Manic episodes in Bipolar I Disorder

Active Ingredient: Aripiprazole

Indication for Aripiprazole

Population group: only adolescents (12 years - 18 years old) , adults (18 - 65 years old)
Therapeutic intent: Curative procedure

Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder in adults.

Aripiprazole is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

For this indication, competent medicine agencies globally authorize below treatments:

2 mg once daily for 2 days, titrated to 5 mg once daily for 2 additional days, then 10 mg once daily

For:

Dosage regimens

In the case that patient age in years is ≥ 13 :

Oral, 2 milligrams aripiprazole, once daily, over the duration of 2 days. Afterwards, oral, 5 milligrams aripiprazole, once daily, over the duration of 2 days. Afterwards, oral, 10 milligrams aripiprazole, once daily, over the duration of up to 80 days.

Detailed description

Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older

The recommended dose for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals. Treatment should be initiated at 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including EPS related events, somnolence, fatigue and weight gain. Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring. Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. Therefore, aripiprazole is not recommended for use in patients below 13 years of age.

15 mg once daily as initial dose followed by 15-30 mg once daily

For:

Dosage regimens

Oral, 15 milligrams aripiprazole, once daily. Afterwards, oral, between 15 milligrams aripiprazole and 30 milligrams aripiprazole, once daily. The maximum allowed total dose is 30 milligrams aripiprazole daily.

Detailed description

The recommended starting dose is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy. Some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.

Active ingredient

Aripiprazole

It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.

Read more about Aripiprazole

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