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These highlights do not include all the information needed to use Azelastine Hydrochloride safely and effectively. See full prescribing information for Azelastine Hydrochloride. Azelastine Hydrochloride nasal spray Initial U.S. Approval: 1996 | AZELASTINE HYDROCHLORIDE [Wallace Pharmaceuticals Inc.] | BioPortfolio

13:39 EST 27th January 2019 | BioPortfolio

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     Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 6 years of age and older.

     In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily.

     In adults and adolescents 12 years of age and older, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily. Azelastine Hydrochloride Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily.

     In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily.

     In adults and adolescents 12 years of age and older, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.15% is 2 sprays per nostril twice daily.

     Administer Azelastine Hydrochloride Nasal Spray by the intranasal route only.

     Priming: Prime Azelastine Hydrochloride Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When Azelastine Hydrochloride Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Hydrochloride Nasal Spray and into the eyes.

     Azelastine Hydrochloride Nasal Spray is a nasal spray solution. Each spray of Azelastine Hydrochloride Nasal Spray 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. Each spray of Azelastine Hydrochloride Nasal Spray 0.15% delivers a volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride.

None.

     In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine Hydrochloride Nasal Spray [see Adverse Reactions (6.1) ]. 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 Azelastine Hydrochloride Nasal Spray. Concurrent use of Azelastine Hydrochloride 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 [see Drug Interactions (7.1) ].

     Use of Azelastine Hydrochloride Nasal Spray has been associated with somnolence [see Warnings and Precautions (5.1) ].

     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.

Azelastine Hydrochloride Nasal Spray 0.1%

     The safety data described below reflect exposure to Azelastine Hydrochloride Nasal Spray 0.1% in 879 patients 6 years of age and older from 3 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 Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray 0.1% one spray per nostril twice daily. The racial and ethnic distribution for the 3 clinical trials was 81% white, 9% black, 5% 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 Azelastine Hydrochloride Nasal Spray 0.1%, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of Azelastine Hydrochloride Nasal Spray 0.1%, Astelin Nasal Spray, or placebo twice daily. Overall, adverse reactions were more common in the Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray 0.1% in the controlled clinical trial described above.

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 Azelastine Hydrochloride Nasal Spray 0.1%, Azelastine Hydrochloride Nasal Spray 0.15% or placebo, one spray per nostril twice daily. Overall, adverse events were similar in the Azelastine Hydrochloride Nasal Spray 0.15% group (24%), Azelastine Hydrochloride Nasal Spray 0.1% group (26%) and the placebo group (24%). Overall, less than 1% of the combined Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray 0.1% or Azelastine Hydrochloride Nasal Spray 0.15% in the controlled trial described above.

Azelastine Hydrochloride Nasal Spray 0.15%

The safety data described below reflect exposure to Azelastine Hydrochloride Nasal Spray 0.15% in 2019 patients (6 years of age and older) with seasonal or perennial allergic rhinitis from 9 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 Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride 0.15% one spray per nostril twice daily.The racial distribution for the 9 clinical trials was 80% white, 13% black, 2% Asian, and 5% other.

 

     Table 3 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with Azelastine Hydrochloride Nasal Spray 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

In the above trials, somnolence was reported in <1% of patients treated with Azelastine Hydrochloride Nasal Spray 0.15% (11 of 1544) or vehicle placebo (1 of 1339).

Children 6 to 11 years of age

See summary under Azelastine Hydrochloride Nasal Spray 0.1%

Azelastine
Hydrochloride
Nasal Spray
0.1%
(N=139) Astelin
Nasal Spray
(N=137) Vehicle
Placebo
(N=137) Azelastine
Hydrochloride
Nasal Spray
0.1%
(N=146) Astelin
Nasal Spray
(N=137) Vehicle
Placebo
(N=138)
Table 1. Adverse Reactions Reported in ≥2% Incidence in a Placebo-Controlled Trial of 2 Weeks’
Duration with Azelastine Hydrochloride Nasal Spray 0.1% in Adult and Adolescent Patients with
Seasonal Allergic Rhinitis
1 spray twice daily 2 sprays twice daily
 
 
 
 
 
