Rolip
Generic Name
Ropinirole
Manufacturer
MediPharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rolip 5 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Rolip 5 mg Tablet contains Ropinirole, a non-ergoline dopamine agonist, used to treat the symptoms of Parkinson's disease and moderate to severe primary Restless Legs Syndrome (RLS). It works by mimicking the action of dopamine, a natural substance in the brain that is necessary to control movement.
Uses & Indications
Dosage
Adults
For Parkinson's Disease: Initial dose typically 0.25 mg three times daily, increased weekly by 0.25-1 mg/day as tolerated, up to a maximum of 24 mg/day. For RLS: Initial dose 0.25 mg once daily, 1-3 hours before bedtime, increased weekly by 0.25 mg up to a maximum of 4 mg/day.
Elderly
No specific dose adjustment is required based on age, but titration should be done carefully, considering potential comorbidities and polypharmacy.
Renal_impairment
For mild to moderate renal impairment (CrCl 30-50 mL/min), no dose adjustment is usually needed. For severe renal impairment (CrCl <30 mL/min), consider a maximum dose of 3 mg/day for RLS and 18 mg/day for Parkinson's disease.
How to Take
Take the tablet orally with or without food. For Parkinson's disease, take three times a day. For RLS, take once a day, 1-3 hours before bedtime. Do not crush, chew, or break extended-release tablets.
Mechanism of Action
Ropinirole is a non-ergoline dopamine D2/D3 receptor agonist. It selectively stimulates post-synaptic dopamine D2 and D3 receptors in the brain, particularly in the striatum, thereby compensating for the decreased dopamine levels seen in Parkinson's disease. For RLS, the exact mechanism is not fully understood but is thought to involve the dopaminergic system in the spinal cord.
Pharmacokinetics
Onset
Within 30-60 minutes for RLS, clinical effects for Parkinson's disease are gradually observed with titration.
Excretion
Mainly excreted in urine (approximately 88% as metabolites, <10% as unchanged drug).
Half life
Approximately 6 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1-2 hours. Bioavailability is approximately 55%.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 CYP1A2, to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to ropinirole or any of its excipients.
- Severe hepatic impairment (use with caution, as it is primarily metabolized in the liver).
Drug Interactions
Smoking
Induces CYP1A2, potentially decreasing ropinirole levels. Smoking cessation may require dose adjustment.
Ciprofloxacin
Increases ropinirole plasma levels by inhibiting CYP1A2, potentially leading to increased side effects. Dose adjustment of ropinirole may be necessary.
Estrogens (e.g., oral contraceptives)
May decrease ropinirole clearance, leading to higher plasma levels. Dose adjustment may be required.
Dopamine antagonists (e.g., antipsychotics like haloperidol, metoclopramide)
May reduce the efficacy of ropinirole.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include nausea, vomiting, dizziness, somnolence, postural hypotension, hallucinations, and dyskinesia. Treatment is primarily symptomatic and supportive, including general supportive measures and gastric lavage if appropriate.
Pregnancy & Lactation
Pregnancy Category C. Ropinirole should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk and may inhibit lactation; therefore, it is not recommended for use during breastfeeding.
Side Effects
Contraindications
- Known hypersensitivity to ropinirole or any of its excipients.
- Severe hepatic impairment (use with caution, as it is primarily metabolized in the liver).
Drug Interactions
Smoking
Induces CYP1A2, potentially decreasing ropinirole levels. Smoking cessation may require dose adjustment.
Ciprofloxacin
Increases ropinirole plasma levels by inhibiting CYP1A2, potentially leading to increased side effects. Dose adjustment of ropinirole may be necessary.
Estrogens (e.g., oral contraceptives)
May decrease ropinirole clearance, leading to higher plasma levels. Dose adjustment may be required.
Dopamine antagonists (e.g., antipsychotics like haloperidol, metoclopramide)
May reduce the efficacy of ropinirole.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include nausea, vomiting, dizziness, somnolence, postural hypotension, hallucinations, and dyskinesia. Treatment is primarily symptomatic and supportive, including general supportive measures and gastric lavage if appropriate.
Pregnancy & Lactation
Pregnancy Category C. Ropinirole should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk and may inhibit lactation; therefore, it is not recommended for use during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24-36 months from the date of manufacture, specific to manufacturer's data.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by regulatory authorities for Parkinson's Disease and Restless Legs Syndrome
Patent Status
Generic available, patent expired
Clinical Trials
Ropinirole has undergone extensive clinical trials demonstrating its efficacy and safety in Parkinson's disease and Restless Legs Syndrome. Ongoing research may explore new indications or formulations.
Lab Monitoring
- No routine laboratory monitoring is specifically required for ropinirole. However, monitor for blood pressure, especially orthostatic changes.
- Periodically assess for impulse control disorders and mental status changes.
Doctor Notes
- Advise patients to report any sudden onset of sleep or changes in behavior, including impulse control disorders.
- Careful titration is crucial to optimize efficacy and minimize side effects.
- Monitor for orthostatic hypotension, especially at initiation and during dose escalation.
Patient Guidelines
- Take Rolip 5 mg exactly as prescribed by your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor, as it can lead to severe withdrawal symptoms.
- Be aware of potential side effects such as drowsiness and dizziness, and avoid driving or operating heavy machinery until you know how the medicine affects you.
Missed Dose Advice
If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not double the dose to make up for a missed one. If multiple doses are missed, consult your doctor.
Driving Precautions
Ropinirole can cause drowsiness, dizziness, and sudden onset of sleep. Patients should be warned not to drive or operate machinery if they experience these effects. Exercise caution until you know how the drug affects you.
Lifestyle Advice
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, which may help manage symptoms of Parkinson's disease and RLS.
- Avoid excessive alcohol consumption, as it can worsen some side effects like drowsiness.
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