Presentation and Status in Health Basket
| Presentation | Basket | Yarpa | Pharmasoft |
|---|---|---|---|
|
Nasal Spray 10 ml X 0.1% |
|
51962 | 18311 |
Dosage
Route of application is topical – nasal mucosa.
Adults: One application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride).
Elderly: There have been no specific studies in the elderly.
Children: For children aged 6 years and older, one application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride).
Indications
Treatment of seasonal allergic rhinitis and perennial allergic rhinitis for adults
and children 6 years and older.
Contra-Indications
Proven allergy against azelastine hydrochloride.
Special Precautions
None.
Side Effects
Common (1 – 10 %): a substance-specific bitter taste may be experienced after administration (often due to incorrect method of application, namely tilting the head too far backwards during administration) which, in rare cases, may lead to nausea.
See prescribing information for full details.
Drug interactions
No specific interactions have been studied.
Pregnancy and Lactation
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 and lactation.
Overdose
The results of animal studies show that toxic doses can produce CNS symptoms, e.g. excitation, tremor, convulsions. Should these occur in humans, symptomatic and supportive treatment should be instigated as there is no specific antidote. Gastric lavage is recommended if the overdose is recent.
With the nasal route of administration overdosage reactions are not anticipated.