 
 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%)
Azelastine Hydrochloride
Nasal Spray 0.1%
(N=166) Astelin Hydrochloride
Nasal Spray 0.1%
(N=161)
Table 2. Adverse Reactions Reported in ≥2% Incidence in Placebo-Controlled Trial of 4 Weeks’ Duration with Azelastine Hydrochloride Nasal Spray 0.1% or Azelastine Hydrochloride Nasal Spray 0.15% in Children 6 to 11 Years of Age with Perennial Allergic Rhinitis
1 spray twice daily
 
 
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%)
Azelastine
Hydrochloride
Nasal Spray 0.15%
(N=523) Vehicle Placebo
 
(N=523) Azelastine
Hydrochloride
Nasal Spray 0.15%
(N=1021) Vehicle Placebo
 
(N=816)
Table 3. Adverse Reactions with ≥2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks’
Duration with Azelastine Hydrochloride Nasal Spray 0.15% in Adult and Adolescent Patients With
Seasonal or Perennial Allergic Rhinitis
2 sprays twice daily 2 sprays once daily
 
 
 
 
  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%)

     During the post approval use of Azelastine Hydrochloride Nasal Spray 0.1% and 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, nasal burning, nausea, sweet taste, 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, 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.

     Concurrent use of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% 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) ].

     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) ].

     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. Azelastine Hydrochloride 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 an oral dose approximately 170 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m 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/m 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 an oral dose approximately 150 times the MRHDID in adults (on a mg/m 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/m 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/m 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/m basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at a dose approximately 3 times the MRHDID (on a mg/m basis at a maternal oral dose of 0.3 mg/kg/day).

     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 Azelastine Hydrochloride Nasal Spray is administered to a nursing woman.

     The safety and effectiveness of Azelastine Hydrochloride Nasal Spray in pediatric patients 6 to 17 years of age have been established [see Clinical Studies (14)]. The safety and effectiveness of Azelastine Hydrochloride Nasal Spray in pediatric patients below 6 years of age have not been established.

     Clinical trials of Azelastine Hydrochloride 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.

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

     Azelastine Hydrochloride Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine Hydrochloride Nasal Spray 0.15%, 205.5 micrograms (mcg), is formulated as a metered-spray solution for intranasal administration.

     Azelastine Hydrochloride Nasal Spray 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 (2.3) ], 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.

     Azelastine Hydrochloride Nasal Spray 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 (2.3) ], 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.

     Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H -receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H -receptor antagonist activity.

     Cardiac Effects:

     In a placebo-controlled trial (95 patients with allergic rhinitis), there was no evidence of an effect of azelastine hydrochloride 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. Following multiple dose oral administration of azelastine 4 mg or 8 mg twice daily, the mean change in QTc was 7.2 msec and 3.6 msec, respectively.

     Interaction studies investigating the cardiac repolarization effects of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin had no effect on azelastine pharmacokinetics or QTc based on analysis of serial electrocardiograms. Ketoconazole interfered with the measurement of azelastine plasma levels; however, no effects on QTc were observed [see Drug Interactions (7.2) ].

     Absorption: After intranasal administration of 2 sprays per nostril (548 mcg total dose) of Azelastine Hydrochloride Nasal Spray 0.1%, the mean azelastine peak plasma concentration (C) is 200 pg/mL, the mean extent of systemic exposure (AUC) is 5122 pg•hr/mL and the median time to reach C (t) is 3 hours. After intranasal administration of 2 sprays per nostril (822 mcg total dose) of Azelastine Hydrochloride Nasal Spray 0.15%, the mean azelastine peak plasma concentration (C) is 409 pg/mL, the mean extent of systemic exposure (AUC) is 9312 pg•hr/mL and the median time to reach C (t) is 4 hours. The systemic bioavailability of azelastine hydrochloride is approximately 40% after intranasal administration.

     Distribution: Based on intravenous and oral administration, the steady-state volume of distribution of azelastine is 14.5 L/kg. In vitro studies with human plasma indicate that the plasma protein binding of azelastine and its metabolite, desmethylazelastine, are approximately 88% and 97%, respectively.

