How To Use Azelastine Hydrochloride Nasal Spray

AZELASTINE
(Azelastine HCl) Nasal Solution (Nasal Spray), 0 .xv%

DESCRIPTION

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

Azelastine hydrochloride occurs equally 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. Information technology has a melting signal of about 225°C and the pH of a saturated solution is betwixt 5.0 and v.4. Its chemical name is (±)-1-(2H)-phthalazinone, 4-[(four- chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C₂₂H₂₄ClN₃O•HCl with the following chemical structure:

Azelastine HCl Nasal Solution (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).

Later on priming [come across DOSAGE AND Assistants], 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 xxx-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.

INDICATIONS

Allergic Rhinitis

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older.

Pediatric use information for patients ages 6 to eleven years of historic period for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is canonical for Meda Pharmaceuticals' azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug product is not labeled with that pediatric information.

DOSAGE AND Assistants

Seasonal Allergic Rhinitis

In adults and adolescents 12 years of historic period and older, the recommended dose of Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is 1 or ii sprays per nostril twice daily. Azelastine HCl Nasal Solution (Nasal Spray), 0.15% may besides be administered as 2 sprays per nostril once daily.

Pediatric use information for patients ages six to 11 years of age for handling of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals' azelastine hydrochloride nasal spray production. Still, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Perennial Allergic Rhinitis

In adults and adolescents 12 years of age and older, the recommended dose of Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen% is 2 sprays per nostril twice daily.

Pediatric use data for patients ages six to 11 years of age for handling of allergic rhinitis, including seasonal and perennial allergic rhinitis is canonical for Meda Pharmaceuticals' azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug production is non labeled with that pediatric data.

Important Administration Instructions

Administrate Azelastine HCl Nasal Solution (Nasal Spray), 0.15% by the intranasal road only.

Priming

Prime Azelastine HCl Nasal Solution (Nasal Spray), 0.15% before initial use by releasing half dozen sprays or until a fine mist appears. When Azelastine HCl Nasal Solution (Nasal Spray), 0.xv% has non been used for 3 or more days, reprime with 2 sprays or until a fine mist appears.

Avoid spraying Azelastine HCl Nasal Solution (Nasal Spray), 0.15% into the eyes.

HOW SUPPLIED

Dosage Forms And Strengths

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is a nasal spray solution. Each spray of Azelastine HCl Nasal Solution (Nasal Spray), 0.15% delivers a book of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride.

Storage And Handling

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is supplied as a xxx-mL package (NDC 45802-026- 83) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metereddose spray pump unit. The spray pump unit of measurement consists of a nasal spray pump fitted with a violet safety clip and a violet plastic dust embrace. The internet content of the canteen is 30 mL (net weight 30 gm of solution). The xxx-mL canteen contains 45 mg (one.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.five mcg of azelastine hydrochloride. The correct corporeality of medication in each spray cannot exist assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, fifty-fifty though the bottle is non completely empty. The bottle should be discarded afterward 200 sprays have been used.

Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen% should not be used later on 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.

Manufactured by Perrigo Yeruham 80500, Israel. Revised: Apr 2014

QUESTION

Allergies can best be described as: See Answer

SIDE Furnishings

Utilize of azelastine HCl nasal solution (nasal spray) 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 exist directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.

AzelastineHCl Nasal Solution (Nasal Spray), 0.ane%

The safety data described beneath reflect exposure to azelastine HCl nasal solution (nasal spray), 0.one% in 713 patients 12 years of age and older from 2 clinical trials of two weeks to 12 months duration. In a two- week, double-blind, placebo-controlled, and active-controlled (azelastine HCl nasal solution (nasal spray) without sweetener; azelastine hydrochloride) clinical trial, 285 patients (115 males and 170 females) 12 years of historic period and older with seasonal allergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.1% one or two sprays per nostril daily. In the 12 month open up-label, activecontrolled (azelastine HCl nasal solution (nasal spray) without sweetener) 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 HCl nasal solution (nasal spray), 0.1% two sprays per nostril twice daily. The racial and indigenous distribution for the 2 clinical trials was 82% white, viii% blackness, 6% Hispanic, iii% Asian, and <one% 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 i of six treatments: ane spray per nostril of either azelastine HCl nasal solution (nasal spray), 0.one%, azelastine HCl nasal solution (nasal spray) without sweetener or placebo twice daily; or 2 sprays per nostril of azelastine HCl nasal solution (nasal spray), 0.i%, azelastine HCl nasal solution (nasal spray) without sweetener, or placebo twice daily. Overall, agin reactions were more common in the azelastine HCl nasal solution (nasal spray), 0.1% treatment groups (21-28%) than in the placebo groups (16-twenty%). Overall, less than i% of patients discontinued due to adverse reactions and withdrawal due to agin reactions was like amid the treatment groups.

Table ane contains agin reactions reported with frequencies greater than or equal to two% and more than oft than placebo in patients treated with azelastine HCl nasal solution (nasal spray), 0.1% in the controlled clinical trial described above.

