Sibelium Flunarizine Hydrochloride Capsules

1. Indications and Usage
Migraine Prophylaxis: Preventive treatment of classic (with aura) or common (without aura) migraine.
Vestibular Disorders: Symptomatic relief of vertigo associated with vestibular function disorders.
2. Dosage and Administration
Migraine Prophylaxis: For patients under 65 years, the starting dose is 5-10 mg at night. For patients 65 years and older, the starting dose is 5 mg at night. If maintenance therapy is needed, the frequency may be reduced to 5 days per week.
Vertigo: The daily dose is the same as for migraine prophylaxis. Therapy should be discontinued as soon as symptoms are controlled, usually within 2 months.
Administration: Usually taken at night due to sedative effects.
3. Mechanism of Action
Calcium Channel Blockade: The mechanism of action is primarily mediated through the blockade of calcium ion influx into cells (especially neuronal and smooth muscle cells).
Vasodilation and Neuroprotection: This effect reduces vasospasm, improves microcirculation, and protects neurons from ischemic injury.
4. Safety and Warnings
Depression and Parkinsonism: It may cause depression and parkinsonism, especially in patients with a history of depression or extrapyramidal disorders.
Sedation: Drowsiness is common, particularly in the early stages of treatment.
Elderly Patients: Older patients are more prone to developing depressive symptoms and extrapyramidal disorders.
Driving and Machinery: Patients should exercise caution when driving vehicles or operating machinery.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Drowsiness and fatigue (often transient).
Rare Adverse Reactions: Weight gain, depression, extrapyramidal symptoms (e.g., bradykinesia, rigidity, restlessness, orofacial dyskinesia, tremor), insomnia, and anxiety.
Clinical Research: Clinical trials have demonstrated efficacy in reducing the frequency and severity of migraine attacks and vertigo symptoms.
6. Drug Interactions
CNS Depressants: Concomitant use with alcohol, hypnotics, or sedatives can lead to excessive sedation.
Anticonvulsants: Concomitant use with phenytoin or carbamazepine may decrease flunarizine blood concentrations.
7. Pharmaceutical Information
Active Ingredient: Flunarizine Hydrochloride.
Appearance: Hard capsules containing white to off-white powder.
Storage: Store at controlled room temperature, protected from light and moisture.