Frego

Frego

flunarizine

Manufacturer:

Kalbe Farma
Full Prescribing Info
Contents
Flunarizine.
Action
Pharmacology: Flunarizine is the derivative of cinnarizine which has antihistamine and selective calcium channel-blocking activities.
Pharmacokinetics: Flunarizine is well-absorbed from the gastrointestinal tract, reaching peak plasma concentration within 2-4 hrs after oral administration. After extensive hepatic metabolism, flunarizine and its metabolites are excreted through the faeces via the bile. The mean terminal elimination half-life is about 18 days. Plasma protein-binding is 90%.
Indications/Uses
Migraine Prophylaxis: Reduce frequency and severity of attacks.
Treatment of Cerebral and Peripheral Vestibular Disturbances: Dizziness, tinnitus, vertigo.
Dosage/Direction for Use
Recommended Dose: 10 mg daily. If adverse effects occur, reduce the dosage to 5 mg. Frego should be taken regularly once a day in the evening to avoid the sedative effect.
Migraine Prophylaxis: Starting Dose: Patients <65 years: 10 mg daily (at night); >65 years: 5 mg daily. If during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued. If after 2 months of this initial treatment, no significant improvement is observed, the administration should also be discontinued.
Maintenance Treatment: If patients are responding satisfactorily and if maintenance treatment is needed, the dose should be decreased to 5-day treatment a week and 2 days a week without Frego. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and should be reinitiated only if the patients relapse.
Treatment of Cerebral and Peripheral Vestibular Disturbances: The same daily doses should be used as for migraine, but the starting treatment should not be given longer than needed for symptom control, which generally takes <2 months. However, if after 1 month for chronic vertigo or after 2 months for paroxysmal vertigo, nonsignificant improvement is observed, the administration should be discontinued.
Frego may be taken with or without food.
Overdosage
On the basis of the pharmacological properties of Frego, sedation and asthenia can occur.
A few cases of acute overdosage (up to 600 mg in 1 intake) have been reported and the observed symptoms were sedation, agitation and tachycardia.
Acute overdosage can be overcome by giving active carbon, gastric lavage and supportive treatment.
Extrapyramidal symptoms and depression have been reported in patients who have taken 10-40 mg daily for 3 weeks and 15 months.
Contraindications
Flunarizine should not be taken by patients who have allergy to any of the ingredients of Frego, history of depression, history of involuntary movement disorders (extrapyramidal symptoms including parkinsonism) and patients treated with β-blocking agents.
Special Precautions
In rare cases, fatigue may increase during therapy. In this case, the therapy should not be discontinued and the recommended dose should not be exceeded. If, during maintenance treatment, the therapeutic effects wane, the treatment should also be discontinued.
Treatment with Frego may give rise to extrapyramidal and depressive symptoms and reveal parkinsonism, especially in predisposed patients eg, elderly. Therefore, it should be used with caution in such patients.
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.
Caution should also be taken in hypotensive patients.
Use with caution in patients with renal failure.
Liver and renal function should be monitored during the long period of treatment.
Effects on the Ability to Drive or Operate Machinery: Frego causes drowsiness and since somnolence may occur especially at the start of the treatment, Frego should not be given to patients doing activities ie, driving or operating machinery.
Use in pregnancy & lactation: Frego is not recommended for pregnant women since safety has not been established.
Flunarizine is excreted in breast milk, therefore, Frego should not be given to breastfeeding women.
Use in the elderly: Use with caution in elderly patients.
Adverse Reactions
The most frequent adverse reactions are drowsiness and/or fatigue. Rare to less common adverse reactions which have been reported are heartburn, nausea, vomiting, insomnia, anxiety, dizziness, dry mouth, muscle aches and skin rash. Serious adverse reactions that occur during chronic treatment are depression, extrapyramidal symptoms (bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor).
Drug Interactions
Alcohol, certain drugs used for epilepsy, sleeping aids, antidepressants and tranquilizers can affect the action of flunarizine or increase the occurrence of side effects.
Galactorrhea will occur when concomitantly used with oral contraceptives.
Storage
Store at room temperature (below 30°C).
ATC Classification
N07CA03 - flunarizine ; Belongs to the class of antivertigo preparations.
Presentation/Packing
Tab 5 mg x 5 x 10's. 10 mg x 5 x 10's.
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