Ketotifen

Registered South African indications:

• Seasonal allergic conjunctivitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Concomitant use of soft contact lenses
• May impair ability to drive and operate machinery

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

Seasonal allergic conjunctivitis

• Ophthalmic (opd): 1 drop into the affected eye(s), 12hrly

Concomitant eye medications must be administered at least 5min apart

To avoid contamination, do not touch any surface with the dropper tip

Soft contact lenses should be removed before application of the drops and not be reinserted earlier than 15 mins after use

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

Seasonal allergic conjunctivitis

Younger than 3 years 

• Not established for use

Older than 3 years 

• See adult dosage

Concomitant eye medications must be administered at least 5min apart

To avoid contamination, do not touch any surface with the dropper tip

Soft contact lenses should be removed before application of the drops and not be reinserted earlier than 15 mins after use

Pregnancy

• Caution
• There are no adequate data from the use of ketotifen eye drops in pregnant women
• Animal studies using maternally toxic oral doses showed increased pre- and postnatal mortality, but no teratogenicity
• Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women

Breastfeeding 

• Compatible 
• Although animal data following administration show excretion into breast milk, topical administration to humans is unlikely to produce detectable quantities in breast milk. Ketotifen eye drops can be used during breastfeeding

Fertility

• There is no data available on the effect of ketotifen fumarate on fertility in humans

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment 

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Somnolence

Gastrointestinal Disorders

• Dry mouth

Skin and Subcutaneous Tissue Disorders

• Rash
• Eczema
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Local allergic reaction
  - Contact dermatitis
  - Eye swelling
  - Eyelid pruritis
  - Oedema
• Systemic allergic reactions
  - Facial swelling/oedema (may be associated with contact dermatitis)
  - Exacerbation of pre-existing allergic conditions such as asthma and eczema

Sensory Disorders

• Eye irritation
• Eye pain
• Punctate keratitis
• Punctate corneal epithelial erosion
• Blurred vision (during instillation)
• Dry eye
• Eyelid disorder
• Conjunctivitis
• Photophobia
• Conjunctival haemorrhage

• Central nervous system depressants
• Other antihistamine agents
• Alcohol

None routine 

Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilization and inhibition of infiltration, activation and degranulation of eosinophils.

Eye drops (per ml) 0.25mg

• Zaditen (Adcock) originator