Table 1: Adverse Reactions in ≥2% Incidence in a Placebo-Controlled Trail of ii Weeks' Elapsing with Azelastine HCl Nasal Solution (Nasap Spray), 0.i% in Developed and Adolescent Patients with Seasonal Allergic Rhinitis

	one spray twice daily			2 sprays twice daily
	Azelastine HCl nasal solution (nasal spary), 0.ane% (North=139)	Azelastine HCl nasal solution (nasal spary), without sweetener (Due north=139)	Vehicle Placebo (N=137)	Azelastine HCl nasal solution (nasal spary), 0.one% (N=146)	Azelastine HCl nasal solution (nasal spary), without sweetener (N=137)	Vehicle Placebo (Northward=138)
Bitter Taste	8 (6%)	13 (ten%)	two (2%)	10 (7%)	11 (8%)	three (2%)
Epistaxis	three (2%)	8 (6%)	iii (2%)	4 (3%)	3 (2%)	0 (0%)
Headache	2 (i%)	v (iv%)	ane (<1%)	4 (3%)	iii (ii%)	one (<1%)
Nasal Discomfort	0 (0%)	3 (2%)	1 (<ane%)	2 (one%)	6 (four%)	0 (0%)
Fatigue	0 (0%)	one (<1%)	one (<1%)	3 (2%)	3 (two%)	1 (<1%)
Somnolence	ii (1%)	two (ii%)	0 (0%)	3 (2%)	2 (ane%)	0 (0%)

Long-Term (12 Calendar month) Safe Trial

In the 12 month, open-label, agile-controlled, long-term condom trial, 862 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.1% ii sprays per nostril twice daily or azelastine HCl nasal solution (nasal spray) without sweetener 2 sprays per nostril twice daily. The most oftentimes reported adverse reactions were headache, bitter sense of taste, epistaxis, and nasopharyngitis and were more often than not similar betwixt handling groups. Focused nasal examinations were performed and showed that the incidence of nasal mucosal ulceration in each handling group was approximately 1% at baseline and approximately 1.5% throughout the 12 month treatment period. In each treatment grouping, 5-7% of patients had mild epistaxis. No patients had reports nasal septal perforation or severe epistaxis. Twenty-2 patients (5%) treated with azelastine HCl nasal solution (nasal spray), 0.1% and 17 patients (4%) treated with azelastine HCl nasal solution (nasal spray) without sweetener discontinued from the trial due to agin events.

AzelastineHCl Nasal Solution (Nasal Spray), 0.fifteen%

The prophylactic data described beneath reverberate exposure to azelastine HCl nasal solution (nasal spray), 0.15% in 1858 patients (12 years of age and older) with seasonal or perennial allergic rhinitis from 8 clinical trials of 2 weeks to 12 months duration. In seven double-bullheaded, placebo-controlled clinical trials of 2 to 4 weeks elapsing, 1544 patients (560 males and 984 females) with seasonal or perennial allergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.xv% two sprays per nostril once or twice daily. In the 12 month open up-label, active-controlled clinical trial, 466 patients (156 males and 310 females) with perennial allergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.15% 2 sprays per nostril twice daily. Of these 466 patients, 152 had participated in the 4-week placebo-controlled perennial allergic rhinitis clinical trials. The racial distribution for the 8 clinical trials was lxxx% white, 13% black, 2% Asian, and v% other.

Adults and Adolescents 12 Years of Historic period and Older

In the 7 placebo controlled clinical trials of two to 4 week duration, 2343 patients with seasonal allergic rhinitis and 540 patients with perennial allergic rhinitis were treated with ii sprays per nostril of either azelastine HCl nasal solution (nasal spray), 0.15% or placebo once or twice daily. Overall, agin reactions were more than common in the azelastine HCl nasal solution (nasal spray), 0.fifteen% treatment groups (16-31%) than in the placebo groups (xi-24%). Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to agin reactions was similar amongst the treatment groups.

Table two contains agin reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with azelastine HCl nasal solution (nasal spray), 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

Tabular array 2: Agin Reactions with ≥2% Incidence in a Placebo-Controlled Trail of 2 to four Weeks' Elapsing with Azelastine HCl Nasal Solution (Nasap Spray), 0.fifteen% in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis

	two sprays twice daily		2 sprays twice daily
	Azelastine HCl nasal solution (nasal spary), 0.15% (N=523)	Vehicle Placebo (Due north=523)	Azelastine HCl nasal solution (nasal spary), 0.fifteen% (Northward=1021)	Vehicle Placebo (N=816)
Bitter Sense of taste	31(half dozen%)	five(i%)	38(4%)	two(<1%)
Nasal Discomfort	18(three%)	12(2%)	37(iv%)	7(one%)
Epistaxis	5(ane%)	vii(1%)	21(2%)	xiv(ii%)
Sneezing	nine(2%)	1(<i%)	xiv(one%)	0(0%)

In the higher up trials, somnolence was reported in <1% of patients treated with azelastine HCl nasal solution (nasal spray), 0.15% (11 of 1544) or vehicle placebo (one 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 azelastine HCl nasal solution (nasal spray), 0.15% two sprays per nostril twice daily and 237 patients were treated with mometasone nasal spray 2 sprays per nostril once daily. The most oftentimes reported adverse reactions (>5%) with azelastine HCl nasal solution (nasal spray), 0.15% were biting gustation, headache, sinusitis, and epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. In each treatment grouping, approximately 3% of patients had balmy epistaxis. No patients had reports of severe epistaxis. L-4 patients (12%) treated with azelastine HCl nasal solution (nasal spray), 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events.

