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    / Janssen


    Active Ingredient
    Paliperidone 3, 6, 9 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Extended-Release Tablets

    28 x 3 mg

    partial basket chart 86203 9258

    Extended-Release Tablets

    28 x 6 mg

    partial basket chart 86204 9259

    Extended-Release Tablets

    28 x 9 mg

    partial basket chart 88019 9292

    Related information


    Dosage

    Schizophrenia: The recommended dose of (paliperidone) Extended-Release Tablets for the treatment of schizophrenia is 6 mg once daily, administered in the morning. Initial dose titration is not required. Although it has not been systematically established that doses above 6 mg have additional benefit, there was a general trend for greater effects with higher doses. This must be weighed against the dose-related increase in adverse reactions. Thus, some patients may benefit from higher doses, up to 12 mg/day, and for some patients, a lower dose of 3 mg/day may be sufficient. Dose increases above 6 mg/day should be made only after clinical reassessment and generally should occur at intervals of more than 5 days. When dose increases are indicated, increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day. In a longer-term study, this product has been shown to be effective in delaying time to relapse in patients with schizophrenia who were stabilized on this product for 6 weeks. this product should be prescribed at the lowest effective dose for maintaining clinical stability and the physician should periodically reevaluate the long-term usefulness of the drug in individual patients.
    Schizoaffective Disorder: The recommended dose (paliperidone) Extended-Release Tablets for the treatment of schizoaffective disorder is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended dose range of 3 to 12 mg once daily. A general trend for greater effects was seen with higher doses. This trend must be weighed against dose-related increase in adverse reactions. Dosage adjustment, if indicated, should occur only after clinical reassessment. Dose increases, if indicated, generally should occur at intervals of more than 4 days. When dose increases are indicated, increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day.


    Indications

    Treatment of schizophrenia.


    Contra-Indications

    Known hypersensitivity to paliperidone, risperidone, or to any components in the formulation.


    Special Precautions

    Severe hepatic impairment. Caution should be exercised in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicdbines throught to prolong QT interval. Neuroleptic Malignant Syndrome (NMS) has been reported to occur with antipsychotics, including paliperidone. medicdbines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia. May induce orthostatic hypotension. Should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. Should not ordinarily be administered to patients with preexisting severe GI narrowing (pathologic or iatrogenic) or in patients with dysphagia or significantly difficulty in swallowing tablets. Should be used with caution in elderly patients with dementia who have risk factors for stroke.
    Pregnancy and lactation: Should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly. Should not be used while breast-feeding. Patients should be advised not to drive or operate machines until their individual suceptibility is known.


    Side Effects

    Very common: Headache.
    Common: Akathisia, dizziness, dystonia, extrapyramidal disorder, hypertonia, Parkinsonism, sedation, somnolence, tremor. First degree atrioventricular block, bradycardia, Bundle branch block, sinus tachycardia, tachycardia. Orthostatic hypotension. Upper abdominal pain, dry mouth, salivary hypersecretion, vomiting. Asthenia, fatigue. Increased weight.


    Drug interactions

    medicines known to prolong the QT interval, e.g., class IA antiarrhythmics, class III antiarrhythmics, some antihistaminics. Other centrally acting medicines, e.g. anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol. Levodopa and other dopamine agonists. Other antipsychotics, tricyclics. Other medicines known to lower the seizure threshold.


    Pregnancy and Lactation

    Pregnancy Category C.: There are no adequate and well controlled studies of this product in pregnant women. this product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use of first generation antipsychotic drugs during the last trimester of pregnancy has been associated with extrapyramidal symptoms in the neonate. These symptoms are usually selflimited. It is not known whether paliperidone, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms. In animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated during the period of organogenesis with up to 8 times the maximumrecommended human dose of paliperidone (on a mg/m2 basis). In rat reproduction studies with risperidone, which is extensively converted to paliperidone in rats and humans, there were increases in pup deaths seen at oral doses which are less than the maximum recommended human dose of risperidone on a mg/m2 basis.
    Nursing Mothers: Paliperidone is 9-hydroxyrisperidone, the active metabolite of risperidone. In animal studies, risperidone and 9-hydroxyrisperidone were excreted in milk. Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Caution should be exercised when this product is administered to a nursing woman. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone.
    Pediatric Use: Safety and effectiveness of this product in patients < 18 years of age have not been established.


    Overdose

    Human Experience: While experience with paliperidone overdose is limited, among the few cases of overdose reported in pre-marketing trials, the highest estimated ingestion of this product was 405 mg. Observed signs and symptoms included extrapyramidal symptoms and gait unsteadiness. Other potential signs and symptoms include those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and somnolence, tachycardia and hypotension, and QT prolongation. Torsade de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose. Paliperidone is the major active metabolite of risperidone. Overdose experience reported with risperidone can be found in the overdose section of the risperidone package insert.
    Management of Overdose: There is no specific antidote to paliperidone, therefore, appropriate supportive measures should be instituted and close medical supervision and monitoring should continue until the patient recovers. Consideration should be given to the extended-release nature of the product when assessing treatment needs and recovery. Multiple drug involvement should also be considered. In case of acute overdose, establish and maintain an airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with an acute overdose of paliperidone. Similarly the alpha-blocking properties of bretylium might be additive to those of paliperidone, resulting in problematic hypotension. Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of paliperidone-induced alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered.


    Manufacturer
    Janssen Cilag S.P.A., Italy
    Licence holder
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