Astepro 0.206 MG/ACTUAT Metered Dose Nasal Spray
DRUG INTERACTIONS
7 7.1 Central Nervous System Depressants Concurrent use of ASTEPRO Nasal Spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [ see Warnings and Precautions (5.1) ].
7.2 Erythromycin and Ketoconazole Interaction studies investigating the cardiac effects, as measured by the corrected QT interval (QTc), of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted.
Oral erythromycin (500 mg three times daily for 7 days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms.
Ketoconazole (200 mg twice daily for 7 days) interfered with the measurement of azelastine plasma concentrations on the analytic HPLC; however, no effects on QTc were observed [ see Clinical Pharmacology (12.2) and (12.3) ].
7.3 Cimetidine Cimetidine (400 mg twice daily) increased the mean C max and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65% [ see Clinical Pharmacology (12.3) ].
OVERDOSAGE
10 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.
DESCRIPTION
11 ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is an antihistamine (H 1 receptor antagonist) formulated as a metered-spray solution for intranasal administration.
ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is an antihistamine (H 1 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 C 22 H 24 ClN 3 O•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 (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.
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 (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 Structural Formula
CLINICAL STUDIES
14 14.1 Seasonal Allergic Rhinitis ASTEPRO 0.1% The efficacy and safety of ASTEPRO 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 ASTEPRO 0.1%, Astelin (azelastine hydrochloride) Nasal Spray or vehicle placebo twice daily; or 2 sprays per nostril of ASTEPRO 0.1%, Astelin 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.
In this trial, ASTEPRO 0.1% two sprays twice a day demonstrated a greater decrease in rTNSS and iTNSS than placebo and the difference was statistically significant.
The trial results are presented in Table 4 (Trial 1).
The efficacy of ASTEPRO 0.1% one spray per nostril twice daily for seasonal allergic rhinitis is supported by two, 2-week, placebo-controlled clinical trials with Astelin (azelastine hydrochloride) Nasal Spray in 413 patients with seasonal allergic rhinitis.
In these trials, efficacy was assessed using the TNSS (described above).
Astelin demonstrated a greater decrease from baseline in the summed AM and PM rTNSS compared with placebo and the difference was statistically significant.
The efficacy of ASTEPRO 0.1% and ASTEPRO 0.15% in children 6 months to 5 years of age with allergic rhinitis was explored in a 4 week, randomized, open-label safety trial in 191 patients.
While the primary objective was to determine the safety of ASTEPRO in this age group, the study included an exploratory efficacy assessment of daily overall allergy symptom scores.
Efficacy in children 6 months to 5 years of age was supported by a numerical decrease in the overall allergy symptom score in both treatment groups.
There was no statistically significant difference between the two treatment groups.
ASTEPRO 0.15% The efficacy and safety of ASTEPRO 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 ASTEPRO Nasal Spray 0.15% dosed at 2 sprays twice daily.
The first trial (Trial 2) compared the efficacy of ASTEPRO 0.15% and Astelin (azelastine hydrochloride) Nasal Spray to vehicle placebo.
The other trial (Trial 3) compared the efficacy of ASTEPRO 0.15% and ASTEPRO 0.1% to vehicle placebo.
In these two trials, ASTEPRO 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 ASTEPRO 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, ASTEPRO 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 ASTEPRO 0.15% are shown in Table 5.
In Trials 5 and 6, ASTEPRO 0.15% demonstrated a greater decrease in iTNSS than placebo and the differences were statistically significant.
Table 4.
Mean Change from Baseline in Reflective TNSS over 2 Weeks * in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis *Sum of AM and PM rTNSS for each day (Maximum score=24) and averaged over the 14 day treatment period Treatment (sprays per nostril) n Baseline LS Mean Change from Baseline Difference From Placebo LS Mean 95% CI P value Trial 1 Two sprays twice daily ASTEPRO 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 ASTEPRO 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 ASTEPRO 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 ASTEPRO 0.15% 177 17.7 -5.1 -3.0 -3.9, -2.1 <0.001 ASTEPRO 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 ASTEPRO 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 ASTEPRO 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 ASTEPRO 0.15% 251 18.5 -3.4 -1.4 -2.1, -0.7 <0.001 Vehicle Placebo 254 18.8 -2.0 Table 5.