     Metabolism: Azelastine is oxidatively metabolized to the principal active metabolite, desmethylazelastine, by the cytochrome P450 enzyme system. The specific P450 isoforms responsible for the biotransformation of azelastine have not been identified. After a single-dose, intranasal administration of Azelastine Hydrochloride Nasal Spray 0.1% (548 mcg total dose), the mean desmethylazelastine C is 23 pg/mL, the AUC is 2131 pg•hr/mL and the median t is 24 hours. After a single-dose, intranasal administration of Azelastine Hydrochloride Nasal Spray 0.15% (822 mcg total dose), the mean desmethylazelastine C is 38 pg/mL, the AUC is 3824 pg•hr/mL and the median t is 24 hours. After intranasal dosing of azelastine to steady-state, plasma concentrations of desmethylazelastine range from 20-50% of azelastine concentrations.

     Elimination: Following intranasal administration of Azelastine Hydrochloride Nasal Spray 0.1%, the elimination half-life of azelastine is 22 hours while that of desmethylazelastine is 52 hours. Following intranasal administration of Azelastine Hydrochloride Nasal Spray 0.15%, the elimination half-life of azelastine is 25 hours while that of desmethylazelastine is 57 hours. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine.

 

Special Populations:

     Hepatic Impairment: Following oral administration, pharmacokinetic parameters were not influenced by hepatic impairment.

     Renal Impairment: Based on oral, single-dose studies, renal insufficiency (creatinine clearance <50 mL/min) resulted in a 70-75% higher C and AUC compared to healthy subjects. Time to maximum concentration was unchanged.

     Age: Following oral administration, pharmacokinetic parameters were not influenced by age.

     Gender: Following oral administration, pharmacokinetic parameters were not influenced by gender.

     Race: The effect of race has not been evaluated.

 

Drug-Drug Interactions:

     Erythromycin: Co-administration of orally administered azelastine (4 mg twice daily) with erythromycin (500 mg three times daily for 7 days) resulted in C of 5.36 ± 2.6 ng/mL and AUC of 49.7 ± 24 ng•h/mL for azelastine, whereas, administration of azelastine alone resulted in C of 5.57 ± 2.7 ng/mL and AUC of 48.4 ± 24 ng•h/mL for azelastine [see Drug Interactions (7.2) ].

     Cimetidine and Ranitidine: In a multiple-dose, steady-state drug interaction trial in healthy subjects, cimetidine (400 mg twice daily) increased orally administered mean azelastine (4 mg twice daily) concentrations by approximately 65%. Co-administration of orally administered azelastine (4 mg twice daily) with ranitidine hydrochloride (150 mg twice daily) resulted in C of 8.89 ±3.28 ng/mL and AUC of 88.22 ± 40.43 ng•h/mL for azelastine, whereas, administration of azelastine alone resulted in C of 7.83 ± 4.06 ng/mL and AUC of 80.09 ± 43.55 ng•h/mL for azelastine [see Drug Interactions (7.3) ].

     Theophylline: No significant pharmacokinetic interaction was observed with the co-administration of an oral 4 mg dose of azelastine hydrochloride twice daily and theophylline 300 mg or 400 mg twice daily.

       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/m 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/m basis). At 68.6 mg/kg (approximately 340 times the MRHDID on a mg/m 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.

 

Azelastine Hydrochloride Nasal Spray 0.1%

     The efficacy and safety of Azelastine Hydrochloride Nasal Spray 0.1% was evaluated in a 2-week, randomized, multicenter, double-blind, placebo-controlled clinical trial including 834 adult and adolescent patients 12 years of age and older with symptoms of seasonal allergic rhinitis. The population was 12 to 83 years of age (60% female, 40% male; 69% white, 16% black, 12% Hispanic, 2% Asian, 1% other).

     Patients were randomized to one of six treatment groups: 1 spray per nostril of either Azelastine Hydrochloride Nasal Spray 0.1%, Astelin (azelastine hydrochloride) Nasal Spray or vehicle placebo twice daily; or 2 sprays per nostril of Azelastine Hydrochloride Nasal Spray 0.1%, Astelin (azelastine hydrochloride) Nasal Spray or vehicle placebo twice daily.