Pediatric use data for patients ages 6 to xi years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals' azelastine hydrochloride nasal spray production. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug production is not labeled with that pediatric information.

Postmarketing Experience

During the post approval use of azelastine HCl nasal solution (nasal spray), 0.one% 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 ever possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Agin reactions reported include: abdominal pain, nasal burning, nausea, sweetness sense of taste, and throat irritation.

Additionally, the following adverse reactions take been identified during the mail service approving utilise of the azelastine HCl nasal solution (nasal spray) without sweetener brand of azelastine hydrochloride 0.one% nasal spray (total daily dose 0.55 mg to 1.ane mg). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or found a causal relationship to drug exposure. Adverse reactions reported include the following: anaphylactoid reaction, application site irritation, atrial fibrillation, blurred vision, breast pain, confusion, dizziness, dyspnea, facial edema, hypertension, involuntary muscle contractions, nervousness, palpitations, paresthesia, parosmia, paroxysmal sneezing, pruritus, rash, disturbance or loss of sense of scent and/or gustation, tachycardia, tolerance, urinary retention, and xerophthalmia.

DRUG INTERACTIONS

Central Nervous System Depressants

Concurrent utilise of Azelastine HCl Nasal Solution (Nasal Spray), 0.15% with alcohol or other central nervous organization depressants should exist avoided because reductions in alacrity and impairment of central nervous system performance may occur [see WARNINGS AND PRECAUTIONS].

Erythromycin And Ketoconazole

Interaction studies investigating the cardiac furnishings, equally 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 seven 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; nevertheless, 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 (four mg twice daily) by approximately 65% [see CLINICAL PHARMACOLOGY].

WARNINGS

Included as role of the "PRECAUTIONS" Section

PRECAUTIONS

Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine HCl nasal solution (nasal spray) [see Adverse REACTIONS]. Patients should be cautioned against engaging in hazardous occupations requiring consummate mental alacrity and motor coordination such equally operating machinery or driving a motor vehicle after administration of Azelastine HCl Nasal Solution (Nasal Spray), 0.15%. Concurrent utilize of Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen% with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and boosted impairment of central nervous system performance may occur [run across DRUG INTERACTIONS]

Patient Counseling Information

See FDA-canonical patient labeling (PATIENT INFORMATION).

Activities Requiring Mental Alertness

Somnolence has been reported in some patients taking azelastine HCl nasal solution (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 HCl Nasal Solution (Nasal Spray), 0.15% [see WARNINGS AND PRECAUTIONS].

Concurrent Use Of Alcohol And Other Central Nervous System Depressants

Concurrent use of Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen% with alcohol or other central nervous system depressants should exist avoided because additional reductions in alertness and boosted impairment of central nervous organisation functioning may occur [meet WARNINGS AND PRECAUTIONS].

Mutual Adverse Reactions

Patients should be informed that the treatment with Azelastine HCl Nasal Solution (Nasal Spray), 0.15% may lead to agin reactions, most mutual of which include bitter taste, nasal discomfort, epistaxis, headache, sneezing, fatigue, and somnolence [see ADVERSE REACTIONS].

Pediatric employ information for patients ages 6 to 11 years of age for handling of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals' azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Priming

Patients should exist instructed to prime number the pump before initial use and when Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen% has not been used for 3 or more than days [encounter DOSAGE AND ADMINISTRATION].

Go along Spray Out Of Optics

Patients should be instructed to avoid spraying Azelastine HCl Nasal Solution (Nasal Spray), 0.15% into their eyes.

Keep Out Of Children'south Reach

Patients should be instructed to keep Azelastine HCl Nasal Solution (Nasal Spray), 0.15% out of the reach of children. If a child accidentally ingests Azelastine HCl Nasal Solution (Nasal Spray), 0.xv%, seek medical help or call a poison control heart immediately.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Damage Of Fertility

In 2-year carcinogenicity studies in rats and mice, azelastine hydrochloride did not testify evidence of carcinogenicity at oral doses upwardly to thirty mg/kg and 25 mg/kg, respectively. These doses were approximately 150 and lx times the maximum recommended man daily intranasal dose [MRHDID] on a mg/yardⁱⁱ footing.

Azelastine hydrochloride showed no genotoxic effects in the Ames exam, Dna repair test, mouse lymphoma forrard mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.

Reproduction and fertility studies in rats showed no furnishings on male person 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/grand² 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; all the same, pre-implantation loss was non increased.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled clinical trials in meaning women. Azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. Azelastine HCl nasal solution (nasal spray), 0.15% should be used during pregnancy just if the potential do good justifies the potential risk to the fetus.

Teratogenic Effects

In mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate; brusk 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/chiliad^two ground at a maternal oral dose of 68.6 mg/kg/day which likewise caused maternal toxicity as evidenced past decreased body weight). Neither fetal nor maternal furnishings occurred in mice at approximately 7 times the MRHDID in adults (on a mg/mⁱⁱ basis at a maternal oral dose of 3 mg/kg/day).

