Azelastine hydrochloride

SCOPE: the intranasal (allergic rhinitis) regimen is published because that is this page's primary route — the ENT specialty file, the page's own 'Nasal: ... ; Eye: ...' ordering and its allergic-rhinitis clinical pearls. The ophthalmic regimen is a different product and is quoted in full below but not published in the dose field. VERBATIM (US label §2.1): 'The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of azelastine hydrochloride nasal spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.' §2.2: 'The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.' STRENGTH PINNED (§3 DOSAGE FORMS AND STRENGTHS, verbatim): 'Each spray of azelastine hydrochloride nasal spray delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.' The spray count is therefore quantified. PRIMING (§2.3, verbatim): 'Prime azelastine hydrochloride nasal spray before initial use by releasing 4 sprays or until a fine mist appears. When azelastine hydrochloride nasal spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying azelastine hydrochloride nasal spray into the eyes.' MAXDOSE LEFT EMPTY: no figure in the fetched nasal label is labelled a maximum; the highest stated regimen is 2 sprays per nostril twice daily. The only 'maximum' anywhere in the bundle is a duration limit for the eye drops (a maximum 6-week course), which is a different route and not a dose ceiling. OPHTHALMIC ROUTE, NOT PUBLISHED ABOVE (UK SPC §4.2 for Azelastine hydrochloride 0.5 mg/ml Eye drops solution, verbatim): 'Seasonal allergic conjunctivitis The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Azelastine hydrochloride Eye drops, solution should be administered prophylactically, prior to the exposure. Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks. Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.' The eye-drop strength is pinned by the product name (0.5 mg/ml solution). EYE DROP PRECAUTIONS (UK SPC §4.4): not intended for treatment of eye infections; contains benzalkonium chloride, which may cause eye irritation especially with dry eyes or corneal disorders, is known to discolour soft contact lenses, and contact with soft lenses should be avoided — remove lenses before application and wait at least 15 minutes before reinsertion. SOMNOLENCE (US §5.1): 'Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration'; concurrent use with alcohol or other CNS depressants should be avoided.

Age-banded spray count, not weight-based, so dosePerKg is null; concentration is null because the product is a metered nasal spray and a millilitre volume calculation would be meaningless (the metered strength is 137 micrograms of azelastine hydrochloride in 0.137 mL per spray). VERBATIM (US label §2.1): 'The recommended dosage of azelastine hydrochloride nasal spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.' Adolescents 12 years and older take the adult regimen (1 or 2 sprays per nostril twice daily for seasonal allergic rhinitis; 2 sprays per nostril twice daily for vasomotor rhinitis). No dosage below 5 years appears in any fetched section of the nasal label. Ophthalmic route (UK SPC §4.2): seasonal allergic conjunctivitis 'in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily'; perennial allergic conjunctivitis is limited to 'adults and children 12 years and older'. These are US nasal figures and a UK ophthalmic SPC — verify any under-18 use against a children's formulary and the UK SPC of the actual product being prescribed.