Paliperidone
ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines · Published , updated
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Articles
22 September 2020
Safety in Lactation: Antipsychotics
Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral and non-depot antipsychotics with less… Amisulpride Aripiprazole Benperidol Chlorpromazine Clozapine Flupentixol Flupentixol decanoate Fluphenazine decanoate Haloperidol Haloperidol decanoate Levomepromazine Loxapine Lurasidone Mental health and illness Obstetrics and gynaecology Olanzapine Olanzapine embonate Paediatrics and neonates Paliperidone Pericyazine Perphenazine Pipotiazine Promazine Quetiapine Risperidone Safety in Breastfeeding Sulpiride Trifluoperazine Zuclopenthixol Zuclopenthixol decanoate
29 May 2020
Which medicines are considered safe for use in the acute porphyrias?
This updated Medicines Q&A presents a table of the medicines considered safe for use in the acute porphyrias. Inclusion of a drug does not guarantee… Anidulafungin Aripiprazole Benralizumab Betahistine Calcium polystyrene sulfonate Cefepime Cefoxitin Cinacalcet Demeclocycline Diclofenac Diclofenac potassium Diclofenac sodium Dimeticone Ertugliflozin Ivabradine Linaclotide Meropenem Midodrine Nutritional and metabolic disorders Paliperidone Prazosin Prucalopride Quetiapine Simeticone Sodium zirconium cyclosilicate TigecyclineMedicine Compliance Aid Stability
InvegaJanssen-Cilag Ltd
Janssen-Cilag Ltd
Invega
Tablets m/r 3mg, 6mg, 9mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Protect from light. Protect from moisture and packed with a desiccant.
1 October 2015
Lactation Safety Information
Oral
Oral
Quetiapine, Haloperidol
Active metabolite of risperidone
No published evidence of safety
Long half-life increases risk of accumulation in breastfed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
9 November 2018
Depot injection as palmitate salt
Depot injection
as palmitate salt
Risperidone depot injection
Active metabolite of risperidone
No published evidence of safety
Long half-life increases risk of accumulation in breast fed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
9 November 2018
New Medicines
Schizophrenia, prevention of relapse - 6-monthly IM formulation
Information
New formulation
Janssen
Janssen
Development and Regulatory status
Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials
Dec 20Filed in EU [6].
Jan 20Company plans to file in EU & US before end of 2020 [4].
Category
Dopamine D2 receptor & serotonin 5HT2 receptor antagonist
In England there are about 800 per 100,000 people with schizophrenia.
Schizophrenia, prevention of relapse - 6-monthly IM formulation
Intramuscular
Trial or other data
May 20PIII trial (NCT03345342) completes [5].
Nov 19PIII trial (NCT03345342) has finished recruiting and expects to complete collection of primary outcome data in Jul 20 [3].
Nov 18PIII trial (NCT03345342) is still recruiting; timescales unchanged [2].
Nov 17PIII trial to assess the non-inferiority in the efficacy of paliperidone palmitate 6-month formulation to the 3-month formulation, in preventing the relapse in patients with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month starts (NCT03345342). 765 patients will be recruited in countries around the world including the US and EU. Collection of primary outcome data (time to relapse) is expected to finish in Jul 20 [1].