Aripraz 10

Aripraz 10

aripiprazole

Manufacturer:

Unison

Distributor:

JustRight Healthcare
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
Schizophrenia Adult Initially 10 or 15 mg daily w/ maintenance dose of 15 mg daily administered on a once-daily schedule. Max daily dose: Not to exceed 30 mg. Adolescent ≥15 yr 10 mg daily administered on a once-daily schedule. Initially 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach recommended daily dose of 10 mg daily administered on a once-daily schedule. Subsequent dose increases should be administered in 5 mg increments w/o exceeding max daily dose: 30 mg. Manic episode in bipolar I disorder Initially 15 mg administered on a once-daily schedule as monotherapy or combination therapy. Max daily dose: Not to exceed 30 mg. Adolescent ≥13 yr Initially 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg administered on a once-daily schedule. Duration: Not to exceed 12 wk. Severe hepatic impairment Max daily dose: 30 mg.
Administration
Should be taken on an empty stomach.
Contraindications
Special Precautions
Hypersensitivity. Discontinue use if patient develops signs & symptoms indicative of NMS or presents w/ unexplained high fever w/o additional clinical manifestations of NMS. Not indicated in dementia-related psychosis. VTE. Tardive dyskinesia. Other extrapyramidal symptoms. Wt gain. Pathological gambling & other impulse control disorders. May cause somnolence, postural hypotension, motor & sensory instability which may lead to falls. Patients w/ known CV disease (eg, history of MI or ischemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions predisposing patients to hypotension or HTN including accelerated or malignant; family history of QT prolongation; history of seizure disorder or conditions associated w/ seizures; at risk for aspiration pneumonia; ADHD comorbidity. Closely supervise for suicidal behavior in high-risk patients. Observe for signs & symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia & weakness) & regularly monitor for worsening of glucose control in patients w/ DM or w/ risk factors for DM. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorptions. Severe hepatic impairment. Pregnancy & lactation. Not recommended in childn <15 yr w/ schizophrenia & <13 yr w/ bipolar I disorder. Childn & adolescents <18 yr w/ irritability associated w/ autistic disorder & 6-18 yr w/ tics associated w/ Tourette's 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
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. Reduce dose to approx ½ in concomitant use w/ quinidine & other CYP2D6 strong inhibitors eg, fluoxetine & paroxetine; ketoconazole & other CYP3A4 strong inhibitors eg, itraconazole & HIV PIs. Modest increases in plasma conc may be expected w/ weak inhibitors of CYP3A4 (eg, diltiazem) or CYP2D6 (eg, escitalopram). Double dose in concomitant use w/ carbamazepine & other CYP3A4 inducers eg, 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
Aripraz 10 FC tab 10 mg
Packing/Price
3 × 10's
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