دواعي استعمال تريفيكتا 525مجم سرنجة معبأة

Trevicta 525 mg pre-filled syringe: 3-monthly long-acting paliperidone palmitate injection (expressed as 525 mg paliperidone = 819 mg palmitate per EU SmPC) by Janssen, marketed in Egypt via Soficopharm.

• العلاج الوقائي لمرض الفصام في البالغين المستقرين على حقن باليبيريدون بالميتات الشهريةالفئة: AdultsEuropean Medicines Agency (EMA)
• Schizophrenia in patients adequately treated with 1-monthly paliperidone palmitate for at least 4 monthsالفئة: AdultsDailyMed (U.S. National Library of Medicine)

• Most common (>=5%): weight increased, upper respiratory tract infection, anxiety, headache, insomnia, injection-site reaction; also akathisia, parkinsonism, hyperprolactinaemia.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Hypersensitivity to paliperidone, risperidone or any excipient.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• BOXED WARNING (US): increased mortality in elderly patients with dementia-related psychosis; not approved for dementia-related psychosis.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
• Neuroleptic malignant syndrome; discontinue all antipsychotics.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• QT prolongation: caution with known cardiovascular disease, family history of QT prolongation or other QT-prolonging drugs.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Tardive dyskinesia/extrapyramidal symptoms.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Metabolic changes: hyperglycaemia/diabetes, dyslipidaemia, weight gain.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Orthostatic hypotension and syncope; falls.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Leukopenia, neutropenia and agranulocytosis.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Hyperprolactinaemia.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Seizures, cognitive/motor impairment, body temperature dysregulation, dysphagia, priapism; intraoperative floppy iris syndrome.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Long-acting: paliperidone detectable in plasma up to 18 months after a single dose; adverse effects may persist.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• QT-prolonging drugs (class IA and III antiarrhythmics, some antihistamines, fluoroquinolones, other antipsychotics, mefloquine)Caution: additive QT prolongation.European Medicines Agency (EMA)
• Centrally acting drugs and alcoholCaution: additive CNS effects.European Medicines Agency (EMA)
• Levodopa and dopamine agonistsPaliperidone may antagonise their effect.European Medicines Agency (EMA)
• Strong CYP3A4/P-gp inducers (e.g. carbamazepine, rifampin, St John's wort)Decrease paliperidone exposure; avoid during the 3-month dosing interval if possible (US).DailyMed (U.S. National Library of Medicine)
• Drugs causing orthostatic hypotensionAdditive hypotensive effect.European Medicines Agency (EMA)

• Should not be used during pregnancy unless clearly necessary; long-acting exposure (plasma up to 18 months) before/during pregnancy may affect the newborn.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Should not be used while breastfeeding: paliperidone is excreted in milk to an extent likely to affect the infant, even from doses given long before breastfeeding.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• US: paliperidone is present in human milk; consider benefits of breastfeeding with clinical need and potential adverse effects on the infant.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)

• Weight, fasting glucose, lipids, prolactin-related symptoms, extrapyramidal symptoms/tardive dyskinesia, complete blood count in patients with history of low WBC, renal function before dosing.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)