Olanzapine 10mg Inj, 1 Vial

Olanzapine is an atypical antipsychotic that exhibits antagonism at dopamine D2 and serotonin 5-HT2A receptors. It also has antagonistic activity at 5-HT2C, 5-HT3, 5-HT6, alpha1-adrenergic, H1 histamine, and muscarinic M1-5 receptors. Its antipsychotic activity is thought to be mediated through a combination of dopamine and serotonin receptor antagonism.

Serious 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Movement problems, such as:
+ Trouble controlling body movements
+ Twitching or changes in balance
+ Difficulty swallowing or speaking
Mental, mood, or behavior changes, including:
+ New or worsening thoughts of hurting yourself or suicide
Severe dizziness or fainting
Abnormal heartbeat (fast or slow)
Inability to sweat during physical activity or in warm temperatures
Seizures
Drooling
Changes in vision
Memory problems or loss
Chest pain
Swelling
Burning, numbness, or tingling sensations
Difficulty urinating
Enlarged breasts, nipple discharge, or changes in menstrual cycle
Erectile dysfunction
Swollen glands
Neuroleptic malignant syndrome (NMS), a potentially life-threatening condition characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion or changes in thinking
+ Fast or irregular 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 that may be irreversible, characterized by:
+ Trouble controlling body movements
+ Problems with the tongue, face, mouth, or jaw (such as tongue sticking out, puffing cheeks, mouth puckering, or chewing)

Other Side Effects

Most people experience few or no side effects while taking this medication. However, some individuals may encounter mild or moderate side effects, including:

Dizziness, drowsiness, tiredness, or weakness
Restlessness or shakiness
Headache
Constipation
Dry mouth
Upset stomach
Weight gain
Increased appetite
Back pain
Joint pain
Difficulty sleeping
* Irritation at the injection site

If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. 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.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
* Any existing health problems, as they may affect the safety of taking this medication.

To avoid potential risks, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.

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 down position, and be cautious when climbing stairs.

Monitoring and Testing
Regular monitoring is crucial to minimize potential risks. Check your blood sugar levels as directed by your doctor. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor.

Interactions with Other Substances
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.

Potential Side Effects
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and related injuries, such as fractures. 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

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.
When used in children, this medication requires caution, as the risk of certain side effects may be higher.
This medication may affect fertility, but this effect is reversible when the medication is stopped. If you have questions, consult your doctor.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is essential 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.

• Intravenous administration of olanzapine (due to risk of cardiorespiratory events)

• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased risk of additive sedation and respiratory depression.
• Antihypertensives: Increased risk of orthostatic hypotension.
• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase olanzapine plasma concentrations, requiring dose reduction.
• CYP1A2 inducers (e.g., carbamazepine, rifampin, omeprazole): May decrease olanzapine plasma concentrations, reducing efficacy.

• Anticholinergic agents: May potentiate anticholinergic effects (e.g., constipation, dry mouth, urinary retention).
• Drugs that prolong QT interval (e.g., quinidine, sotalol, thioridazine): Use with caution, especially in patients with pre-existing cardiac conditions.
• Dopamine agonists (e.g., levodopa): Olanzapine may antagonize the effects of dopamine agonists.

• Not many specific minor interactions listed for IM formulation.

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Excessive sedation
• Difficulty breathing
• Muscle stiffness or spasms (dystonia)
• Restlessness (akathisia)
• Uncontrolled movements (tardive dyskinesia, though rare with acute use)
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Allergic reactions (rash, itching, swelling)

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.

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.

Safety and efficacy of olanzapine IM for acute agitation have not been established in pediatric patients. Use is generally not recommended.

Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death (Black Box Warning). Increased risk of orthostatic hypotension, falls, and other adverse effects. Use with extreme caution, consider lower starting doses (e.g., 5 mg IM), and monitor closely.

• Olanzapine IM is specifically indicated for the rapid control of acute agitation and is not intended for long-term maintenance treatment.
• Do NOT administer olanzapine IM intravenously due to the risk of serious cardiorespiratory events.
• Monitor patients closely for orthostatic hypotension, especially during the first few hours after injection. Patients should remain recumbent for a period after administration until stable.
• Be aware of the Black Box Warning regarding increased mortality in elderly patients with dementia-related psychosis; olanzapine is not approved for this indication.
• Consider the patient's hydration status and concomitant medications that may increase the risk of hypotension or sedation.

• Haloperidol IM (e.g., 5 mg IM)
• Ziprasidone IM (e.g., 10-20 mg IM)
• Lorazepam IM (e.g., 1-2 mg IM, often used in combination with antipsychotics for agitation)
• Aripiprazole IM (e.g., 9.75 mg IM)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, as there may be drug take-back programs available in your area.

This medication is accompanied by a Medication Guide, which provides important information about its use. Read this guide carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.