Astepro (Azelastine Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Central Nervous System Depressants

Concurrent use of ASTEPRO Nasal Spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [see Warnings and Precautions (5.1)].

Erythromycin and Ketoconazole

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 (500 mg three times daily for 7 days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms. Ketoconazole (200 mg twice daily for 7 days) interfered with the measurement of azelastine plasma concentrations on the analytic HPLC; however, no effects on QTc were observed [see Clinical Pharmacology (12.2) and (12.3)].

Cimetidine

Cimetidine (400 mg twice daily) increased the mean C_max and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65% [see Clinical Pharmacology (12.3)].

OVERDOSAGE

There have been no reported overdosages with ASTEPRO Nasal Spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence, since one 30-mL bottle of ASTEPRO Nasal Spray 0.1% contains up to 30 mg of azelastine hydrochloride and one 30-mL bottle of ASTEPRO Nasal Spray 0.15% contains up to 45 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events. General supportive measures should be employed if overdosage occurs. There is no known antidote to ASTEPRO Nasal Spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, ASTEPRO Nasal Spray should be kept out of the reach of children.

CONTRAINDICATIONS

None.