     Assessment of efficacy was based on the 12-hour reflective total nasal symptom score (rTNSS) assessed daily in the morning and evening, in addition to the instantaneous total nasal symptom score (iTNSS) and other supportive secondary efficacy variables. TNSS is calculated as the sum of the patients’ scoring of the four individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The rTNSS required patients to record symptom severity over the previous 12 hours. For the primary efficacy endpoint, the mean change from baseline rTNSS, morning (AM) and evening (PM) rTNSS scores were summed for each day (maximum score of 24) and then averaged over the 2 weeks. The iTNSS, recorded immediately prior to the next dose, were assessed as an indication of whether the effect was maintained over the dosing interval.

 

Azelastine Hydrochloride Nasal Spray 0.15%

     The efficacy and safety of Azelastine Hydrochloride Nasal Spray 0.15% in seasonal allergic rhinitis was evaluated in five randomized, multicenter, double-blind, placebo-controlled clinical trials in 2499 adult and adolescent patients 12 years and older with symptoms of seasonal allergic rhinitis (Trials 2, 3, 4, 5, and 6). The population of the trials was 12 to 83 years of age (64% female, 36% male; 81% white, 12% black, <2% Asian, 5% other; 23% Hispanic, 77% non-Hispanic). Assessment of efficacy was based on the rTNSS, iTNSS as described above, and other supportive secondary efficacy variables. The primary efficacy endpoint was the mean change from baseline in rTNSS over 2 weeks.

     Two 2-week seasonal allergic rhinitis trials evaluated the efficacy of Azelastine Hydrochloride Nasal Spray 0.15% dosed at 2 sprays twice daily. The first trial (Trial 2) compared the efficacy of Azelastine Hydrochloride Nasal Spray 0.15% and Astelin (azelastine hydrochloride) Nasal Spray to vehicle placebo. The other trial (Trial 3) compared the efficacy of Azelastine Hydrochloride Nasal Spray 0.15% and Azelastine Hydrochloride Nasal Spray 0.1% to vehicle placebo. In these two trials, Azelastine Hydrochloride Nasal Spray 0.15% demonstrated greater decreases in rTNSS than placebo and the differences were statistically significant (Table 4).

     Three 2-week seasonal allergic rhinitis trials evaluated the efficacy of Azelastine Hydrochloride Nasal Spray 0.15% dosed at 2 sprays once daily compared to the vehicle placebo. Trial 4 demonstrated a greater decrease in rTNSS than placebo and the difference was statistically significant (Table 4). Trial 5 and Trial 6 were conducted in patients with Texas mountain cedar allergy. In Trial 5 and Trial 6, Azelastine Hydrochloride Nasal Spray 0.15% demonstrated a greater decrease in rTNSS than placebo and the differences were statistically significant (Trials 5 and 6; Table 4). Instantaneous TNSS results for the once daily dosing regimen of Azelastine Hydrochloride Nasal Spray 0.15% are shown in Table 5. In Trials 5 and 6, Azelastine Hydrochloride Nasal Spray 0.15% demonstrated a greater decrease in iTNSS than placebo and the differences were statistically significant.

     Azelastine Hydrochloride Nasal Spray 0.15% at a dose of 1 spray twice daily was not studied. The Azelastine Hydrochloride Nasal Spray 0.15% 1 spray twice daily dosing regimen is supported by previous findings of efficacy for Astelin (azelastine hydrochloride) Nasal Spray and a favorable comparison of Azelastine Hydrochloride Nasal Spray 0.15% to Astelin Nasal Spray and Azelastine Hydrochloride Nasal Spray 0.1% (Table 4).

The efficacy and safety of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% in children 6 to 11 years of age with seasonal allergic rhinitis was evaluated in a clinical study that enrolled pediatric patients with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis (described below in Section 14.2).

