Before initial use, prime the pump until a fine mist appears, using up to 4 actuations of the pump.If inhaler has not been used for ≥3 days, reprime pump with 2 actuations or until a fine mist appears.To actuate the pump, hold the bottle in one hand, with 2 fingers on the shoulders of the pump unit and the thumb on the bottom of the bottle.Prior to administration, gently blow the nose to clear nasal passages.Use caution to avoid spraying nasal spray into the eyes.Remove soft contact lenses prior to administration of each dose (since benzalkonium chloride may be absorbed by the lenses); may reinsert lenses 10 minutes after administration if eyes are not red.Available as azelastine hydrochloride; dosage expressed in terms of the salt.When properly primed, the nasal spray pump delivers approximately 100 metered doses per bottle.Children ≥12 years of age: 2 sprays (274 mcg) in each nostril twice daily.Children 5–11 years of age: 1 spray (137 mcg) in each nostril twice daily.Children ≥12 years of age: 2 sprays (274 mcg) in each nostril twice daily.Children ≥3 years of age: 1 drop of a 0.05% solution in the affected eye(s) twice daily.1 drop of a 0.05% solution in the affected eye(s) twice daily.Known hypersensitivity to azelastine or any ingredient in the formulation.Somnolence reported in patients receiving azelastine nasal solution.Concurrent use of nasal solution with other CNS depressants may potentiate CNS depression.Not known whether azelastine is distributed into milk.Safety and efficacy of nasal solution for treatment of seasonal allergic rhinitis not established in children <5 years of age;Safety and efficacy of ophthalmic solution not established in children <3 years of age.Response to nasal solution does not appear to differ from that in younger adults.No substantial differences in safety and efficacy of ophthalmic solution relative to younger adults.Nasal solution: Transient nasal burning or stinging,Ophthalmic solution: Transient ocular burning/stinging, bitter taste, headache.Potential additive CNS depression with astelazine nasal solutionFollowing intranasal administration, systemic bioavailability is 40%.Absorption following ophthalmic administration is low.Following intranasal administration, symptomatic relief is evident within 1 hour; substantial relief usually is apparent within 3 hours; peak effect occurs between 4–6 hours.Following ophthalmic administration, onset of action is rapid (3 minutes).Following intranasal administration, effect persists throughout the 12-hour dosage interval.Approximately 75% of an oral dose is excreted in feces, with <10% as unchanged drug.Azelastine: 22 hours (following oral and IV administration).In patients with hepatic impairment, pharmacokinetics not altered.May inhibit the accumulation of eosinophils at the site of allergic inflammation and prevent eosinophil degranulation.Proper techniques for assembly and priming of nasal spray pump and for administration of the nasal solution.Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic solution container.Importance of removing soft contact lenses prior to administration of each ophthalmic dose.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.Potential for intranasal azelastine to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of informing patients of other important precautionary information.4. 1 11 16 Peak plasma concentrations occur 2–3 hours after intranasal administration. Pelucchi A, Chiapparino A, Mastropasqua B et al. The drug interactions of the combination are expected to reflect those of the individual components.Concurrent use of azelastine hydrochloride and fluticasone propionate nasal spray with alcohol or other central nervous system depressants should be avoided because somnolence and impairment of central nervous system performance may occur [Ritonavir (a strong CYP3A4 inhibitor) significantly increased plasma fluticasone propionate exposure following administration of fluticasone propionate aqueous nasal spray, resulting in significantly reduced serum cortisol concentrations [Ketoconazole (also a strong CYP3A4 inhibitor), administered in multiple 200 mg doses to steady-state, increased plasma exposure of fluticasone propionate, reduced plasma cortisol AUC, but had no effect on urinary excretion of cortisol, following administration of a single 1000 mcg dose of fluticasone propionate by oral inhalation route.Caution should be exercised when azelastine hydrochloride and fluticasone propionate nasal spray is coadministered with ketoconazole and other known strong CYP3A4 inhibitors.Limited data from postmarketing experience with azelastine hydrochloride and fluticasone propionate nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes.

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