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Abilify Maintena

Abilify Maintena

aripiprazole

Manufacturer:

Otsuka

Distributor:

Zuellig Pharma

Marketer:

Thai Otsuka
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
Schizophrenia. Maintenance monotherapy treatment of bipolar I disorder in adults.
Dosage/Direction for Use
IM Deep inj into gluteal or deltoid muscle. Recommended starting & maintenance dose: 400 mg mthly (no sooner than 26 days after previous inj). 1 inj start: Administer one 400 mg inj & continue w/ oral aripiprazole 10-20 mg daily for 14 consecutive days. 2 inj start: Administer 2 separate 400 mg inj along w/ one 20 mg oral aripiprazole. May reduce dose to 300 mg once mthly if there are adverse reactions. Patients who are CYP2D6 poor metabolizers & taking 400-mg Abilify Maintena w/ strong CYP2D6 or CYP3A4 inhibitors for >14 days 300 mg mthly.
Special Precautions
Discontinue treatment if NMS occurs; in patients w/ severe neutropenia (ANC <1,000/mm3) & follow their WBC counts until recovery. Consider discontinuation if signs & symptoms of tardive dyskinesia appear; at 1st sign of clinically significant decline in WBC in absence of other causative factors. Consider dose reduction or stopping treatment if compulsive urges develop. Not for treatment of dementia-related psychosis. Not to inj both inj, if initiating w/ the 2-inj start, concomitantly into same deltoid or gluteal muscle. Cerebrovascular adverse reactions eg, stroke, transient ischemic attack; tardive dyskinesia; hyperglycemia/DM, dyslipidemia, wt gain; pathological gambling & compulsive behaviors; orthostatic hypotension; somnolence, postural hypotension, motor & sensory instability leading to falls & fractures or other injuries; leukopenia, neutropenia, agranulocytosis; disruption of body's ability to reduce core body temp; esophageal dysmotility & aspiration. Patients w/ history of seizures or conditions that lower seizure threshold; at risk for aspiration pneumonia. Monitor worsening of glucose control; symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, & weakness; wt; fever or other symptoms or signs of infection in patients w/ clinically significant neutropenia. Perform fasting blood glucose testing in patients w/ risk factors for DM at the beginning & periodically during treatment; CBC in patients w/ history of clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia during 1st few mth of therapy. May impair ability to drive or operate machinery. Pregnancy & lactation. May decrease milk supply in post-partum period if exposed during pregnancy. Risk of extrapyramidal &/or w/drawal symptoms in neonates exposed to antipsychotic drugs during 3rd trimester following delivery. Monitor breastfed infant for dehydration & lack of appropriate wt gain. Childn ≤18 yr. Elderly w/ dementia-related psychosis.
Adverse Reactions
Constipation, dry mouth, diarrhea, vomiting, abdominal discomfort; inj site pain; URTI; increased or decreased wt; arthralgia, back & musculoskeletal pain, myalgia; akathisia, sedation, dizziness, tremor; nasal decongestion.
Drug Interactions
Increased exposure w/ strong CYP3A4 (eg, ketoconazole) or strong CYP2D6 (eg, paroxetine, fluoxetine) inhibitors. Decreased exposure w/ strong CYP3A4 inducers (eg, carbamazepine). Enhanced effect of antihypertensives. Greater intensity of sedation & orthostatic hypotension w/ benzodiazepines (eg, lorazepam).
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Abilify Maintena susp for inj 300 mg
Packing/Price
(pre-filled dual chamber syringe) 1's
Form
Abilify Maintena susp for inj 400 mg
Packing/Price
(pre-filled dual chamber) 1's
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