Rhea Aripiprazole

Rhea Aripiprazole

aripiprazole

Manufacturer:

Korea Otsuka

Distributor:

Philusa
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
Schizophrenia; acute & mixed episodes of bipolar I disorder & maintenance treatment of bipolar I disorder. Adjunct treatment of major depressive disorder (MDD). Irritability associated w/ autistic disorder. Tourette's disorder.
Dosage/Direction for Use
Schizophrenia Adult Initially 10 or 15 mg/day. Dose range: 10-30 mg/day. Dose should not be increased before 2 wk. Adolescent Target dose: 10 mg/day, 13-17 yr Starting daily dose: 2 mg. Titrate to 5 mg after 2 days & to the target dose after additional & subsequently increase dose in 5 mg increments. Acute treatment & maintenance of manic & mixed episodes bipolar I disorder Adult Monotherapy: 15 mg once daily as starting dose. Adjunctive therapy: 10-15 mg once daily w/ lithium or valproate. Max: 30 mg/day. Childn 10-17 yr Monotherapy: 2 mg/day as starting dose. Titrate to 5 mg/day after 2 days & target dose of 10 mg/day after additional 2 days. Adjunctive therapy w/ lithium or valproate is the same. Subsequently increase dose in 5 mg/day increments. Adjunctive treatment of MDD Adult patient already taking antidepressant 2-5 mg/day. MDD 2-15 mg/day. Adjust dose gradually up to 5 mg/day at intervals of no <1 wk. Irritability associated w/ autistic disorder Individualized dose. Childn 6-17 yr 5-15 mg/day. Initially 2 mg/day & increase to 5 mg/day, w/ subsequent increases to 10 mg/day or 15 mg/day if needed. Adjust dose gradually up to 5 mg/day at intervals of no <1 wk. Tourette's disorder Childn 6-18 yr 2-20 mg/day. Initially 2 mg/day. Adjust dose gradually up to 5 mg/day at intervals of no <2 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Pruritus/urticaria, anaphylaxis.
Special Precautions
Not for treatment of dementia-related psychosis especially in elderly patients. Patients w/ known CV disease, cerebrovascular disease or predisposing conditions to hypotension; history of seizures/convulsions; at risk for aspiration pneumonia & certain concomitant illness. Esophageal dysmotility & aspiration may occur. Patients w/ MDD may experience worsening of depression &/or emergence of suicidal ideation & behaviour. Monitor appropriately & observe closely during initial few mth of therapy or changes in dosage for unusual behaviour. Discontinue if neuroleptic malignant syndrome or tardive dyskinesia occurs. Hyperglycemia; leukopenia/neutropenia & agranulocytosis may occur. Patients w/ DM should be monitored regularly for worsening of glucose control. Perform fasting glucose testing at the beginning & periodically in patients w/ risk factors for DM. May impair ability to operate hazardous machinery including automobiles. May disrupt body's ability to reduce core body temp. Concomitant use w/ benzodiazepine. Pregnancy & lactation. Childn w/ MDD or agitation associated w/ schizophrenia or bipolar mania. Elderly (w/ psychosis associated w/ Alzheimer's disease).
Adverse Reactions
Nausea, vomiting, headache, insomnia. Adult: Constipation, dizziness, akathisia, anxiety, restlessness. Childn: Somnolence, extrapyramidal disorder, fatigue, increased appetite & wt, nasopharyngitis.
Drug Interactions
Other centrally-acting drugs or alcohol. May enhance the effect of certain antihypertensives. Increased clearance & decreased blood levels w/ CYP3A4 inducers (eg, carbamazepine). Inhibited elimination & increased blood levels w/ CYP3A4 inhibitors (eg, ketoconazole) or CYP2D6 inhibitors (eg, quinidine, fluoxetine or paroxetine). May reduce dose in concomitant use w/ ketoconazole (1/2 dose), other strong CYP3A4 inhibitors (itraconazole), moderate inhibitors (erythromycin, grapefruit juice); other CYP2D6 inhibitors (eg, fluoxetine or paroxetine). May increase dose (doubled) w/ carbamazepine.
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Rhea Aripiprazole tab 10 mg
Packing/Price
30's (P128.13/tab)
Form
Rhea Aripiprazole tab 15 mg
Packing/Price
30's (P128.13/tab)
Form
Rhea Aripiprazole tab 5 mg
Packing/Price
30's (P87.95/tab)
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