Arepra 10/Arepra 15

Arepra 10/Arepra 15

aripiprazole

Manufacturer:

Teva Pharma

Distributor:

DKLL
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
Schizophrenia. Acute treatment of manic & mixed episodes associated w/ bipolar I disorder. Adjunctive treatment of major depressive disorder. Irritability associated w/ autism. Tourette's disorder.
Dosage/Direction for Use
Schizophrenia Adult Initially 10 or 15 mg once daily. Maintenance: 15 mg daily. Dose range: 10-30 mg daily. Adolescent 13-17 yr Recommended target dose: 10 mg daily. Initially 2 mg, then titrated to 5 mg after 2 days & additional 2 days to reach the target dose of 10 mg. Subsequently, increase dose to 5 mg increments. Max: 30 mg daily. Acute treatment of manic & mixed episodes of bipolar I disorder Adult Initially 15 mg once daily as monotherapy & 10-15 mg once daily as adjunct to lithium or valproate. Recommended target dose: 15 mg daily as monotherapy or adjunctive treatment. May be increased to max dose of 30 mg daily. Ped 10-17 yr Monotherapy & adjunctive therapy: Initially 2 mg daily, then titrate to 5 mg daily after 2 days & additional 2 days to reach the target dose of 10 mg daily. Subsequently, administer increments of 5 mg daily, if needed. Adjuvant treatment of major depressive disorder Adult Initially 2-5 mg daily as adjunctive treatment. Recommended dose: 2-15 mg daily. Gradually adjust dose up to 5 mg daily at no <1 wk interval. Irritability associated w/ autism Ped 6-17 yr Recommended dose range: 5-15 mg daily. Initially at 2 mg daily, may be increased to 5 mg daily w/ subsequent increases to 10 or 15 mg daily if needed. Gradually adjust dose up to 5 mg daily at no <1 wk interval. Tourette's disorder Ped 6-18 yr Recommended dose range: 5-20 mg daily. Patient weighing ≥50 kg Initially 2 mg daily for 2 days, & then increase to 5 mg daily for 5 days, w/ 10 mg daily target dose on day 8. May be increased up to 20 mg daily in patients who do not achieve optimal control of tics. Gradually adjust dose in increments of 5 mg daily at no <1 wk interval. Patient weighing <50 kg Initially 2 mg daily w/ 5 mg daily target dose after 2 days. May further increase to 10 mg daily in patients who do not achieve optimal control of tics. Gradually adjust dose at no <1 wk interval. Severe hepatic impairment Max: 30 mg daily.
Administration
May be taken with or without food: Place tab on the tongue & allow to disintegrate before swallowing w/ or w/o liqd. Take immediately on opening the blister. May disperse tab in water & drink the susp.
Special Precautions
Hypersensitivity. Discontinue if patient develops signs & symptoms of NMS or presents w/ unexplained high fever w/o additional clinical manifestations of NMS. Not indicated for treatment of dementia-related psychosis. VTE. Patients w/ known cerebrovascular & CV disease (history of MI or ischaemic heart disease, heart failure, or conduction abnormalities), conditions predisposing to hypotension (dehydration, hypovolemia & treatment w/ antihypertensives) or HTN, including accelerated or malignant; family history of QT prolongation & diabetes; history of seizure or conditions associated w/ seizures; obesity; at risk for aspiration pneumonia; phenylketonuria. Close supervision of high-risk patients for suicidal behavior. Consider dose reduction if signs & symptoms of tardive dyskinesia (or discontinuation) & other extrapyramidal symptoms (& clinical monitoring) appear; in clinically significant wt gain; if patient develops increased gambling & sexual urges, compulsive shopping, binge or compulsive eating, or other impulsive & compulsive behaviours (or stop medication). Observe for signs & symptoms of hyperglycaemia (eg, polydipsia, polyuria, polyphagia & weakness). Regularly monitor for worsening of glucose control in patients w/ DM or risk factors for DM; wt gain in adolescents w/ bipolar mania. Concomitant use w/ stimulants in patients w/ ADHD comorbidity; strong CYP2D6 inhibitors & CYP3A4 inhibitors or inducers. May affect ability to drive & use machines. Severe hepatic impairment. Not to be used in pregnancy. Lactation. Monitor newborn infants exposed during 3rd trimester of pregnancy. Elderly ≥65 yr w/ schizophrenia or manic episodes in bipolar I disorder.
Adverse Reactions
DM; insomnia, anxiety, restlessness; akathisia, extrapyramidal disorder, tremor, headache, sedation, somnolence, dizziness; blurred vision; constipation, dyspepsia, nausea, salivary hypersecretion, vomiting; fatigue.
Drug Interactions
Enhanced effect of certain antihypertensives. Overlapping adverse reaction eg, sedation w/ alcohol or other CNS medicinal products. Concomitant use w/ QT-prolonging medicinal products & known to cause electrolyte imbalance. Increased AUC w/ strong CYP2D6 inhibitor eg, quinidine, fluoxetine & paroxetine. Increased AUC & Cmax w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole & HIV PIs. Increased plasma conc w/ weak CYP3A4 (eg, diltiazem) or CYP2D6 (eg, escitalopram) inhibitors. Lowered Cmax & AUC w/ strong CYP3A4 inducers eg, carbamazepine, rifampicin, rifabutin, phenytoin, phenobarb, primidone, efavirenz, nevirapine & St. John's wort. Serotonin syndrome w/ other serotonergics (eg, SSRI/SNRI), or medicinal products increasing aripiprazole conc.
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Arepra 10 orodispersible tab 10 mg
Packing/Price
30's
Form
Arepra 15 orodispersible tab 15 mg
Packing/Price
30's
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