Drug: Astepro

ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is an antihistamine (H1 receptor antagonist) formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is an antihistamine (H1 receptor antagonist) formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O•HCl with the following chemical structure: ASTEPRO 0.1% contains 0.1% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4). After priming [see DOSAGE AND ADMINISTRATION], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays. ASTEPRO 0.15% contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4). After priming [see DOSAGE AND ADMINISTRATION], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.

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Use of ASTEPRO has been associated with somnolence [see WARNINGS AND PRECAUTIONS]. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. ASTEPRO 0.1% The safety data described below reflect exposure to ASTEPRO 0.1% in 975 patients 6 months of age and older from 4 clinical trials of 2 weeks to 12 months duration. In a 2-week, double-blind, placebo-controlled, and active-controlled (Astelin® Nasal Spray; azelastine hydrochloride) clinical trial, 285 patients (115 males and 170 females) 12 years of age and older with seasonal allergic rhinitis were treated with ASTEPRO 0.1% one or two sprays per nostril daily. In the 12 month open-label, active-controlled (Astelin Nasal Spray) clinical trial, 428 patients (207 males and 221 females) 12 years of age and older with perennial allergic rhinitis and/or nonallergic rhinitis were treated with ASTEPRO 0.1% two sprays per nostril twice daily. In a 4-week, double-blind, placebo-controlled clinical trial, 166 patients (101 males and 65 females) ages 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with ASTEPRO 0.1% one spray per nostril twice daily. In a 4-week clinical trial, 96 patients (51 males and 45 females) ages 6 months to 5 years of age with seasonal and/or perennial allergic rhinitis were treated with ASTEPRO 0.1% one spray per nostril twice daily. The racial and ethnic distribution for the 4 clinical trials was 80% white, 11% black, 8% Hispanic, 3% Asian, and 2% other. Adults and Adolescents 12 Years of Age and Older In the two week clinical trial, 835 patients 12 years of age and older with seasonal allergic rhinitis were treated with one of six treatments: one spray per nostril of either ASTEPRO 0.1%, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of ASTEPRO 0.1%, Astelin Nasal Spray, or placebo twice daily. Overall, adverse reactions were more common in the ASTEPRO 0.1% treatment groups (21-28%) than in the placebo groups (16-20%). Overall, less than 1% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups. Table 1 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with ASTEPRO 0.1% in the controlled clinical trial described above. Table 1: Adverse Reactions Reported in ≥ 2% Incidence in a Placebo-Controlled Trial of 2 Weeks’ Duration with ASTEPRO 0.1% in Adult and Adolescent Patients with Seasonal Allergic Rhinitis
  1 spray twice daily 2 sprays twice daily ASTEPRO 0.1%
(N=139) Astelin Nasal Spray
(N=137) Vehicle Placebo
(N=137) ASTEPRO 0.1%
(N=146) Astelin Nasal Spray
(N=137) Vehicle Placebo
(N=138) 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 (12 Month) Safety Trial In the 12 month, open-label, active-controlled, long-term safety trial, 862 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with ASTEPRO 0.1% 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 that the incidence of nasal mucosal ulceration in each treatment group was approximately 1% at baseline and approximately 1.5% throughout the 12 month treatment period. In each treatment group, 5-7% of patients had mild epistaxis. No patients had reports of nasal septal perforation or severe epistaxis. Twenty-two patients (5%) treated with ASTEPRO 0.1% and 17 patients (4%) treated with Astelin Nasal Spray discontinued from the trial due to adverse events. Children 6 to 11 Years of Age In a 4 week clinical trial, 489 patients ages 6 to 11 years with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with either ASTEPRO 0.1%, ASTEPRO 0.15% or placebo, one spray per nostril twice daily. Overall, adverse events were similar in the ASTEPRO 0.15% group (24%), ASTEPRO 0.1% group (26%) and the placebo group (24%). Overall, less than 1% of the combined ASTEPRO groups discontinued due to adverse events. Table 2 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in children 6 to 11 years of age treated with ASTEPRO 0.1% or ASTEPRO 0.15% in the controlled trial described above. Table 2: Adverse Reactions Reported in ≥ 2% Incidence in a Placebo-Controlled Trial of 4 Weeks’ Duration with ASTEPRO 0.1% or ASTEPRO 0.15% in Children 6 to 11 Years of Age with Perennial Allergic Rhinitis
  1 spray twice daily ASTEPRO 0.1%
(N=166) ASTEPRO 0.15%
(N=161) Vehicle Placebo
