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Rizelium5 mg
Capsule
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Medicine overview
Indications of Rizelium 5 mg
Rizelium 5 mg is indicated for
Prophylaxis of classic (with aura) or common (without aura) migraine
Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
Peripheral Vascular Disease (PVD)
Motion sickness
Refractory epilepsy resistant to conventional antiepileptic therapy.
Theropeutic Class
Miscellaneous prophylactic migraine preparations
Pharmacology
Rizelium 5 mg is the difluorinated derivative of cinnarizine.
Absorption
It is a selective calcium channel antagonist.
Distribution
It binds at an affinity of 99% to plasma protein.
Metabolism
It does not interfere with normal cellular calcium homeostasis.
Excretion
Rizelium 5 mg also has some antihistaminic and sedative properties.
Dosage & Administration of Rizelium 5 mg
Migraine Prophylaxis
Dosage:Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years
Notes:If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued
Maintenance Treatment
Dosage:If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week
Notes:Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses
Peripheral Vascular disease
Dosage:10 mg twice daily, up to 30 mg per day if required
Vertigo & motion sickness
Dosage:10-20 mg daily for adults and 5 mg daily for children (> 40 kg)
Epileptic seizure
Dosage:15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
| Condition | Dosage | Notes |
|---|---|---|
| Migraine Prophylaxis | Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years | If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued |
| Maintenance Treatment | If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week | Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses |
| Peripheral Vascular disease | 10 mg twice daily, up to 30 mg per day if required | |
| Vertigo & motion sickness | 10-20 mg daily for adults and 5 mg daily for children (> 40 kg) | |
| Epileptic seizure | 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy |
Dosage of Rizelium 5 mg
Migraine Prophylaxis
Dosage:Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years
Notes:If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued
Maintenance Treatment
Dosage:If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week
Notes:Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses
Peripheral Vascular disease
Dosage:10 mg twice daily, up to 30 mg per day if required
Vertigo & motion sickness
Dosage:10-20 mg daily for adults and 5 mg daily for children (> 40 kg)
Epileptic seizure
Dosage:15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
| Condition | Dosage | Notes |
|---|---|---|
| Migraine Prophylaxis | Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years | If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued |
| Maintenance Treatment | If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week | Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses |
| Peripheral Vascular disease | 10 mg twice daily, up to 30 mg per day if required | |
| Vertigo & motion sickness | 10-20 mg daily for adults and 5 mg daily for children (> 40 kg) | |
| Epileptic seizure | 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy |
Interaction of Rizelium 5 mg
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Rizelium 5 mg treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with Rizelium 5 mg by increasing its metabolism. So an increase in dosage of Rizelium 5 mg may be required.
Contraindications
Hypersensitivity to Rizelium 5 mg. Rizelium 5 mg is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
Side Effects of Rizelium 5 mg
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Rizelium 5 mg: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
Pregnancy & Lactation
Safety in pregnancy and lactation has not been established.
Precautions & Warnings
Rizelium 5 mg may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Rizelium 5 mg is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Rizelium 5 mg. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Rizelium 5 mg should therefore be used with caution in such patients.
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Drug Classes
Miscellaneous prophylactic migraine preparations
Mode Of Action
Rizelium 5 mg is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Rizelium 5 mg prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Rizelium 5 mg also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
Pregnancy
Safety in pregnancy and lactation has not been established.
Frequently Asked Questions
What is Rizelium 5 mg used for?
Flunarizine is indicated for Prophylaxis of classic (with aura) or common (without aura) migraine Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system). Peripheral Vascular Disease (PVD) Motion sickness Refractory epilepsy resistant to conventional antiepileptic therapy.
What is the dosage of Rizelium 5 mg?
Migraine Prophylaxis: Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-respond…
What are the side effects of Rizelium 5 mg?
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderl…
Who should not take Rizelium 5 mg?
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
What precautions should be taken with Rizelium 5 mg?
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is …
Is Rizelium 5 mg safe during pregnancy and breastfeeding?
Safety in pregnancy and lactation has not been established.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.