Renapine-XR
Generic Name
Renapine extended-release
Manufacturer
Global Pharma Inc.
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| renapine xr 50 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Renapine-XR 50 mg Tablet is an atypical antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and as an adjunctive treatment for major depressive disorder. Its extended-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
Initial dose for schizophrenia or bipolar mania is typically 300 mg once daily, titrated up to 400-800 mg/day. For bipolar depression, initial dose is 50 mg at bedtime, increasing to 300 mg/day. For MDD adjunct, 50 mg at bedtime, increasing to 150-300 mg/day.
Elderly
Lower initial doses (e.g., 50 mg/day) and slower titration are recommended for elderly patients, with careful monitoring due to increased sensitivity.
Renal_impairment
No dosage adjustment is generally required for renal impairment, but caution is advised.
How to Take
Take Renapine-XR tablets orally once daily, preferably at bedtime, with or without food. Swallow the tablet whole; do not chew, crush, or split it.
Mechanism of Action
Renapine acts as an antagonist at various neurotransmitter receptors, including serotonin 5-HT2A and dopamine D1 and D2 receptors. It also has affinity for histamine H1 and adrenergic alpha1 and alpha2 receptors. This receptor profile contributes to its antipsychotic and mood-stabilizing effects with a lower propensity for extrapyramidal symptoms.
Pharmacokinetics
Onset
Antipsychotic effects may take several days to weeks to manifest fully, though sedative effects may occur within hours.
Excretion
Primarily excreted in urine (73%) and feces (20%) as metabolites.
Half life
Approximately 7-12 hours.
Absorption
Well absorbed after oral administration, with peak plasma concentrations achieved in approximately 6 hours for the XR formulation.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, to inactive and active metabolites.
Side Effects
Contraindications
- Known hypersensitivity to renapine or any component of the formulation
- Concomitant use with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, nefazodone, protease inhibitors)
Drug Interactions
Antihypertensive agents
May potentiate orthostatic hypotension.
CNS depressants (e.g., alcohol, benzodiazepines)
Increased risk of sedation and respiratory depression.
Strong CYP3A4 inducers (e.g., phenytoin, rifampin)
Can significantly decrease renapine plasma levels, potentially reducing efficacy and requiring dose increase.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
Can significantly increase renapine plasma levels, requiring dose reduction.
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. There is no specific antidote. Management involves supportive care, including maintaining an open airway, ensuring adequate oxygenation and ventilation, and monitoring cardiovascular status. Activated charcoal may be considered.
Pregnancy & Lactation
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 as renapine is excreted in breast milk; consult a physician.
Side Effects
Contraindications
- Known hypersensitivity to renapine or any component of the formulation
- Concomitant use with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, nefazodone, protease inhibitors)
Drug Interactions
Antihypertensive agents
May potentiate orthostatic hypotension.
CNS depressants (e.g., alcohol, benzodiazepines)
Increased risk of sedation and respiratory depression.
Strong CYP3A4 inducers (e.g., phenytoin, rifampin)
Can significantly decrease renapine plasma levels, potentially reducing efficacy and requiring dose increase.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
Can significantly increase renapine plasma levels, requiring dose reduction.
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. There is no specific antidote. Management involves supportive care, including maintaining an open airway, ensuring adequate oxygenation and ventilation, and monitoring cardiovascular status. Activated charcoal may be considered.
Pregnancy & Lactation
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 as renapine is excreted in breast milk; consult a physician.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Available in pharmacies
Approval Status
Approved
Patent Status
Patented
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Renapine-XR in the treatment of schizophrenia, bipolar disorder, and as an adjunctive therapy for major depressive disorder. Studies involved thousands of patients across various age groups and demographics, confirming its therapeutic benefits and characterizing its side effect profile.
Lab Monitoring
- Fasting blood glucose (at baseline and periodically)
- Lipid panel (at baseline and periodically)
- Weight (at baseline and periodically)
- Liver function tests (periodically, especially with signs of hepatic impairment)
- Complete Blood Count (CBC) with differential (if signs of infection or blood dyscrasia)
Doctor Notes
- Monitor patients for signs of metabolic syndrome (weight, glucose, lipids) regularly.
- Assess for suicidal ideation, especially at the initiation of therapy and during dose changes.
- Educate patients on the importance of adherence and potential for orthostatic hypotension.
- Consider lower starting doses and slower titration in elderly or debilitated patients.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Do not stop taking Renapine-XR suddenly without consulting your doctor, as this may lead to withdrawal symptoms.
- Report any unusual side effects or worsening of symptoms to your healthcare provider immediately.
- 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
Renapine-XR can cause drowsiness and dizziness, especially at the beginning of treatment. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that renapine-XR does not affect them adversely.
Lifestyle Advice
- Maintain a healthy diet and regular exercise to manage potential weight gain.
- Avoid sudden changes in posture (e.g., standing up quickly) to minimize dizziness or lightheadedness due to orthostatic hypotension.
- Stay hydrated and avoid overheating, especially during exercise or hot weather.
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