Presentation

Florium 5: Each tablet contains Flunarizine Dihydrochloride BP equivalent to Flunarizine 5 mg.

Florium 10: Each tablet contains Flunarizine Dihydrochloride BP equivalent to Flunarizine 10 mg.

Description

Flunarizine is a selective calcium channel antagonist. Flunarizine is the difluorinated derivative of cinnarizine. It prevents cellular calcium overload by reducing excessive transmembrane influxes of calcium. It does not interfere with normal cellular calcium homeostasis. It has also antihistaminic and sedative properties.

Indications

? Prophylaxis of classic (with aura) or common (without aura) migraine

? Symptomatic treatment of vestibular vertigo and motion sickness

? Peripheral vascular disease

? Refractory epilepsy resistant to conventional antiepileptic therapy

Dosage & Administration

The usual dose is 5 to 10 mg daily, usually given at night to minimize the effects of drowsiness.

For migraine prophylaxis: Starting dose is 10 mg daily (at night) for patients less than 65 years and 5 mg daily for patients older than 65 years.

Maintenance treatment: If a patient?s response is satisfactory and if a maintenance treatment is needed, the dose should be decreased to 5 days (of a week) treatment at the same daily dose and 2 successive drug free days. Treatment should be interrupted after 6 months and re-initiated only if the patient relapses.The recommended maximum daily dose is 10 mg daily in adults and 5 mg daily in children (< 40 kg).

For vertigo and motion sickness : The recommended maximum daily dose of Flunarizine in the treatment of vertigo is 10 mg daily in adults and 5 mg daily in children ( < 40 kg).

For peripheral vascular disorders: The recommended daily dose of Flunarizine in the treatment of peripheral vascular disorders is 5 to 10 mg in the evening.

For epilepsy: An optimal therapeutic dosage in epileptic patients receiving other anti-epileptic drugs is 15 to 20 mg daily in adults and 5 to 10 mg daily in children.

Side Effects

Flunarizine is well tolerated and seldom causes serious side effects. The main adverse effects experienced by the patients are as follows:

Central Nervous System: Depression, drowsiness, sedation, anxiety.

Gastrointestinal: Heart burn, nausea, emesis, dry mouth, gastralgia.

Miscellaneous: Weight gain, and/or increased appetite, asthenia, muscle aches, skin rash.

Precautions

Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should avoid driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine should therefore be used with caution in such patients.

Use in Pregnancy & Lactation

The safety of Flunarizine for use in pregnancy and lactation has not been established.

Drug Interaction

Galactorrhea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as carbamazepine and phenytoin increase the metabolism of Flunarizine. So an increase in dose of the drug may be required. Concomitant use of a calcium channel blocker and amiodorone has been reported to result in sinus arrest and atrioventricular block.

Storage

Store in a cool & dry place, away from light. Keep out of the reach of children.

Commercial Pack

Florium 5: Each box contains 10 blister strips of 10 tablets.

Florium 10: Each box contains 6 blister strips of 10 tablets.