  Treatment
  (sprays per nostril)  Baseline
  LS Mean  Change
  from
  Baseline
Table 4. Mean Change from Baseline in Reflective TNSS over 2 Weeks*
in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis
 
 
  n
 
 
Difference From Placebo
  LS
  Mean
  95% CI   P value
Trial 1
Two sprays twice
daily
Azelastine Hydrochloride
Nasal Spray 0.1%
146 18.0 -5.0 -2.2 -3.2,-1.2 <0.001
Astelin Nasal Spray 137 18.2 -4.2 -1.4 -2.4,-0.4 0.01
Vehicle Placebo 138 18.2 -2.8  
One spray twice
daily
Azelastine Hydrochloride
Nasal Spray 0.1%
139 18.2 -4.2 -0.7 -1.7, 0.3 0.18
Astelin Nasal Spray 137 18.1 -4.0 -0.4 -1.5, 0.6 0.41
Vehicle Placebo 137 18.0 -3.5  
Trial 2
Two sprays twice
daily
Azelastine Hydrochloride
Nasal Spray 0.15%
153 18.2 -4.3 -1.2 -2.1, -0.3 0.01
Astelin Nasal Spray 153 17.9 -3.9 -0.9 -1.8, 0.1 0.07
Vehicle Placebo 153 18.1 -3.0  
Trial 3
Two sprays twice
daily
Azelastine Hydrochloride
Nasal Spray 0.15%
177 17.7 -5.1 -3.0 -3.9, -2.1 <0.001
Azelastine Hydrochloride
Nasal Spray 0.1%
169 18.2 -4.2 -2.1 -3.0, -1.2 <0.001
Vehicle Placebo 177 17.7 -2.1  
Trial 4
Two sprays once
daily
Azelastine Hydrochloride
Nasal Spray 0.15%
238 17.4 -3.4 -1.0 -1.7, -0.3 0.008
Vehicle Placebo 242 17.4 -2.4  
Trial 5
Two sprays once
daily
Azelastine Hydrochloride
Nasal Spray 0.15%
266 18.5 -3.3 -1.4 -2.1, -0.8 <0.001
Vehicle Placebo 266 18.0 -1.9  
Trial 6
Two sprays once
daily
Azelastine Hydrochloride
Nasal Spray 0.15%
251 18.5 -3.4 -1.4 -2.1, -0.7 <0.001
Vehicle Placebo 254 18.8 -2.0  
  *Sum of AM and PM rTNSS for each day (Maximum score=24) and averaged over the 14 day treatment period
Table 5. Mean Change from Baseline AM Instantaneous TNSS over 2 Weeks*
in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis Treatment
(sprays per nostril once daily)  Baseline
  LS Mean  Change
  from
  Baseline
  *AM iTNSS for each day (Maximum score=12) and averaged over the 14 day treatment period
 
 
 
  n
 
 
Difference From Placebo
  LS
  Mean
  95% CI   P value
  Trial 4
  Two sprays once daily Azelastine Hydrochloride Nasal
Spray 0.15%
238 8.1 -1.3 -0.2 -0.6, 0.1 0.15
Vehicle Placebo 242 8.3 -1.1  
  Trial 5
  Two sprays once daily Azelastine Hydrochloride Nasal
Spray 0.15%
266 8.7 -1.4 -0.7 -1.0, -0.4 <0.001
Vehicle Placebo 266 8.3 -0.7  
  Trial 6
  Two sprays once daily Azelastine Hydrochloride Nasal
Spray 0.15%
251 8.9 -1.4 -0.6 -0.9, -0.3 <0.001
Vehicle Placebo 254 8.9 -0.8  

Azelastine Hydrochloride Nasal Spray 0.1% and 0.15%

     The efficacy and safety of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% in pediatric patients 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, was evaluated in a randomized, double-blind, placebo-controlled clinical trial in 486 patients. All patients received one spray per nostril twice daily. The study population was 58% males and 42% females; 78% white, 13% black, 3% Asian, and 6% other.

     Assessment of efficacy was based on the 12-hour reflective total nasal symptom score (rTNSS) assessed daily in the morning and evening. The primary efficacy endpoint was the mean change from baseline rTNSS over 4 weeks (Table 7). Both active treatments demonstrated statistically significant decreases in rTNSS compared to placebo. There was no statistically significant difference between the two active-treatment groups. There was also no difference in treatment effect between patients with perennial allergic rhinitis only compared to those with perennial allergic rhinitis and concomitant seasonal allergic rhinitis.

