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Paliperidone

Also known as: Paliperidone

Atypical Antipsychotic

Route: Oral

6 interactions on record⛔ Black Box Warning

Paliperidone has 6 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Alcohol, Carbamazepine, Divalproex Sodium. Patients taking Paliperidone should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 6
Moderate: 5
Minor: 1

Moderate (5)

Paliperidone + Alcohol— CNS effects; use caution in combination and avoid alcohol.
Paliperidone + Carbamazepine— Strong CYP3A4/P-gp inducer may increase paliperidone clearance; dose increase may be necessary. Dose decrease needed upo…
Paliperidone + Divalproex Sodium— Co-administration increased paliperidone Cmax and AUC by approximately 50%; dose adjustment may be necessary based on cl…
Paliperidone + Dopamine Agonists— Paliperidone may antagonize the effect of dopamine agonists; use with caution.
Paliperidone + Levodopa— Paliperidone may antagonize the effect of levodopa and other dopamine agonists.

Minor (1)

Paliperidone + Lithium— Pharmacokinetic interaction between lithium and paliperidone is unlikely based on available data.

Paliperidone + Alcohol🟡Moderate

CNS effects; use caution in combination and avoid alcohol.

Paliperidone + Carbamazepine🟡Moderate

Strong CYP3A4/P-gp inducer may increase paliperidone clearance; dose increase may be necessary. Dose decrease needed upon discontinuation.

Paliperidone + Divalproex Sodium🟡Moderate

Co-administration increased paliperidone Cmax and AUC by approximately 50%; dose adjustment may be necessary based on clinical assessment.

Paliperidone + Dopamine Agonists🟡Moderate

Paliperidone may antagonize the effect of dopamine agonists; use with caution.

Paliperidone + Levodopa🟡Moderate

Paliperidone may antagonize the effect of levodopa and other dopamine agonists.

Paliperidone + Lithium🟢Minor

Pharmacokinetic interaction between lithium and paliperidone is unlikely based on available data.

⛔ FDA Black Box Warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychos is treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1)] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning . Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for use in patients with dementia-related psychosis. (5.1)

Contraindications

4 CONTRAINDICATIONS Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablet formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Known hypersensitivity to paliperidone, risperidone, or to any excipients in paliperidone extended-release tablets.( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including paliperidone, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery ( see Clinical Considerations ). Overall, available data from published epidemiologic studies of pregnant women exposed to paliperidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes ( see Data ). There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including paliperidone, during pregnancy ( see Clinical Considerations ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated with paliperidone during the period of organogenesis with up to 8 times the maximum recommended human dose (MRHD) based on mg/m 2 body surface area. Additional reproduction toxicity studies were conducted with orally administered risperidone, which is extensively converted to paliperidone (see Animal data). Clinical Considerations Disease-associated maternal and/or embryo/fetal risk There is a risk to the mother from untreated sc

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.