FLUDAN CAPSULES: Each capsule contains Flunarizine 5 mg.
Pharmacology: Pharmacodynamics: Flunarizine is the difluorinated derivative of cinnarizine. It has antihistamine, sedative, and calcium-channel blocking activity. It is thought to inhibit calcium ion entry through select voltage-sensitive areas termed "slow channels" across cell membranes. Flunarizine acts on vascular smooth muscle.
Pharmacokinetics: Absorption: Flunarizine is well absorbed from the gastrointestinal tract, peak plasma concentrations occurring 2 to 4 hours after oral doses.
Distribution: Flunarizine is very lipophilic. Its plasma protein binding is 99%.
Metabolism: Flunarizine appears to undergo extensive metabolism.
Elimination: Flunarizine has an elimination half-life of about 18 - 19 days. Metabolites are excreted principally in the bile. Within first 48 hours after administration, flunarizine is eliminated in the feces as parent drug and metabolite less than 6% and less than 0.2% is excreted via renal.
FLUDAN CAPSULE is indicated for migraine prophylaxis, vertigo and vestibular disorders.
FLUDAN CAPSULE is administered orally. The usual dose is 5 to 10 mg daily, usually given at night to minimize the effects of drowsiness.
Overdosage with sedating antihistamines is associated with antimuscarinic, extrapyramidal and CNS effects. When CNS stimulation predominates over CNS depression, which is more likely in children or the elderly, it causes ataxia, excitement, tremors, psychoses, hallucinations, and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults, CNS depression is more common with drowsiness, coma, and convulsions, progressing to respiratory failure and cardiovascular collapse.
FLUDAN CAPSULES are contraindicated in patients with a known hypersensitivity to flunarizine or to any excipients contained in the formulation and in patients with porphyria, history of mental depression, Parkinson's disease or other extrapyramidal disorders.
Drowsiness is a major problem with FLUDAN CAPSULES and those affected should not drive or operate machinery; alcohol should be avoided. Because of its antimuscarinic actions FLUDAN CAPSULES should be used with care in conditions such as angle-closure glaucoma, urinary retention, prostatic hyperplasia, or pyloroduodenal obstruction.
Use in Children: FLUDAN CAPSULES should not be given to neonates because the latter are more susceptible to antimuscarinic effects.
Use in Pregnancy: There are no data from the use of FLUDAN CAPSULES in pregnant women. It is preferable to avoid the use of FLUDAN CAPSULES during pregnancy.
Use in nursing mother: It is unknown whether FLUDAN CAPSULES is distributed into human breast milk. Nursing should therefore be discouraged in woman taking FLUDAN CAPSULES.
The most common adverse effects FLUDAN CAPSULES are CNS depression, drowsiness, headache, dry mouth, constipation, parkinsonian extrapyramidal effects, galactorrhea, mental depression, increased appetite and weight gain.
Hepatic Enzyme Inducers: Hepatic enzyme inducers such as Carbamazepine, Phenytoin, and Valproate may interact with flunarizine by increasing its metabolism; an increase in dosage of FLUDAN CAPSULES may be required.
CNS Depressants: FLUDAN CAPSULES may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesic, anxiolytic sedative and antipsychotics.
Antimuscarinic Drugs: FLUDAN CAPSULES have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs).
Store at temperature not exceeding 30°C.
N07CA03 - flunarizine ; Belongs to the class of antivertigo preparations.
Fludan cap 5 mg
10 × 10's;50 × 10's
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