

• Antacids: No significant effect on absorption.

• Sedation/Somnolence
• Dizziness/Orthostatic Hypotension
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Weight gain
• Increased thirst/urination (signs of hyperglycemia)
• Muscle stiffness/tremor/restlessness (EPS)
• Involuntary movements (Tardive Dyskinesia)
• Changes in mood or behavior
• Signs of Neuroleptic Malignant Syndrome (NMS): fever, severe muscle rigidity, altered mental status, autonomic instability

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. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitoring for sedation, poor feeding, and developmental milestones in the infant is recommended.

Safety and efficacy not established for children under 13 years of age. Adolescents (13-17 years) may experience higher rates of weight gain, increases in lipids, and prolactin elevations compared to adults.

Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death and cerebrovascular adverse events. Olanzapine is not approved for this indication. Generally, lower starting doses and slower titration are recommended due to increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation).

• Olanzapine is associated with a high risk of metabolic side effects (weight gain, dyslipidemia, hyperglycemia), requiring diligent monitoring.
• It has a relatively low risk of EPS compared to first-generation antipsychotics.
• Sedation is a common side effect, especially at the beginning of treatment; taking it at bedtime can help mitigate this.
• Smoking can significantly reduce olanzapine levels due to CYP1A2 induction, potentially leading to loss of efficacy. Dose adjustments may be needed if a patient starts or stops smoking.
• The orally disintegrating tablet (Zyprexa Zydis) can be useful for patients who have difficulty swallowing pills or who may be non-adherent.
• Consider alternative agents or aggressive metabolic monitoring/interventions for patients with pre-existing metabolic risk factors.

• 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.

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 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.