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Siberizin

Ingredients

Flunarizine dihydrochloride equivalent to …..5 mg of Flunarizine

Excipients: Lactose monohydrate, Dicalcium phosphate, Polyvinyl pyrolidone K30, Magnesium stearate, Talc…… q.s 1 capsule

Dosage form: Hard capsule containing white drug powder.

Presentation: Box of 10 blisters x 10 capsules.

Pharmacodynamics properties

Siberizin® contains the active ingredient flunarizine, which is a diflouriant derivative of cinnarizine. Flunarizine has anti-histamine, sedative and calcium channel blocking properties. Flunarizine is used to prevent migraine, dizziness caused by vestibular disorder and cerebrovascular disorders. Flunarizine is also used in combination with antiepileptic drugs to treat epilepsy for patients not responding to standard treatment regimens.

The mechanism of action of flunarizine is not completely clear. It is possible that flunarizine blocks calcium channel and reduces cellular calcium overload, which in turn results in vasodilatation. In addition, flunarizine may be inhibit the vasoconstriction by reducing intermediates such as serotonin, prostaglandin, increasing oxygen supply to nerve cells, improving blood viscosity. Unlike ergostamin, flunarizine does not affect contraction and conduction of cardiac muscles.

Pharmacokinetic properties

Flunarizine is well absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 2 to 4 hours after oral dosing and steady state at week 4 and 5. Flunarizine is 99% bound to plasma proteins. After complete metabolism through the liver, flunarizine is primarily eliminated as parent drug and metabolites through the faeces via bile. The terminate half-life of flunarizine is about 18 days.

Indications

Siberizin® is indicated for:

Prophylaxis of migraine in cases where other treatment measures are ineffective or poorly tolerated.

Contraindications

Hypersensitivity to flunarizine or to any excipients contained in the formulation.

Patients with pre-existing symptoms of Parkinson's disease.

Patients with history of extrapyramidal disorders.

Patients with current depressive illness or with a history of recurrent depression.

Precautions and warnings for use

Flunarizine is used with caution in patients with liver disease or porphyria.

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.

In rare cases fatigue may increase progressively during flunarizine therapy. In this event, the therapy should be discontinued.

Interactions

Increased metabolism of Siberizin® may have been reported by concurrent use of Siberizin® and hepatic inducers (including carbamazepine, phenytoin). Therefore, the dose of Siberizin® should be increased. Excessive sedation can occur when alcohol or tranquillisers are taken simultaneously with Siberizin®.

Pregnancy and lactation

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, or parturition. As a precautionary measure, it is preferable to avoid the use of Siberizin® during pregnancy.

Lactation: Animal studies have shown excretion of flunarizine in breast milk higher than plasma concentrations. Data on human milk excretion are not yet available. It is therefore not recommended Siberizin® for breastfeeding women.

Effects on ability to drive and use machines

Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities such as driving or operating dangerous machinery.

Dosage & administration

Adults aged ≤ 65 years and elderly aged > 65 years: 5 mg daily (at night) for 4 to 8 weeks.

If, during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued.

If, after 8 weeks of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.

The therapy should not exceed 6 months.

Recommendation is only available for patients younger than 65 years of age: If the patient is responding satisfactorily, the daily dose may be increased to 10 mg.

Children

Children aged 12 years and older, particularly unknown migraine: 5 mg daily (at night). The therapy should not exceed 6 months.

Children aged < 12 years: Not recommended. There is no adequate evidence of the efficacy and safety of flunarizine on this subject.

Undesirable effects

Siberizin® generally is well tolerated. Adverse effects that occur at the start of treatment are mild, including drowsiness, fatigue, weight gain or increased appetite. Other adverse effects such as heartburn, nausea, stomachache, insomnia, anxiety, dry mouth, and muscle pain rarely occur. Flunarizine can cause depression or extrapyramidal disorders (tremor, movement disorders) in elderly patients who require long-term treatment.

Inform your doctor about any side effects that may occur during the treatment.

Overdose

In case of overdose or accidental drug poisoning, contact immediately to a medical staff for necessary measures. No specific antidote is known. Treatment of acute overdosage consists of gastric lavage or charcoal administration if necessary.

Shelf-life: 24 months from the manufacturing date.

Storage: Store in cool dry places, below 30oC.

Specifications: Manufacturer’s.

Registration number: VD-20247-13
Nhà máy:
Quang Minh Industrial Zone, Me Linh Dist., Hanoi, Vietnam. 
Tel: +844.3584.1213/14/16 - Fax: +844.3584.0788
Email: info@saokimpharma.com



Sao Kim Pharmaceutical joint stock company. Phone : 0243.5841213/0243.584.1216. Email : info@saokimpharma.com.
Business code: 2500169960. Date of issue: November 19, 2007, issued by Hanoi Planning and Investment Department.
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