Sizolex
Generic Name
sizolex-2-mg-tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sizolex 2 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Sizolex 2 mg Tablet contains Risperidone, an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autistic disorder. It helps to restore the balance of certain natural substances in the brain.
Uses & Indications
Dosage
Adults
For schizophrenia, typically starting with 0.5-1 mg orally once or twice daily, gradually increasing to a usual dose range of 2-8 mg/day. For bipolar mania, start at 2-3 mg once daily.
Elderly
Lower starting dose (e.g., 0.5 mg twice daily), gradual titration, maximum 4 mg/day.
Renal_impairment
Initial dose 0.5 mg twice daily, may be gradually increased. Use with caution.
How to Take
Take orally with or without food. Can be taken as a single dose or divided doses. Do not crush or chew if it's an extended-release tablet (Sizolex is usually immediate release).
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. Risperidone's antipsychotic activity is mediated through a combination of dopamine D2 and serotonin 5-HT2 antagonism.
Pharmacokinetics
Onset
Initial effects may be seen within a few days, but full therapeutic effect may take several weeks.
Excretion
Approximately 70% excreted in urine and 14% in feces, mainly as metabolites.
Half life
Risperidone: approximately 3 hours; 9-hydroxyrisperidone (active metabolite): approximately 21 hours.
Absorption
Well absorbed orally, peak plasma concentrations typically reached within 1-2 hours for risperidone and 3-6 hours for 9-hydroxyrisperidone.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6 to 9-hydroxyrisperidone, which is equally active. A minor pathway involves CYP3A4.
Side Effects
Contraindications
- Known hypersensitivity to risperidone or any component of the formulation
- Lactation (relative contraindication due to excretion in breast milk)
Drug Interactions
Antihypertensive agents
May enhance hypotensive effects.
CNS depressants (e.g., Alcohol, Benzodiazepines)
Additive CNS depressant effects.
CYP3A4 inducers (e.g., Carbamazepine, Phenytoin)
May decrease active antipsychotic fraction plasma levels.
Strong CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine)
May increase risperidone plasma levels.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. In severe cases, coma and arrhythmias may occur. Treatment is primarily supportive; maintain airway, monitor cardiac rhythm and vital signs. Activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Risperidone and its active metabolite are excreted in human breast milk; breastfeeding is not recommended.
Side Effects
Contraindications
- Known hypersensitivity to risperidone or any component of the formulation
- Lactation (relative contraindication due to excretion in breast milk)
Drug Interactions
Antihypertensive agents
May enhance hypotensive effects.
CNS depressants (e.g., Alcohol, Benzodiazepines)
Additive CNS depressant effects.
CYP3A4 inducers (e.g., Carbamazepine, Phenytoin)
May decrease active antipsychotic fraction plasma levels.
Strong CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine)
May increase risperidone plasma levels.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. In severe cases, coma and arrhythmias may occur. Treatment is primarily supportive; maintain airway, monitor cardiac rhythm and vital signs. Activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Risperidone and its active metabolite are excreted in human breast milk; breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies like FDA, DGDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Risperidone has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of schizophrenia, bipolar disorder, and autism-related irritability across various age groups. Ongoing research explores its broader applications and long-term outcomes.
Lab Monitoring
- Weight and BMI
- Fasting plasma glucose and HbA1c (baseline and periodically)
- Lipid panel (baseline and periodically)
- Prolactin levels (if symptoms of hyperprolactinemia occur)
- ECG (before treatment, especially in patients with cardiac risk factors)
Doctor Notes
- Monitor patients for extrapyramidal symptoms (EPS) and metabolic changes (weight, glucose, lipids).
- Caution in elderly patients with dementia-related psychosis due to increased mortality risk.
- Assess for suicidal ideation, especially at the initiation of treatment or dose changes.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking this medication suddenly, as it may lead to withdrawal symptoms.
- Report any unusual side effects or worsening of symptoms to your doctor immediately.
- Avoid alcohol while on this medication.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular schedule. Do not double the dose.
Driving Precautions
This medicine may cause drowsiness, dizziness, or blurred vision, especially at the start of treatment. Avoid driving or operating machinery until you know how this medication affects you.
Lifestyle Advice
- Maintain a healthy diet and regular exercise to manage weight gain, a common side effect.
- Stay hydrated.
- Regular monitoring of blood sugar and cholesterol levels is important.
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