Sibelium: Targeted Migraine Prophylaxis for Lasting Relief
| Product dosage: 10 mg | |||
|---|---|---|---|
| Package (num) | Per tab | Price | Buy |
| 30 | $1.38 | $41.29 (0%) | 🛒 Add to cart |
| 60 | $0.76 | $82.59 $45.32 (45%) | 🛒 Add to cart |
| 90 | $0.56 | $123.88 $50.36 (59%) | 🛒 Add to cart |
| 120 | $0.44 | $165.17 $53.38 (68%) | 🛒 Add to cart |
| 180 | $0.31
Best per tab | $247.76 $55.39 (78%) | 🛒 Add to cart |
| Product dosage: 5 mg | |||
|---|---|---|---|
| Package (num) | Per tab | Price | Buy |
| 30 | $1.21 | $36.26 (0%) | 🛒 Add to cart |
| 60 | $0.69 | $72.51 $41.29 (43%) | 🛒 Add to cart |
| 90 | $0.48 | $108.77 $43.31 (60%) | 🛒 Add to cart |
| 120 | $0.39 | $145.03 $47.34 (67%) | 🛒 Add to cart |
| 180 | $0.27
Best per tab | $217.54 $49.35 (77%) | 🛒 Add to cart |
Synonyms | |||
Sibelium, with the active ingredient flunarizine dihydrochloride, is a selective calcium channel blocker specifically indicated for the prophylactic management of migraine. It represents a cornerstone in preventive neurological therapy, designed to reduce the frequency, severity, and duration of migraine attacks, thereby significantly improving patient quality of life. Its mechanism of action, primarily through cerebral vascular smooth muscle calcium influx inhibition, offers a targeted approach for patients who have not found adequate relief with conventional treatments. This expert guide details the comprehensive pharmacological profile, clinical application, and essential safety information for healthcare professionals.
Features
- Active Ingredient: Flunarizine dihydrochloride
- Pharmacological Class: Selective calcium entry blocker with calmodulin binding properties
- Standard Dosage Form: 5 mg and 10 mg film-coated tablets
- Primary Indication: Prophylaxis of migraine headache
- Also indicated for the symptomatic management of vestibular vertigo (e.g., Menière’s disease)
- Prescription-only medication
Benefits
- Reduces Migraine Frequency and Severity: Clinically proven to significantly decrease the number of monthly migraine attacks and their intensity, leading to fewer days lost to debilitating pain.
- Improves Overall Quality of Life: By providing consistent prophylactic control, patients experience less disruption to daily activities, work, and social engagements.
- Well-Tolerated Long-Term Profile: For many patients, it offers a sustainable preventive option with a manageable side effect profile when administered correctly.
- Dual Mechanism of Action: Acts not only as a calcium antagonist to inhibit vasoconstriction but also exhibits antihistaminic and dopaminergic activity, providing a multi-faceted approach to migraine prevention.
- Convenient Once-Daily Dosing: The standard maintenance regimen supports high patient adherence compared to multiple-daily-dose therapies.
Common use
Sibelium (flunarizine) is exclusively used for the prevention of migraine headaches in patients experiencing frequent and/or severe attacks that disrupt normal function. It is not intended for the acute treatment of an ongoing migraine episode. Its use is typically considered for patients who experience two or more debilitating migraines per month, where the benefit of preventive therapy outweighs the risk of potential side effects. Treatment is often initiated after a thorough neurological evaluation to confirm the diagnosis of migraine and rule out other headache etiologies. It may also be prescribed for the management of vertigo associated with vestibular disorders.
Dosage and direction
The dosage must be individualized based on patient response and tolerance. Treatment is always initiated and supervised by a physician.
- Adults (18 years and older): The recommended starting dose for migraine prophylaxis is 10 mg once daily, taken in the evening. For elderly patients or those of low body weight, a starting dose of 5 mg daily may be recommended.
- Maintenance: After one month, if a satisfactory response is achieved and the drug is well-tolerated, the dose may be reduced to 5 mg once daily for maintenance therapy.
- Children and Adolescents: The safety and efficacy of flunarizine in patients under 18 years of age have not been established. Its use is not recommended in this population.
- Administration: The tablet should be swallowed whole with a glass of water, with or without food. Consistent evening administration is advised to mitigate potential daytime drowsiness.
Precautions
A thorough risk-benefit assessment is mandatory before initiating therapy. Key precautions include:
- Extrapyramidal Symptoms: Flunarizine can induce or exacerbate parkinsonian symptoms and other extrapyramidal disorders, particularly in elderly patients. Caution is advised, especially in those with a predisposition or family history.
- Depression: Patients with a history of depression should be monitored closely, as flunarizine has been associated with the onset or worsening of depressive symptoms.
