Rizelium
Generic Name
Anxiolytin Hydrobromide
Manufacturer
Medix Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rizelium 10 mg capsule | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Rizelium 10 mg capsule is an antidepressant and anxiolytic medication belonging to the SSRI class, used to treat various mood and anxiety disorders.
Uses & Indications
Dosage
Adults
Initially 10 mg once daily, may be increased to 20 mg after 1-2 weeks based on response. Max 20 mg/day.
Elderly
Initially 5 mg once daily, may be increased cautiously. Max 10 mg/day.
Renal_impairment
No dosage adjustment needed for mild to moderate impairment. Use with caution in severe impairment.
How to Take
Take orally, once daily, with or without food. Swallow the capsule whole with water.
Mechanism of Action
Anxiolytin Hydrobromide works by inhibiting the reuptake of serotonin in the brain, thereby increasing the concentration of serotonin in the synaptic cleft, which helps to improve mood and reduce anxiety.
Pharmacokinetics
Onset
Therapeutic effects may begin within 1-2 weeks, full effect in 4-6 weeks.
Excretion
Mainly excreted in urine as metabolites, with a small amount in feces.
Half life
Approximately 20-24 hours.
Absorption
Well absorbed orally, peak plasma concentrations typically reached within 4-8 hours.
Metabolism
Extensively metabolized in the liver, primarily via CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Anxiolytin or any component of the capsule
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI treatment
- Concomitant use with pimozide
Drug Interactions
MAOIs
May lead to serotonin syndrome, which can be fatal.
Pimozide
Increased pimozide levels, risk of QT prolongation.
Warfarin
Increased anticoagulant effect, monitor INR.
NSAIDs/Aspirin
Increased risk of bleeding.
Other serotonergic drugs (e.g., Triptans, Tramadol)
Increased risk of serotonin syndrome.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, nausea, vomiting, tremor, tachycardia, and rarely, serotonin syndrome. Management involves symptomatic and supportive care, maintaining an open airway, and monitoring cardiac and vital signs. No specific antidote is available.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as Anxiolytin may be excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to Anxiolytin or any component of the capsule
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI treatment
- Concomitant use with pimozide
Drug Interactions
MAOIs
May lead to serotonin syndrome, which can be fatal.
Pimozide
Increased pimozide levels, risk of QT prolongation.
Warfarin
Increased anticoagulant effect, monitor INR.
NSAIDs/Aspirin
Increased risk of bleeding.
Other serotonergic drugs (e.g., Triptans, Tramadol)
Increased risk of serotonin syndrome.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, nausea, vomiting, tremor, tachycardia, and rarely, serotonin syndrome. Management involves symptomatic and supportive care, maintaining an open airway, and monitoring cardiac and vital signs. No specific antidote is available.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as Anxiolytin may be excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Patented in Bangladesh
Clinical Trials
Extensive Phase I, II, and III clinical trials have demonstrated the efficacy and safety of Anxiolytin Hydrobromide for its approved indications. Post-marketing surveillance continues to monitor long-term effects.
Lab Monitoring
- Routine lab monitoring is generally not required.
- Monitor liver and renal function in patients with pre-existing impairment.
- Monitor serum sodium in elderly patients or those on diuretics.
Doctor Notes
- Counsel patients on potential delayed onset of action and the importance of adherence.
- Monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
- Assess for suicidal ideation, particularly in pediatric and young adult patients, at the initiation of therapy and with dose changes.
Patient Guidelines
- Do not stop taking Rizelium abruptly; gradually reduce the dose under medical supervision to avoid withdrawal symptoms.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Avoid driving or operating heavy machinery until you know how this medicine affects you.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or drowsiness, especially at the beginning of treatment. Patients should be advised to exercise caution when driving or operating machinery.
Lifestyle Advice
- Engage in regular physical activity and maintain a balanced diet.
- Consider psychotherapy or counseling in conjunction with medication.
- Avoid alcohol and recreational drugs as they can worsen your condition or interfere with treatment.
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