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When considering treatment with ARISTADA INITIO, it's important to be aware of several safety concerns:

Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly individuals with dementia-related psychosis who are treated with antipsychotic medications, including ARISTADA INITIO, have a higher risk of death. Therefore, this medication is not approved for treating dementia-related psychosis.

Cerebrovascular Events: In elderly patients with dementia, there is an increased incidence of cerebrovascular adverse events, such as strokes and transient ischemic attacks, including fatalities, when treated with antipsychotics like ARISTADA INITIO. This medication is not approved for use in this population.

Neuroleptic Malignant Syndrome (NMS): A rare but serious condition known as NMS can occur with antipsychotic medications. Symptoms include high fever, muscle stiffness, confusion, and irregular heart rate or blood pressure. Immediate medical attention is required if these symptoms develop.

Tardive Dyskinesia: Long-term use of antipsychotics may lead to tardive dyskinesia, a condition characterized by involuntary, repetitive body movements. The risk increases with prolonged treatment and higher doses. Regular monitoring is essential, and discontinuation of the medication should be considered if symptoms appear.

Metabolic Changes: ARISTADA INITIO may cause metabolic changes, including elevated blood sugar levels, abnormal lipid profiles, and weight gain. Patients should be monitored for signs of hyperglycemia, such as excessive thirst and urination, and undergo regular assessments of blood glucose and lipid levels.

Compulsive Behaviors: Some individuals may experience uncontrollable urges, such as gambling, binge eating, or excessive shopping, while on this medication. Patients and caregivers should be vigilant for these behaviors and consult a healthcare provider if they occur.

Orthostatic Hypotension and Falls: ARISTADA INITIO can cause a sudden drop in blood pressure upon standing, leading to dizziness or fainting. This may increase the risk of falls, especially in the elderly or those with existing cardiovascular conditions. Caution is advised when changing positions from sitting or lying down to standing.

Blood Cell Count Changes: Decreases in white blood cell counts, including conditions like leukopenia, neutropenia, and agranulocytosis, have been reported. Patients with a history of low white blood cell counts should have their blood monitored regularly.

Seizures: Use ARISTADA INITIO cautiously in individuals with a history of seizures or conditions that lower the seizure threshold, as it may increase the risk of seizures.

Cognitive and Motor Impairment: This medication may impair judgment, thinking, or motor skills. Patients should avoid operating hazardous machinery, including automobiles, until they are certain the medication does not adversely affect them.

Body Temperature Regulation: ARISTADA INITIO may disrupt the body's ability to regulate core temperature. Patients should take precautions to avoid overheating and dehydration, especially during strenuous exercise or exposure to extreme heat.

Swallowing Difficulties (Dysphagia): There is a risk of esophageal dysmotility and aspiration, which can lead to pneumonia. Use caution in patients at risk for aspiration.

Medication Errors: ARISTADA INITIO is intended for single administration only and should not be substituted for ARISTADA due to differing pharmacokinetic profiles. Care should be taken to avoid dosing and medication errors.

Pregnancy and Nursing: Neonates exposed to antipsychotic drugs, including ARISTADA INITIO, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Aripiprazole is present in human breast milk and may decrease milk supply. The benefits of breastfeeding should be considered along with the mother's clinical need for the medication and any potential adverse effects on the infant.

Patients should discuss these risks with their healthcare provider to determine if ARISTADA INITIO is appropriate for their treatment plan.

Aristada Initio, an injectable medication used to treat schizophrenia, may cause various side effects. It's important to be aware of these potential reactions to manage them effectively. Common Side Effects:

• Restlessness (Akathisia): A frequent side effect where individuals feel an uncontrollable urge to move. This sensation can be uncomfortable but is manageable with medical guidance.
• Injection Site Reactions: Some people may experience pain, redness, or swelling at the injection site. These reactions are typically mild and tend to decrease with subsequent injections. Serious Side Effects:
• Uncontrolled Movements (Tardive Dyskinesia): This condition involves involuntary movements, especially in the face, tongue, or other body parts. While it may not resolve even after stopping the medication, early detection can help manage symptoms.
• Neuroleptic Malignant Syndrome (NMS): A rare but serious condition characterized by high fever, stiff muscles, confusion, sweating, and changes in heart rate or blood pressure. Immediate medical attention is required if these symptoms occur.
• Metabolic Changes: Some individuals may experience high blood sugar levels, leading to increased thirst, frequent urination, and fatigue. Monitoring blood sugar levels is advisable, especially for those with diabetes or risk factors for diabetes.
• Orthostatic Hypotension: A sudden drop in blood pressure upon standing, causing dizziness or lightheadedness. Rising slowly from a sitting or lying position can help mitigate this effect.
• Seizures: Although uncommon, seizures have been reported. Caution is advised for individuals with a history of seizures or conditions that lower the seizure threshold.
• Difficulty Swallowing (Dysphagia): Some may experience trouble swallowing, which can lead to aspiration pneumonia. It's important to report any swallowing difficulties to a healthcare provider promptly. Other Considerations:
• Compulsive Behaviors: There have been reports of uncontrollable urges, such as gambling, binge eating, or excessive shopping. If such behaviors develop, consult a healthcare provider.
• Body Temperature Regulation: Aristada Initio may impair the body's ability to regulate temperature, increasing the risk of overheating. Avoid strenuous exercise, stay hydrated, and dress appropriately in hot weather.
• Cognitive and Motor Impairment: The medication can affect thinking and motor skills. Exercise caution when driving or operating machinery until you know how the drug affects you. It's crucial to discuss any side effects or concerns with your healthcare provider to ensure safe and effective use of Aristada Initio.

When starting treatment with Aristada Initio, it's important to be aware of potential interactions with other medications:

• Strong CYP3A4 and CYP2D6 Inhibitors: Medications like Itraconazole, Clarithromycin, quinidine, Fluoxetine, and paroxetine can increase aripiprazole levels in the body. Since the dosage of Aristada Initio cannot be adjusted, it's recommended to avoid using these inhibitors concurrently.

• Strong CYP3A4 Inducers: Drugs such as Carbamazepine and Rifampin may decrease aripiprazole levels, potentially reducing its effectiveness. Concurrent use with Aristada Initio should be avoided.

• Antihypertensive Medications: Aripiprazole can enhance the effects of blood pressure-lowering drugs like Carvedilol, Lisinopril, and Prazosin, which may lead to low blood pressure. It's advisable to avoid combining these medications with Aristada Initio.

• Benzodiazepines: Combining aripiprazole with benzodiazepines, such as Lorazepam, can increase sedation and the risk of low blood pressure upon standing. Therefore, concurrent use with Aristada Initio is not recommended.

On the other hand, certain medications like Famotidine, valproate, Lithium, Lamotrigine, and Sertraline do not have significant interactions with Aristada Initio, and no dosage adjustments are necessary when used together.

Always inform your healthcare provider about all medications and supplements you're taking to ensure safe and effective use of Aristada Initio.