Reagila

Cariprazine

Adults w/ schizophrenia. Depressive episodes associated w/ bipolar I disorder. Acute treatment of manic or mixed episodes associated w/ bipolar I disorder.

Schizophrenia Initially 1.5 mg once daily. Slowly increased dose in 1.5 mg increments to max of 6 mg daily. Manic or mixed episodes associated w/ bipolar I disorder Recommended dose range: 3-6 mg once daily. Initially 1.5 mg once daily & may be increased to 3 mg on day 2. Dose adjustment: 1.5 or 3 mg increments. Max: 6 mg daily. Depressive episodes associated w/ bipolar I disorder Initially 1.5 mg once daily, may be increased to 3 mg once daily on day 15. Max: 3 mg once daily.

May be taken with or without food: Take at the same time each day.

Hypersensitivity. Concomitant administration of strong or moderate CYP3A4 inhibitors & inducers.

Discontinue if signs & symptoms of tardive dyskinesia; NMS or w/ unexplained high fever w/o clinical manifestations of NMS occurs. Possibility of suicidality (eg, suicidal ideation, suicide attempt & completed suicide). Patients who are prone to, or already exhibits symptoms of akathisia; w/ Parkinson's disease; history of seizures or conditions lowering seizure threshold; risk factors for stroke; CV disease predisposing to BP changes; family history of QT prolongation & those concomitantly treated w/ medicinal products causing QT prolongation; risk factors for VTE & DM. Perform ophth exam & re-evaluate treatment continuation in patients who develop symptoms potentially related to cataract. Monitor BP; serum glucose levels. Regularly monitor wt. May affect ability to drive & use machines. Severe renal (CrCl <30 mL/min) &/or hepatic (Child-Pugh score 10-15) impairment. Women of childbearing potential must use highly effective contraception during & at least 10 wk after treatment. Not recommended during pregnancy & in women of childbearing potential not using effective contraception. Discontinue lactation during treatment. Neonates during 3rd trimester of pregnancy. Childn & adolescents <18 yr. Not recommended in elderly w/ dementia. Elderly ≥65 yr.

Akathisia, parkinsonism. Increased wt & appetite, decreased appetite, dyslipidaemia; sleep disorders, anxiety; sedation, dizziness, dystonia, other extrapyramidal diseases & abnormal movement disorders, headache, parkinsonism; blurred vision; tachyarrhythmia, tachycardia; HTN, hypotension; nausea, constipation, vomiting, dyspepsia, dry mouth; increased hepatic enzymes; increased blood creatine phosphokinase, musculoskeletal pain; fatigue.

Increased plasma exposure w/ strong or moderate CYP3A4 inhibitors eg, boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole, verapamil. Avoid consumption of grapefruit juice. Decreased exposure w/ strong & moderate CYP3A4 inducers eg, carbamazepine, phenobarb, phenytoin, rifampicin, St. John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin. Concomitant use w/ P-gp substrates w/ narrow therapeutic index eg, dabigatran & digoxin; hormonal contraceptives; centrally acting medicinal products & alcohol.

Antipsychotics

N05AX15 - cariprazine ; Belongs to the class of other antipsychotics.

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