In rats, azelastine hydrochloride acquired 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/1000² ground at a maternal oral dose of 30 mg/kg/solar day). Azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 340 times the MRHDID (on a mg/g² 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 two 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 thirty mg/kg/24-hour interval). Neither fetal nor maternal effects occurred at approximately 3 times the MRHDID (on a mg/yardⁱⁱ basis at a maternal oral dose of 0.iii mg/kg/mean solar day).

Nursing Mothers

It is not known whether azelastine hydrochloride is excreted in human milk. Considering many drugs are excreted in human milk, caution should be exercised when Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is administered to a nursing woman.

Pediatric Use

The prophylactic and effectiveness of azelastine HCl nasal solution (nasal spray) in pediatric patients 6 to 17 years of age have been established [see Clinical Studies]. The safety and effectiveness of azelastine HCl nasal solution (nasal spray) in pediatric patients below 6 years of age have not been established.

Pediatric employ information for patients ages vi to xi years of historic period for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is canonical for Meda Pharmaceuticals' azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug product is non labeled with that pediatric information.

Geriatric Use

Clinical trials of azelastine HCl nasal solution (nasal spray) did not include sufficient numbers of patients 65 years of historic period and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses betwixt the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low finish of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant affliction or other drug therapy.

Overdosage & Contraindications

OVERDOSE

There have been no reported overdosages with azelastine HCl nasal solution (nasal spray). Acute overdosage by adults with this dosage grade is unlikely to effect in clinically meaning agin events, other than increased somnolence, since one 30-mL bottle of Azelastine HCl Nasal Solution (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 xvi 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 HCl nasal solution (nasal spray). Oral ingestion of antihistamines has the potential to cause serious adverse furnishings in children. Accordingly, Azelastine HCl Nasal Solution (Nasal Spray), 0.15% should be kept out of the achieve of children.

CONTRAINDICATIONS

None.

CLINICAL PHARMACOLOGY

Mechanism Of Activeness

Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H₁ -receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine HCl nasal solution (nasal spray) is administered as a racemic mixture with no divergence in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H₁ -receptor adversary activity.

Pharmacodynamics

Cardiac Effects

In a placebo-controlled trial (95 patients with allergic rhinitis), there was no prove of an effect of azelastine hydrochloride nasal spray (ii sprays per nostril twice daily for 56 days) on cardiac repolarization as represented past the corrected QT interval (QTc) of the electrocardiogram. Following multiple dose oral administration of azelastine iv mg or viii mg twice daily, the mean modify in QTc was 7.2 msec and 3.half-dozen msec, respectively.

Interaction studies investigating the cardiac repolarization furnishings of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin had no outcome on azelastine pharmacokinetics or QTc based on assay of serial electrocardiograms. Ketoconazole interfered with the measurement of azelastine plasma levels; however, no effects on QTc were observed [see DRUG INTERACTIONS].

Pharmacokinetics

Absorption

Afterwards intranasal administration of 2 sprays per nostril (548 mcg full dose) of azelastine HCl nasal solution (nasal spray), 0.ane%, the mean azelastine tiptop plasma concentration (Cmax) is 200 pg/mL, the mean extent of systemic exposure (AUC) is 5122 pg•hour/mL and the median time to reach Cmax (tmax is 3 hours. Later intranasal administration of 2 sprays per nostril (822 mcg total dose) of azelastine HCl nasal solution (nasal spray), 0.xv%, the mean azelastine peak plasma concentration (Cmax) is 409 pg/mL, the hateful extent of systemic exposure (AUC) is 9312 pg•60 minutes/mL and the median time to reach Cmax (tmax ) is 4 hours. The systemic bioavailability of azelastine hydrochloride is approximately 40% later on intranasal administration.

Distribution

Based on intravenous and oral administration, the steady-country volume of distribution of azelastine is xiv.5 L/kg. In vitro studies with human plasma signal 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 agile metabolite, desmethylazelastine, past the cytochrome P450 enzyme system. The specific P450 isoforms responsible for the biotransformation of azelastine have not been identified. Later a single-dose, intranasal administration of azelastine HCl nasal solution (nasal spray), 0.one% (548 mcg total dose), the mean desmethylazelastine Cmax is 23 pg/mL, the AUC is 2131 pg•60 minutes/mL and the median tmax is 24 hours. After a single-dose, intranasal administration of azelastine HCl nasal solution (nasal spray), 0.15% (822 mcg total dose), the mean desmethylazelastine Cmax is 38 pg/mL, the AUC is 3824 pg•hr/mL and the median tmax is 24 hours. After intranasal dosing of azelastine to steady-state, plasma concentrations of desmethylazelastine range from twenty-50% of azelastine concentrations.

Elimination

Following intranasal administration of azelastine HCl nasal solution (nasal spray), 0.1%, the elimination half-life of azelastine is 22 hours while that of desmethylazelastine is 52 hours. Following intranasal assistants of azelastine HCl nasal solution (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 damage.

Renal Impairment

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

Age

Post-obit oral administration, pharmacokinetic parameters were non influenced by age.

Gender

Following oral assistants, pharmacokinetic parameters were non influenced by gender.

