Moderate-to-severe: 800 mg/day PO divided BID.
Please confirm that you would like to log out of Medscape. For the treatment of endometriosis.
DOSAGE & INDICATIONS. 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.
Keep bottle tightly closed and away from children.Trials Supporting Two Sprays Per Nostril Twice DailyTable 1: Summary of Primary Efficacy* Analyses for Pivotal Studies Supporting Two Sprays Per Nostril Twice Daily.Trials Supporting One Spray Per Nostril Twice DailyTable 2: Summary of Primary Efficacy* Analyses for Pivotal Studies Supporting One Spray Per Nostril Twice Daily.Carcinogenesis, Mutagenesis, Impairment of Fertility:To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or IMPORTANT: FOLLOW INSTRUCTIONS CAREFULLY TO ENSURE PROPER DOSING.and repeat until a fine mist appears (4 sprays or less).CAUTION: In case of accidental ingestion by a young child, seek professional assistance or contact a poison control center immediately. Diseases & Conditions
Therapy typically continued for 6 months; may continue up to 9 months. Adult females. Oral erythromycin (500 mg three times daily for seven days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms.
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What happens if I overdose (Danocrine)?
Continue uninterrupted therapy for 3 to 6 months; … 1 spray (137 mcg/spray using 0.1% spray) per nostril twice daily. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Titrate downward to dose sufficient to maintain amenorrheaTherapy typically continued for 6 months; may continue up to 9 monthsDecrease dose by 50% at intervals of at least 1-3 monthsIf attack occurs, increase dose by increments up to 200 mg/dayThromboembolism, thrombophlebitic, and thrombotic events, including life-threatening or fatal strokes, have been reportedPeliosis hepatitis and benign hepatic adenoma have been observed with long-term useBenign intracranial hypertension (pseudotumor cerebri) has been reportedPreliminary epidemiological evidence suggests that the use of danazol might increase the baseline risk of ovarian cancer in patients being treated for endometriosisA: Generally acceptable. The clinical relevance of these reports has not been established.In addition, the following spontaneous adverse events have been reported during the marketing of AstelinThere have been no reported overdosages with AstelinBefore initial use, the delivery system should be primed with 4 sprays or until a fine mist appears. Ketoconazole (200 mg twice daily for seven days) interfered with the measurement of azelastine plasma concentrations; however, no effects on QTc were observed.No significant pharmacokinetic interaction was observed with the coadministration of an oral 4 mg dose of azelastine hydrochloride twice daily and theophylline 300 mg or 400 mg twice daily.Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.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/mIn rats, an oral dose of 30 mg/kg (approximately 240 times the maximum recommended daily intranasal dose in adults on a mg/mIn rabbits, oral doses of 30 mg/kg and greater (approximately 500 times the maximum recommended daily intranasal dose in adults on a mg/mThere are no adequate and well-controlled clinical studies in pregnant women.