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ARIPIPRAZOLE, 5mg, tab.

https://unicat.msf.org/cat/product/99475
NST DORAARIP05T-

Valid Article

24.1 - Medicines for psychotic disorders
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
24.2.2 - Medicines for bipolar disorders
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
N05AX12
Anatomical Therapeutic Chemical Classification according to WHOCC
P
The order of this product needs to be justified and is only acceptable under certain conditions.
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
SC subscriptions: included in supply or field tools
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ARIPIPRAZOLE

Therapeutic Action

Atypical antipsychotic, a dopamine-serotonin system stabilizer

Indications

Treatment of schizophrenia, and other psychosis, in adults and adolescents aged 15 years and older

Treatment of manic episode in Bipolar I disorder in adults and adolescents aged 15 years and older

Recurrence prevention of manic episodes in Bipolar I disorder in adults and adolescents aged 15 years and older

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Instructions for use

Posology (Adults)

  • Schizophrenia: 10–15 mg once daily; do not exceed 30 mg /day
  • Manic episodes in Bipolar I disorder: 15 mg once daily as monotherapy or combination therapy; do not exceed 30 mg/day
  • Recurrence prevention of manic episode in bipolar I disorder: in patients, who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.

Adjustments of daily dosage, including dose reduction should be considered based on clinical status.

Adolescents aged 15 years and older: dosing is indication and age-dependent; contact your OC Mental Health advisor for more details.

Closely monitor:

  • Weight/BMI (and ideally waist circumference)
  • Blood pressure
  • Blood glucose (fasting glucose or HbA1c) and lipids
  • Akathisia/extra pyramidal symptoms (EPS) after initiation or dose increases
  • Tardive dyskinesia
  • Clinical response, sleep, agitation, suicidality (where relevant)

Precautions for Use

Do not administer in patients below 15 years of age.

Avoid abrupt stop of the treatment; consider gradual taper to reduce relapse/withdrawal-related symptoms.

Common side effects: akathisia, anxiety, insomnia, headache, nausea, vomiting, constipation, orthostatic hypotension, weight gain

Serious adverse effects: extrapyramidal symptoms, neuroleptic malignant syndrome, seizures, hyperglycaemia/diabetes, dyslipidaemia

Use with caution in:

  • Elderly, especially with dementia
  • History of seizures
  • Cardiovascular disease, risk of hypotension, arrhythmias, or QT prolongation
  • History of EPS/tardive dyskinesia
  • Hepatic impairment

Aripiprazole is metabolised mainly by CYP2D6 and CYP3A4:

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, some HIV protease inhibitors): can increase aripiprazole levels
  • Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampicin, St John's wort): can decrease aripiprazole levels
  • Antihypertensives: increased risk of hypotension.

Storage

Below 25ºC