Race

The outcome 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 vii days) resulted in Cmax of 5.36 ± two.half dozen ng/mL and AUC of 49.7 ± 24 ng•h/mL for azelastine, whereas, assistants of azelastine alone resulted in Cmax of five.57 ± 2.seven ng/mL and AUC of 48.4 ± 24 ng•h/mL for azelastine [see DRUG INTERACTIONS].

Cimetidine And Ranitidine

In a multiple-dose, steady-state drug interaction trial in salubrious subjects, cimetidine (400 mg twice daily) increased orally administered mean azelastine (4 mg twice daily) concentrations past approximately 65%. Co-administration of orally administered azelastine (4 mg twice daily) with ranitidine hydrochloride (150 mg twice daily) resulted in Cmax of 8.89 ±three.28 ng/mL and AUC of 88.22 ± 40.43 ng•h/mL for azelastine, whereas, administration of azelastine alone resulted in Cmax of 7.83 ± iv.06 ng/mL and AUC of eighty.09 ± 43.55 ng•h/mL for azelastine [run across DRUG INTERACTIONS].

Theophylline

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

Clinical Studies

Seasonal Allergic Rhinitis

AzelastineHCl Nasal Solution (Nasal Spray), 0.1%

The efficacy and safety of azelastine HCl nasal solution (nasal spray), 0.1% was evaluated in a 2-week, randomized, multicenter, double-bullheaded, 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 historic period (60% female, forty% male; 69% white, sixteen% black, 12% Hispanic, 2% Asian, 1% other).

Patients were randomized to ane of six treatment groups: i spray per nostril of either azelastine HCl nasal solution (nasal spray), 0.1%, azelastine HCl nasal solution (nasal spray) without sweetener or vehicle placebo twice daily; or 2 sprays per nostril of azelastine HCl nasal solution (nasal spray), 0.1%, azelastine HCl nasal solution (nasal spray) without sweetener or vehicle placebo twice daily.

Assessment of efficacy was based on the 12-60 minutes reflective total nasal symptom score (rTNSS) assessed daily in the morning time and evening, in improver to the instantaneous full 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-minded, 1 = mild, two = moderate, 3 = astringent). The rTNSS required patients to record symptom severity over the previous 12 hours. For the chief 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 so averaged over the 2 weeks. The iTNSS, recorded immediately prior to the adjacent dose, were assessed as an indication of whether the event was maintained over the dosing interval.

In this trial, azelastine HCl nasal solution (nasal spray), 0.1% two sprays twice a 24-hour interval demonstrated a greater decrease in rTNSS and iTNSS than placebo and the deviation was statistically pregnant.

The trial results are presented in Table 3 (Trial one).

The efficacy of azelastine HCl nasal solution (nasal spray), 0.ane% i spray per nostril twice daily for seasonal allergic rhinitis is supported by two, two-week, placebo-controlled clinical trials with azelastine HCl nasal solution (nasal spray) without sweetener in 413 patients with seasonal allergic rhinitis. In these trials, efficacy was assessed using the TNSS (described above). Azelastine HCl nasal solution (nasal spray) without sweetener demonstrated a greater decrease from baseline in the summed AM and PM rTNSS compared with placebo and the difference was statistically pregnant.

AzelastineHCl Nasal Solution (Nasal Spray), 0.15%

The efficacy and safety of azelastine HCl nasal solution (nasal spray), 0.15% in seasonal allergic rhinitis was evaluated in five randomized, multicenter, double-blind, placebo-controlled clinical trials in 2499 developed and adolescent patients 12 years and older with symptoms of seasonal allergic rhinitis (Trials 2, 3, four, 5, and half-dozen). 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 every bit described to a higher place, and other supportive secondary efficacy variables. The primary efficacy endpoint was the mean change from baseline in rTNSS over 2 weeks.

2 ii-calendar week seasonal allergic rhinitis trials evaluated the efficacy of azelastine HCl nasal solution (nasal spray), 0.15% dosed at ii sprays twice daily. The first trial (Trial 2) compared the efficacy of azelastine HCl nasal solution (nasal spray), 0.fifteen% and azelastine HCl nasal solution (nasal spray) without sweetener to vehicle placebo. The other trial (Trial 3) compared the efficacy of azelastine HCl nasal solution (nasal spray), 0.15% and azelastine HCl nasal solution (nasal spray), 0.1% to vehicle placebo. In these two trials, azelastine HCl nasal solution (nasal spray), 0.15% demonstrated greater decreases in rTNSS than placebo and the differences were statistically significant (Tabular array 3).

Three 2-week seasonal allergic rhinitis trials evaluated the efficacy of azelastine HCl nasal solution (nasal spray), 0.15% dosed at 2 sprays one time daily compared to the vehicle placebo. Trial 4 demonstrated a greater decrease in rTNSS than placebo and the difference was statistically meaning (Tabular array 3). Trial five and Trial 6 were conducted in patients with Texas mountain cedar allergy. In Trial five and Trial 6, azelastine HCl nasal solution (nasal spray), 0.xv% demonstrated a greater decrease in rTNSS than placebo and the differences were statistically meaning (Trials 5 and vi; Table three). Instantaneous TNSS results for the once daily dosing regimen of azelastine HCl nasal solution (nasal spray), 0.15% are shown in Tabular array 4. In Trials 5 and 6, azelastine HCl nasal solution (nasal spray), 0.15% demonstrated a greater decrease in iTNSS than placebo and the differences were statistically significant.

