Drug Topics - January 2009 - (Page 30) that the incidence of nasal mucosal ulceration in each treatment group was approximately 1.5% at baseline and approximately 4% throughout the 6 month treatment period. In each treatment group, 3% - 5% of patients had mild epistaxis. No patients had reports of nasal septal perforation or severe epistaxis. Postmarketing Experience: The following adverse reactions have been identified during the post approval use of Astelin Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include the following: anaphylactoid reaction, application site irritation, atrial fibrillation, blurred vision, chest pain, confusion, dizziness, dyspnea, facial edema, hypertension, involuntary muscle contractions, nervousness, palpitations, paresthesia, parosmia, paroxysmal sneezing, pruritus, rash, disturbance or loss of sense of smell and/or taste, tachycardia, tolerance, urinary retention, and xerophthalmia. 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]. 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; however, no effects on QTc were observed. Cimetidine: Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65%. USE IN SPECIFIC POPULATION: Pregnancy: Pregnancy Category C: There are no adequate and well-controlled clinical studies in pregnant women. ASTEPRO Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Teratogenic Effects: Azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. In mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at an oral dose approximately 280 times the maximum recommended daily intranasal dose (MRDID) in adults on a mg/m2 basis. This dose also caused maternal toxicity as evidenced by decreased body weight. Neither fetal nor maternal effects occurred at a dose that was approximately 10 times the MRDID. In rats, azelastine hydrochloride caused malformations (oligo- and brachydactylia), delayed ossification and skeletal variations, in the absence of maternal toxicity, at an oral dose approximately 240 times the MRDID in adults on a mg/m2 basis. At a dose approximately 560 times the MRDID, azelastine hydrochloride also caused embryo-fetal death and decreased fetal weight; however, this dose caused severe maternal toxicity. Neither fetal nor maternal effects occurred at a dose approximately 25 times the MRDID. In rabbits, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight at oral doses approximately 500 times or greater the MRDID in adults on a mg/m2 basis; however, these doses also resulted in severe maternal toxicity. Neither fetal nor maternal effects occurred at a dose approximately 5 times the MRDID. Nursing Mothers: It is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ASTEPRO Nasal Spray is administered to a nursing woman. Pediatric Use: Safety and effectiveness of ASTEPRO Nasal Spray in pediatric patients below the age of 12 years have not been established. Geriatric Use: Clinical studies of ASTEPRO Nasal Spray did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Asthmatic Patients: Oral azelastine has been safely administered to over 1400 asthmatic subjects, supporting the safety of administering azelastine hydrochloride nasal spray to allergic rhinitis patients with asthma. Astelin, ASTEPRO and MEDA Pharmaceuticals are trademarks or registered trademarks of MEDA Pharmaceuticals Inc. Brief Summary of Prescribing Information (for complete prescribing information please see package insert) INDICATIONS AND USAGE: ASTEPRO Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. DOSAGE AND ADMINISTRATION: Administer ASTEPRO Nasal Spray by the intranasal route only. The recommended dose of ASTEPRO Nasal Spray is 1 or 2 sprays per nostril twice daily. Priming: Prime ASTEPRO Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When ASTEPRO Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying ASTEPRO Nasal Spray into the eyes. WARNINGS AND PRECAUTIONS Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking ASTEPRO Nasal Spray [see Adverse Reactions]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of ASTEPRO Nasal Spray. Concurrent use of ASTEPRO Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur. ADVERSE REACTIONS Use of ASTEPRO Nasal Spray has been associated with somnolence [see Warnings and Precautions]. Clinical Studies Experience: The safety data described below reflect exposure to ASTEPRO Nasal Spray in 564 patients 12 years of age and older from 2 clinical trials of 2 weeks to 6 months duration. In a 2 week, double-blind, placebo-controlled, and active controlled (Astelin® Nasal Spray) clinical trial, 285 patients 12 years of age and older with seasonal allergic rhinitis were treated with ASTEPRO Nasal Spray one or two sprays per nostril daily. In the 6 month open-label, active controlled (Astelin Nasal Spray) clinical trial, 279 