Fluzin 5 Tablet

Generic Name: Flunarizine

Strength: 5 mg

Manufacturer: ACME Laboratories Ltd.

Indications:

• Prophylaxis of classic (with aura) or common (without aura) migraine.

• Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).

• Peripheral Vascular Disease (PVD)

• Motion sickness.

• Refractory epilepsy resistant to conventional antiepileptic therapy.

Pharmacology:

• Flunarizine is a selective calcium channel antagonist.

• It reduces excessive transmembrane influx of calcium, preventing cellular calcium overload.

• Flunarizine does not interfere with normal cellular calcium homeostasis.

• It also has some antihistaminic and sedative properties.

Dosage & Administration:

• Migraine Prophylaxis:

  • Starting Dose: 10 mg at night for patients less than 65 years old, and 5 mg daily for patients older than 65 years.

  • If depressive, extrapyramidal, or other unacceptable symptoms occur, discontinue administration.

  • If no significant improvement is observed after 2 months of initial treatment, the patient should be considered a non-responder, and administration should be discontinued.

  • Maintenance Treatment: If a patient responds satisfactorily and needs maintenance treatment, the dose should be decreased to 5 days of treatment at the same daily dose, with two successive medicine-free days every week.

  • Even if prophylactic maintenance treatment is successful and well-tolerated, it should be interrupted after 6 months and re-initiated only if the patient relapses.

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

• Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).

• Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy.

Contraindications:

• Hypersensitivity to Flunarizine.

• Patients with a history of depressive illness or pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.

Side Effects:

• Drowsiness and/or fatigue, weight gain, and/or increased appetite may occur.

• Other reported adverse effects during chronic treatment with Fluzin: depression (particularly in female patients with a history of depressive illness), extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor).

• Infrequent adverse reactions: heartburn, nausea, gastralgia, insomnia, anxiety, galactorrhea, dry mouth, muscle ache, skin rash.

Precautions:

• Fluzin may lead to drowsiness, which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants.

• Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents.

• Fluzin is not suitable for aborting a migraine attack.

• This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly.

• Use with caution in patients with hepatic impairment.

Drug Interactions:

• Galactorrhea has been reported in a few women on oral contraceptives within the first two months of Fluzin treatment.

• Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with Fluzin by increasing its metabolism, potentially requiring an increase in Fluzin dosage.

Pregnancy & Lactation:

• There is no evidence of safety during pregnancy or lactation.

Storage Conditions:

• Keep below 30°C temperature, away from light & moisture.