Properties
- Form
- kafsula
- Dosage mg
- 1.5
- Pack
- 28
What is it?
International Nonproprietary Name - cariprazine Clinical-pharmacological group: Central Nervous System → Psychotropic agents → Neuroleptics (antipsychotics) Indications for use Treatment of schizophrenia in adult patients. Method of administration and dosage Method of administration Reagila is taken orally once a day at the same time, regardless of food intake. Dosage The recommended starting dose of cariprazine is 1.5 mg once daily. Subsequently, if necessary, the dose can be gradually increased in increments of 1.5 mg/day up to a maximum dose of 6 mg/day. The minimum effective dose is determined by the treating physician based on clinical assessment. Due to the long half-life of cariprazine and its active metabolites, dose adjustments have a small effect on drug concentration in blood plasma for several weeks. It is necessary to monitor for adverse reactions and patient response to therapy for several weeks after starting cariprazine and after each dose adjustment (see section "Pharmacokinetics"). Switching from other antipsychotic drugs to cariprazine When switching from treatment with other antipsychotic drugs to treatment with cariprazine, the possibility of gradual cross-titration should be considered, with gradual reduction of the dose of the previous drug concurrently with the initiation of cariprazine. Switching from cariprazine to other antipsychotic drugs When switching from treatment with cariprazine to other antipsychotic drugs, gradual cross-titration is not necessary; it is necessary to start the new antipsychotic drug at the minimum dose, simultaneously discontinuing cariprazine. It should be taken into account that the concentration of cariprazine and its active metabolites in blood plasma will decrease by 50% after approximately 1 week (see section "Pharmacokinetics"). Special populations of patients Elderly patients In patients aged 65 years and older, data on the use of cariprazine are insufficient to identify differences in treatment response compared to younger patients (see section "Pharmacokinetics"). Dose selection in elderly patients should be done with particular caution. Patients with renal impairment In patients with mild to moderate renal impairment (creatinine clearance (CrCl) ≥30 ml/min and <89 ml/min), dose adjustment of the drug is not required. The safety and efficacy of cariprazine in patients with severe renal impairment (CrCl <30 ml/min) have not been evaluated (see section "Pharmacokinetics"). The use of cariprazine is not recommended in patients with severe renal impairment. Patients with hepatic impairment In patients with mild to moderate hepatic impairment (5-9 points according to Child-Pugh), dose adjustment of the drug is not required. The safety and efficacy of cariprazine in patients with severe hepatic impairment (10-15 points according to Child-Pugh) have not been evaluated (see section "Pharmacokinetics"). The use of cariprazine is not recommended in patients with severe hepatic impairment. Pediatric population The efficacy and safety of cariprazine in children and adolescents under 18 years of age have not been established. No data are available. Contraindications - Hypersensitivity to the active substance or any of the excipients of the drug (see section "Composition"). - Concomitant administration of strong or moderate inhibitors of the CYP3A4 isoenzyme (see section "Interactions with other medicinal products"). - Concomitant administration of strong or moderate inducers of the CYP3A4 isoenzyme (see section "Interactions with other medicinal products").