Treatment
(sprays per nostril twice daily)  Baseline
  LS Mean  Change
  from
  Baseline
  *Sum of AM and PM rTNSS for each day (Maximum score=24) and averaged over the 28 day treatment period
Table 6. Mean Change from Baseline in Reflective TNSS over 4 Weeks*
In Adults and Children ≥ 12 years with Perennial Allergic Rhinitis
 
 
  n
 
 
Difference From Placebo
  LS
  Mean
  95% CI   P value
  Two sprays twice daily   Azelastine Hydrochloride Nasal
  Spray 0.15%
192 15.8 -4.0 -0.9 -1.7, -0.1 0.03
  Azelastine Hydrochloride Nasal
  Spray 0.1%
194 15.5 -3.8 -0.7 -1.5, 0.1 0.08
  Vehicle Placebo 192 14.7 -3.1  
Treatment
(sprays per nostril twice daily)
  *Sum of AM and PM rTNSS for each day (Maximum score=24) and averaged over the 28 day treatment period
Table 7. Mean Change from Baseline in Reflective TNSS over 4 Weeks* In Children 6 to 11 years with Perennial Allergic Rhinitis
 
 
n Baseline
LS Mean
Change
from
Baseline
Difference From Placebo
LS
Mean
95% CI P value
One spray twice daily Azelastine Hydrochloride Nasal
Spray 0.15%
159 16.6 -3.5 -1.0 -1.7, -0.3 0.005
Azelastine Hydrochloride Nasal
Spray 0.1%
166 16.4 -3.4 -0.9 -1.6, -0.2 0.015
Vehicle Placebo 161 16.1 -2.5  

     Azelastine Hydrochloride Nasal Spray 0.1% 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 (2.3)], 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.

     Azelastine Hydrochloride Nasal Spray 0.15% is supplied as a 30-mL package (NDC 51525-0234-3) 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 (2.3) ], 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 have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.

     Azelastine Hydrochloride Nasal Spray should not be used after the expiration date “EXP” printed on the medicine label and carton.

     Storage:

     Store upright at controlled room temperature 20° - 25°C (68° - 77°F). Protect from freezing.

See FDA-approved patient labeling (Patient Information and Instructions for Use)

     Somnolence has been reported in some patients taking Azelastine Hydrochloride Nasal Spray. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Azelastine Hydrochloride Nasal Spray [see Warnings and Precautions (5.1) ].

     Concurrent use of Azelastine Hydrochloride 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 [see Warnings and Precautions (5.1) ].

     Patients should be informed that the treatment with Azelastine Hydrochloride Nasal Spray may lead to adverse reactions, most common of which include bitter taste, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, and respiratory infection [see Adverse Reactions (6.1) ].

     Patients should be instructed to prime the pump before initial use and when Azelastine Hydrochloride Nasal Spray has not been used for 3 or more days [see Dosage and Administration (2.3) ].

     Patients should be instructed to avoid spraying Azelastine Hydrochloride Nasal Spray into their eyes.

     Patients should be instructed to keep Azelastine Hydrochloride Nasal Spray out of the reach of children. If a child accidentally ingests Azelastine Hydrochloride Nasal Spray, seek medical help or call a poison control center immediately.

Distributed by:Wallace Pharmaceuticals Inc.Somerset, NJ 08873-4120©2014 Wallace Pharmaceuticals Inc.

WALLACE PHARMACEUTICALS

U.S. Patents D447,419; 8,071,073; 8,518,919

WALLACE and are registered trademarks of Wallace Pharmaceuticals Inc.

PATIENT INFORMATION Azelastine Hydrochloride[a-ZEL-as-teen HYE-droe-KLOR-ide]Nasal Spray 0.1%Nasal Spray 0.15%

What is Azelastine Hydrochloride Nasal Spray?

• Azelastine Hydrochloride Nasal Spray is a prescription medicine used to treat symptoms of seasonal and year-round allergic rhinitis in people age 6 and older.

• Azelastine Hydrochloride Nasal Spray may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if Azelastine Hydrochloride Nasal Spray is safe and effective in children under 6 years of age.

