Rasalet
Generic Name
Rasagiline Mesylate
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rasalet 05 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Rasalet 0.5 mg Tablet contains Rasagiline, which is used to treat the symptoms of Parkinson's disease. It helps to improve motor symptoms like tremor, rigidity, and slowness of movement.
Uses & Indications
Dosage
Adults
0.5 mg or 1 mg orally once daily, with or without levodopa. For monotherapy or adjunctive therapy, the recommended dose is 1 mg once daily. Rasalet 0.5 mg is typically used for initial titration or specific patient needs.
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is necessary for mild to moderate renal impairment. Caution is advised in severe renal impairment.
How to Take
Rasalet 0.5 mg Tablet should be taken orally once daily, with or without food.
Mechanism of Action
Rasagiline is a selective, irreversible inhibitor of monoamine oxidase-B (MAO-B). By inhibiting MAO-B, it prevents the breakdown of dopamine in the brain, leading to increased dopamine levels in the synaptic clefts, which helps to alleviate Parkinson's symptoms.
Pharmacokinetics
Onset
Clinical effects are typically observed within weeks of initiating treatment, with gradual improvement in Parkinsonian symptoms.
Excretion
Excreted predominantly in the urine (62%) and to a lesser extent in the feces (22%) as metabolites.
Half life
The terminal half-life is 0.6-2 hours, but its pharmacodynamic effect (MAO-B inhibition) is much longer due to irreversible binding.
Absorption
Rapidly absorbed after oral administration, reaching peak plasma concentrations within approximately 1 hour. Absolute bioavailability is about 36%.
Metabolism
Extensively metabolized in the liver, primarily by N-dealkylation and hydroxylation, mainly via the cytochrome P450 1A2 (CYP1A2) isoenzyme.
Side Effects
Contraindications
- Hypersensitivity to Rasagiline or any component
- Concomitant use with other MAO inhibitors (including other selective MAO-B inhibitors, non-selective MAO inhibitors)
- Concomitant use with pethidine, tramadol, methadone, St. John's wort, dextromethorphan, cyclobenzaprine
- Use within 14 days of discontinuing any of the above medications
- Severe hepatic impairment
Drug Interactions
Sympathomimetics
Increased risk of hypertensive reactions due to enhanced norepinephrine levels.
Other MAO Inhibitors
Increased risk of hypertensive crisis and serotonin syndrome. Avoid concomitant use.
Pethidine, Tramadol, Methadone
Risk of serotonin syndrome. Contraindicated.
SSRIs, SNRIs, Tricyclic Antidepressants
Risk of serotonin syndrome. Exercise caution; dose adjustment or alternative treatment may be necessary.
Ciprofloxacin (and other CYP1A2 inhibitors)
May increase Rasagiline exposure. Reduce Rasagiline dose or avoid concomitant use.
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 may include severe hypertension, serotonin syndrome (agitation, hallucinations, coma, hyperthermia, tachycardia, labile blood pressure, hyperreflexia). Treatment should be supportive and symptomatic, with appropriate monitoring of vital signs and cardiac function.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Rasagiline is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to Rasagiline or any component
- Concomitant use with other MAO inhibitors (including other selective MAO-B inhibitors, non-selective MAO inhibitors)
- Concomitant use with pethidine, tramadol, methadone, St. John's wort, dextromethorphan, cyclobenzaprine
- Use within 14 days of discontinuing any of the above medications
- Severe hepatic impairment
Drug Interactions
Sympathomimetics
Increased risk of hypertensive reactions due to enhanced norepinephrine levels.
Other MAO Inhibitors
Increased risk of hypertensive crisis and serotonin syndrome. Avoid concomitant use.
Pethidine, Tramadol, Methadone
Risk of serotonin syndrome. Contraindicated.
SSRIs, SNRIs, Tricyclic Antidepressants
Risk of serotonin syndrome. Exercise caution; dose adjustment or alternative treatment may be necessary.
Ciprofloxacin (and other CYP1A2 inhibitors)
May increase Rasagiline exposure. Reduce Rasagiline dose or avoid concomitant use.
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 may include severe hypertension, serotonin syndrome (agitation, hallucinations, coma, hyperthermia, tachycardia, labile blood pressure, hyperreflexia). Treatment should be supportive and symptomatic, with appropriate monitoring of vital signs and cardiac function.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Rasagiline is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
DGDA approved
Patent Status
Generic available
Clinical Trials
Rasagiline has been evaluated in several well-controlled clinical trials, demonstrating its efficacy and safety as monotherapy and adjunctive therapy in Parkinson's disease. Key trials include the TEMPO and ADAGIO studies.
Lab Monitoring
- Regular blood pressure monitoring, especially during initiation and dose adjustments.
- Liver function tests for patients with mild to moderate hepatic impairment, and caution in severe impairment.
Doctor Notes
- Carefully monitor patients for adverse effects, especially serotonin syndrome when co-administered with serotonergic agents.
- Advise patients about potential for orthostatic hypotension and impulse control disorders.
- Ensure patients understand the importance of not discontinuing the medication abruptly.
Patient Guidelines
- Take Rasalet 0.5 mg Tablet exactly as prescribed by your doctor.
- Do not stop taking this medication suddenly without consulting your doctor, as it may worsen Parkinson's symptoms.
- Report any unusual or severe side effects, especially new or worsening dyskinesia, hallucinations, or behavioral changes.
- Be aware of potential interactions with other medications, particularly cold and cough remedies containing dextromethorphan or pseudoephedrine, and certain antidepressants.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, 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
Rasagiline may cause dizziness, somnolence, or sudden onset of sleep. Patients should be advised to exercise caution when operating machinery or driving until they have determined how the drug affects them.
Lifestyle Advice
- Engage in regular physical activity suitable for Parkinson's patients to maintain mobility and balance.
- Maintain a healthy and balanced diet.
- Take precautions to prevent falls, such as removing tripping hazards from your home and using assistive devices if needed.
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