Product Overview
[Drug Name]
Generic Name: Flunarizine Hydrochloride Capsules
Trade Name: Sibelium
English Name: Flunarizine
Chinese Pinyin: Yansuan fuguiliqin Jiaonang
[Ingredients]
Flunarizine Hydrochloride Chemical Name: (E)-1-[Bis(4-fluorophenyl)methyl]-4-(2-propenyl-3-phenyl)-piperazine dihydrochloride Molecular Formula: C26H26F2N22HCL Molecular Weight: 477.42.
[Properties]
This product is a capsule containing a white or off-white powder.
[Indications]
1. Preventive treatment of typical (with aura) or atypical (without aura) migraine; 2. Symptomatic treatment of vertigo caused by vestibular dysfunction.
[Dosage and Administration]
1. Preventive treatment of migraine. Starting Dose: 10 mg per night for patients under 65 years of age; 5 mg per night for patients over 65 years of age. Maintenance Therapy: If the therapeutic effect is satisfactory and the patient requires maintenance therapy, the dosage should be reduced to five days per week (dose as above).
2. Dizziness: The daily dose should remain the same as above, but the drug should be discontinued promptly after symptoms are controlled. The initial course of treatment is usually less than two months.
[Adverse Reactions]
1. The most common adverse reactions (often transient) are drowsiness and/or fatigue (20%). Some patients may also experience weight gain (and/or increased appetite) (11%). 2. The following serious adverse reactions (occurring occasionally in long-term users) include: depression, which is more common in women with a history of depression. Extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, oral and mandibular dyskinesia, tremor, etc.) are more common in the elderly. 3. Rare adverse reactions have been reported: Gastrointestinal reactions: heartburn, nausea, stomach pain. Central nervous system effects: insomnia, anxiety. 4. Other: galactorrhea, dry mouth, muscle pain, and rash.
[Contraindications]
This product is contraindicated in patients with a history of depression, Parkinson's disease, or other extrapyramidal disorders.
[Precautions]
1. If fatigue symptoms gradually worsen after use, the dosage should be reduced or discontinued. 2. Strictly control the dosage. If the maintenance dose is ineffective or extrapyramidal symptoms develop with long-term use, the dosage should be reduced or discontinued. 3. This product should be used with caution in patients with extrapyramidal disorders such as Parkinson's disease. 4. Drivers and machinery operators should use with caution to avoid accidents.
[Use in Special Populations]
Precautions for Children:
Because this drug can cross the blood-brain barrier, it has known adverse central nervous system reactions, and the central nervous system of children is sensitive to the drug. Children's metabolic function is relatively weak. Although there are currently no detailed research data on its use in children, this drug should generally be used with caution or avoided in children.
Precautions During Pregnancy and Lactation:
Because this drug can cross the placenta and is secreted in breast milk, although there have been no reports of teratogenicity or effects on embryonic development, it should generally not be used by pregnant or lactating women.
Precautions for Elderly Patients:
Due to the more sensitive nervous systems and reduced metabolic capacity of elderly patients, the dosage should be reduced as appropriate.
[Drug Interactions]
Excessive sedation may occur when this drug is used in combination with alcohol, hypnotics, or sedatives. This drug is not contraindicated in patients taking beta-blockers.
[Pharmacological Actions]
Flunarizine hydrochloride is a selective calcium antagonist that blocks the entry of excessive calcium ions across cell membranes, preventing excessive intracellular calcium overload. It also prevents excessive calcium entry into neurons during ischemia and hypoxia, improving cerebral microcirculation and neuronal metabolism, inhibiting cerebral vasospasm, platelet aggregation, and increased blood viscosity. It also has a cell membrane stabilizing effect. This drug is highly lipid-soluble and readily crosses the blood-brain barrier. It has no effect on cardiac contraction or conduction.
[Storage] Store in a sealed container away from light.
[Specification] 5mg x 20 tablets
[Packaging] Box
[Expiration Period] 36 months
[Approval Number] National Medicine Standard H10930003
[Manufacturer] Company Name: Xi'an Janssen Pharmaceutical Co., Ltd.
