Fludan

Fludan

flunarizine

Manufacturer:

Biolab

Distributor:

Medispec
Full Prescribing Info
Contents
Flunarizine hydrochloride.
Description
Each capsule contains Flunarizine HCl equivalent to Flunarizine 5 mg.
Action
The effects of FLUDAN are based on its selective antagonism of the calcium-transfer through the cell membranes of the vascular smooth muscle cells, the red blood cells and the cerebral cells.
Toxicology: Acute toxicity: Single dose study of oral administration of Flunarizine in rats, mice and guinea pigs produce median lethal dose (LD50) value of 312, 815 and 640 mg/kg respectively. Behavioural effects observed included disorders of breathing, piloerection, decrease spontaneous movement, ptosis, hypothermia, tonic convulsion, catalepsy tremor and sedation.
Teratogenicity: In standard teratogenic study in rats at doses of 10, 20, 40 mg/kg and rabbits at doses of 2.5 and 10 mg/kg, Flunarizine showed no potential harmful effects.
Indications/Uses
Prophylaxis of migraine, peripheral venous insufficiency occlusive arterial disease.
Dosage/Direction for Use
The usual dose is 1 capsule twice daily or 2 capsules in the evening.
Overdosage
Information of the acute toxicity of Flunarizine in man is limited. Symptomatic and supportive treatment should be employed if overdosage occurs.
Contraindications
Depression. History of extrapyramidal symptoms or Parkinsonism.
Special Precautions
Extrapyramidal motor signs and psychic depression were reported especially in predisposed patients such as the elderly. Therefore, it should be used with caution in such patients. No data are available on the excretion in human breast milk. Nursing should therefore be discouraged in women taken FLUDAN.
Use in pregnancy: There is, as yet, no evidence of embryotoxic effects of Flunarizine in experimental animals. Nevertheless, the anticipated therapeutic benefits should be weighed against potential hazards before administering the compound during pregnancy.
Use In Pregnancy & Lactation
Use in pregnancy: There is, as yet, no evidence of embryotoxic effects of Flunarizine in experimental animals. Nevertheless, the anticipated therapeutic benefits should be weighed against potential hazards before administering the compound during pregnancy.
Adverse Reactions
Drowsiness, depression, weight gain and gastrointestinal disturbances with long term use of drug.
Drug Interactions
Galactorrhoea was reported in a few female patients on oral contraceptives within the first 2 months of FLUDAN treatment. Excessive sedation can occur when alcohol, hypnotics or tranquilizers are taken simultaneously with FLUDAN. FLUDAN is not contraindicated in patients who use β-blocking agent.
Storage
Store in a dry place at temperature not exceeding 30°C.
Avoid exposure to light and moisture.
The shelf-life period is 3 years.
ATC Classification
N07CA03 - flunarizine ; Belongs to the class of antivertigo preparations.
Presentation/Packing
Cap 5 mg x 10 x 10's.
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