Each tablet of Abilex® contains: 

• Aripiprazole                     15 mg

¤ The oral formulations of Abilex® are indicated for:

• Schizophrenia
• Acute Treatment of Manic and Mixed Episodes associated with Bipolar I
• Adjunctive Treatment of Major Depressive Disorder 
• Irritability Associated with Autistic Disorder 
• Treatment of Tourette’s disorder

¤ Abilex® tablets can not be used, if

• the patient is allergic to Aripiprazole.
• Reactions have ranged from pruritus/urticaria to anaphylaxis.

• Using strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) concomitantly with Abilex® will increase the exposure of Aripiprazole compared to the use of Abilex® alone. Consequently, reducing the Abilex® dosage is clinically recommended.
• Using strong CYP3A4 Inducers (e.g., carbamazepine, rifampin), concomitantly with Abilex® will decreased the exposure of aripiprazole compared to the use of Abilex® alone. Therefore, increasing the Abilex® dosage is clinically recommended.
• Antihypertensive Drugs: Aripiprazole has the potential to enhance the effect of certain antihypertensive agents due to its alpha adrenergic antagonism so monitoring blood pressure and adjust dose accordingly is clinically recommended.
• Benzodiazepines (e.g., lorazepam), intensity of sedation and orthostatic hypotension for using Aripiprazole and lorzepam together were greater than using each one alone so monitoring sedation and blood pressure and Adjust dose accordingly is clinically recommended.

• Pregnancy: may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure 
• Lactation: There are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating 

¤ Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were:

• 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
• Pediatric patients (6 to 18 years) with Tourette’s disorder: sedation, somnolence, nausea, headache, nasopharyngitis, fatigue, increased appetite
• Adult patients with agitation associated with schizophrenia or bipolar mania: nausea.

Overdose:

¤ Patients who have taken too much Abilex® tablets have experienced the following symptoms:

• rapid heartbeat, agitation/aggressiveness, problems with speech.
• Unusual movements (especially of the face or tongue) and reduced level of consciousness.

Immediate consultation of doctor must be taken if the above manifestations are experienced. 

¤ Oral formulations are administrated once daily without regard to meal.

Schizophrenia – adults:

• Initial Dose: 10 - 15 mg/day.
• Recommended Dose:10 - 15 mg/day.
• Maximum Dose: 30 mg/day.

Schizophrenia – adolescents:

• Initial Dose:  2 mg/day.
• Recommended Dose: 10 mg/day.
• Maximum Dose: 30 mg/day.

Bipolar mania – adults: monotherapy:

• Initial Dose: 15 mg/day.
• Recommended Dose: 15 mg/day.
• Maximum Dose: 30 mg/day.

Bipolar mania – adults: adjunct to lithium or valproate:

• Initial Dose: 10 - 15 mg/day.
• Recommended Dose: 15 mg/day.
• Maximum Dose: 30 mg/day.

Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate:

• Initial Dose: 2 mg/day.
• Recommended Dose: 10 mg/day.
• Maximum Dose: 30 mg/day.

Major Depressive Disorder – Adults adjunct to antidepressants:

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

Irritability associated with autistic disorder – pediatric patients:

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

Tourette’s disorder  Patients < 50 kg:

• Initial Dose: 2 mg/day.
• Recommended Dose:  5 mg/day.
• Maximum Dose: 10 mg/day.

Tourette’s disorder Patients ≥ 50 kg:

• Initial Dose: 2 mg/day.
• Recommended Dose: 10 mg/day.
• Maximum Dose: 20 mg/day.

• Cerebrovascular: Adverse reactions in elderly patients with Dementia- Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) 
• Neuroleptic Malignant Syndrome: manage with immediate discontinuation and close monitoring. 
• Tardive Dyskinesia: discontinue if clinically appropriate.
• Pathological Gambling and other Compulsive behaviors: consideration the reduction of dose or discontinuation. 
• Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain 
• Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes.
• Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics.
• Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight. 
• Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. 
• Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including Abilex®. 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 Abilex® should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
• Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold 
• Potential for Cognitive and Motor Impairment: Use cautiously when operating machinery. 
• Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients.

• Abilex® 15 Tablets (Blister of 10  Tablets, Pack of two blister).

• Store in a dry place at a temperature not exceeding 25ºC.