Fluzin 10 mg Tablet

Fluzin 10 mg Tablet

DESCRIPTION

FLUZIN (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.

COMPOSITION

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

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

INDICATIONS

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

 Symptomatic treatment of vestibular vertigo and motion sickness

 Peripheral Vascular Disease (PVD)

 Refractory epilepsy resistant to conventional antiepileptic therapy

DOSAGE AND ADMINISTRATION

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

Maintenance treatment: If a patient’s response is satisfactory and a maintenance treatment is needed, the dose should be decreased to 5 days (of a week) treatment at the same daily dose with two successive medicine free days. Even if the prophylactic maintenance treatment becomes successful and well tolerated, it should be interrupted after 6 months and re-initiated only if the patient relapses. For vertigo and motion sickness: The recommended maximum daily dose of FLUZIN in the treatment of vertigo is 10 mg daily in adults and 5 mg in children (<40 kg).

Peripheral Vascular Disease: 10 mg twice daily, up to 30 mg per day if required.

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

Or as directed by the physician.

SIDE EFFECTS

Flunarizine is well tolerated and seldom causes serious side effects. The main adverse reactions experienced by the patients are as follows: Central Nervous System: Depression, drowsiness, sedation, anxiety Gastrointestinal: Heartburn, nausea, emesis, dry mouth, gastralgia Miscellaneous: Weight gain and/or increased appetite, muscle aches, rash

CONTRAINDICATION

Hypersensitivity to Flunarizine or any of the excipients of this product.

Flunarizine is contraindicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson’s disease or other extrapyramidal disorders.

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 AND LACTATION

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

DRUG INTERACTION

Galactorrhoea 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 may interact with

Flunarizine by increasing its metabolism. So an increase in dosage of

Flunarizine may be required. Concomitant use of a calcium channel blocker and amiodarone has been reported to result in sinus arrest and atrioventricular block.

SUPPLY

FLUZIN 5: Each box contains 5X10 tablets in blister strips.

FLUZIN 10: Each box contains 5X10 tablets in blister strips.