Based on intravenous and oral administration, the elimination half-life, steady-state volume of distribution, and plasma clearance are 22 hours, 14.5 L/kg, and 0.5 L/h/kg, respectively. The following information includes only the average doses of this medicine.

In a placebo-controlled study (95 subjects with allergic rhinitis), there was no evidence of an effect of Astelin® Nasal Spray (2 sprays per nostril twice daily for 56 days) on cardiac repolarization as represented by the corrected QT interval (QTc) of the electrocardiogram. The recommended dose of Astelin® Nasal Spray in adults and children 12 years and older with seasonal allergic rhinitis is two sprays per nostril twice daily. The following adverse events were reported with frequencies >/=2% in the Astelin® Nasal Spray treatment group and more frequently than placebo.

Oral doses of 120 mg/kg and greater (approximately 460 times the maximum recommended daily intranasal dose in adults and children on a mg/m The recommended dosage of Astelin Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.

Side Effects; During Pregnancy or Breastfeeding; Drug Interactions; Pricing & Coupons; En Español; 115 Reviews; Drug class: nasal antihistamines and decongestants; Consumer resources. Serious Interactions. The recommended dosage of Astelin Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. The incidence of discontinuation due to adverse reactions in patients receiving Astelin® Nasal Spray was not different from vehicle placebo (2.8% vs 2.9%, respectively).

1 spray (137 mcg/spray using 0.1% spray) per nostril twice daily. 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.

Professional resources Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine.

Each spray delivers a mean of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. BRAND NAME(S): Astelin. The bottle can deliver 200 metered sprays. Follow your doctor's orders or the directions on the label. The Astelin® (azelastine hydrochloride) Nasal Spray, 137 mcg, bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride.

Two hundred sixteen patients with vasomotor rhinitis received Astelin® Nasal Spray two sprays per nostril twice a day in two U.S. placebo controlled trials.

When 3 or more days have elapsed since the last use, the pump should be reprimed with 2 sprays or until a fine mist appears.

Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses up to 30 mg/kg (approximately 240 times the maximum recommended daily intranasal dose in adults on a mg/m Ketoconazole interfered with the measurement of azelastine plasma levels; however, no effects on QTc were observed (see PRECAUTIONS , Drug Interactions ).
Astelin.

At higher oral exposures (>/=4 mg twice daily), a nonclinically significant mean change on the QTc (3-7 millisecond increase) was observed. Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65%.

Directions for Use: Illustrated patient instructions for proper use accompany each package of Astelin® Nasal Spray. Studies show that azelastine nasal spray is more effective than oral antihistamines like Benadryl and some corticosteroid nasal sprays. Do not spray in eyes.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or

The recommended dose of Astelin® Nasal Spray in adults and children 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. Oral erythromycin (500 mg three times daily for seven days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms.