Azelastine

Registered South African indications:

• Allergic conjunctivitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Children younger than 4 years

Cautions

• Pregnancy
• Breastfeeding
• Concomitant use with soft contact lenses
• Eye infections

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

Seasonal and perennial allergic conjunctivitis

• Ophthalmic (opd): 1 drop into affected eye(s), 12hrly; Max duration: 6 weeks

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

Seasonal allergic conjunctivitis

Younger than 4 years

• Not established for use

Older than 4 years

• See adult dosage

Seasonal and perennial allergic conjunctivitis

Younger than 12 years

• Not established for use

Older than 12 years

• See adult dosage

Pregnancy

• Caution
• There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using azelastine during pregnancy

Breastfeeding

• Caution; not recommended
• Azelastine is excreted into the milk in low quantities. For that reason azelastine is not recommended during breastfeeding

Fertility

• There is only limited data with regard to fertility

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

• Bitter taste in mouth

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritis

Sensory Disorders

• Mild, transient irritation in the eye

No information available

None routine

Azelastine is a selective H1-receptor antagonist that inhibits release of antihistamine and other inflammatory mediators.

Eye drops (per ml) 0.5mg

• Optilast (Mylan) originator

Also available in the following form: Nasal spray.