Mean Change from Baseline AM Instantaneous TNS over 2 Weeks* in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis *AM iTNSS for each day (Maximum score=12) and averaged over the 14 day treatment period Treatment (sprays per nostril once daily) n Baseline LS Mean Change from Baseline Difference From Placebo LS Mean 95% CI P value Trial 4 Two sprays once daily ASTEPRO 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 ASTEPRO 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 ASTEPRO 0.15% 251 8.9 -1.4 -0.6 -0.9, -0.3 <0.001 Vehicle Placebo 254 8.9 -0.8 ASTEPRO 0.15% at a dose of 1 spray twice daily was not studied.
The ASTEPRO 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 ASTEPRO 0.15% to Astelin Nasal Spray and ASTEPRO 0.1% (Table 4).
The efficacy and safety of ASTEPRO 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 ).
14.2 Perennial Allergic Rhinitis ASTEPRO 0.1% and ASTEPRO 0.15% The efficacy and safety of ASTEPRO 0.15% in perennial allergic rhinitis was evaluated in one randomized, multicenter, double-blind, placebo-controlled clinical trial in 578 adult and adolescent patients 12 years and older with symptoms of perennial allergic rhinitis.
The population of the trial was 12 to 84 years of age (68% female, 32% male; 85% white, 11% black, 1% Asian, 3% other; 17% Hispanic, 83% non-Hispanic).
Assessment of efficacy was based on the 12-hour reflective total nasal symptom score (rTNSS) assessed daily in the morning and evening, the instantaneous total nasal symptom score (iTNSS), and other supportive secondary efficacy variables.
The primary efficacy endpoint was the mean change from baseline rTNSS over 4 weeks.
The one 4-week perennial allergic rhinitis trial evaluated the efficacy of ASTEPRO 0.15%, ASTEPRO 0.1%, and vehicle placebo dosed at 2 sprays per nostril twice daily.
In this trial, ASTEPRO 0.15% demonstrated a greater decrease in rTNSS than placebo and the difference was statistically significant (Table 6).
Table 6.
Mean Change from Baseline in Reflective TNSS over 4 Weeks* in Adults and Children ≥ 12 years with Perennial Allergic Rhinitis *Sum of AM and PM rTNSS for each day (Maximum score=24) and averaged over the 28 day treatment period Treatment (sprays per nostril twice daily) n Baseline LS Mean Change from Baseline Difference From Placebo LS Mean 95% CI P value Two sprays twice daily ASTEPRO 0.15% 192 15.8 -4.0 -0.9 -1.7, -0.1 0.03 ASTEPRO 0.1% 194 15.5 -3.8 -0.7 -1.5, 0.1 0.08 Vehicle Placebo 192 14.7 -3.1 The efficacy and safety of ASTEPRO 0.1% and ASTEPRO 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.
Table 7.
Mean Change from Baseline in Reflective TNSS over 4 Weeks* in Children 6 to 11 years with Perennial Allergic Rhinitis *Sum of AM and PM rTNSS for each day (Maximum score=24) and averaged over the 28 day treatment period Treatment (sprays per nostril twice daily) n Baseline LS Mean Change from Baseline Difference From Placebo LS Mean 95% CI P value One spray twice daily ASTEPRO 0.15% 159 16.6 -3.5 -1.0 -1.7, -0.3 0.005 ASTEPRO 0.1% 166 16.4 -3.4 -0.9 -1.6, -0.2 0.015 Vehicle Placebo 161 16.1 -2.5 The efficacy of ASTEPRO 0.1% and ASTEPRO 0.15% in children 6 months to 5 years of age with allergic rhinitis was explored in a clinical study (described above in Section 14.1 ).
HOW SUPPLIED
16 /STORAGE AND HANDLING ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is supplied as a 30-mL package (NDC 0037-0242-30) 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).
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.
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 (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 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 at controlled room temperature 20° to 25°C (68° to 77°F).