Table 3: Mean Alter from Baseline in Cogitating TNSS over 2 Weeks* in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis

	Treatment (sprays per calendar month)	n	Baseline LS Mean	Change from Baseline	Difference From Placebo
					LS Mean	95% CI	P value
Trial 1
Two sprays twice daily	Azelastine HCl nasal solution (nasal spary), 0.ane%	146	18.0	-five.0	-ii.2	-3.2, -1.2	<0.001
	Azelastine HCl nasal solution (nasal spary), without sweetener	137	18.2	-iv.2	-1.4	-2.4, -0.iv	0.01
	Vehicle Placebo	138	xviii.2	-2.8
One sprays twice daily	Azelastine HCl nasal solution (nasal spary), 0.1%	139	xviii.ii	-4.two	-0.7	-i.7, 0.three	0.18
	Azelastine HCl nasal solution (nasal spary), without sweetener	137	18.one	-4.0	-0.iv	-ane.5, 0.6	0.41
	Vehicle Placebo	137	xviii.0	-3.5
Trial 2
Two sprays twice daily	Azelastine HCl nasal solution (nasal spary), 0.15%	153	xviii.ii	-4.3	-ane.2	-ii.1, -0.3	0.01
	Azelastine HCl nasal solution (nasal spary), without sweetener	153	17.9	-3.9	-0.9	-1.8, 0.1	0.07
	Vehicle Placebo	153	18.ane	-three.0
Trial iii
Two sprays twice daily	Azelastine HCl nasal solution (nasal spary), 0.15%	177	17.seven	-5.1	-iii.0	-3.nine, -two.ane	<0.001
	Azelastine HCl nasal solution (nasal spary), 0.one%	169	18.2	-4.2	-ii.i	-3.0, -1.2	<0.001
	Vehicle Placebo	177	17.7	-two.1
Trial 4
Two sprays once daily	Azelastine HCl nasal solution (nasal spary), 0.15%	238	17.4	-3.4	-1.0	-1.7, -0.3	0.008
	Vehicle Placebo	242	17.four	-two.4
Trial 5
2 sprays once daily	Azelastine HCl nasal solution (nasal spary), 0.15%	266	18.5	-3.3	-1.0	-2.1, -0.8	<0.001
	Vehicle Placebo	266	18.0	-1.9
Trial vi
Two sprays in one case daily	Azelastine HCl nasal solution (nasal spary), 0.15%	251	18.5	-three.iii	-1.iv	-two.1, -0.8	<0.001
	Vehicle Placebo	254	eighteen.8	-2.0
*Sum of AM and PM rTNSS for each twenty-four hour period (Maximum score =24) and averaged over the fourteen day treatment period

Table 4: Hateful Change from Baseline AM Instantaneous TNSS over 2 Weeks* in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis

	Handling (sprays per nostril once daily)	n	Baseline LS Mean	Alter from Baseline	Difference From Placebo
					LS Hateful	95% CI	P value
Trial four
Two sprays once daily	Azelastine HCl nasal solution (nasal spary), 0.15%	238	8.ane	-one.iii	-0.2	-0.half dozen, 0.1	0.15
	Vehicle Placebo	242	8.iii	-1.1
Trial 5
Two sprays once daily	Azelastine HCl nasal solution (nasal spary), 0.15%	266	eight.7	-1.4	-0.7	-i.0, -0.4	<0.001
	Vehicle Placebo	266	8.3	-0.7
Trial 6
Ii sprays once daily	Azelastine HCl nasal solution (nasal spary), 0.xv%	251	8.9	-1.4	-0.6	-0.nine, -0.3	<0.001
	Vehicle Placebo	254	8.nine	-0.8
*AM iTNSS for each day (Maximum score =12) and averaged over the fourteen 24-hour interval handling flow

Azelastine HCl nasal solution (nasal spray), 0.15% at a dose of 1 spray twice daily was non studied. The azelastine HCl nasal solution (nasal spray), 0.fifteen% 1 spray twice daily dosing regimen is supported by previous findings of efficacy for azelastine HCl nasal solution (nasal spray) without sweetener and a favorable comparison of azelastine HCl nasal solution (nasal spray), 0.15% to azelastine HCl nasal solution (nasal spray) without sweetener and azelastine HCl nasal solution (nasal spray), 0.ane% (Tabular array 3).

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals' azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Perennial Allergic Rhinitis

AzelastineHCl Nasal Solution (Nasal Spray), 0.15%

The efficacy and condom of azelastine HCl nasal solution (nasal spray), 0.fifteen% in perennial allergic rhinitis was evaluated in 1 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% blackness, 1% Asian, 3% other; 17% Hispanic, 83% not-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 full nasal symptom score (iTNSS), and other supportive secondary efficacy variables. The master efficacy endpoint was the mean modify from baseline rTNSS over 4 weeks. The i 4-week perennial allergic rhinitis trial evaluated the efficacy of azelastine HCl nasal solution (nasal spray), 0.fifteen%, azelastine HCl nasal solution (nasal spray), 0.1%, and vehicle placebo dosed at 2 sprays per nostril twice daily. In this trial, azelastine HCl nasal solution (nasal spray), 0.15% demonstrated a greater decrease in rTNSS than placebo and the difference was statistically significant (Tabular array 5).

