ABILIFY^® Tablet 5 mg, 10 mg & 15 mg

Composition :

Tablets containing 5 mg, 10 mg and 15 mg aripiprazole.

Indication :

• Acute treatment and maintaining stability in patients with schizophrenia for adult and adolescent.
• Treatment of acute mania and mixed episode and maintaining efficacy in patients with bipolar I disorder for adult, children and adolescent.
• Adjunctive therapy to either lithium or valproate for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder in adult, children and adolescent.
• Adjunctive therapy for Major Depressive Disorder.
• Irritability associated with autistic disorder.

Dosage :

• Schizophrenia

Recommended starting and target dose is 10 or 15 mg once-a-day without regard to meals.

• Bipolar Disorder

Effective dose is 15 – 30 mg given once a day (as mono therapy).

• Major Depresive Disorder

Initial dose 2-5 mg/day, effective dose 2-15 mg/day.

• Irritability Associated with Autistic Disorder.

Initial dose 2 mg/day, effective dose 5-10 mg/day, maximum dose 15 mg/day.

Contra Indications :

Hypersensitivity to the product.

Warning and Precautions:

Reduce dose or discountinue if sign or symptoms of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution of patients with a history of seizure. Do not use in pregnancy unless benefit outweight risk, breastfeeding not advised. Until individual patient response established caution not to drive or operate machinery.

Drug Interactions :

Agents that induce CYP3A4 (e.g. carbamazepine) could cause an increase in Abilify clearance and lower blood levels.
Inhibitors of CYP3A4 (e.g. ketoconazole) or CYP2D6 (e.g. quinidine, fluoxetine, or paroxetine) can inihibit Abilify elemination and cause increased blood level.

Adverse Events :

Headache, nausea, vomiting, constipation, anxiety, insomnia, ligtheadedness, somnolence, akathisia, dyspepsia, agitation.

Presentation & Packing :

• Tablet 5 mg x 10`s Reg. No. DKI 0809700110D1
• Tablet 10 mg x 10`s Reg. No. DKI 0409700110A1
• Tablet 15 mg x 10`s Reg. No. DKI 0409700110B1

DRUG PRESCRIPTION ONLY

ABILIFY^® Oral Solution 150 ml (1 mg/ml )

Composition :

Oral Solution 150 ml Containing: Aripiprazole 1mg/ml

Indication :

• Acute treatment and maintaining stability in patients with schizophrenia for adult and adolescent.
• Treatment of acute mania and mixed episode and maintaining efficacy in patients with bipolar I disorder for adult, children and adolescent.
• Adjunctive therapy to either lithium or valproate for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder in adult, children and adolescent.
• Adjunctive therapy for Major Depressive Disorder.
• Irritability associated with autistic disorder.

Dosage :

• Schizophrenia

Recommended starting and target dose is 10 or 15 mg once-a-day without regard to meals.

• Bipolar Disorder

Effective dose is 15 – 30 mg given once a day (as mono therapy)

• Major Depresive Disorder

Initial dose 2-5 mg/day, effective dose 2-15 mg/day.

• Irritability Associated with Autistic Disorder.

Initial dose 2 mg/day, effective dose 5-10 mg/day, maximum dose 15 mg/day.

Contra Indications :

Hypersensitivity to the product.

Warning and Precautions:

Reduce dose or discountinue if sign or symptoms of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution of patients with a history of seizure. Do not use in pregnancy unless benefit outweight risk, breastfeeding not advised. Until individual patient response established caution not to drive or operate machinery.

Drug Interactions :

Agents that induce CYP3A4 (e.g. carbamazepine) could cause an increase in Abilify clearance and lower blood levels.
Inhibitors of CYP3A4 (e.g. ketoconazole) or CYP2D6 (e.g. quinidine, fluoxetine, or paroxetine) can inihibit Abilify elemination and cause increased blood level.

Adverse Events :

Headache, nausea, vomiting, constipation, anxiety, insomnia, ligtheadedness, somnolence, akathisia, dyspepsia.

