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Paliperidone: Brands, Price & Uses in Bangladesh
Paliperidone is an atypical (second-generation) antipsychotic, the major active metabolite of risperidone.
About Paliperidone
Indications of Paliperidone
Paliperidone is an atypical (second-generation) antipsychotic, the major active metabolite of risperidone. Its evidence-based uses include:
- Established/FDA-approved uses:
- Treatment of schizophrenia in adults and in adolescents aged 12–17 years (acute treatment and prevention of recurrence).
- Treatment of schizoaffective disorder in adults, as monotherapy or as an adjunct to mood stabilizers or antidepressants.
- Maintenance/long-term use: Once stabilized, Paliperidone (oral extended-release) may be continued for relapse prevention; a long-acting injectable ester of Paliperidone (paliperidone palmitate) is also available separately for once-monthly or longer-interval maintenance therapy.
- Off-label use (not FDA-approved, used in some clinical settings): Adjunctive management of treatment-resistant mood symptoms in bipolar disorder; this is not a standard first-line use and should only be undertaken by a specialist.
Paliperidone is not approved for treatment of dementia-related psychosis in elderly patients (see Precautions and Warnings for the boxed warning).
Dosage & Administration of Paliperidone
Adults — Schizophrenia
| Parameter | Dose |
|---|---|
| Initial dose | 6 mg once daily, in the morning |
| Recommended range | 3–12 mg once daily |
| Titration | Increase by 3 mg increments; allow at least 5 days between dose increases |
| Maximum dose | 12 mg once daily |
Adults — Schizoaffective Disorder
| Parameter | Dose |
|---|---|
| Initial dose | 6 mg once daily, in the morning |
| Recommended range | 3–12 mg once daily |
| Titration | Increase by 3 mg increments; allow at least 4 days between dose increases |
Adolescents (12–17 years) — Schizophrenia
| Body weight | Dose |
|---|---|
| Initial dose (all weights) | 3 mg once daily |
| Less than 51 kg | Maximum 6 mg once daily |
| 51 kg or more | Maximum 12 mg once daily |
Paliperidone is not established as safe and effective for schizoaffective disorder in patients under 18 years of age.
Renal Impairment (Adults)
| Renal function | Dose |
|---|---|
| Mild impairment (CrCl 50 to <80 mL/min) | Initial 3 mg once daily; maximum 6 mg once daily |
| Moderate to severe impairment (CrCl 10 to <50 mL/min) | Initial 1.5 mg once daily; maximum 3 mg once daily |
Administration
Tablets must be swallowed whole with the aid of liquid and must not be chewed, divided, or crushed. Paliperidone extended-release tablets may be taken with or without food, at approximately the same time each day. Patients should be counselled that the tablet shell is non-deformable and may occasionally be seen intact in the stool — this is expected with the OROS delivery system and does not indicate the dose was not absorbed.
Side Effects of Paliperidone
| Category | Effects |
|---|---|
| Very common / common | Akathisia, somnolence/sedation, tremor, dystonia, cogwheel rigidity (extrapyramidal symptoms), tachycardia, weight gain, dyspepsia, constipation, anxiety, headache |
| Hyperprolactinemia-related | Menstrual irregularities, galactorrhea, gynecomastia, decreased libido, erectile dysfunction |
| Less common but clinically important (see Precautions and Warnings) | Neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, orthostatic hypotension and syncope, significant weight gain and metabolic changes (hyperglycemia, dyslipidemia), leukopenia/neutropenia (rare) |
Contraindications of Paliperidone
Paliperidone is contraindicated in patients with known hypersensitivity to Paliperidone or to risperidone, or to any component of the formulation. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.
Frequently Asked Questions about Paliperidone
What is Paliperidone used for?
Paliperidone is used to treat schizophrenia in adults and adolescents (12–17 years), and schizoaffective disorder in adults, either alone or together with mood stabilizers or antidepressants.
How should I take Paliperidone tablets?
Paliperidone extended-release tablets should be swallowed whole with liquid, once daily at about the same time each day, with or without food. Never chew, crush, or split the tablet. It is normal to occasionally see the empty tablet shell in the stool — this does not mean the dose was not absorbed.
Can Paliperidone be used in elderly patients with dementia?
No. Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Paliperidone, have an increased risk of death. Paliperidone is not approved for this use.
Is Paliperidone safe during pregnancy and breastfeeding?
Paliperidone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus, since third-trimester exposure has been linked to extrapyramidal and withdrawal symptoms in newborns. Paliperidone also passes into breast milk, so breastfeeding while taking it should only be done after discussing the risks and benefits with a physician.
What are the common side effects of Paliperidone?
Common side effects of Paliperidone include restlessness (akathisia), drowsiness, tremor, muscle stiffness, fast heartbeat, weight gain, indigestion, and constipation. Serious but less common effects include neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, and significant metabolic changes — seek medical advice if any severe or unusual symptoms occur.
What should I do if I miss a dose or suspect an overdose of Paliperidone?
If a dose of Paliperidone is missed, take it as soon as remembered unless it is close to the next scheduled dose, in which case skip the missed dose — do not double up. If an overdose is suspected, seek immediate medical attention or contact emergency services/poison control right away, as overdose can cause severe drowsiness, low blood pressure, fast heart rate, and abnormal heart rhythm.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.