(N=162) Epistaxis 8 (5%) 7 (4%) 5 (3%) Nasal Discomfort 1 ( < 1%) 7 (4%) 0 (0%) Dysgeusia 4 (2%) 6 (4%) 1 ( < 1%) Upper respiratory infection 4 (2%) 4 (3%) 3 (2%) Sneezing 3 (2%) 4 (3%) 2 (1%) Children 6 Months to 5 Years In a 4 week clinical trial, 191 patients ages 6 months to 5 years with either seasonal and/or perennial allergic rhinitis were treated with either ASTEPRO 0.1% or ASTEPRO 0.15% one spray per nostril twice daily. The most frequently ( ≥ 2%) reported adverse reactions were pyrexia, cough, epistaxis, sneezing, dysgeusia, rhinalgia, upper respiratory infection, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. Overall, adverse events were slightly higher in the ASTEPRO 0.15% group (28%) compared to ASTEPRO 0.1% group (21%). Focused nasal examinations were performed and showed no incidence of nasal mucosal ulceration at any time point during the study. No patients had reports of nasal septal perforation. Overall, less than 3% of the combined ASTEPRO groups discontinued due to adverse events. ASTEPRO 0.15% The safety data described below reflect exposure to ASTEPRO 0.15% in 2114 patients (6 months of age and older) with seasonal or perennial allergic rhinitis from 10 clinical trials of 2 weeks to 12 months duration. In 8 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1703 patients (646 males and 1059 females) with seasonal or perennial allergic rhinitis were treated with ASTEPRO 0.15% one or two sprays per nostril once or twice daily. In the 12 month open-label, active-controlled clinical trial, 466 patients (156 males and 310 females) with perennial allergic rhinitis were treated with ASTEPRO 0.15% two sprays per nostril twice daily. Of these 466 patients, 152 had participated in the 4-week placebo-controlled perennial allergic rhinitis clinical trials. In a 4-week, double-blind, placebo-controlled clinical trial, 161 patients (87 males and 74 females) ages 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with ASTEPRO 0.15% one spray per nostril twice daily. In a 4-week clinical trial, 95 patients (59 males and 36 females) ages 6 months to 5 years of age with seasonal and/or perennial allergic rhinitis were treated with ASTEPRO 0.15% one spray per nostril twice daily. The racial distribution for the 10 clinical trials was 79% white, 14% black, 2% Asian, and 5% other. Adults and Adolescents 12 Years of Age and Older In the 7 placebo controlled clinical trials of 2 to 4 week duration, 2343 patients with seasonal allergic rhinitis and 540 patients with perennial allergic rhinitis were treated with two sprays per nostril of either ASTEPRO 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the ASTEPRO 0.15% treatment groups (16-31%) than in the placebo groups (11-24%). Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups. Table 3 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with ASTEPRO 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials. Table 3: Adverse Reactions with ≥ 2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks’ Duration with ASTEPRO 0.15% in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis
  2 sprays twice daily 2 sprays once daily ASTEPRO 0.15%
(N=523) Vehicle Placebo
(N=523) ASTEPRO 0.15%
(N=1021) Vehicle Placebo
(N=816) Bitter Taste 31 (6%) 5 (1%) 38 (4%) 2 ( < 1%) Nasal Discomfort 18 (3%) 12 (2%) 37 (4%) 7 (1%) Epistaxis 5 (1%) 7 (1%) 21 (2%) 14 (2%) Sneezing 9 (2%) 1 ( < 1%) 14 (1%) 0 (0%) In the above trials, somnolence was reported in < 1% of patients treated with ASTEPRO 0.15% (11 of 1544) or vehicle placebo (1 of 1339). Long-Term (12 Month) Safety Trial In the 12 month, open-label, active-controlled, long-term safety trial, 466 patients (12 years of age and older) with perennial allergic rhinitis were treated with ASTEPRO 0.15% two sprays per nostril twice daily and 237 patients were treated with mometasone nasal spray two sprays per nostril once daily. The most frequently reported adverse reactions ( > 5%) with ASTEPRO 0.15% were bitter taste, headache, sinusitis, and epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. In each treatment group, approximately 3% of patients had mild epistaxis. No patients had reports of severe epistaxis. Fifty-four patients (12%) treated with ASTEPRO 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events. Children 6 months to 11 Years Of Age See summary under ASTEPRO 0.1% Postmarketing Experience During the post approval use of ASTEPRO 0.1% and ASTEPRO 0.15%, the following adverse reactions have been identified. 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: abdominal pain, atrial fibrillation, blurred vision, chest pain, confusion, disturbance or loss of sense of smell and/or taste, dizziness, dyspnea, facial swelling, hypertension, involuntary muscle contractions, nasal burning, nausea, nervousness, palpitations, paresthesia, parosmia, pruritus, rash, sneezing, insomnia, sweet taste, tachycardia, and throat irritation. Additionally, the following adverse reactions have been identified during the post approval use of the Astelin brand of azelastine hydrochloride 0.1% nasal spray (total daily dose 0.55 mg to 1.1 mg). 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, facial edema, paroxysmal sneezing, tolerance, urinary retention, and xerophthalmia. Read the Astepro (azelastine hydrochloride nasal spray) Side Effects Center for a complete guide to possible side effectsLearn More »

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Seasonal Allergic Rhinitis Children 2 to 5 Years Of Age ASTEPRO 0.1%, 1 spray per nostril twice daily. Children 6 to 11 Years Of Age ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice daily. Adults and Adolescents 12 Years Of Age and Older ASTEPRO 0.1% or ASTEPRO 0.15%, 1 or 2 sprays per nostril twice daily. ASTEPRO 0.15% may also be administered as 2 sprays per nostril once daily. Perennial Allergic Rhinitis Children 6 Months to 5 Years Of Age ASTEPRO 0.1%, 1 spray per nostril twice daily. Children 6 to 11 Years Of Age ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice daily. Adults and Adolescents 12 Years Of Age and Older ASTEPRO 0.15%, 2 sprays per nostril twice daily. Important Administration Instructions Administer ASTEPRO by the intranasal route only. Priming Prime ASTEPRO before initial use by releasing 6 sprays or until a fine mist appears. When ASTEPRO has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying ASTEPRO into the eyes.

