Renapine-XR
Generic Name
Quetiapine Extended-Release 200 mg Tablet
Manufacturer
Generic Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| renapine xr 200 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Renapine-XR 200 mg Tablet contains Quetiapine, an atypical antipsychotic used to treat schizophrenia, bipolar disorder (depressive, manic, and mixed episodes), and as an adjunctive therapy for major depressive disorder. The extended-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
For schizophrenia: initial dose 300 mg once daily, usually titrated to 400-800 mg/day. For bipolar depression: 300 mg once daily. For bipolar mania: initial 300 mg once daily, titrated to 400-800 mg/day. For adjunctive MDD: 50 mg once daily, titrated to 150-300 mg/day.
Elderly
Lower starting dose (e.g., 50 mg once daily) and slower titration, due to potential for greater sensitivity and increased risk of orthostatic hypotension.
Renal_impairment
No dose adjustment is routinely required, but caution is advised in patients with severe renal impairment.
How to Take
Take orally once daily, usually in the evening, with or without food. Swallow the tablet whole; do not crush, chew, or break. Doing so may affect the extended-release properties of the tablet.
Mechanism of Action
Quetiapine's therapeutic effects are mediated through a combination of antagonism at serotonin (5-HT2A) and dopamine (D1 and D2) receptors. It also antagonizes histamine (H1) and alpha1/alpha2 adrenergic receptors, contributing to its sedative and orthostatic hypotensive effects.
Pharmacokinetics
Onset
Initial sedation often within hours. Antipsychotic effects may take days to weeks to manifest fully.
Excretion
Approximately 73% excreted in the urine and 20% in the feces. Less than 1% is excreted as unchanged drug.
Half life
Mean terminal half-life of quetiapine is approximately 7 hours, but the active metabolite norquetiapine contributes to sustained therapeutic action, especially with XR formulation.
Absorption
Rapidly absorbed, with peak plasma concentrations reached approximately 6 hours post-dose for XR formulation. Food does not significantly affect bioavailability.
Metabolism
Extensively metabolized in the liver, primarily via the cytochrome P450 3A4 (CYP3A4) enzyme system, to various inactive and active metabolites.
Side Effects
Contraindications
- Hypersensitivity to quetiapine or any component of the formulation.
- Concomitant use with strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, erythromycin, protease inhibitors like ritonavir).
Drug Interactions
CNS Depressants
Concomitant use with alcohol or other CNS depressants may have additive effects on sedation and cognitive impairment.
CYP3A4 Inducers
Strong inducers (e.g., carbamazepine, rifampicin, phenytoin) can significantly decrease quetiapine plasma concentrations, reducing its efficacy. Dose increase of quetiapine may be necessary.
CYP3A4 Inhibitors
Strong inhibitors (e.g., ketoconazole, erythromycin) can significantly increase quetiapine plasma concentrations, leading to increased risk of side effects. Dose reduction of quetiapine may be necessary.
Drugs that Prolong QT Interval
Increased risk of QT interval prolongation when co-administered with other drugs known to prolong the QT interval.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. Management is supportive, focusing on maintaining an open airway, oxygenation, and ventilation. Activated charcoal may be considered. There is no specific antidote.
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 are at risk for extrapyramidal and/or withdrawal symptoms. Quetiapine is excreted in human milk; therefore, breastfeeding is not recommended.
Side Effects
Contraindications
- Hypersensitivity to quetiapine or any component of the formulation.
- Concomitant use with strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, erythromycin, protease inhibitors like ritonavir).
Drug Interactions
CNS Depressants
Concomitant use with alcohol or other CNS depressants may have additive effects on sedation and cognitive impairment.
CYP3A4 Inducers
Strong inducers (e.g., carbamazepine, rifampicin, phenytoin) can significantly decrease quetiapine plasma concentrations, reducing its efficacy. Dose increase of quetiapine may be necessary.
CYP3A4 Inhibitors
Strong inhibitors (e.g., ketoconazole, erythromycin) can significantly increase quetiapine plasma concentrations, leading to increased risk of side effects. Dose reduction of quetiapine may be necessary.
Drugs that Prolong QT Interval
Increased risk of QT interval prolongation when co-administered with other drugs known to prolong the QT interval.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. Management is supportive, focusing on maintaining an open airway, oxygenation, and ventilation. Activated charcoal may be considered. There is no specific antidote.
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 are at risk for extrapyramidal and/or withdrawal symptoms. Quetiapine is excreted in human milk; therefore, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Available in pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Quetiapine XR has been extensively studied in various clinical trials demonstrating efficacy and safety for its approved indications including schizophrenia, bipolar disorder, and as an adjunctive treatment for major depressive disorder. Trials have focused on its extended-release profile and once-daily dosing.
Lab Monitoring
- Baseline and periodic lipid profile (cholesterol, triglycerides)
- Baseline and periodic glucose levels (fasting glucose, HbA1c)
- Weight and BMI monitoring
- Thyroid function tests (TSH) at baseline and periodically
- Complete Blood Count (CBC) with differential if clinically indicated
Doctor Notes
- Emphasize the importance of consistent daily dosing, preferably in the evening to leverage sedating effects and aid compliance.
- Educate patients about metabolic risks and the need for regular monitoring of weight, glucose, and lipids.
- Counsel on the black box warnings regarding increased mortality in elderly dementia patients and suicidal ideation in younger populations.
- Advise against abrupt discontinuation to prevent withdrawal symptoms.
Patient Guidelines
- Do not stop taking Renapine-XR suddenly, as this can lead to withdrawal symptoms. Always consult your doctor.
- Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
- Avoid alcohol while taking this medication as it may increase sedation.
- Stand up slowly from a sitting or lying position to minimize dizziness or lightheadedness caused by orthostatic hypotension.
Missed Dose Advice
If a dose is missed, 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
Renapine-XR can cause drowsiness, dizziness, and blurred vision, especially at the start of treatment. Avoid driving or operating heavy machinery until you know how this medication affects you.
Lifestyle Advice
- Maintain a healthy diet and regular exercise to manage potential weight gain.
- Stay hydrated and avoid overheating, especially in hot weather or during strenuous exercise.
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