Pizotifen

Registered South African indications:

• Vascular headaches
• Migraines

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Closed angle glaucoma
• Risk factors for urinary retention 
• History of epilepsy
• Galactose intolerance
• Lactase deficiency
• Glucose-galactose malabsorption

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

Migraine - prophylaxis
Vascular headache - prophylaxis

• Oral (tab): Initial: 0.5mg, dly at night; Titrate gradually; Maintenance: 1.5mg/day, in 1-3 divided doses; Max: 4.5mg/24hrs

Therapeutic response may require several weeks of therapy

Drug holidays are recommended periodically to assess the need for ongoing therapy; Do not discontinue abruptly (reduce gradually over a 2 week period)

Not approved for use in South Africa for children below 12 years

Pregnancy

• Caution; not recommended
• As clinical data with pizotifen in pregnancy are very limited it should only be administered during pregnancy if the expected benefits outweigh the potential risks
• There is no data for recommendations in women of child-bearing potential

Breastfeeding

• Caution; not recommended
• Although the concentrations of pizotifen measured in the milk of treated mothers are not likely to affect the infant, its use in nursing mothers is not recommended

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Caution; dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Depression
• Central nervous system stimulation
• Hallucination
• Insomnia
• Anxiety
• Drowsiness
• Dizziness
• Paraesthesia
• Seizures

Gastrointestinal Disorders

• Nausea
• Dry mouth
• Constipation

Hepatobiliary Disorders

• Increased hepatic enzymes
• Jaundice
• Hepatitis

Endocrine and Metabolic Disorders

• Increased appetite
• Increase in body weight

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Muscle cramps

Skin and Subcutaneous Tissues Disorders

• Urticaria
• Rash

Immune System Disorders

• Hypersensitivity reactions
• Facial oedema

• Central nervous system depressants 
• Alcohol 
• Adrenergic neuron blockers 
• Monoamine oxidase inhibitors

None routine

Pizotifen also possesses appetite-stimulating properties

Pizotifen is a serotonin and histamine antagonist, which acts to cause constriction of the intracranial extracerebral blood vessels.

Tablet 0.5mg

•  Sandomigran (Novartis) originator