Sizolex
Generic Name
Risperidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sizolex 4 mg tablet | ৳ 9.00 | ৳ 90.00 |
Description
Overview of the medicine
Sizolex 4 mg tablet contains Risperidone, an atypical antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and irritability associated with autistic disorder.
Uses & Indications
Dosage
Adults
Schizophrenia: Initially 2 mg daily, target dose usually 4-6 mg daily (max 16 mg/day). Bipolar Mania: Initially 2-3 mg daily (max 6 mg/day). Autistic irritability: 0.5 mg daily, adjust based on response and tolerability.
Elderly
Lower initial doses (e.g., 0.5 mg twice daily) and slower titration, especially for dementia-related psychosis.
Renal_impairment
Initial dose 0.5 mg twice daily for severe renal impairment (creatinine clearance <30 mL/min). Titrate slowly.
How to Take
Take orally, with or without food. Swallow the tablet whole with water. Do not chew or crush.
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 alpha2-adrenergic and H1-histaminergic receptors. It has no affinity for cholinergic muscarinic receptors.
Pharmacokinetics
Onset
Within 1-2 weeks for full antipsychotic effect, but some effects may be seen earlier.
Excretion
Approximately 70% excreted in urine and 14% in feces, primarily as metabolites.
Half life
Risperidone: approximately 3 hours; active moiety (risperidone + 9-hydroxyrisperidone): approximately 20-24 hours.
Absorption
Rapidly and well absorbed after oral administration. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Extensively metabolized by CYP2D6 to 9-hydroxyrisperidone (which is equipotent to risperidone) and by N-dealkylation.
Side Effects
Contraindications
- Hypersensitivity to risperidone or any component of the formulation.
Drug Interactions
Antihypertensives
May enhance hypotensive effects due to alpha1-adrenergic antagonism.
CNS depressants (e.g., alcohol, benzodiazepines)
May enhance CNS depressant effects.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine)
May increase plasma concentrations of risperidone and its active metabolite.
Enzyme inducers (e.g., carbamazepine, rifampicin)
May decrease plasma concentrations of the active antipsychotic fraction.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. Management is symptomatic and supportive, including maintaining airway, adequate oxygenation, and cardiovascular monitoring.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding due to excretion into breast milk and potential for adverse effects in infants. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to risperidone or any component of the formulation.
Drug Interactions
Antihypertensives
May enhance hypotensive effects due to alpha1-adrenergic antagonism.
CNS depressants (e.g., alcohol, benzodiazepines)
May enhance CNS depressant effects.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine)
May increase plasma concentrations of risperidone and its active metabolite.
Enzyme inducers (e.g., carbamazepine, rifampicin)
May decrease plasma concentrations of the active antipsychotic fraction.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. Management is symptomatic and supportive, including maintaining airway, adequate oxygenation, and cardiovascular monitoring.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding due to excretion into breast milk and potential for adverse effects in infants. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, refer to packaging for exact expiry.
Availability
Pharmacies, hospitals
Approval Status
Approved (FDA, DGDA)
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials support the efficacy and safety of risperidone for its approved indications. Ongoing research explores new applications and patient populations.
Lab Monitoring
- Fasting blood glucose (risk of hyperglycemia)
- Lipid profile (risk of dyslipidemia)
- Complete blood count (rare agranulocytosis)
- Prolactin levels (especially with symptoms like galactorrhea, amenorrhea)
- Weight and BMI regularly
Doctor Notes
- Monitor patients for metabolic changes (weight, glucose, lipids).
- Assess for Extrapyramidal Symptoms (EPS) and Tardive Dyskinesia regularly.
- Consider dosage adjustment in patients with renal or hepatic impairment and in CYP2D6 poor metabolizers.
- Educate patients about orthostatic hypotension and potential for sedation.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine suddenly without consulting your doctor, as this may lead to withdrawal symptoms or relapse.
- Avoid alcohol while taking this medication.
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 take a double dose to make up for a missed one.
Driving Precautions
May cause drowsiness, dizziness, or visual disturbances. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a healthy diet and exercise to manage potential weight gain.
- Stay hydrated.
- Report any unusual side effects or worsening of symptoms to your doctor immediately.
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