ABIZOL 10MG N28 TB

Abizol, 5 mg; 10 mg; 15 mg tablets

Composition of Abizol

Active substance: Aripiprazole is present in the amount of 5 mg, 10 mg, or 15 mg in 1 tablet.

Contraindications

It is contraindicated in patients with hypersensitivity to aripiprazole, the active substance, or to any of the excipients contained in the tablet.

Use during pregnancy and lactation

Appropriate clinical studies with aripiprazole have not been conducted in pregnant women. Although congenital anomalies have been reported, it is not known whether this is due to aripiprazole use. Animal studies do not rule out the potential for toxicity to development. Patients should inform their doctor if they are planning to become pregnant or if they become pregnant during treatment with aripiprazole. In any case, because information on safety for humans is limited and the results of animal studies raise concerns, aripiprazole should be used in pregnant women only if the benefit it provides to the mother outweighs the risk to the fetus.
Infants exposed to antipsychotic medicines (including aripiprazole) during the 3rd trimester of pregnancy may experience additional side effects such as extrapyramidal and/or “withdrawal” symptoms, which can vary in severity and duration after birth. It has been reported that such infants may have agitation, hypotonia, hypertension, tremor, drowsiness, respiratory distress, and feeding disorders. Therefore, such infants should be kept under careful monitoring.
Aripiprazole is excreted into breast milk. A decision should be made whether to discontinue aripiprazole treatment and/or to discontinue breastfeeding, taking into account the benefit of aripiprazole treatment for the mother and the benefit of breastfeeding for the child.

Directions for use and dosage

Adults
Schizophrenia
The recommended starting dose is 10 or 15 mg/day; thereafter, the dose is maintained at 15 mg/day, taken once daily, regardless of food intake.
Abizol is effective within the dose range of 10–30 mg/day. Although there is no evidence that efficacy increases at daily doses higher than 15 mg, efficacy at higher doses may be possible in some patients.
The maximum daily dose should not exceed 30 mg.
Manic episodes in bipolar disorder type I
For monotherapy or combination therapy, the daily dose is 15 mg regardless of food intake. Some patients may benefit from higher doses. The maximum daily dose should not exceed 30 mg.
To prevent recurrence of manic episodes in bipolar disorder type I, in patients who have received aripiprazole for monotherapy of a manic episode or for combination therapy, treatment is continued at the same dose to prevent recurrence. Any adjustment of the daily dose or reduction of the dose is performed based on clinical indications.
Children and adolescents
Schizophrenia in adolescents aged 15 years and older
The recommended dose for Abizol is 10 mg/day, once daily, regardless of food intake.
Treatment should be started with a dose of 2 mg once daily for 2 days, then increased to 5 mg once daily for the next 2 days, and should be titrated to the recommended daily dose of 10 mg. If necessary, subsequent dose increases may be made in steps of 5 mg, provided that the daily dose does not exceed 30 mg.
Abizol is effective within the dose range of 10–30 mg/day. Although there is no evidence that efficacy increases at daily doses higher than 10 mg in adolescents, efficacy at higher doses may be possible in some patients.
Because information on the use, efficacy, and safety of Abizol in patients with schizophrenia under 15 years of age is limited, it is not recommended.
Manic episodes in bipolar disorder type I in adolescents aged 13 years and older
The recommended dose for Abizol is 10 mg/day, once daily, regardless of food intake. Treatment should be started with a dose of 2 mg once daily for 2 days, then increased to 5 mg once daily for the next 2 days, and should be titrated to the recommended daily dose of 10 mg. The duration of treatment should be as short as necessary to control symptoms and should not exceed 12 weeks. No increase in efficacy has been observed at daily doses higher than 10 mg, and higher daily doses (up to 30 mg/day) have resulted in a significant increase in the frequency of adverse reactions, including EPS-related events, drowsiness, fatigue, and increased body weight. Therefore, daily doses higher than 10 mg may be used only in exceptional cases under strict clinical monitoring. Since younger patients are more likely to experience adverse reactions related to aripiprazole,
the use of Abizol in patients under 13 years of age is not recommended.
Irritability associated with autistic disorder
The efficacy and safety of aripiprazole in children and adolescents under 18 years of age have not been established.
Tics associated with Tourette’s syndrome
The efficacy and safety of aripiprazole in children and adolescents aged 6–18 years have not been established.
Special patient groups
Hepatic impairment
No dose adjustment is required in patients with mild to moderate hepatic impairment. Data on the effects in patients with severe hepatic impairment are limited. In such patients, dosing should be carried out with caution, and the maximum daily dose of 30 mg/day should be prescribed with great caution.
Renal impairment
No dose adjustment is required in patients with renal impairment.
Elderly
The efficacy of aripiprazole has not been established in patients aged ≥ 65 years with schizophrenia and bipolar disorder. Considering the higher sensitivity of this population and if clinical factors warrant it, a lower starting dose should be prescribed.
Gender
No dose adjustment is required based on gender in women and men.
Smokers
Based on aripiprazole metabolic pathways, no dose adjustment is required in smokers.
Dose adjustment related to interactions
When aripiprazole is prescribed together with strong CYP3A4 and/or CYP2D6 inhibitors, the dose should be reduced. After discontinuation of CYP3A4 and/or CYP2D6 inhibitors, the dose of aripiprazole should be increased.
When aripiprazole is prescribed together with strong CYP3A4 inducers, the dose should be increased. After discontinuation of CYP3A4 inducers, the dose of aripiprazole should be reduced to the required dose.