دواعي استعمال ريجيلا 6مجم 28 كبسولة

Cariprazine 6 mg hard capsules, an atypical antipsychotic for schizophrenia in adults; 28 capsules (4 strips), Gedeon Richter, distributed by Hikma Pharma.

• Schizophrenia in adult patientsالفئة: Adultselectronic medicines compendium (eMC)

• Most frequent: akathisia (19%) and parkinsonism (17.5%); other common reactions include sedation, dizziness, insomnia, anxiety, weight gain, nausea, vomiting, constipation, blurred vision, hypertension and raised CPK/hepatic enzymes.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)

• Hypersensitivity to cariprazine or any excipient; concomitant strong CYP3A4 inhibitors; concomitant strong or moderate CYP3A4 inducers.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)

• Suicidal thoughts and behaviour: close supervision of high-risk patients.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Akathisia and restlessness, typically early in treatment; tardive dyskinesia (consider discontinuation).نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Not recommended in elderly patients with dementia (increased mortality and cerebrovascular adverse events with antipsychotics).نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Neuroleptic malignant syndrome; seizures; Parkinson's disease (may worsen); lens opacities/cataract reported in animals - eye examination advised.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Orthostatic hypotension or hypertension; QT prolongation caution; venous thromboembolism risk factors should be identified.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Hyperglycaemia/diabetes and weight gain; monitor glucose and body weight.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Moderate CYP3A4 inhibitors are not recommended. The 3 mg, 4.5 mg and 6 mg capsules contain Allura red AC (E129), which may cause allergic reactions.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)

• Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir)Ketoconazole about doubled total cariprazine exposure; contraindicated.electronic medicines compendium (eMC)
• Strong/moderate CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St John's wort)Markedly reduced exposure; contraindicated.electronic medicines compendium (eMC)
• Moderate CYP3A4 inhibitors (e.g. erythromycin)About 1.4-fold increase in exposure; not recommended.electronic medicines compendium (eMC)
• Grapefruit juiceCYP3A4 inhibition; avoid.electronic medicines compendium (eMC)
• P-gp substrates with narrow therapeutic index (dabigatran, digoxin)Cariprazine may inhibit intestinal P-gp; monitor/adjust.electronic medicines compendium (eMC)
• Alcohol and centrally acting medicinesAdditive CNS effects; use with caution.electronic medicines compendium (eMC)

• Not recommended during pregnancy or in women of childbearing potential not using effective contraception, which should continue for at least 10 weeks after the last dose. Neonates exposed in the third trimester are at risk of extrapyramidal and/or withdrawal symptoms.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)
• Breast-feeding should be discontinued during treatment.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)

• Monitor blood pressure, blood glucose and body weight; watch for extrapyramidal symptoms and suicidality.نشرة دولية لنفس المنتج · electronic medicines compendium (eMC)

• Partial agonist at dopamine D3, D2 and serotonin 5-HT1A receptors and antagonist at 5-HT2B, 5-HT2A and histamine H1 receptors (UK SmPC).