Table 4: Hateful Modify from Baseline in Reflective TNSS over four Weeks* in Adults and Children ≥ 12 years with Perennial Allergic Rhinitis

	Treatment (sprays per nostril twice daily)	n	Baseline LS Hateful	Alter from Baseline	Difference From Placebo
					LS Mean	95% CI	P value
Ii sprays once daily	Azelastine HCl nasal solution (nasal spary), 0.xv%	192	fifteen.viii	-4.0	-0.9	-1.7, -0.ane	0.03
	Azelastine HCl nasal solution (nasal spary), 0.1%	194	xv.5	-3.viii	-0.vii	-ane.five, 0.ane	0.08
	Vehicle Placebo	192	fourteen.7	-three.1
*Sum of AM and PM rTNSS for each day (Maximum score =24) and averaged over the 28 day treatment period

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals' azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals' marketing exclusivity rights, this drug product is not labeled with that pediatric information.

PATIENT Data

Azelastine HCl Nasal Solution (Nasal Spray), 0.xv%

Important: For use in your nose only.

What is AzelastineHCl Nasal Solution (Nasal Spray), 0.fifteen%?

• Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is a prescription medicine used to treat symptoms of seasonal and year-circular allergic rhinitis in people age 12 and older.
• Azelastine HCl Nasal Solution (Nasal Spray), 0.xv% may assistance to reduce your nasal symptoms including stuffy olfactory organ, runny olfactory organ, itching and sneezing.

It is not known if Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is safe and effective in children under 6 years of age.

What should I tell my healthcare provider before using AzelastineHCl Nasal Solution (Nasal Spray), 0.15%?

Before using AzelastineHCl Nasal Solution (Nasal Spray), 0.fifteen%, tell your healthcare provider if you are:

• allergic to whatsoever of the ingredients in Azelastine HCl Nasal Solution (Nasal Spray), 0.15%. See the cease of this leaflet for a consummate list of ingredients in Azelastine HCl Nasal Solution (Nasal Spray), 0.15%.
• significant, or programme to become significant. Information technology is non known if Azelastine HCl Nasal Solution (Nasal Spray), 0.15% will harm your unborn baby.
• breastfeeding, or plan to breastfeed. It is not known if Azelastine HCl Nasal Solution (Nasal Spray), 0.15% passes into your chest milk. Yous and your healthcare provider should decide if you will utilise Azelastine HCl Nasal Solution (Nasal Spray), 0.15% if you plan to breastfeed.

Tell your healthcare provider nearly all the medicines y'all take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Azelastine HCl Nasal Solution (Nasal Spray), 0.15% and other medicines may affect each other, causing side effects.

How should I use AzelastineHCl Nasal Solution (Nasal Spray), 0.fifteen%?

• Read the Instructions for Use at the end of this leaflet for information about the correct way to use Azelastine HCl Nasal Solution (Nasal Spray), 0.xv%.
• Spray Azelastine HCl Nasal Solution (Nasal Spray), 0.15% in your olfactory organ merely. Practise not spray information technology into your eyes or oral cavity.
• Utilize Azelastine HCl Nasal Solution (Nasal Spray), 0.15% exactly as your healthcare provider tells you lot to use it.
• Do non use more than than your healthcare provider tells you.
• Throw away your Azelastine HCl Nasal Solution (Nasal Spray), 0.xv% bottle later on using 200 sprays. Fifty-fifty though the canteen may not exist completely empty, you may not get the correct dose of medicine.
• If you lot use also much or a child accidentally swallows Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen%, call your healthcare provider or go to the nearest infirmary emergency room right away.

What should I avoid while using AzelastineHCl Nasal Solution (Nasal Spray), 0.15%?

AzelastineHCl Nasal Solution (Nasal Spray), 0.15% tin can cause sleepiness:

• Do not drive, operate machinery, or do other dangerous activities until you know how Azelastine HCl Nasal Solution (Nasal Spray), 0.xv% affects y'all.
• Exercise not drinkable alcohol or take other medicines that may cause you to feel sleepy while using Azelastine HCl Nasal Solution (Nasal Spray), 0.15%. It may make your sleepiness worse.

What are the possible side furnishings of AzelastineHCl Nasal Solution (Nasal Spray), 0.15%?

The most common side effects of Azelastine HCl Nasal Solution (Nasal Spray), 0.15% include:

• unusual biting taste
• olfactory organ pain or discomfort
• nosebleeds
• headache
• sneezing
• fatigue
• sleepiness

Tell your healthcare provider if you accept any side effect that bothers you or that does non become abroad.

These are not all of the possible side effects of Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen%. For more than data, ask your healthcare provider or chemist.

Phone call your medico for medical communication about side effects. Yous may report side effects to FDA at i-800- FDA-1088.

How should I store AzelastineHCl Nasal Solution (Nasal Spray), 0.15%?

