Frenia
Generic Name
Risperidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
frenia 1 mg tablet | ৳ 3.00 | ৳ 30.00 |
Description
Overview of the medicine
Frenia 1 mg Tablet contains Risperidone, an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autistic disorder.
Uses & Indications
Dosage
Adults
Schizophrenia: Initially 2 mg daily, may be increased to 4-8 mg daily. Bipolar Mania: Initially 2-3 mg daily, may be adjusted based on response. Autistic Irritability: Initially 0.5 mg daily, adjust gradually.
Elderly
Schizophrenia: Initially 0.5 mg twice daily, adjusted gradually to 1-2 mg twice daily. Bipolar Mania: Consult physician for lower starting dose and careful titration.
Renal_impairment
Initially 0.5 mg twice daily for severe renal impairment, gradual titration up to 1-2 mg twice daily. Use with caution.
How to Take
Take orally, with or without food. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Risperidone works by blocking dopamine D2 and serotonin 5-HT2A receptors in the brain, which helps to improve mood, thought processes, and behavior.
Pharmacokinetics
Onset
Initial effects typically within days, full therapeutic effect may take several weeks.
Excretion
Approximately 70% eliminated in urine and 14% in feces, primarily as metabolites.
Half life
Risperidone: approximately 3 hours; 9-hydroxyrisperidone (active metabolite): approximately 24 hours.
Absorption
Well absorbed from the gastrointestinal tract; peak plasma concentrations reached within 1-2 hours for risperidone and 3-6 hours for 9-hydroxyrisperidone.
Metabolism
Extensive hepatic metabolism via CYP2D6 to 9-hydroxyrisperidone (active metabolite) and N-dealkylation.
Side Effects
Contraindications
- Hypersensitivity to risperidone or any component of the formulation.
- Patients with severe central nervous system depression or comatose states.
Drug Interactions
CNS depressants
May potentiate the effects of alcohol and other CNS depressants.
Antihypertensives
May enhance the hypotensive effects of antihypertensive agents.
CYP2D6 inhibitors
Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase plasma levels of risperidone.
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. Treatment is supportive; maintain adequate airway, oxygenation, and ventilation. Gastric lavage and activated charcoal may be considered. Monitor cardiovascular function and vital signs.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Caution is advised during lactation; risperidone and its active metabolite are excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to risperidone or any component of the formulation.
- Patients with severe central nervous system depression or comatose states.
Drug Interactions
CNS depressants
May potentiate the effects of alcohol and other CNS depressants.
Antihypertensives
May enhance the hypotensive effects of antihypertensive agents.
CYP2D6 inhibitors
Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase plasma levels of risperidone.
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. Treatment is supportive; maintain adequate airway, oxygenation, and ventilation. Gastric lavage and activated charcoal may be considered. Monitor cardiovascular function and vital signs.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Caution is advised during lactation; risperidone and its active metabolite are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, specific to batch.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Risperidone has undergone extensive clinical trials demonstrating its efficacy and safety for approved indications. Ongoing post-marketing surveillance and new trials continue to explore its uses and effects.
Lab Monitoring
- Baseline and periodic monitoring of blood glucose and lipid profile (due to risk of metabolic changes).
- Prolactin levels (especially if symptoms of hyperprolactinemia occur).
- Liver function tests and renal function tests, particularly in patients with pre-existing impairment.
Doctor Notes
- Emphasize the importance of patient adherence to prevent relapse.
- Monitor for metabolic side effects (weight, glucose, lipids) and extrapyramidal symptoms regularly.
- Consider dose adjustments in patients with renal or hepatic impairment and in CYP2D6 poor metabolizers.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor, as it can lead to withdrawal symptoms.
- Report any unusual side effects or worsening of symptoms to your doctor immediately.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause drowsiness, dizziness, or visual disturbances. Avoid driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Maintain a healthy diet and exercise regularly to manage potential weight gain.
- Avoid alcohol and illicit drugs while on this medication.
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