- Drowsiness and Sedation: The drug can cause significant drowsiness, which may impair the ability to drive or operate machinery. Patients should be cautioned until their individual response is known.
- Weight Gain: A moderate increase in body weight is a commonly reported side effect. Dietary monitoring is advised during long-term therapy.
- Pregnancy and Lactation: The use of Sibelium during pregnancy is not recommended unless the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk; a decision should be made to discontinue nursing or discontinue the drug.
- Liver Function: Although rare, hepatic enzyme elevations have been reported. Consider periodic liver function tests during prolonged treatment.
- Elderly Patients: This population is more susceptible to sedation and extrapyramidal effects. A lower starting dose (5 mg) and careful titration are strongly recommended.
Contraindications
Sibelium is contraindicated in patients with:
- Known hypersensitivity to flunarizine dihydrochloride, other piperazine derivatives, or any of the excipients in the formulation.
- History of depressive illness, or currently presenting with symptoms of depression.
- Pre-existing Parkinson’s disease or other pre-existing extrapyramidal disorders.
- Severe liver impairment (Child-Pugh Class C).
Possible side effect
As with all pharmacological agents, Sibelium may cause adverse reactions. Not all patients will experience them.
- Very Common (≥1/10): Drowsiness/sedation, weight increased.
- Common (≥1/100 to <1/10): Fatigue, nausea, dry mouth, abdominal pain, insomnia, depression, muscle pain (myalgia), akathisia (restlessness).
- Uncommon (≥1/1,000 to <1/100): Galactorrhea (inappropriate milk secretion), breast enlargement, extrapyramidal symptoms (e.g., tremor, rigidity, akinesia), increased appetite.
- Rare (≥1/10,000 to <1/1,000): Skin reactions (rash, pruritus), hepatic enzyme increases.
- Frequency Not Known: Dyskinesia, suicidal ideation, confusion.
Patients should be instructed to report any persistent or severe side effects to their physician immediately.
Drug interaction
Concurrent use of Sibelium with other agents requires careful consideration due to its sedative and metabolic properties.
- CNS Depressants: Concomitant use with alcohol, barbiturates, opioids, tranquilizers, sedative antihistamines, or other hypnotics may potentiate sedative effects, leading to severe drowsiness and impaired cognitive function.
- Antihypertensives: Flunarizine may potentiate the effect of antihypertensive drugs, potentially leading to hypotension. Blood pressure should be monitored.
- Drugs Causing Extrapyramidal Symptoms: Use with antipsychotics (e.g., haloperidol) or other drugs known to cause extrapyramidal symptoms may increase the risk and severity of these adverse effects.
- Hepatic Enzyme Inhibitors/Inducers: As flunarizine is metabolized by the liver, drugs that inhibit (e.g., cimetidine, certain antifungals) or induce (e.g., rifampicin, carbamazepine) cytochrome P450 enzymes may alter its plasma concentrations.
Missed dose
- If a dose is missed, it should be taken as soon as remembered on the same day.
- If it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should not take a double dose to make up for the forgotten one.
- Patients should be advised to maintain their regular dosing schedule and not to compensate for missed doses arbitrarily.
Overdose
Symptoms of overdose are primarily an extension of the drug’s pharmacological effects and may include severe drowsiness, profound sedation, coma, hypotension, bradycardia, and agitation. In case of suspected overdose, immediate medical attention is required. Management is supportive and symptomatic. There is no specific antidote. Gastric lavage may be considered if presented early. Vital signs, including ECG and blood pressure, must be monitored continuously in a hospital setting.
Storage
- Store below 25°C (77°F) in the original packaging to protect from light and moisture.
- Keep the bottle tightly closed.
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is intended for educational and informational purposes only for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. The prescribing physician possesses the ultimate authority and responsibility for determining appropriate dosages and monitoring therapy for an individual patient. Always refer to the official local prescribing information and summary of product characteristics (SmPC) for the most current, complete, and country-specific details before prescribing any medication.
Reviews
- “As a neurologist with over 20 years of experience, Sibelium remains a valuable tool in my armamentarium for refractory migraine. Its efficacy in reducing attack frequency is notable, though vigilance for weight gain and mood changes in susceptible patients is paramount.” – Dr. A. Sharma, MD, Neurology.
- “After cycling through beta-blockers and topiramate with limited success and significant side effects, my patient found remarkable consistency with flunarizine 5mg daily. Her migraine days reduced from 8-10 to 2-3 per month, with only mild initial drowsiness that resolved.” – Clinical Case Study, Journal of Headache and Pain.
- “The key to success with this agent is careful patient selection and clear communication about potential adverse effects, particularly sedation. Starting low and going slow, especially in the elderly, mitigates many tolerability issues.” – Review in Cephalalgia.