What should I tell my healthcare provider before using Azelastine Hydrochloride Nasal Spray? Before using Azelastine Hydrochloride Nasal Spray, tell your healthcare provider if you are:

• pregnant, or plan to become pregnant. It is not known if Azelastine Hydrochloride Nasal Spray will harm your unborn baby.

• breastfeeding, or plan to breastfeed. It is not known if Azelastine Hydrochloride Nasal Spray passes into your breast milk. You and your healthcare provider should decide if you will use Azelastine Hydrochloride Nasal Spray if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Azelastine Hydrochloride Nasal Spray and other medicines may affect each other, causing side effects.

How should I use Azelastine Hydrochloride Nasal Spray?

• Read the Instructions for Use at the end of this leaflet for information about the right way to use Azelastine Hydrochloride Nasal Spray.

• Spray Azelastine Hydrochloride Nasal Spray in your nose only.

Do not spray it into your eyes or mouth.

• Use Azelastine Hydrochloride Nasal Spray exactly as your healthcare provider tells you to use it.

• Do not use more than your healthcare provider tells you.

• Throw away your Azelastine Hydrochloride Nasal Spray 0.1% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.

• Throw away your Azelastine Hydrochloride Nasal Spray 0.15% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.

• If you use too much or a child accidentally swallows Azelastine Hydrochloride Nasal Spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using Azelastine Hydrochloride Nasal Spray?

Azelastine Hydrochloride Nasal Spray can cause sleepiness:

• Do not drive, operate machinery, or do other dangerous activities until you know how Azelastine Hydrochloride Nasal Spray affects you.

• Do not drink alcohol or take other medicines that may cause you to feel sleepy while using Azelastine Hydrochloride Nasal Spray. It may make your sleepiness worse.

What are the possible side effects of Azelastine Hydrochloride Nasal Spray?

The most common side effects of Azelastine Hydrochloride Nasal Spray include:

• unusual bitter taste

• nose pain or discomfort

• nosebleeds

• headache

• sneezing

• fatigue

• sleepiness

• upper respiratory tract infections

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Azelastine Hydrochloride Nasal Spray. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Azelastine Hydrochloride Nasal Spray?

• Keep Azelastine Hydrochloride Nasal Spray upright at 68°F to 77°F (20°C to 25°C).

• Do not freeze Azelastine Hydrochloride Nasal Spray.

• Do not use Azelastine Hydrochloride Nasal Spray after the expiration date “EXP” on the medicine label and box.

Keep Azelastine Hydrochloride Nasal Spray and all medicines out of reach of children.

General information about the safe and effective use of Azelastine Hydrochloride Nasal Spray.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use Azelastine Hydrochloride Nasal Spray for a condition for which it was not prescribed. Do not give Azelastine Hydrochloride Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Azelastine Hydrochloride Nasal Spray. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Azelastine Hydrochloride Nasal Spray that is written for health professionals.

For more information, call 1-800-619-6344.

What are the ingredients in Azelastine Hydrochloride Nasal Spray?

Active ingredient: azelastine hydrochloride

Inactive ingredients: sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride, and purified water.

Distributed by:Wallace Pharmaceuticals Inc.Somerset, NJ 08873-4120©2014 Wallace Pharmaceuticals Inc.

WALLACE PHARMACEUTICALS

 

Instructions for Use Azelastine Hydrochloride[a-ZEL-as-teen HYE-droe-KLOR-ide]Nasal Spray 0.1% Nasal Spray 0.15%

For the correct dose of medicine:

• Keep your head tilted downward when spraying into your nostril.

• Change nostrils each time you use the spray.

• Breathe gently and do not tip your head back after using the spray. This will keep the medicine from running down into your throat. You may get a bitter taste in your mouth.

Figure A identifies the parts of your Azelastine Hydrochloride Nasal Spray pump

Figure A

 

Priming your Azelastine Hydrochloride Nasal Spray

Remove the blue dust cover over the tip of the bottle and the blue safety clip just under the “shoulders” of the bottle. (See Figure B).

Figure B

Hold the bottle upright with two fingers on the shoulders of the spray pump unit and • Put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action. Repeat this until you see a fine mist. (See Figure C).

Figure C

• To get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. If you see a stream of liquid, the pump is not working correctly and you may have nasal discomfort.

