Rispolux
Generic Name
Risperidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rispolux 1 mg tablet | ৳ 3.20 | ৳ 32.00 |
Description
Overview of the medicine
Rispolux 1 mg Tablet contains Risperidone, an atypical antipsychotic used to treat schizophrenia, bipolar mania, and irritability associated with autistic disorder. It helps restore the balance of certain natural substances in the brain.
Uses & Indications
Dosage
Adults
Schizophrenia: Initially 0.5-2 mg/day, gradually increased to a target range of 2-8 mg/day. Bipolar Mania: Initially 2-3 mg/day, typically 1-6 mg/day. Adjust dose based on response and tolerability.
Elderly
For schizophrenia and bipolar mania, a lower starting dose of 0.25-0.5 mg twice daily is recommended, with slower titration.
Renal_impairment
Initial dose of 0.25-0.5 mg twice daily is recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). Dose should be titrated cautiously.
How to Take
Rispolux tablet can be taken with or without food. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Risperidone is a selective monoaminergic antagonist with high affinity for serotonin 5-HT2 and dopamine D2 receptors. It also binds to alpha1-adrenergic and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors. It acts by rebalancing dopamine and serotonin to improve thinking, mood, and behavior.
Pharmacokinetics
Onset
Initial symptomatic improvement may be seen within a few days, but full therapeutic effect may take several weeks.
Excretion
Approximately 70% of the administered dose is excreted in the urine and 14% in the feces. Renal excretion is the primary route for the active moiety.
Half life
The elimination half-life of risperidone is approximately 3 hours. The half-life of 9-hydroxyrisperidone and the active antipsychotic fraction is about 20-24 hours.
Absorption
Rapidly and well absorbed after oral administration. Peak plasma concentrations are reached within 1-2 hours for risperidone and 3-6 hours for the active metabolite, 9-hydroxyrisperidone.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6, to 9-hydroxyrisperidone, which has similar pharmacological activity to risperidone. Some individuals are poor metabolizers of CYP2D6.
Side Effects
Contraindications
- Hypersensitivity to risperidone or any component of the formulation
- Severe central nervous system (CNS) depression
Drug Interactions
CNS Depressants
Increased sedation when co-administered with alcohol, opioids, benzodiazepines, or other CNS depressants.
Antihypertensives
May enhance the hypotensive effects of antihypertensive agents due to alpha-adrenergic blocking effects.
CYP3A4 Inducers (e.g., Carbamazepine)
May decrease plasma concentrations of the active antipsychotic fraction, leading to reduced efficacy.
CYP2D6 Inhibitors (e.g., Fluoxetine, Paroxetine)
May increase plasma concentrations of risperidone and its active metabolite, requiring dose adjustment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. In rare cases, QT prolongation and seizures have been reported. Management is supportive, including maintaining airway, oxygenation, ventilation, and cardiovascular monitoring. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Risperidone is excreted in human breast milk; therefore, mothers receiving risperidone should not breastfeed.
Side Effects
Contraindications
- Hypersensitivity to risperidone or any component of the formulation
- Severe central nervous system (CNS) depression
Drug Interactions
CNS Depressants
Increased sedation when co-administered with alcohol, opioids, benzodiazepines, or other CNS depressants.
Antihypertensives
May enhance the hypotensive effects of antihypertensive agents due to alpha-adrenergic blocking effects.
CYP3A4 Inducers (e.g., Carbamazepine)
May decrease plasma concentrations of the active antipsychotic fraction, leading to reduced efficacy.
CYP2D6 Inhibitors (e.g., Fluoxetine, Paroxetine)
May increase plasma concentrations of risperidone and its active metabolite, requiring dose adjustment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. In rare cases, QT prolongation and seizures have been reported. Management is supportive, including maintaining airway, oxygenation, ventilation, and cardiovascular monitoring. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Risperidone is excreted in human breast milk; therefore, mothers receiving risperidone should not breastfeed.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Risperidone has been extensively studied in numerous clinical trials demonstrating its efficacy and safety across its approved indications. Post-marketing surveillance continues to monitor for rare adverse events.
Lab Monitoring
- Baseline and periodic monitoring of blood pressure, heart rate, and body weight.
- Periodic monitoring of fasting plasma glucose and lipid profiles.
- Prolactin levels should be monitored, especially if symptomatic.
- Baseline and periodic complete blood count (CBC) if clinically indicated.
Doctor Notes
- Monitor patients for metabolic changes (glucose, lipids, weight).
- Assess for extrapyramidal symptoms and tardive dyskinesia regularly.
- Caution in patients with cardiovascular disease or seizure history.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not stop taking this medicine suddenly, as it can lead to withdrawal symptoms.
- Inform your doctor if you experience any unusual side effects or changes in your condition.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause drowsiness, dizziness, or blurred vision. Avoid driving or operating heavy machinery until you know how it affects you.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity to help manage weight gain.
- Avoid smoking and excessive alcohol consumption.
- Stay hydrated and get adequate rest.
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