Abizol 30MG N28 Tb

ABIZOL, 5 mg; 10 mg; 15 mg tablets

Abizol composition

 Active ingredient: Each tablet contains 5 mg, 10 mg, or 15 mg of aripiprazole.

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

No relevant clinical studies have been conducted with aripiprazole in pregnant women. Although congenital anomalies have been reported, it is not established that this is due to aripiprazole intake. 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 intend to 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 may be used in pregnant women only when the benefit to the mother outweighs the risk to the fetus. During the third trimester of pregnancy, infants exposed to the effects of antipsychotic medicines (including aripiprazole) may experience additional side effects such as extrapyramidal and/or “withdrawal” symptoms, which can vary in severity and duration after birth. It has been noted that such infants may experience agitation, hypotonia, hypertension, tremor, drowsiness, respiratory disorders, 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.

Abizol dosage and method of use

Adults For schizophrenia The recommended starting dose is 10 or 15 mg/day, then 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 doses higher than 15 mg per day, some patients may be effective at higher doses. The maximum daily dose should not exceed 30 mg. In bipolar disorder type I for manic episodes The daily dose is 15 mg, regardless of food intake, during monotherapy or combination therapy. Some patients may be effective at 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 or combination therapy of a manic episode, treatment is continued at the same dose to prevent recurrence. Dose adjustments or dose reductions are made based on clinical indications. Children and adolescents For 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 then increased to the recommended daily dose of 10 mg. If necessary, subsequent dose increases by 5 mg may be carried out, provided 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 doses higher than 10 mg per day in adolescents, some patients may be effective at higher doses. Use of Abizol® in patients with schizophrenia under 15 years of age is not recommended due to limited data on efficacy and safety. For 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 then increased 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 additional side effects, including EPS-related events, drowsiness, fatigue, and weight gain. Therefore, daily doses higher than 10 mg should be used only in exceptional cases under strict clinical monitoring. Because younger patients have a higher likelihood of experiencing side effects 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 have not been established in children and adolescents under 18 years of age. Tic disorders related to Tourette syndrome The efficacy and safety of aripiprazole have not been established in children and adolescents aged 6–18 years. Special patient groups Hepatic impairment In patients with mild to moderate hepatic impairment, no dose adjustment is required. 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 In patients with renal impairment, no dose adjustment is required. Elderly patients The efficacy of aripiprazole has not been established in patients aged ≥ 65 years with schizophrenia and bipolar disorder. Considering the higher risk of hypersensitivity in this population and if clinical factors warrant it, a lower starting dose should be prescribed. Gender There is no need for dose adjustment depending on gender in women and men. Smokers Based on aripiprazole metabolic pathways, no dose adjustment is required in smokers. Dose adjustments 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 aripiprazole dose should be increased. When aripiprazole is prescribed together with strong CYP3A4 inducers, the dose should be increased. After discontinuation of CYP3A4 inducers, the aripiprazole dose should be reduced to the required dose.