Palido-OD® Extended Release Tablets

Description

What is Paliperidone?

Paliperidone is an atypical antipsychotic medication primarily prescribed for the treatment of schizophrenia and schizoaffective disorder. It is the active metabolite of risperidone and is marketed under the paliperidone trade name Invega. Designed as an extended-release tablet, paliperidone offers consistent plasma concentrations over 24 hours, enhancing therapeutic efficacy and tolerability.

Paliperidone Brand Names by Region

• United States & Canada: Invega

• European Union: Invega, Xeplion (long-acting injection)

• United Kingdom: Invega

• Australia: Invega, Invega Sustenna (LAI formulation)

Mechanism of Action

Paliperidone primarily works by antagonizing dopamine D2 and serotonin 5-HT2A receptors in the brain. This receptor blockade reduces psychotic symptoms such as hallucinations, delusions, and disorganized thinking. The drug also exhibits alpha-adrenergic and histaminergic receptor affinity, contributing to its sedative and cardiovascular profile. Unlike first-generation antipsychotics, paliperidone maintains lower risk for extrapyramidal side effects at therapeutic doses【source: https://www.ncbi.nlm.nih.gov/books/NBK534810/】.

Approved (On-Label) Uses

Schizophrenia

Paliperidone is approved for the treatment of schizophrenia in adults and adolescents aged 12 and older. Clinical trials have shown significant improvement in both positive (e.g., hallucinations, delusions) and negative (e.g., anhedonia, social withdrawal) symptoms【source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159062/】.

Schizoaffective Disorder

It is also FDA-approved for schizoaffective disorder, either as monotherapy or in conjunction with mood stabilizers or antidepressants. Paliperidone addresses both psychotic and mood-related components of the illness, a unique feature among atypical antipsychotics【source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s008lbl.pdf】.

Off-Label Uses

Although not officially approved, paliperidone has been studied and used off-label in managing:

• Bipolar disorder (manic episodes): Particularly in treatment-resistant patients where other mood stabilizers fail.

• Autism Spectrum Disorder (ASD): For aggression and irritability in adults.

• Post-Traumatic Stress Disorder (PTSD): Limited evidence supports its use in severe, treatment-refractory cases.

These off-label applications are based on receptor pharmacodynamics and case-based clinical reports but require physician oversight【source: https://pubmed.ncbi.nlm.nih.gov/24992105/】.

Formulation and Pharmacokinetics

Paliperidone 3mg and 6mg tablets utilize OROS® (osmotic-controlled release oral delivery system) technology. This facilitates consistent blood levels and improves patient adherence. Peak plasma concentration is reached approximately 24 hours post-dose, with steady-state levels attained after 4–5 days.

What is Invega and Why is Invega So Expensive?

Invega is the trade name for paliperidone, and its high cost is attributed to proprietary extended-release technology, research and development, and limited generic competition in some regions. The Invega price can vary significantly depending on the country and insurance status.

• Invega cost without insurance in the U.S. can exceed $1,000 per month, although prices are typically lower in Canada and the EU.

• Generic paliperidone may be available in select markets, which can reduce the paliperidone cost significantly.

Paliperidone Reviews

Patient and healthcare provider reviews generally highlight the drug’s effectiveness in reducing relapse rates and managing core symptoms of schizophrenia. Many note the convenience of once-daily dosing. Side effects reported in paliperidone reviews include weight gain, somnolence, and prolactin-related issues such as gynecomastia and menstrual irregularities.

Safety, Side Effects, and Monitoring

Common Side Effects

• Somnolence

• Dizziness

• Weight gain

• Elevated prolactin levels

Serious Adverse Events

• Extrapyramidal symptoms (EPS)

• Neuroleptic malignant syndrome (NMS)

• QT interval prolongation

• Orthostatic hypotension

Monitoring

Patients should undergo regular monitoring of weight, blood pressure, blood glucose, lipid profile, and prolactin levels. ECG may be indicated in those with cardiac risk.

Contraindications and Drug Interactions

Contraindications include hypersensitivity to paliperidone or risperidone. Use caution with other CNS depressants, QT-prolonging drugs, and dopamine agonists. Paliperidone is minimally metabolized by CYP enzymes, making it less prone to drug-drug interactions compared to other antipsychotics【source: https://www.drugs.com/ppa/paliperidone.html】.

Dosage and Administration

Initial dose: 3mg once daily
Maintenance dose: 3–6mg once daily depending on response and tolerability
Maximum dose: 12mg/day

Tablets should be taken with or without food and swallowed whole.

Availability and Packaging

Paliperidone extended-release tablets are available in sealed blister packs to maintain drug stability. Each unit is marked for dose accuracy. Available strengths include 3mg and 6mg.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from moisture and light.

Conclusion

Paliperidone (Invega) Extended Release Tablets provide a reliable, evidence-based treatment for schizophrenia and schizoaffective disorder. With its once-daily formulation and consistent pharmacokinetics, it is a preferred option among atypical antipsychotics for long-term stabilization. Given the growing demand and high Invega cost without insurance, generic or international options offer patients a cost-effective solution.

Frequently Asked Questions (FAQ)

What is paliperidone used for?
Paliperidone is used to treat schizophrenia and schizoaffective disorder in adults and adolescents.

What is the paliperidone brand name?
The main brand name is Invega. It is also available as Invega Sustenna (injectable) and in generic forms.

Why is Invega so expensive?
Invega’s high cost is due to extended-release technology, R&D expenses, and limited generic availability.

What is the difference between Invega and Risperdal?
Invega (paliperidone) is the active metabolite of Risperdal (risperidone). It has a longer half-life and smoother pharmacokinetics.

Is paliperidone safe long-term?
Yes, clinical studies support long-term use with appropriate monitoring for side effects.

What is the typical paliperidone cost?
Costs vary. In the U.S., without insurance, it may exceed $1,000/month. Generic forms are often cheaper.