Aripiprazole

Aripiprazole is an atypical antipsychotic medicine used in the treatment of schizophrenia (a mental disorder that can result in hallucinations or delusions) and mania. It can also be used to treat depression and bipolar disorders.

Aripiprazole works by changing the action of certain chemical messengers in the brain that affect thoughts. It is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and an antagonist at serotonin 5-HT2A receptors.

Common side effects include akathisia, anxiety, headache, fatigue, nausea, constipation, sleepiness, and dizziness.

• Schizophrenia
• Bipolar disorder (manic or mixed episodes)
• Major depressive disorder (adjunctive treatment)
• Irritability associated with autistic disorder
• Agitation associated with schizophrenia or bipolar mania

Aripiprazole is an atypical antipsychotic and it has been proposed that the efficacy of Aripiprazole is mediated through a combination of partial agonist activity at Dopamine D2 and Serotonin 5-HT1A receptors and antagonist activity at Serotonin 5-HT2A receptors.

This is associated with improvement of schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autistic disorder, and agitation associated with schizophrenia or bipolar disorder.

Aripiprazole acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and as an antagonist at serotonin 5-HT2A receptors. This balanced regulation of dopamine and serotonin pathways helps reduce symptoms of schizophrenia and bipolar disorder such as hallucinations, delusions, mania, and depression.

Schizophrenia:

• Adults: Initial: 10-15 mg/day, Recommended: 10-15 mg/day, Maximum: 30 mg/day
• Adolescents (13-17 years): Initial: 2 mg/day → 5 mg/day after 2 days → 10 mg/day after 2 more days, Maximum: 30 mg/day

Bipolar Mania:

• Adults (Monotherapy): Initial: 15 mg/day, Maximum: 30 mg/day
• Adults (Adjunct to lithium/valproate): Initial: 10-15 mg/day, Recommended: 15 mg/day, Maximum: 30 mg/day
• Pediatric (10-17 years): Initial: 2 mg/day → 5 mg/day after 2 days → 10 mg/day after 2 more days, Maximum: 30 mg/day

Major Depressive Disorder (Adjunct):

• Initial: 2-5 mg/day, Recommended: 5-10 mg/day, Maximum: 15 mg/day

Irritability in Autistic Disorder (6-17 years):

• Initial: 2 mg/day → 5 mg/day (within 1 week), Maximum: 15 mg/day

Tourette Disorder (6-18 years):

• <50 kg: 2 mg/day → 5 mg/day after 2 days → up to 10 mg/day if needed
• ≥50 kg: 2 mg/day (2 days) → 5 mg/day (5 days) → 10 mg/day (Day 8), Maximum: 20 mg/day

Special Populations: No dose adjustment needed in renal impairment. No dose adjustment likely needed in hepatic impairment.

Take this medicine in the dose and duration as advised by your doctor. Swallow the tablet whole - do not chew, crush or break. May be taken with or without food, preferably in the morning at a fixed time.

IM Injection: Wait at least 2 hours between doses. Maximum daily dose 30 mg.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

• Akathisia (inability to stay still)
• Anxiety
• Blurred vision
• Constipation
• Dizziness
• Fatigue
• Headache
• Increased saliva production
• Indigestion
• Insomnia (difficulty in sleeping)
• Nausea
• Parkinsonism
• Restlessness
• Sleepiness
• Tremor
• Vomiting
• Extrapyramidal disorder
• Sedation
• Pyrexia
• Decreased appetite

Serious Precautions:

• Increased incidence of cerebrovascular adverse events (stroke, TIA, including fatalities) in elderly patients with dementia-related psychosis
• Increased risk of suicidality in children, adolescents, and young adults with major depressive disorder
• Tardive dyskinesia - discontinue if clinically appropriate
• Metabolic changes: hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain - monitor blood sugar and cholesterol regularly
• Orthostatic hypotension - caution in patients with known cardiovascular or cerebrovascular disease
• Seizures - use cautiously in patients with a history of seizures
• Caution when operating machinery - may cause dizziness and sleepiness
• Do not stop suddenly - may worsen symptoms
• Caution during pregnancy and lactation - animal studies have shown harmful effects on the developing baby
• Inform your doctor if you notice sudden mood changes, unusual movements or develop suicidal thoughts

• Known hypersensitivity to Aripiprazole
• Lactation (not recommended)
• Children <18 years (except for specific indications)

• Carbamazepine: Increases aripiprazole clearance and lowers blood levels
• Ketoconazole, Quinidine, Fluoxetine, Paroxetine: Inhibit aripiprazole elimination and increase blood levels
• Alcohol and other CNS-active drugs: Additive effects may occur - caution required

[UNSAFE] It is unsafe to consume alcohol with Aripiprazole. Alcohol may cause excessive drowsiness and increase side effects.

[CONSULT YOUR DOCTOR] Aripiprazole may be unsafe to use during pregnancy (Pregnancy Category C). Animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and potential risks before prescribing. Should be avoided during pregnancy.

[CONSULT YOUR DOCTOR] Aripiprazole is excreted in human breast milk. It may harm the baby if used during breastfeeding. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Schizophrenia (13-17 years): 2 mg/day initially, titrate to 10-30 mg/day.

Bipolar Mania (10-17 years): 2 mg/day initially, titrate to 10-30 mg/day.

Irritability in Autistic Disorder (6-17 years): 2 mg/day initially, titrate to 5-15 mg/day.

Tourette Disorder (6-18 years): Dosage as per weight-based table.

Increased incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis. Caution in patients with cardiovascular or cerebrovascular disease.

[SAFE IF PRESCRIBED] Safe to use in patients with kidney disease. No dose adjustment recommended.

[SAFE IF PRESCRIBED] Probably safe to use in patients with liver disease. Dose adjustment may not be needed. Please consult your doctor.

Aripiprazole at doses up to 1080 mg caused no fatalities. Signs and symptoms of overdose include nausea, vomiting, asthenia, diarrhea, and somnolence.

Keep below 30°C, away from light & moisture. Keep out of reach of children.