- Aripiprazole is an antiscychotic drug which belongs to atypical antipsychotic
- Abilifin® tablets are 87% bioavailable and reach peak plasma concentrationsin 3 to 
  5 hours. These tablets can be taken with or without food, but a high fat meal can
  delay the time to max concentration by 3 hours and up to 12 hours for the active
- protein binding of Aripiprazole is >99%. 
- The half life of aripiprazole is 75 hours while the half life of the active
   metabolite is 94 hours. Elemination of aripiprazole is mainly through hepatic
   metabolism involving two P450 isozymes, CYP2D6 and CYP3A4.   
   For populations that are poor CYP2D6 metabolizers, the half life of aripiprazole
   is 146 hours and these patients should be treated with half the normal dose.

* Each tablet of Abilifin® contains: 
   Aripiprazole                     5mg

   Aripiprazole                     10 mg
   Aripiprazole                     15 mg
   Aripiprazole                     20 mg

   Aripiprazole                     30mg

- Abilifin® 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
  Abilifin® will increase the exposure of aripiprazole compared to use Abilifin® alone.
  Consequently, reducing the Abilifin® dosage is clinically recommended.
- Using strong CYP3A4 Inducers (e.g., carbamazepine, rifampin), concomitantly with
  Abilifin® will decreased the exposure of aripiprazole compared to use Abilifin® 
  alone. Therefore, increasing the Abilifin® dosage is clinically recommended. 
- Antihypertensive Drugs: Abilifin® 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 Abilifin® and lorzepam together were greater than using each one alone so
  monitoring sedation and blood pressure and Adjust dose accordinglyis clinically

- 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 women taking

 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 
- 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. 
- This include any possible side effects not listed in this leaflet. you can report side
  effect directly via the: http\\www.modernpharmaye.com\adrs.pdf. and send to
  uson: adrs@modernpharmaye.com

- 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
- 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
- Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients
  with known cardiovascular or cerebrovascular disease, and risk of dehydration or
- Leukopenia, Neutropenia, and Agranulocytosis: have been reported with
  antipsychotics including Abilifin®. 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 Abilifin® 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 caution when operating
- Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar
  disorder. Closely supervise high-risk patients.

- Abilifin® 5Tablets (Blister of 10  Tablets, Pack of 3 blister)

- Abilifin® 10 Tablets (Blister of 10  Tablets, Pack of 3 blister)
- Abilifin® 15 Tablets (Blister of 10  Tablets, Pack of 3 blister)
- Abilifin® 20 Tablets (Blister of 10  Tablets, Pack of 3 blister)

- Abilifin® 30Tablets (Blister of 10  Tablets, Pack of 3 blister)

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