Rozenon
Generic Name
Roxenone Hydrochloride
Manufacturer
MediCorp Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rozenon 5 mg tablet | ৳ 13.00 | ৳ 130.00 |
Description
Overview of the medicine
Rozenon is an atypical anxiolytic used for the management of generalized anxiety disorder (GAD). It helps to alleviate symptoms such as excessive worry, tension, and restlessness.
Uses & Indications
Dosage
Adults
Initial dose: 5 mg twice daily. May be increased to 10 mg twice daily after 1-2 weeks based on response. Maximum dose: 20 mg daily.
Elderly
No specific dose adjustment required, but start with a lower dose (e.g., 2.5 mg twice daily) and titrate carefully.
Renal_impairment
Use with caution. For severe impairment (CrCl <30 mL/min), consider a reduced dose or extended dosing interval.
How to Take
Take Rozenon tablet orally, with or without food. It should be taken at regular intervals as prescribed by the doctor.
Mechanism of Action
Roxenone Hydrochloride is thought to exert its anxiolytic effects by acting as a partial agonist at 5-HT1A serotonin receptors and modulating other neurotransmitter systems, leading to a reduction in anxiety without significant sedative effects.
Pharmacokinetics
Onset
Anxiolytic effects typically begin within 1-2 weeks of consistent use, with full effects seen after 3-4 weeks.
Excretion
Excreted mainly via urine (60%) and feces (40%) as metabolites.
Half life
Approximately 8-12 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations reached within 1-2 hours.
Metabolism
Primarily metabolized in the liver by cytochrome P450 enzymes (CYP3A4).
Side Effects
Contraindications
- Hypersensitivity to Roxenone or any component of the formulation
- Severe hepatic impairment
- Concomitant use with MAO inhibitors
Drug Interactions
MAO Inhibitors
Concomitant use may lead to serotonin syndrome. Avoid concurrent use and maintain a washout period.
CYP3A4 Inducers (e.g., Rifampicin)
May decrease Roxenone plasma levels, potentially reducing efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole)
May increase Roxenone plasma levels, requiring dose adjustment.
CNS Depressants (e.g., Alcohol, Benzodiazepines)
May potentiate sedative effects; use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include increased dizziness, drowsiness, nausea, and vomiting. Treatment is supportive and symptomatic; maintain airway, monitor vital signs, and provide gastric lavage if indicated.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. It is unknown if Roxenone is excreted in human milk; use with caution in breastfeeding mothers.
Side Effects
Contraindications
- Hypersensitivity to Roxenone or any component of the formulation
- Severe hepatic impairment
- Concomitant use with MAO inhibitors
Drug Interactions
MAO Inhibitors
Concomitant use may lead to serotonin syndrome. Avoid concurrent use and maintain a washout period.
CYP3A4 Inducers (e.g., Rifampicin)
May decrease Roxenone plasma levels, potentially reducing efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole)
May increase Roxenone plasma levels, requiring dose adjustment.
CNS Depressants (e.g., Alcohol, Benzodiazepines)
May potentiate sedative effects; use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include increased dizziness, drowsiness, nausea, and vomiting. Treatment is supportive and symptomatic; maintain airway, monitor vital signs, and provide gastric lavage if indicated.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. It is unknown if Roxenone is excreted in human milk; use with caution in breastfeeding mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Patent pending
Clinical Trials
Phase III clinical trials demonstrated significant reduction in GAD symptoms compared to placebo. Ongoing long-term safety and efficacy studies are being conducted.
Lab Monitoring
- Liver function tests (baseline and periodically)
- Renal function tests (for patients with impairment)
Doctor Notes
- Educate patients on the delayed onset of action and the importance of compliance.
- Advise patients not to abruptly discontinue the medication to avoid withdrawal symptoms.
- Monitor for signs of serotonin syndrome, especially if co-administered with other serotonergic agents.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Rozenon suddenly without consulting your doctor, as this may lead to withdrawal symptoms.
- Avoid alcohol and other CNS depressants during treatment.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rozenon may cause dizziness or drowsiness, especially at the start of treatment. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a healthy diet and regular exercise.
- Practice stress-reduction techniques like meditation or yoga.
- Ensure adequate sleep.
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Global Brand Names
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