SIBELIUM Flunarizine Dihydrochloride 5mg Capsule 1's
RXDRUG-DR-XY38084-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
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.
Dosage/Direction for Use
Migraine Prophylaxis: Starting Dose: Treatment is started at 10 mg daily (at night) for patients aged 18 to 64 years and at 5 mg for patients >65 years. If during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued. If after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a nonresponder and administration should be discontinued.
Maintenance Treatment: If the patient responds satisfactorily and if a maintenance treatment is needed, the dosage schedule should be changed to that each week the patient receives 5 days of treatment at the same daily dose and 2 successive drug-free days. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and reinitiated only if the patient relapses.
Vertigo: The same daily doses should be used as for migraine, but the starting treatment should not be given longer than needed for symptom control, which generally takes <2 months. If however, no significant improvement is observed after 1 month for chronic vertigo or after 2 months for paroxysmal vertigo, the patient should be considered a nonresponder and administration should be discontinued.
Special populations: Pediatrics (6-17 years of age): migraine prophylaxis: The recommended dose is 5 mg daily (at night).
The dose may be increased to 10 mg daily in patients weighing over 40 kg, if required.
If, during this treatment, depressive symptoms or other unacceptable adverse experiences occur, administration should be discontinued. If, after 3 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued. The maximum recommended treatment duration is 6 months.
Pediatrics (5 years of age and younger): migraine prophylaxis: The safety and efficacy of flunarizine (Sibelium) for prophylaxis of migraine in pediatric patients aged 5 years and younger have not been established.
Pediatrics (17 years of age and younger): vertigo: The safety and efficacy of flunarizine (Sibelium) for treatment of vertigo in pediatric patients have not been established.
Maintenance Treatment: If the patient responds satisfactorily and if a maintenance treatment is needed, the dosage schedule should be changed to that each week the patient receives 5 days of treatment at the same daily dose and 2 successive drug-free days. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and reinitiated only if the patient relapses.
Vertigo: The same daily doses should be used as for migraine, but the starting treatment should not be given longer than needed for symptom control, which generally takes <2 months. If however, no significant improvement is observed after 1 month for chronic vertigo or after 2 months for paroxysmal vertigo, the patient should be considered a nonresponder and administration should be discontinued.
Special populations: Pediatrics (6-17 years of age): migraine prophylaxis: The recommended dose is 5 mg daily (at night).
The dose may be increased to 10 mg daily in patients weighing over 40 kg, if required.
If, during this treatment, depressive symptoms or other unacceptable adverse experiences occur, administration should be discontinued. If, after 3 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued. The maximum recommended treatment duration is 6 months.
Pediatrics (5 years of age and younger): migraine prophylaxis: The safety and efficacy of flunarizine (Sibelium) for prophylaxis of migraine in pediatric patients aged 5 years and younger have not been established.
Pediatrics (17 years of age and younger): vertigo: The safety and efficacy of flunarizine (Sibelium) for treatment of vertigo in pediatric patients have not been established.
Overdosage
Symptoms: On the basis of the pharmacological properties of Sibelium, sedation and asthenia may be expected to occur. A few cases of acute overdosage (up to 600 mg in 1 intake) have been reported and the observed symptoms were sedation, agitation and tachycardia.
Treatment: There is no specific antidote. Within the 1st hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.
Treatment: There is no specific antidote. Within the 1st hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.
Administration
May be taken with or without food.
Contraindications
Patients with a history of depressive illness, or with preexisting symptoms of Parkinson's disease or other extrapyramidal disorders (see Adverse Reactions).
Special Precautions
This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients eg, the elderly. Therefore, it should be used with caution in such patients.
In rare cases, fatigue may increase progressively during Sibelium therapy. In this event, the therapy should be discontinued.
The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. If during maintenance treatment, the therapeutic effects wane, treatment should also be discontinued (for duration of treatment, see also Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities eg, driving or operating dangerous machinery.
Use in pregnancy & lactation: The safety of Sibelium for use in human pregnancy has not been established. An evaluation of animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or fetus, the course of gestation or peri- and postnatal development.
Studies in lactating dogs have shown that Sibelium is excreted in the milk and that the concentration in the milk is greater than in the plasma. No data are available on the excretion in human breast milk. Nursing should therefore be discouraged in women taking Sibelium.
In rare cases, fatigue may increase progressively during Sibelium therapy. In this event, the therapy should be discontinued.
The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. If during maintenance treatment, the therapeutic effects wane, treatment should also be discontinued (for duration of treatment, see also Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities eg, driving or operating dangerous machinery.
Use in pregnancy & lactation: The safety of Sibelium for use in human pregnancy has not been established. An evaluation of animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or fetus, the course of gestation or peri- and postnatal development.
Studies in lactating dogs have shown that Sibelium is excreted in the milk and that the concentration in the milk is greater than in the plasma. No data are available on the excretion in human breast milk. Nursing should therefore be discouraged in women taking Sibelium.
Adverse Reactions
The most frequent adverse experiences are drowsiness and/or fatigue (20%) which are generally transient, and also weight gain (and/or increased appetite) (11%).
The following serious adverse experiences may occur during chronic treatment: Depression of which female patients with a history of depressive illness may particularly be at risk.
Extrapyramidal symptoms (eg, bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor) of which elderly patients seem particularly at risk.
Infrequently reported adverse experiences are: Gastrointestinal: Heartburn, nausea, gastralgia.
Central Nervous System: Insomnia, anxiety.
Others: Galactorrhoea, dry mouth, muscle ache, skin rash.
The following serious adverse experiences may occur during chronic treatment: Depression of which female patients with a history of depressive illness may particularly be at risk.
Extrapyramidal symptoms (eg, bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor) of which elderly patients seem particularly at risk.
Infrequently reported adverse experiences are: Gastrointestinal: Heartburn, nausea, gastralgia.
Central Nervous System: Insomnia, anxiety.
Others: Galactorrhoea, dry mouth, muscle ache, skin rash.
Drug Interactions
Excessive sedation can occur when alcohol, hypnotics or tranquilisers are taken simultaneously with Sibelium.
Sibelium is not contraindicated in patients who use β-blocking agents.
Sibelium is not contraindicated in patients who use β-blocking agents.
Storage
Store between 15°C and 30°C.
Action
Pharmacology: Flunarizine is a selective calcium antagonist. It prevents cellular calcium overload by reducing excessive transmembrane calcium influx. Flunarizine has no effect on contractility or conduction of the heart.
Pharmacokinetics: Flunarizine is well absorbed from the gut, reaching peak plasma levels within 2-4 hrs and reaching steady state at 5-6 weeks. After extensive hepatic metabolism, flunarizine and its metabolites are excreted through the feces via the bile. The mean terminal elimination half-life is about 18 days. Plasma protein-binding is 90%.
Pharmacokinetics: Flunarizine is well absorbed from the gut, reaching peak plasma levels within 2-4 hrs and reaching steady state at 5-6 weeks. After extensive hepatic metabolism, flunarizine and its metabolites are excreted through the feces via the bile. The mean terminal elimination half-life is about 18 days. Plasma protein-binding is 90%.
MedsGo Class
Antimigraine Preparations
Features
Brand
Sibelium
Full Details
Dosage Strength
5 mg
Drug Ingredients
- Flunarizine
Drug Packaging
Capsule 1's
Generic Name
Flunarizine Dihydrochloride
Dosage Form
Capsule
Registration Number
DR-XY38084
Drug Classification
Prescription Drug (RX)
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