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Paliperidone Palmitate: Brands, Price & Uses in Bangladesh
Established (FDA-approved) indications Schizophrenia in adults, as a long-acting maintenance treatment given by intramuscular injection.
About Paliperidone Palmitate
Indications of Paliperidone Palmitate
Established (FDA-approved) indications
- Schizophrenia in adults, as a long-acting maintenance treatment given by intramuscular injection.
- Schizoaffective disorder in adults, as monotherapy or as an adjunct to mood stabilizers and/or antidepressants (established for the once-monthly formulation).
Formulation-specific use
- Extended dosing-interval formulations (three-monthly and six-monthly injections) of Paliperidone Palmitate are approved only for the maintenance treatment of schizophrenia in adults who have already been adequately treated with the once-monthly formulation for a minimum period, per product-specific labelling.
Paliperidone Palmitate is not approved for treatment of acute agitation, and is not approved for dementia-related psychosis in elderly patients (see Contraindications and Precautions).
Dosage & Administration of Paliperidone Palmitate
General administration
Paliperidone Palmitate must be administered only by a qualified healthcare professional as a deep intramuscular injection into the deltoid or gluteal muscle; it must never be administered by any other route (e.g., intravenous or subcutaneous). Needle length is selected according to the injection site and the patient's body weight.
Adult dosing by formulation
| Formulation | Typical regimen |
|---|---|
| Once-monthly | Initiate with two loading doses one week apart in the deltoid muscle, followed by a monthly maintenance dose in the deltoid or gluteal muscle, individualized within the approved dose range. |
| Once-every-3-months | Used only after the patient has been adequately treated with the once-monthly formulation for at least four months; dose is calculated from the last effective monthly dose and given in the deltoid or gluteal muscle every three months. |
| Once-every-6-months | Used only after the patient has been adequately treated with the once-monthly formulation for at least four months, or has completed at least one cycle of the three-monthly formulation; given in the gluteal muscle every six months. |
Pediatric dosing
Safety and efficacy of Paliperidone Palmitate injection have not been established in pediatric patients; it is not recommended for use in this population.
Renal impairment
In patients with mild renal impairment, a reduced dose is used with careful individualization; Paliperidone Palmitate is generally not recommended in patients with moderate to severe renal impairment because clearance is significantly reduced and required dose adjustments have not been well established for the long-acting formulations.
Hepatic impairment
No dose adjustment is required in mild to moderate hepatic impairment. Paliperidone Palmitate has not been studied in severe hepatic impairment, so caution is advised.
Before initiating Paliperidone Palmitate, tolerability to paliperidone or risperidone should generally be established, since once injected the medicine cannot be immediately removed from the body.
Side Effects of Paliperidone Palmitate
Common side effects
- Injection site reactions (pain, redness, induration)
- Weight gain
- Somnolence/sedation
- Akathisia and other extrapyramidal symptoms (tremor, rigidity, abnormal gait)
- Headache
- Anxiety and insomnia
Less common but serious side effects
- Neuroleptic malignant syndrome (rare, potentially fatal) — see Precautions and Warnings
- Tardive dyskinesia — see Precautions and Warnings
- Metabolic changes: hyperglycemia, new-onset diabetes, dyslipidemia — see Precautions and Warnings
- QT-interval prolongation and arrhythmia
- Orthostatic hypotension and syncope, particularly during initiation and dose titration
- Leukopenia, neutropenia, and agranulocytosis
- Hyperprolactinemia (may present as galactorrhea, gynecomastia, menstrual irregularities, sexual dysfunction)
- Seizures
- Priapism (rare)
Contraindications of Paliperidone Palmitate
Paliperidone Palmitate is contraindicated in patients with a known hypersensitivity to paliperidone, risperidone, or any excipient of the formulation, as serious hypersensitivity reactions, including anaphylaxis, have been reported.
Frequently Asked Questions about Paliperidone Palmitate
What is Paliperidone Palmitate used for?
Paliperidone Palmitate is a long-acting injectable antipsychotic used for the maintenance treatment of schizophrenia in adults, and for schizoaffective disorder (as monotherapy or combined with mood stabilizers/antidepressants), depending on the specific formulation.
How is Paliperidone Palmitate given?
Paliperidone Palmitate is given only as an intramuscular injection by a trained healthcare professional, into the deltoid or gluteal muscle, at intervals of one, three, or six months depending on the product formulation. It is never self-injected or taken by mouth.
Is Paliperidone Palmitate safe for elderly patients with dementia?
No. Paliperidone Palmitate carries a boxed warning that elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Paliperidone Palmitate, have an increased risk of death, and it is not approved for this use.
Can Paliperidone Palmitate be used during pregnancy or breastfeeding?
Paliperidone Palmitate should be used in pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus, as babies exposed in the third trimester may develop movement or withdrawal symptoms after birth. Breastfeeding is generally not recommended during treatment because the drug passes into breast milk. Always consult a physician before use in either situation.
What are the most serious risks of Paliperidone Palmitate?
Serious but uncommon risks include neuroleptic malignant syndrome, tardive dyskinesia (which may be irreversible), significant metabolic changes (high blood sugar, high cholesterol, weight gain), QT prolongation, low blood pressure on standing (especially early in treatment), and low white blood cell counts. Report any unusual symptoms to your physician promptly.
What should I do if a dose of Paliperidone Palmitate is missed or an overdose is suspected?
Because Paliperidone Palmitate is administered only by a healthcare professional on a fixed schedule, contact your clinic promptly if an injection appointment is missed so it can be rescheduled appropriately. If overdose is suspected, seek immediate medical attention or contact emergency services/poison control, as there is no specific antidote.
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.