Presentation & Packing :

• Boxes of 1 bottle of 150 ml

Reg. No. DKI 0657002035A1

DRUG PRESCRIPTION ONLY

ABILIFY^® DISCMELT 10 mg, 15 mg

Composition :

Orally Disintegrating Tablets (ODT) 10 mg dan 15 mg

How to use :

• Put on the tongue and will dissolve in seconds
• Can be taken with or without food

Indication :

• Acute treatment and maintaining stability in patients with schizophrenia for adult, child and adolescent.
• Treatment of acute mania and mixed episode and maintaining efficacy in patients with bipolar disorder for adult, child and adolescent.
• Adjunctive therapy to either lithium or valproate for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder in adult, children and adolescent.
• Adjunctive therapy for Major Depressive Disorder.
• Irritability associated with autistic disorder.

Dosage :

• Schizophrenia

Recommended starting and target dose is 10 or 15 mg once-a-day without regard to meals.

• Bipolar Disorder

Effective dose is 15 – 30 mg given once a day (as mono therapy)

• Major Depresive Disorder

Initial dose 2-5 mg/day, effective dose 2-15 mg/day.

• Irritability Associated with Autistic Disorder.

Initial dose 2 mg/day, effective dose 5-10 mg/day, maximum dose 15 mg/day.

Contra Indications :

Hypersensitivity to the product.

Warning and Precautions:

Reduce dose or discountinue if sign or symptoms of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution of patients with a history of seizure. Do not use in pregnancy unless benefit outweight risk, breastfeeding not advised. Until individual patient response established caution not to drive or operate machinery.

Drug Interactions :

Agents that induce CYP3A4 (e.g. carbamazepine) could cause an increase in Abilify clearance and lower blood levels.
Inhibitors of CYP3A4 (e.g. ketoconazole) or CYP2D6 (e.g. quinidine, fluoxetine, or paroxetine) can inihibit Abilify elemination and cause increased blood level.

Adverse Events :

Headache, nausea, vomiting, constipation, anxiety, insomnia, ligtheadedness, somnolence, akathisia, dyspepsia.

Presentation & Packing :

• Discmelt 10 mg x 10’ s Reg. No. DKI0857002181A1
• Discmelt 15 mg x 10’ 2 Reg. No. DKI0857002181B1

DRUG PRESCRIPTION ONLY

ABILIFY^® Intra Muscular Injection 9.75 mg/1.3 ml (7.5 mg/ml)

Composition :

IM Injection containing 9.75 mg / 1.3 ml (7.5 mg/ml) aripiprazole.

Indication :

Acute agitation in schizophrenia and bipolar disorder.

Dosage :
Schizophrenia and Bipolar Disorder

Usual Dose for Adults
The recommended dose in these patients is 9.75 mg. The effectiveness of Abilify IM Injection in controlling agitation in Schizophrenia or Bipolar Mania was demonstrate over a dose range of 5.25 mg to 15 mg. If agitation warranting a second dose persists following initial dose, cumulative doses up to total 30 mg/day may be given. Injection period between previous injection to next injection is 2 hours.

Contra Indications :

Hypersensitivity to the product.

Warning and Precautions :

Reduce dose or discountinue if sign or symptoms of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution of patients with a history of seizure. Do not use in pregnancy unless benefit outweight risk, breastfeeding not advised. Until individual patient response established caution not to drive or operate machinery.

Drug Interaction :

Agents that induce CYP3A4 (e.g. carbamazepine) could cause an increase in Abilify clearance and lower blood levels.
Inhibitors of CYP3A4 (e.g. ketoconazole) or CYP2D6 (e.g. quinidine, fluoxetine, or paroxetine) can inihibit Abilify elemination and cause increased blood level.

Adverse Event :

Headache, nausea, vomiting, constipation, anxiety, insomnia, ligtheadedness, somnolence, akathisia, dyspepsia, agitation.

Presentation & Packing:

• Intra Muscular Injections 9.75 mg/1.3 ml (7.5 mg/ml)

Reg No. DKI0957002243A1

DRUG PRESCRIPTION ONLY