Protect from freezing.
GERIATRIC USE
8.5 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.
DOSAGE FORMS AND STRENGTHS
3 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.
Nasal spray solution available in two dosage strengths: • ASTEPRO Nasal Spray 0.1%: 137 mcg of azelastine hydrochloride in each 0.137 mL spray ( 3 ).
• ASTEPRO Nasal Spray 0.15%: 205.5 mcg of azelastine hydrochloride in each 0.137 mL spray ( 3 ).
MECHANISM OF ACTION
12.1 Mechanism of Action Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H 1 -receptor antagonist activity in isolated tissues, animal models, and humans.
ASTEPRO 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 1 -receptor antagonist activity.
INDICATIONS AND USAGE
1 ASTEPRO is an H 1 -receptor antagonist indicated for the relief of the symptoms of: • Seasonal allergic rhinitis in patients 2 years of age and older.
( 1.1 ) • Perennial allergic rhinitis in patients 6 months of age and older.
( 1.1 ) 1.1 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.
PEDIATRIC USE
8.4 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 (14) ].
The safety and effectiveness of ASTEPRO in pediatric patients below 6 months of age have not been established.
PREGNANCY
8.1 Pregnancy Risk Summary Limited data from postmarketing experience over decades of use with ASTEPRO in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes.
In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 4 times the clinical daily dose.
Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 180 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.644 mg.
However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hydrochloride caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 200 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight.
Neither fetal nor maternal effects occurred in mice at approximately 9 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 3 mg/kg/day).
In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hydrochloride caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 180 times the MRHDID in adults (on a mg/m 2 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 410 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/kg/day).
Neither fetal nor maternal effects occurred at approximately 10 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 2 mg/kg/day).
In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 360 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 30 mg/kg/day).
Neither fetal nor maternal effects occurred at approximately 4 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 0.3 mg/kg/day).
In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hydrochloride produced no adverse developmental effects on pups at maternal doses up to approximately 180 times the MRHDID (on mg/m 2 basis at a maternal dose of 30 mg/kg/day).
WARNING AND CAUTIONS
5 WARNINGS AND PRECAUTIONS • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking ASTEPRO ( 5.1 ) • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with ASTEPRO because further decreased alertness and impairment of CNS performance may occur.
( 5.1 ) 5.1 Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking ASTEPRO [ 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 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 (7.1) ].
INFORMATION FOR PATIENTS
17 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 (5.1) ].
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 (5.1) ].
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 (6.1) ].
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 (2.3) ].
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.
Manufactured for: Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120 ©2018 Meda Pharmaceuticals Inc.
ASTEPRO and MEDA PHARMACEUTICALS are registered trademarks of Meda Pharmaceuticals Inc.
or a related entity.
U.S.
Patents 8,071,073; 8,518,919
DOSAGE AND ADMINISTRATION
2 • For intranasal use only ( 2.3 ).
• Seasonal allergic rhinitis : ▪ 2 to 5 years : ASTEPRO 0.1%: 1 spray per nostril twice daily ( 2.1 ) ▪ 6 to 11 years : ASTEPRO 0.1% or ASTEPRO 0.15%: 1 spray per nostril twice daily ( 2.1 ) ▪ Adults and adolescents 12 years of age and older : o ASTEPRO 0.1% or ASTEPRO 0.15%: 1 or 2 sprays per nostril twice daily ( 2.1 ), or o ASTEPRO 0.15%: 2 sprays per nostril once daily ( 2.1 ) • Perennial allergic rhinitis : ▪ 6 months to 5 years : ASTEPRO 0.1%: 1 spray per nostril twice daily ( 2.2 ) ▪ 6 to 11 years : ASTEPRO 0.1% or ASTEPRO 0.15%: 1 spray per nostril twice daily ( 2.2 ) ▪ Adults and adolescents 12 years of age and older : ASTEPRO 0.15%: 2 sprays per nostril twice daily ( 2.2 ) • Prime ASTEPRO before initial use and when it has not been used for 3 or more days.
( 2.3 ) 2.1 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.
2.2 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.
2.3 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.