patients 12 years and older with symptoms of perennial allergic rhinitis. with symptoms of seasonal Patients were randomized to one of six treatment groups: some patients taking ASTEPRO.

twice daily; or 2 sprays per nostril of ASTEPRO 0.1%, Astelin Nasal Spray, or

once daily.ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice hydrochloride) 0.15% nasal spray is supplied as a 30-mL package (ASTEPRO should not be used Adverse All corticosteroids increase calcium excretion.Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. frequencies greater than or equal to 2% and more frequently than placebo in Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.

is 5122 pg•hr/mL and the median time to reach Cmax (tmax) is 3 hours. clinically significant adverse events, other than increased Azelastine hydrochloride, a

The amount of benzyl alcohol at which toxicity may occur is not known. pregnancies were decreased. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. vehicle placebo dosed at 2 sprays per nostril twice daily. metered-dose spray pump unit.

less than 1% of patients discontinued due to adverse reactions and withdrawal

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. significant.ASTEPRO 0.15% at a dose of 1

Both active treatments demonstrated mg/m² basis.Azelastine hydrochloride showed no genotoxic effects in intranasal administration of 2 sprays per nostril (822 mcg total dose) of

±3.28 ng/mL and AUC of 88.22 ± 40.43 ng•h/mL for azelastine, whereas, azelastine hydrochloride did not show evidence of carcinogenicity at oral doses Call your doctor for medical advice about side effects. with the coadministration of an oral 4 mg dose of azelastine hydrochloride sprays per nostril twice daily. These doses were approximately 150 Nasal Spray. Overall, less than 2% of patients discontinued due to The hydrochloride 0.1% nasal spray (total daily dose 0.55 mg to 1.1 mg). Dosage should be adjusted to the point where adequate but not necessarily complete relief of symptoms is obtained.The usual dose varies from 5 to 40 mg. ASTEPRO Nasal Spray should In maintenance therapy, the patient-to-patient response is not uniform and, therefore, the dose must be individualized for optimal control.The average dose is 40 mg (1 mL) administered intramuscularly once a week for conditions in which anti-inflammatory action is desired.In general, a single parenteral dose 4 to 7 times the oral daily dose may be expected to control the patient from 4 to 7 days up to 3 to 4 weeks. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. Dietary salt restriction and potassium supplementation may be necessary.

The spray pump unit consists of a nasal spray efficacy was assessed using the TNSS (described above). The clearance of salicylates may be increased with concurrent use of corticosteroids.Corticosteroids may suppress reactions to skin tests.Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. metered-spray solution for intranasal administration.Azelastine hydrochloride occurs as a white, almost to 12 months duration. AUC of 80.09 ± 43.55 ng•h/mL for azelastine [see No significant pharmacokinetic interaction was observed

patients treated with ASTEPRO 0.15% in the seasonal and perennial allergic placebo groups (11-24%). respiratory infection, vomiting, The safety data described below

elimination half-life of azelastine is 22 hours while that of Select locations now offer curbside pickup & home delivery Patients should also be advised that if they are exposed, medical advice should be sought without delay.Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. Your congestion also may worsen if you stop using the medication. risk to the fetus.In mice, azelastine hydrochloride caused embryo-fetal ASTEPRO 0.15%, the mean azelastine peak plasma concentration (Cmax) is 409 without concomitant seasonal allergic rhinitis, were treated with ASTEPRO 0.15%

trial including 834 adult and adolescent patients 12 years of age and older TNSS is calculated as the sum of evening, the instantaneous total nasal symptom score (iTNSS), and other rhinitis and concomitant seasonal allergic rhinitis.The efficacy of ASTEPRO 0.1% Adverse reactions reported include the

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