Abilify Maintena

Abilify Maintena

aripiprazole

Manufacturer:

Lundbeck

Distributor:

Zuellig Pharma

Marketer:

Otsuka
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
Acute & maintenance treatment of schizophrenia in adults stabilized w/ oral aripiprazole. Maintenance monotherapy treatment of bipolar I disorder in adults.
Dosage/Direction for Use
Initially 1 IM inj, continue treatment w/ oral aripiprazole 10-20 mg daily for 14 days or 2 separate IM inj w/ oral aripiprazole 20 mg. Maintenance dose: 400 mg once mthly as single IM inj, no sooner than 26 days after previous inj. May reduce dose to 300 mg once mthly if AR occur.
Special Precautions
Hypersensitivity reactions. Not to be inj IV or SC. Not indicated for dementia-related psychosis. Avoid inadvertent inj into blood vessel. Suicidal behaviour; known CV & cerebrovascular disease or other conditions predisposing to hypotension or HTN; VTE; history of QT prolongation & seizures. Tardive dyskinesia; NMS; hyperglycemia & DM; wt gain; pathological gambling & impulse-control disorders; somnolence, postural hypotension, motor & sensory instability leading to falls, fractures & other injuries; orthostatic hypotension. Patients at risk for aspiration pneumonia. Avoid concomitant use w/ CYP3A4 inducers. Concomitant use w/ strong CYP2D6 &/or CYP3A4 inhibitors. May affect ability to drive & use machines. Severe hepatic impairment. Not to be used during pregnancy. Lactation. Childn & adolescents ≤17 yr. Elderly ≥65 yr.
Adverse Reactions
Increased/decreased wt, DM; agitation, anxiety, restlessness, insomnia; extrapyramidal disorder, akathisia, tremor, dyskinesia, sedation, somnolence, dizziness, headache; dry mouth; musculoskeletal stiffness; erectile dysfunction; inj site pain & induration, fatigue; increased blood creatine phosphokinase.
Drug Interactions
Enhanced effect of certain antihypertensives. Increased conc w/ quinidine or other CYP2D6 inhibitors. 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. Decreased Cmax & AUC w/ carbamazepine & other strong CYP3A4 inducers eg, rifampicin, rifabutin, phenytoin, phenobarb, primidone, efavirenz, nevirapine, St. John's wort. Serotonin syndrome w/ other serotonergic medicinal products eg, SSRI/SNRI or medicinal products increasing aripiprazole conc. Alcohol or other CNS drugs; medicinal products causing QT prolongation or electrolyte imbalance.
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Abilify Maintena PR susp for inj (vial) 400 mg
Packing/Price
1's
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