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Trevicta 175 mg Prolonged Release Suspension for Injection

NAFDAC Reg. No. A4-100554 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Trevicta 175 mg Prolonged Release Suspension for Injection
NAFDAC number
A4-100554
Active ingredient
Paliperidone (Paliperidone Palmitate)
Strength
175 mg/0.88 mL
Form
Suspension for injection
Pack size
0.88 mL x 1's (in a pre-filled syringe)
Manufacturer
Not listed
Applicant (holder)
J & J Company West Africa Limited
Approved
31 Oct 2023
Status
Active View on NAFDAC ↗
Registration valid to
30 Oct 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Trevicta 175 mg Prolonged Release Suspension for Injection is on the NAFDAC register with an active registration (A4-100554). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Trevicta 175 mg Prolonged Release Suspension for Injection is used for

From the official U.S. FDA label for paliperidone (paliperidone palmitate), the active ingredient registered with NAFDAC.

Boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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 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. …
What it is used for

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2) Efficacy was established in two 6-week trials in adult patients. (14.2) 1.1 Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. …

Possible side effects

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] QT prolongation [see Warnings and Precautions (5.4) ] Tardive dyskinesia [see Warnings and Precautions (5.5) ] Metabolic changes [see Warnings and Precautions (5.6) ] Hyperprolactinemia [see Warnings and Precautions (5.7) ] Potential for gastrointestinal obstructi …

Do not use if

Paliperidone extended-release tablets are 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. …

Warnings

Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotics. (5.2) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of drug and close monitoring. (5.3) QT Prolongation: Increase in QT interval, avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval. (5.4) Tardive Dyskinesia: Discontinue drug if clinically appropriate. …

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/ . …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Trevicta 175 mg Prolonged Release Suspension for Injection

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Trevicta 175 mg Prolonged Release Suspension for Injection

What is in Trevicta 175 mg Prolonged Release Suspension for Injection?

Trevicta 175 mg Prolonged Release Suspension for Injection contains Paliperidone (Paliperidone Palmitate) (175 mg/0.88 mL), as suspension for injection, according to its NAFDAC registration record.

Is Trevicta 175 mg Prolonged Release Suspension for Injection registered with NAFDAC?

Yes. Trevicta 175 mg Prolonged Release Suspension for Injection is listed on the NAFDAC register under registration number A4-100554, and its registration is active as of 5 November 2026.

Has Trevicta 175 mg Prolonged Release Suspension for Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Trevicta 175 mg Prolonged Release Suspension for Injection in our automatically synced alert list.

How can I check that my pack of Trevicta 175 mg Prolonged Release Suspension for Injection is genuine?

Run a free authenticity scan with the NAFDAC number A4-100554, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Trevicta 175 mg Prolonged Release Suspension for Injection used for?

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepre (Summarised from the official U.S. FDA label for paliperidone (paliperidone palmitate). Always follow your doctor or pharmacist.)

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