Olanzapine 15mg Tablets

Olanzapine is an atypical antipsychotic with affinity for a number of neurotransmitter receptors. It is a potent antagonist of serotonin 5-HT2A/2C, 5-HT6, 5-HT7, dopamine D1, D2, D3, D4, D5, muscarinic M1-5, and alpha-1 adrenergic receptors. Its antipsychotic activity is thought to be mediated through a combination of dopamine D2 and serotonin 5-HT2A antagonism, with a higher affinity for 5-HT2A receptors than D2 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 experience 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, 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 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, 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 side effects or may only have minor 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 symptoms bother you or do not go away, contact your doctor or seek medical attention. 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 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 or exacerbate underlying health issues.

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

Important Warnings and Cautions

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
Drugs 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. Regularly check your blood sugar levels as instructed by your doctor, and undergo blood work and other lab tests as recommended.

Substance Interactions
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.

Dizziness and Falling Risks
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls, broken bones, and other health problems.

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

Special Considerations

Older adults with dementia taking medications like this one have a higher risk of 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 used in children, this medication requires careful consideration, as the risk of certain side effects may be higher.
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have questions, consult with your doctor.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You and your doctor will need to discuss the benefits and risks of this medication to you and your baby.
Taking this medication during the third trimester of pregnancy may lead to side effects or withdrawal symptoms in the newborn.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased sedation and CNS depression.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolones): Increased risk of arrhythmias.
• Dopamine agonists (e.g., levodopa): Olanzapine may antagonize effects.

• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase olanzapine plasma concentrations.
• CYP1A2 inducers (e.g., carbamazepine, rifampin, omeprazole, smoking): May decrease olanzapine plasma concentrations.
• Anticholinergic agents: Potentiation of anticholinergic effects (e.g., constipation, dry mouth, blurred vision).
• Antihypertensive agents: Potentiation of orthostatic hypotension.

• Sedation/Drowsiness
• Orthostatic Hypotension (dizziness upon standing)
• Extrapyramidal Symptoms (EPS) including akathisia, dystonia, parkinsonism
• Metabolic changes (e.g., increased thirst, urination, hunger, weight gain)
• Anticholinergic effects (e.g., dry mouth, constipation, blurred vision)
• Suicidal ideation or worsening of psychiatric symptoms
• Neuroleptic Malignant Syndrome (NMS) symptoms (fever, muscle rigidity, altered mental status, autonomic instability)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) symptoms (rash, fever, lymphadenopathy, organ involvement)

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. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones. Weigh the benefits of breastfeeding against the potential risks to the infant.

Approved for schizophrenia and bipolar I disorder in adolescents (13-17 years). Adolescents may be at higher risk for weight gain and dyslipidemia compared to adults. Close monitoring of metabolic parameters is crucial.

Increased risk of mortality and cerebrovascular adverse events (including stroke) in elderly patients with dementia-related psychosis; olanzapine is not approved for this indication. Consider lower starting doses and slower titration due to potential for increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation).

• Olanzapine has a high propensity for weight gain and metabolic side effects (hyperglycemia, dyslipidemia). Regular monitoring of weight, glucose, and lipids is essential.
• It is generally very sedating and often taken at bedtime to mitigate daytime drowsiness.
• Risk of orthostatic hypotension, especially during initiation and dose titration. Advise patients to rise slowly.
• Consider the long half-life when adjusting doses or managing side effects.
• Smoking (due to CYP1A2 induction) can significantly reduce olanzapine levels, potentially leading to loss of efficacy. Dose adjustments may be needed if a patient starts or stops smoking.

• Other atypical antipsychotics (e.g., Aripiprazole, Quetiapine, Risperidone, Ziprasidone, Lurasidone, Cariprazine, Brexpiprazole)
• Typical antipsychotics (e.g., Haloperidol, Chlorpromazine) - generally less preferred due to higher EPS risk.
• Mood stabilizers (e.g., Lithium, Valproate, Carbamazepine) for bipolar disorder.
• Antidepressants (e.g., SSRIs, SNRIs) for depression (often in combination for treatment-resistant depression).

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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.