Symvenu

Cariprazine HCl

Schizophrenia. Depressive episodes associated w/ bipolar I disorder (bipolar depression). Acute treatment of manic or mixed episodes associated w/ bipolar I disorder.

Adult Schizophrenia Initially 1.5 mg once daily at the same time each day. Can be increased slowly in 1.5 mg increments (max: 6 mg daily). Depressive episodes associated w/ bipolar I disorder (bipolar depression) Initially 1.5 mg once daily at the same time each day. Can be increased to 3 mg once daily on Day 15 (max: 3 mg once daily). Manic or mixed episodes associated w/ bipolar I disorder Recommended dose range: 3-6 mg once daily. Initially 1.5 mg at the same time each day, increased to 3 mg on Day 2. Can be adjusted in 1.5 or 3 mg increments (max: 6 mg daily).

May be taken with or without food.

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

Closely supervise high-risk patients for possible suicidal ideation, suicide attempt & completed suicide. Patients who are prone to or already exhibit akathisia symptoms. Consider discontinuation if signs & symptoms of tardive dyskinesia appear. May exacerbate the underlying disease & worsen Parkinson’s disease symptoms. Ophthalmologic exam & re-evaluation for treatment continuation should be advised in patients who would develop potential cataract-related symptoms. Immediately discontinue use if a patient develops signs & symptoms indicative of NMS or presents w/ unexplained high fever w/o additional clinical manifestations of NMS. Patients w/ history of seizures or w/ conditions potentially lowering the seizure threshold. Patients w/ risk factors for stroke. Patients w/ known CV disease predisposing to BP changes or w/ family history of QT prolongation & in patients treated w/ possibly QT-prolonging medications. Possible VTE. Monitor serum glucose levels in patients w/ an established DM diagnosis or risk factors (eg, obesity, family history of diabetes). Monitor wt regularly. Consider gradual cross-titration when switching from another antipsychotic to cariprazine. Initiate new antipsychotic in its lowest dose while cariprazine is discontinued when switching to another antipsychotic. Extra monitoring & dose adjustment w/ use of P-gp substrates w/ narrow therapeutic index eg, dabigatran & digoxin. Avoid concomitant alcohol intake & grapefruit consumption. May affect the ability to drive & use machines. Not recommended in patients w/ severe renal & hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using effective contraception. Discontinue breastfeeding during treatment. Childn & adolescent <18 yr. Not recommended in elderly patients w/ dementia; elderly ≥65 yr.

Akathisia, Parkinsonism. Increased wt; sleep disorders, anxiety; sedation, dizziness, other extrapyramidal diseases & abnormal movement disorders; nausea, vomiting; fatigue. Schizophrenia & manic or mixed episodes associated w/ bipolar I disorder: Decreased appetite; dystonia; blurred vision; HTN; constipation. Manic or mixed episodes associated w/ bipolar I disorder & bipolar depression: Musculoskeletal pain. Schizophrenia: Dyslipidaemia, increased appetite; tachyarrhythmia; increased hepatic enzymes; increased blood creatine phosphokinase. Manic or mixed episodes associated w/ bipolar I disorder: Headache; tachycardia; hypotension; dyspepsia, dry mouth. Bipolar depression: Increased appetite.

Increased plasma exposure w/ CYP3A4 inhibitors (eg, boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole, verapamil). Decreased plasma exposure w/ CYP3A4 inducers [eg, carbamazepine, phenobarb, phenytoin, rifampicin, St. John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin]. Potential effect w/ P-gp substrates w/ narrow therapeutic index. Possible primary CNS effects in combination w/ other centrally acting medicinals & alcohol.

Antipsychotics

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

POM