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Product Name
:
NARIZINE
Chemical Name
:
Flunarizine
Therapeutic Category
:
Central nervous system drugs
Pharmacologic Category
:
Calcium Channel Antagonist
Pharmaceutical Form
:
Capsules
Composition
:
Flunarizine 5mg
Dosing
Use
 
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)
Adverse Reactions
 
Frequency not defined.
Central nervous system: Anxiety, dizziness, drowsiness, fatigue, insomnia, vertigo
Dermatologic: Rash
Endocrine & metabolic: Galactorrhea, prolactin levels increased
Gastrointestinal: Appetite increased, epigastric pain, heartburn, nausea, vomiting, weight gain, xerostomia
Neuromuscular & skeletal: Asthenia/weakness, muscle ache
Contraindications
 
Hypersensitivity to flunarizine, any component of the formulation, or other calcium channel antagonist; depression; Parkinson's disease, or other extrapyramidal disorders
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Monitor for fatique symptoms.
• Depression: May precipitate depression; greater risk in younger patients. Monitor for depressive symptoms.
• Extrapyramidal symptoms: May produce extrapyramidal symptoms in individuals with no prior history of neurological deficits; risk is increased in elderly patients. Monitor for symptoms.
Disease-related concerns:
• Acute migraines: Not indicated for treatment of acute migraine attacks.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions:
• Appropriate use: Do not exceed recommended dose; discontinue use if therapeutic effects diminish during treatment.
Metabolism/Transport Effects
Substrate of CYP2D6
Interactions
 
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
CarBAMazepine: May decrease the serum concentration of Flunarizine. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification
Fosphenytoin: May decrease the serum concentration of Flunarizine. Risk C: Monitor therapy
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Phenytoin: May decrease the serum concentration of Flunarizine. Risk C: Monitor therapy
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy
Pregnancy
 
Pregnancy Implications
No data to support use during pregnancy; weigh benefits versus potential risks
Lactation
 
Excretion in breast milk unknown/not recommended
Monitoring Parameters
 
Monitor for extrapyramidal, depressive, and/or fatigue symptoms and discontinue therapy with flunarizine if observed.
Mechanism of Action
 
Monitor for extrapyramidal, depressive, and/or fatigue symptoms and discontinue therapy with flunarizine if observed.
Pharmacodynamics / Kinetics
 
Absorption: Well absorbed
Distribution: Vd: Mean: 43.2 L/kg
Protein binding: 99%
Metabolism: Hepatic: N-oxidation, aromatic hydroxylation
Half-life elimination: ∼19 days
Time to peak, plasma: 2-4 hours
Excretion: Urine (minimal)
 
   
 
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