Azelastine

Registered South African indications:

• Allergic rhinitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding

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

Seasonal and perennial allergic rhinitis

• Nasal (nas): 0.14mg (1 actuation) per nostril, 12hrly

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

Seasonal and perennial allergic rhinitis

Younger than 6 years

• Not established for use

Older than 6 years

• See adult dosage

Pregnancy

• Caution
• At high oral doses in animals, 500 times the proposed oral human daily dose, foetal death, growth retardation and an increased incidence of skeletal abnormalities occurred during reproduction toxicity testing. Due to the nasal route of administration and the low dose administered, minimal systemic exposure can be expected. However as with all medicines caution should be exercised with use during pregnancy

Breastfeeding

• Caution 
• Due to the nasal route of administration and the low dose administered, minimal systemic exposure can be expected. However as with all medicines caution should be exercised with use 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

• Caution; no information available

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warning

Respiratory Disorders

• Irritation of nasal mucousa
• Stinging
• Itching
• Sneezing
• Epistaxis

Gastrointestinal Disorders

• Bitter taste in mouth
• Nausea

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritis
• Urticaria

No information available

None routine

Azelastine is a selective H1-receptor antagonist that inhibits release of histamine and other inflammatory mediators. It also increases motility of bronchial epithelial cilia, thus improving mucous clearance.

Nasal spray (per ml) 0.14mg

• Rhinolast (Mylan) originator

Also available in the following form: Eye drop