• Keep Azelastine HCl Nasal Solution (Nasal Spray), 0.15% upright at 68°F to 77°F (twenty°C to 25°C).
• Do not freeze Azelastine HCl Nasal Solution (Nasal Spray), 0.xv%.
• Practice not use Azelastine HCl Nasal Solution (Nasal Spray), 0.15% later on the expiration date "EXP" on the medicine label and box.

Keep AzelastineHCl Nasal Solution (Nasal Spray), 0.15% and all medicines out of reach of children.

General data nearly the safe and effective utilize of AzelastineHCl Nasal Solution (Nasal Spray), 0.xv%.

Medicines are sometimes prescribed for weather other than those listed in a Patient Information leaflet.

Do not use Azelastine HCl Nasal Solution (Nasal Spray), 0.15% for a condition for which it was not prescribed. Practise not give Azelastine HCl Nasal Solution (Nasal Spray), 0.15% to other people, even if they have the aforementioned symptoms that you take. It may harm them.

This Patient Data leaflet summarizes the near important information about Azelastine HCl Nasal Solution (Nasal Spray), 0.xv%. If you would like more information, talk with your healthcare provider. You can ask your chemist or healthcare provider for information about Azelastine HCl Nasal Solution (Nasal Spray), 0.15% that is written for health professionals.

What are the ingredients in Azelas tineHCl Nasal Solution (Nasal Spray), 0.xv%?

Agile ingredient: azelastine hydrochloride

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

Patient Instructions for Use

Of import: For use in your nose simply.

For the correct dose of medicine:

• Keep your head tilted downward when spraying into your nostril.
• Change nostrils each fourth dimension you utilise the spray.
• Breathe gently and do not tip your caput back later on using the spray. This will keep the medicine from running downward into your throat. Yous may get a bitter taste in your mouth.

Figure A identifies the parts of your Azelastine HCl Nasal Solution (Nasal Spray), 0.15% pump

Before you use AzelastineHCl Nasal Solution (Nasal Spray), 0.15% for the first time, y'all volition need to prime the bottle.

Priming your AzelastineHCl Nasal Solution (Nasal Spray), 0.15%

Remove the violet dust cover over the tip of the canteen and the violet safety prune just under the "shoulders" of the canteen. (See Figure B).

Concord the bottle upright with 2 fingers on the shoulders of the spray pump unit and

• put your pollex on the bottom of the bottle. Printing upwardly with your thumb and release for the pumping activeness. Repeat this until you lot run across a fine mist. (See Effigy C).



• To go a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. If you encounter a stream of liquid, the pump is not working correctly and yous may have nasal discomfort.
• This should happen in 6 sprays or less.

Now your pump is primed and set to use.

• Practise non employ Azelastine HCl Nasal Solution (Nasal Spray), 0.15% unless you lot run into a fine mist afterward you do the priming sprays. If you lot do not run into a fine mist, clean the tip of the spray nozzle. See the "Cleaning the Spray Tip of your AzelastineHCl Nasal Solution (Nasal Spray), 0.xv%" section below.
• If you lot do non use Azelastine HCl Nasal Solution (Nasal Spray), 0.15% for 3 or more days, you will need to prime the pump with 2 sprays or until yous run across a fine mist.

Using your AzelastineHCl Nasal Solution (Nasal Spray), 0.fifteen%

Step ane.Accident your nose to clear your nostrils.

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

Step 3.Place the spray tip well-nigh ¼ inch to ½ inch into ane nostril. Hold bottle upright and aim the spray tip toward the back of your nose (Encounter Figure D).

Stride 4.Close your other nostril with a finger. Press the pump 1 fourth dimension and sniff gently at the same fourth dimension, keeping your caput tilted forwards and down (Meet Figure Eastward).

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

Step half dozen.If your healthcare provider tells y'all to use 2 sprays in each nostril, repeat Steps two through 4 higher up for the second spray in each nostril.

Step 7.Breathe in gently, and do not tilt your head back afterwards using Azelastine HCl Nasal Solution (Nasal Spray), 0.15%. This volition aid to proceed the medicine from going into your throat.

Step eight.When you cease using your Azelastine HCl Nasal Solution (Nasal Spray), 0.fifteen%, wipe the spray tip with a clean tissue or textile. Put the safe clip and grit cover back on the bottle.

Cleaning the Spray Tip of your AzelastineHCl Nasal Solution (Nasal Spray), 0.xv%

• If the spray tip opening is clogged, exercise 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 just the spray pump unit in warm water. Squirt the spray unit of measurement several times while holding it under water. Use the pumping action to clear the opening in the tip (Come across Figure M).



• Let the spray pump unit air dry. Make sure it is dry before you put it back onto the canteen.
• Put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the correct).
• To proceed the medicine from leaking out, use firm pressure when you put the pump back onto the canteen.
• After cleaning, follow the instructions for priming.

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

From

Report Issues to the Nutrient and Drug Administration

You are encouraged to report negative side furnishings of prescription drugs to the FDA. Visit the FDA MedWatch website or phone call ane-800-FDA-1088.

How To Use Azelastine Hydrochloride Nasal Spray,

Source: https://www.rxlist.com/azelastine-nasal-spray-drug.htm

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