Arilan

Arilan

aripiprazole

Manufacturer:

Sandoz

Distributor:

Multicare
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
Schizophrenia in adults & adolescents ≥15 yr. Moderate to severe manic episodes in bipolar I disorder & prevention of new manic episode in adults who experienced predominantly manic episodes & whose manic episodes responded to aripiprazole treatment. Moderate to severe manic episodes in bipolar I disorder in adolescents ≥13 yr up to 12 wk of treatment.
Dosage/Direction for Use
Adult Schizophrenia Initially 10 or 15 mg/day. Maintenance dose: 15 mg once daily. Max: 30 mg/day. Manic episode in bipolar I disorder Initially 15 mg once daily as monotherapy or combination therapy. Max: 30 mg/day. Recurrence prevention of manic episode in bipolar I disorder Continue therapy at same dose in patient receiving aripiprazole as monotherapy or combination therapy. Adolescent ≥15 yr Schizophrenia Initially 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach 10 mg daily dose. When appropriate, subsequent dose increases should be in 5 mg increments w/o exceeding the 30 mg max daily dose. Adolescent ≥13 yr Manic episode in bipolar I disorder Initially 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach 10 mg daily dose. Treatment duration: Not to exceed 12 wk. Severe hepatic impairment Max: 30 mg daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Hypersensitivity. Discontinue use if signs & symptoms indicative of NMS develops or unexplained high fever w/o additional clinical manifestations presents. Not indicated for treatment of patients w/ dementia-related psychosis. Suicidality. Patients w/ known CV disease (eg, history of MI or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions predisposing patients to hypotension or HTN including accelerated or malignant; VTE; family history of QT prolongation; history of seizure disorder or conditions associated w/ seizures. Consider dose reduction or discontinuation if signs & symptoms of tardive dyskinesia or extrapyramidal symptoms appear; increased urges particularly gambling, sexual urges, compulsive shopping, binge or compulsive eating, or other urges develop. Akathisia, parkinsonism & other extrapyramidal symptoms in ped patients. Observe for signs & symptoms of hyperglycaemia & regularly monitor patients w/ DM or w/ risk factors for DM for worsening of glucose control. Wt gain. Dysphalgia; oesophageal dysmotility & aspiration; patients at risk for aspiration pneumonia. Increased urges (particularly for gambling) & inability to control these urges. Concomitant use w/ stimulants in patients w/ ADHD comorbidity. Minor to moderate influence on ability to drive & use machines. Severe hepatic impairment. Pregnancy & lactation. Not recommended in childn <15 yr w/ schizophrenia & <13 yr. Childn & adolescents <18 yr w/ irritability associated w/ autistic disorder & 6-18 yr w/ tics associated w/ Tourette's disorder. Elderly ≥65 yr or those w/ psychosis associated w/ Alzheimer's disease.
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
May enhance effect of certain antihypertensive medicinal products. Concomitant use w/ alcohol or other CNS medicinal products w/ overlapping adverse reactions eg, sedation; medicinal products known to cause QT prolongation or electrolyte imbalance. Increased AUC w/ potent CYP2D6 inhibitors eg, quinidine, fluoxetine, & paroxetine. Increased AUC & Cmax w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole & HIV PIs. Modest increases in plasma conc w/ weak inhibitors of CYP3A4 (eg, diltiazem) or CYP2D6 (eg, escitalopram). Decreased AUC & Cmax w/ CYP3A4 inducers eg, carbamazepine, rifampicin, rifabutin, phenytoin, phenobarb, primidone, efavirenz, nevirapine, & St. John's wort. Cases of serotonin syndrome w/ SSRI/SNRI or medicinal products known to increase conc.
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Arilan tab 10 mg
Packing/Price
30's (P88/tab)
Form
Arilan tab 5 mg
Packing/Price
30's (P60/tab)
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