patients 12 years of age and older with perennial allergic rhinitis and/or nonallergic rhinitis were treated with ASTEPRO Nasal Spray two sprays per nostril twice daily. Of the 564 patients, 256 were male and 308 were female. The racial and ethnic distribution of the 564 patients was 86% white, 11% black, 6% Hispanic, 2% Patients in a 2 Week Controlled Trial in Adult and Adolescent Patients with SAR 1 spray twice daily 2 sprays twice daily ASTEPRO Astelin Vehicle ASTEPRO Astelin Vehicle Nasal Nasal Placebo Nasal Nasal Placebo Spray Spray (N=137) Spray Spray (N=138) (N=139) (N=137) (N=146) (N=137) Bitter Taste 8 (6%) 13 (10%) 2 (2%) 10 (7%) 11 (8%) 3 (2%) Epistaxis 3 (2%) 8 (6%) 3 (2%) 4 (3%) 3 (2%) 0 (0%) Headache 2 (1%) 5 (4%) 1 (<1%) 4 (3%) 3 (2%) 1 (<1%) Nasal Discomfort 0 (0%) 3 (2%) 1 (<1%) 2 (1%) 6 (4%) 0 (0%) Fatigue 0 (0%) 1 (<1%) 1 (<1%) 3 (2%) 3 (2%) 1 (<1%) Somnolence 2 (1%) 2 (2%) 0 (0%) 3 (2%) 2 (1%) 0 (0%) Long-Term (6 Month) Safety Trial: In the 6 month, open-label, active-controlled, long-term safety trial, 555 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with ASTEPRO Nasal Spray two sprays per nostril twice daily or Astelin Nasal Spray two sprays per nostril twice daily. The most frequently reported adverse reactions were headache, bitter taste, epistaxis, and nasopharyngitis and were generally similar between treatment groups. Focused nasal examinations were performed and showed Rev: 12/08 SP8049
Table of Contents Feed for the Digital Edition of Drug Topics - January 2009 Drug Topics - January 2009 Contents Letters Up Front Up Front in Depth Community Practice Drug Pipeline: What to Watch in 2009 OTC Community-Aquired MRSA Infections New Products Viewpoint Drug Topics - January 2009 Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 3) Drug Topics - January 2009 - Contents (Page 4) Drug Topics - January 2009 - Contents (Page 5) Drug Topics - January 2009 - Contents (Page 6) Drug Topics - January 2009 - Contents (Page 7) Drug Topics - January 2009 - Contents (Page 8) Drug Topics - January 2009 - Contents (Page 9) Drug Topics - January 2009 - Contents (Page 10) Drug Topics - January 2009 - Contents (Page H1) Drug Topics - January 2009 - Contents (Page H2) Drug Topics - January 2009 - Contents (Page H1) Drug Topics - January 2009 - Contents (Page H2) Drug Topics - January 2009 - Contents (Page H3) Drug Topics - January 2009 - Contents (Page H4) Drug Topics - January 2009 - Contents (Page H5) Drug Topics - January 2009 - Contents (Page H6) Drug Topics - January 2009 - Contents (Page H7) Drug Topics - January 2009 - Contents (Page H8) Drug Topics - January 2009 - Contents (Page 13) Drug Topics - January 2009 - Up Front (Page 14) Drug Topics - January 2009 - Up Front (Page 15) Drug Topics - January 2009 - Up Front (Page 16) Drug Topics - January 2009 - Up Front (Page 17) Drug Topics - January 2009 - Up Front in Depth (Page 18) Drug Topics - January 2009 - Up Front in Depth (Page 19) Drug Topics - January 2009 - Community Practice (Page 20) Drug Topics - January 2009 - Community Practice (Page 20a) Drug Topics - January 2009 - Community Practice (Page 20b) Drug Topics - January 2009 - Community Practice (Page 21) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 22) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 23) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 24) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 25) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 26) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 27) Drug Topics - January 2009 - OTC (Page 28) Drug Topics - January 2009 - OTC (Page 29) Drug Topics - January 2009 - OTC (Page 30) Drug Topics - January 2009 - OTC (Page 31) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 32) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 33) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 34) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 35) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 36) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 37) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 38) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 39) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 40) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 41) Drug Topics - January 2009 - New Products (Page 42) Drug Topics - January 2009 - New Products (Page 43) Drug Topics - January 2009 - New Products (Page 44) Drug Topics - January 2009 - New Products (Page 45) Drug Topics - January 2009 - New Products (Page 46) Drug Topics - January 2009 - New Products (Page 47) Drug Topics - January 2009 - Viewpoint (Page 48) Drug Topics - January 2009 - Viewpoint (Page Cover3) Drug Topics - January 2009 - Viewpoint (Page Cover4)
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