Aripiprazole

What is Aripiprazole?

• Aripiprazole (Abilify) is an atypical antipsychotic used in the treatment of schizophrenia and bipolar illness.

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What are the uses of this medicine?

This medicine is used for the:

• Treatment of schizophrenia
• Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate
• Maintenance treatment of bipolar I disorder
• Adjunctive treatment of major depressive disorder (MDD)
• Treatment of irritability associated with autistic disorder
• Acute treatment of agitation associated with schizophrenia or bipolar I disorder

How does this medicine work?

• Aripiprazole (ar" i pip' ra zole) is a partial agonist for dopamine type 2 (D2) and serotonin (5-HT1A) receptors and has antagonist activity against serotonin 5HT2A receptors.
• Aripiprazole is indicated for the therapy of schizophrenia and as either monotherapy or adjunctive therapy for manic and mixed episodes in bipolar disorder, irritability associated with autistic disorder, and as adjunctive treatment with antidepressants for major depressive disorder.
• Aripiprazole is also indicated for treatment of Tourette disorder.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity reaction to Abilify.

What drug interactions can this medicine cause?

• Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase Abilify drug concentrations; reduce Abilify dose by one-half when used concomitantly, except when used as adjunctive treatment with antidepressants.
• CYP3A4 inducers (eg, carbamazepine) will decrease Abilify drug concentrations; double Abilify dose when used concomitantly.

Is this medicine FDA approved?

• It was approved for use in the United States in 2002.

How should this medicine be used?

Recommended Dosage: The Recommended Dosage is shown below:

	Initial
Dose	Recommended
Dose	Maximum
Dose
Schizophrenia – adults	10-15 mg/day	10-15 mg/day	30 mg/day
Schizophrenia – adolescents	2 mg/day	10 mg/day	30 mg/day
Bipolar mania – adults: monotherapy or as an adjunct to lithium or valproate	15 mg/day	15 mg/day	30 mg/day
Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate	2 mg/day	10 mg/day	30 mg/day
As an adjunct to antidepressants for the treatment of major depressive disorder – adults	2-5 mg/day	5-10 mg/day	15 mg/day
Irritability associated with autistic disorder – pediatric patients	2 mg/day	5-10 mg/day	15 mg/day
Agitation associated with schizophrenia or bipolar mania – adults	9.75 mg/1.3 mL
injected IM		30 mg/day
injected IM

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
• Orally Disintegrating Tablets: 10 mg and 15 mg
• Oral Solution: 1 mg/mL
• Injection: 9.75 mg/1.3 mL single-dose vial

This medicine is available in fallowing brand namesː

• Abilify

What side effects can this medication cause?

The most common side effects of this medicine include:

• Adult patients with schizophrenia: akathisia
• Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor
• Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder
• Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder
• Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness
• Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision
• Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy
• Adult patients with agitation associated with schizophrenia or bipolar mania: nausea.

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis.
• Abilify may increases risk of suicidality in children, adolescents, and young adults with major depressive disorder.
• Neuroleptic Malignant Syndrome may occur. Manage with immediate discontinuation and close monitoring.
• A syndrome of potentially irreversible, involuntary, dyskinetic movements called Tardive Dyskinesia may develop in patients treated with antipsychotic drugs. Discontinue if clinically appropriate.
• Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia in patients treated with Abilify. Monitor glucose regularly in patients with and at risk for diabetes.
• Aripiprazole may cause orthostatic hypotension. Use with caution in patients with known cardiovascular or cerebrovascular disease.
• Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics including Abilify. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Abilify should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
• Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
• Abilify, like other antipsychotics, may have the potential to impair judgment, thinking, or motor skills.Use caution when operating machinery.
• The possibility of a suicide attempt is inherent in psychotic illnesses, bipolar disorder, and major depr essive disorder, and close supervision of high-risk patients should accompany drug therapy. The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients.

What to do in case of emergency/overdose?

• Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor.
• Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

Management of overdosage:

• No specific information is available on the treatment of overdose with aripiprazole.
• An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted.
• Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
• Close medical supervision and monitoring should continue until the patient recovers.

• Charcoal: In the event of an overdose of Abilify, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole.
• Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with aripiprazole, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• It is not known whether aripiprazole can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• Aripiprazole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients with major depressive disorder or agitation associated with schizophrenia or bipolar mania have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• aripiprazole

Inactive ingredients:

• starch, corn
• hydroxypropyl cellulose
• lactose monohydrate
• magnesium stearate
• cellulose, microcrystalline
• ferric oxide red
• ferric oxide yellow
• fd&c blue no. 2
• aluminum oxide

Who manufactures and distributes this medicine?

• Packager: Rebel Distributors Corp.

What should I know about storage and disposal of this medication?

• Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F).

• Dailymed label info on Aripiprazole
• FDA Aripiprazole

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