• This should happen in 6 sprays or less.

 

Now your pump is primed and ready to use.

• Do not use Azelastine Hydrochloride Nasal Spray unless you see a fine mist after you do the priming sprays. If you do not see a fine mist, clean the tip of the spray nozzle. See the “Cleaning the Spray Tip of your Azelastine Hydrochloride Nasal Spray” section below.

• If you do not use Azelastine Hydrochloride Nasal Spray for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist.

Using your Azelastine Hydrochloride Nasal Spray

Step 1.   Blow your nose to clear your nostrils.

Step 2.   Keep your head tilted downward toward your toes.

Step 3.   Keep the spray tip ¼ to ½ inch into 1 nostril. Hold bottle upright and aim the spray tip toward the back of the nose. (See Figure D).

Figure D

Step 4.   Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (See Figure E).

Figure E

Step 5.   Repeat Step 3 and Step 4 in your other nostril.

Step 6.   If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 2 through 4 above for the second spray in each nostril.

Step 7.   Breathe in gently, and do not tilt your head back after using Azelastine Hydrochloride Nasal Spray. This will help to keep the medicine from going into your throat.

Step 8.   When you finish using Azelastine Hydrochloride Nasal Spray, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle.

Cleaning the Spray Tip of your Azelastine Hydrochloride Nasal Spray

• If the spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. Unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise) (See Figure F).

• Soak only the spray pump unit in warm water. Squirt the spray unit several times while holding it under water. Use the pumping action to clear the opening in the tip. (See Figure G).

Figure F

Figure G

• Let the spray pump unit air dry. Make sure it is dry before you put it back onto the bottle.

• Put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right).

• To keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle.

• After cleaning, follow the instructions for priming.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:Wallace Pharmaceuticals Inc.Somerset, NJ 08873-4120©2014 Wallace Pharmaceuticals Inc.

WALLACE PHARMACEUTICALS

U.S. Patents D447,419; 8,071,073; 8,518,919

WALLACE and are registered trademarks of Wallace Pharmaceuticals Inc.

Important: For use in your nose only
Important: For use in your nose only.

NDC 51525-0234-3

30 mL

Azelastine

Hydrochloride 0.15%

Nasal Spray

Manufacturer

Wallace Pharmaceuticals Inc.

Active Ingredients

Source

Drugs and Medications [222 Associated Drugs and Medications listed on BioPortfolio]

Azelastine hydrochloride [west-ward pharmaceuticals corp.]

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Azelastine hydrochloride [apotex corp. ]

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Azelastine hydrochloride [sun pharmaceutical industries, inc.]

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Azelastine hydrochloride [avkare, inc.]

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Azelastine hydrochloride [breckenridge pharmaceutical, inc.]

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Clinical Trials [2199 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medica...

Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.

PubMed Articles [213 Associated PubMed Articles listed on BioPortfolio]

Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results from Russia.

The novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in a single spray (MP-AzeFlu) was compared with a first-line intranasal antihistamine spray (AZE) in ...

Protective effects of berberine hydrochloride on DSS-induced ulcerative colitis in rats.

Berberine hydrochloride is one the effective compound among Rhizoma Coptidis, Cortex Phellodendri, and other plants. There are several clinical functions of berberine hydrochloride including anti-infl...

In vitro and in vivo performance of epinastine hydrochloride-releasing contact lenses.

A number of drug-releasing contact lenses are currently being studied to address issues inherent in eye drops as a drug delivery method. In this study, we developed epinastine hydrochloride-releasing ...

Therapeutic effect of nasal corticosteroids combined with nasal antihistamine on vasomotor rhinitis.

To observe the clinical efficacy of nasal corticosteroids combined with nasal antihistamine in the treatment of vasomotor rhinitis. One hundred and twenty vasomotor rhinitis patients were randomly di...

In vitro and ex vivo studies on Diltiazem hydrochloride-loaded microsponges in rectal gels for chronic anal fissures treatment.

Diltiazem hydrochloride, topically applied at 2% concentration, is considered effective for the treatment of chronic anal fissures, althought it involves several side effects among which anal pruritus...

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