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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 on the analytic HPLC; however, no effects on QTc were observed [see CLINICAL PHARMACOLOGY]. Cimetidine Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65% [see CLINICAL PHARMACOLOGY]. Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.

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Allergic Rhinitis ASTEPRO Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.

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None. Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.

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There have been no reported overdosages with ASTEPRO. 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 0.1% contains up to 30 mg of azelastine hydrochloride and one 30-mL bottle of ASTEPRO 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. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, ASTEPRO should be kept out of the reach of children.

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Dosage Forms And Strengths ASTEPRO is a nasal spray solution available in two dosage strengths:
  • Each spray of ASTEPRO 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.
  • Each spray of ASTEPRO 0.15% delivers a volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride.
Storage And Handling ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is supplied as a 30-mL package delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see DOSAGE AND ADMINISTRATION], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is supplied as a 30-mL package (NDC 0037-0243-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [see DOSAGE AND ADMINISTRATION], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. ASTEPRO should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage Store upright at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. Manufactured by: Meda Pharmaceuticals, Somerset, NJ 08873-4120. Revised: 2/2015 Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.

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Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking ASTEPRO [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. Concurrent use of ASTEPRO 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 [see DRUG INTERACTIONS]. Patient Counseling Information See FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use). Activities Requiring Mental Alertness Somnolence has been reported in some patients taking ASTEPRO. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of ASTEPRO [see WARNINGS AND PRECAUTIONS]. Concurrent Use of Alcohol and other Central Nervous System Depressants Avoid concurrent use of ASTEPRO with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur [see WARNINGS AND PRECAUTIONS]. Common Adverse Reactions Inform patients that the treatment with ASTEPRO may lead to adverse reactions, most common of which include pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. [see ADVERSE REACTIONS]. Priming Instruct patients to prime the pump before initial use and when ASTEPRO has not been used for 3 or more days [see DOSAGE AND ADMINISTRATION]. Keep Spray Out of Eyes Instruct patients to avoid spraying ASTEPRO into their eyes. Keep Out of Children’s Reach Instruct patients to keep ASTEPRO out of the reach of children. If a child accidentally ingests ASTEPRO, seek medical help or call a poison control center immediately. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility In 2-year carcinogenicity studies in rats and mice, azelastine hydrochloride did not show evidence of carcinogenicity at oral doses up to 30 mg/kg and 25 mg/kg, respectively. These doses were approximately 150 and 60 times the maximum recommended human daily intranasal dose [MRHDID] on a mg/m² basis. 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 150 times the MRHDID in adults on a mg/m² basis). At 68.6 mg/kg (approximately 340 times the MRHDID on a mg/m² basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, pre-implantation loss was not increased. Use In Specific Populations Pregnancy Pregnancy Category C There are no adequate and well-controlled clinical trials in pregnant women. Azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. ASTEPRO Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Teratogenic Effects 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 approximately 170 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m² basis at a maternal oral dose of 68.6 mg/kg/day which also caused maternal toxicity as evidenced by decreased body weight). Neither fetal nor maternal effects occurred in mice at approximately 7 times the MRHDID in adults (on a mg/m² basis at a maternal oral dose of 3 mg/kg/day). In rats, azelastine hydrochloride caused malformations (oligo-and brachydactylia), delayed ossification and skeletal variations, in the absence of maternal toxicity, at approximately 150 times the MRHDID in adults (on a mg/m² basis at a maternal oral dose of 30 mg/kg/day). Azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 340 times the MRHDID (on a mg/m² basis at a maternal oral dose of 68.6 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 15 times the MRHDID (on a mg/m² basis at a maternal oral dose of 2 mg/kg/day). In rabbits, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 300 times the MRHDID in adults (on a mg/m² basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 3 times the MRHDID (on a mg/m² basis at a maternal oral dose of 0.3 mg/kg/day). 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 is administered to a nursing woman. Pediatric Use The safety and effectiveness of ASTEPRO have been established for seasonal allergic rhinitis in pediatric patients 2 to 17 years of age and perennial allergic rhinitis in pediatric patients 6 months of age to 17 years of age [see Clinical Studies]. The safety and effectiveness of ASTEPRO in pediatric patients below 6 months of age have not been established. Geriatric Use Clinical trials of ASTEPRO 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. Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.

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