In case of accidental ingestion by a young child, seek professional assistance or contact a poison control center immediately. Patients should be advised against the concurrent use of Azelastine Hydrochloride Nasal Spray with other antihistamines without consulting a physician. Patients who are, or may become, pregnant should be told that this product should be used in pregnancy or during lactation only if the potential benefit justifies the potential risks to the fetus or nursing infant.
Patients should be advised to assess their individual responses to Azelastine Hydrochloride Nasal Spray before engaging in any activity requiring mental alertness, such as driving a car or operating machinery.
Patients should be advised that the concurrent use of Azelastine Hydrochloride Nasal Spray with alcohol or other CNS depressants may lead to additional reductions in alertness and impairment of CNS performance and should be avoided see Drug Interactions.
Ranitidine hydrochloride mg twice daily had no effect on azelastine pharmacokinetics. Interaction studies investigating the cardiac effects, as measured by the corrected QT interval QTc , of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted.
Oral erythromycin mg three times daily for seven days had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms. If you miss a dose, take it at the earliest. If it is time for the next dose, skip the missed dose. The common side effect of overdose is extreme sleepiness. Get immediate medical attention in case of an overdose. You must not stop using Astelin without consulting your doctor. You must store Astelin at room temperature between 20 and 25 degrees Celsius.
Keep it away from heat and moisture. Patients were randomized to one of six treatment groups: Assessment of efficacy was based on the hour reflective total nasal symptom score rTNSS assessed daily in the morning and evening, in addition to the instantaneous total nasal symptom score iTNSS and other supportive secondary efficacy variables. The rTNSS required patients to record symptom severity over the previous 12 hours.
The iTNSS, recorded immediately prior to the next dose, were assessed as an indication of whether the effect was maintained over the dosing interval. The trial results are presented in Table 4 Trial 1. There were no findings on nasal examination in an 8-week study that suggested any adverse effect of azelastine on the nasal mucosa. Vasomotor Rhinitis Two hundred sixteen patients with vasomotor rhinitis received azelastine hydrochloride nasal solution two sprays per nostril twice a day in two U.
These patients had vasomotor rhinitis for at least one year, negative skin tests to indoor and outdoor aeroallergens, negative nasal smears for eosinophils, and negative sinus X-rays. Azelastine hydrochloride nasal solution significantly improved a symptom complex comprised of rhinorrhea, post nasal drip, nasal congestion, and sneezing.
Concurrent use of azelastine hydrochloride nasal solution with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur. Information for Patients Patients should be instructed to use azelastine hydrochloride nasal solution only as prescribed.
There were no findings on nasal examination in an 8-week study that suggested any adverse effect of azelastine on the nasal mucosa. For the proper use of the nasal spray and to attain maximum improvement, the patient should read and follow carefully the accompanying patient instructions. Patients should also be instructed to store the bottle upright at room temperature with the pump tightly closed and out of the reach of children.
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