Flunarizine

Registered South African indications:

• Migraine
  - Prophylaxis of classic (with aura) or common (without aura) migraine
• Vestibular vertigo
  - Symptomatic treatment due to a diagnosed functional disorder of the vestibular system

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• History of depression
• Parkinson's disease 
• Extrapyramidal disorders

Cautions

• Pregnancy
• Breastfeeding
• Hepatic impairment
• Elderly 

Forms avail. in SA and covered in this monograph: tab

South African registered indications and dosages

Migraine
- Prophylaxis of classic (with aura) or common (without aura) migraine

• Oral (tab): Initial: 10mg, daily at night; Maintenance: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dosage schedule should be changed so that each week the patient receives 5 days of treatment at the same daily dose and 2 successive medicine free days

If, during the initial 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 patient should be considered a non-responder and administration should be discontinued

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

Vestibular vertigo
- Symptomatic treatment due to a diagnosed functional disorder of the vestibular system

• Oral (tab): Same daily doses should be used as for migraine, however, initial treatment should not be given longer than needed for symptom control, which is generally <2 months

The dose will be as described below

• Patient takes the same number of tablets they are used to taking (1 or half a tablet(s) every day before going to bed for 5 days in a row; and do not take any tablets for 2 days in a row
• Patient repeats this pattern (5 days with medicine followed by 2 days with no medicine) for the rest of the treatment

If, however, no significant improvement is observed, after 1 month of treatment for chronic vertigo or after 2 months treatment for paroxysmal vertigo, the patient should be considered a non-responder and administration should be discontinued

Paed. forms avail. in SA and covered in this monograph: tab

South African registered indications and dosages

Migraine
- Prophylaxis of classic (with aura) or common (without aura) migraine

Younger than 5 years

• Safety and efficacy have not been established

Between 6-17 years old

• Oral (tab): Initial: 5mg, daily at night; Dose may be increased to 10mg, daily in patients weighing over 40kg, if required; Maximum recommended treatment duration: 6 months

If, during this treatment, depressive symptoms or other unacceptable adverse experiences occur, administration should be discontinued. If, after 3 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued

The safety and efficacy of flunarizine for treatment of vertigo in paediatric patients (17 years of age and younger) have not been established

Pregnancy

• Caution; not recommended
• In animal reproduction studies, adverse reactions were observed

Breastfeeding

• Caution; not recommended 
• There is no evidence as to whether flunarizine is excreted into breast milk

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Drowsiness
• Fatigue
• Extrapyramidal symptoms
• Depression
• Insomnia
• Anxiety

Gastrointestinal Disorders

• Heartburn
• Nausea
• Gastralgia
• Dry mouth

Genitourinary Disorders

• Galactorrhea

Musculoskeletal Disorders

• Muscle ache

Skin and Subcutaneous Tissue Disorders

• Skin rash

Others

• Weight gain
• Increased appetite

• Oral contraceptives
• CYP450 inducers
• Agents that may cause extrapyramidal effects

None routine

Flunarizine inhibits calcium influx into cells, which decreases intracellular calcium. This inhibits the contractile processes of smooth muscle cells and so doing results in vasodilation. Flunarizine also has antihistamine properties (blocks histamine H1-receptors).

Tablet 5mg

• Sibelium T (Janssen) originator

Tablet 10mg

• Sibelium (Janssen) originator