FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Available from:
Hi-Tech Pharmacal Co., Inc.
INN (International Name):
FLUTICASONE PROPIONATE
Composition:
FLUTICASONE PROPIONATE 50 ug in 0.1 g
Administration route:
NASAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Fluticasone propionate nasal spray, USP is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. Fluticasone propionate nasal spray, USP is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3) , Description (11) ]. Teratogenic Effects Pregnancy Category C. There are no adequate and well-controlled trials with fluticasone propionate nasal spray, USP in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray, USP. Mice and rat
Product summary:
Fluticasone Propionate Nasal Spray, USP 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, in a box of 1 with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used. Store between 4° and 30°C (39° and 86°F).
Authorization status:
Abbreviated New Drug Application
Authorization number:
50383-700-09, 50383-700-16

FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

Hi-Tech Pharmacal Co., Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Fluticasone Propionate Nasal Spray, USP

safely and effectively. See full prescribing information for Fluticasone Propionate Nasal Spray, USP.

Fluticasone Propionate Nasal Spray, USP, 50 mcg

FOR INTRANASAL USE

Initial U.S. Approval: 1994

RECENT MAJOR CHANGES

Indications and Usage (1) 01/2015

INDICATIONS AND USAGE

Fluticasone propionate nasal spray, USP is a corticosteroid indicated for the management of the nasal symptoms of

perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (1) (1)

DOSAGE AND ADMINISTRATION

For intranasal use only. Recommended starting dosages: (2)

DOSAGE FORMS AND STRENGTHS

Nasal spray: 50 mcg of fluticasone propionate in each 100-mg spray. (3) (3)

CONTRAINDICATIONS

Hypersensitivity to any ingredient. (4) (4)

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions (>3%) are headache, pharyngitis, epistaxis, nasal burning/nasal irritation,

nausea/vomiting, asthma symptoms, and cough. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA

at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of

systemic corticosteroid effects. (7.1) (7)

USE IN SPECIFIC POPULATIONS

Hepatic impairment: Monitor patients for signs of increased drug exposure. (8.6) (8)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2016

Adults: 2 sprays per nostril once daily (200 mcg per day). (2.1)

Adolescents and children aged 4 years and older: 1 spray per nostril once daily (100 mcg per day). (2.2)

Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing. Monitor

patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers,

nasal surgery, or nasal trauma. (5.1)

Close monitoring for glaucoma and cataracts is warranted. (5.2)

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported

after administration of fluticasone propionate nasal spray, USP. Discontinue fluticasone propionate nasal spray, USP if

such reactions occur. (5.3)

Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular

herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox

or measles can occur in susceptible patients. (5.4)

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible

individuals. If such changes occur, discontinue fluticasone propionate nasal spray, USP slowly. (5.5)

Monitor growth of pediatric patients. (5.7)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Adults

2.2 Adolescents and Children (Aged 4 Years and Older)

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Effects

5.2 Glaucoma and Cataracts

5.3 Hypersensitivity Reactions including Anaphylaxis

5.4 Immunosuppression

5.5 Hypercorticism and Adrenal Suppression

5.6 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

5.7 Effect on Growth

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Inhibitors of Cytochrome P450 3A4

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Fluticasone propionate nasal spray, USP is indicated for the management of the nasal symptoms of

perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older.

2 DOSAGE AND ADMINISTRATION

Administer fluticasone propionate nasal spray, USP by the intranasal route only. Prime fluticasone

Sections or subsections omitted from the full prescribing information are not listed.

propionate nasal spray, USP before using for the first time or after a period of non-use (1 week or

more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake

fluticasone propionate nasal spray, USP gently before each use.

Patients should use fluticasone propionate nasal spray, USP at regular intervals since its effectiveness

depends on its regular use. Maximum effect may take several days and individual patients will

experience a variable time to onset and different degree of symptom relief.

2.1 Adults

The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each

nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril

administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may

be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.

Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There

is no evidence that exceeding the recommended dose is more effective.

2.2 Adolescents and Children (Aged 4 Years and Older)

The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each

nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each

nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). Once adequate control is

achieved, the dosage should be decreased to 1 spray in each nostril once daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). There is no

evidence that exceeding the recommended dose is more effective.

3 DOSAGE FORMS AND STRENGTHS

Fluticasone propionate nasal spray, USP is a nasal spray suspension. Each 100-mg spray delivers 50

mcg of fluticasone propionate.

4 CONTRAINDICATIONS

Fluticasone propionate nasal spray, USP is contraindicated in patients with hypersensitivity to any of its

ingredients [see Warnings and Precautions (5.3), Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Effects

Epistaxis

In clinical trials of 2 to 26 weeks’ duration, epistaxis was observed more frequently in subjects treated

with fluticasone propionate nasal spray, USP than those who received placebo [see Adverse Reactions

(6.1)].

Nasal Ulceration

Postmarketing cases of nasal ulceration have been reported in patients treated with fluticasone

propionate nasal spray, USP [see Adverse Reactions (6.2)].

Candida Infection

In clinical trials with fluticasone propionate administered intranasally, the development of localized

infections of the nose and pharynx with Candida albicans has occurred. When such an infection

develops, it may require treatment with appropriate local therapy and discontinuation of fluticasone

propionate nasal spray, USP. Patients using fluticasone propionate nasal spray, USP over several months

or longer should be examined periodically for evidence of Candida infection or other signs of adverse

effects on the nasal mucosa.

Nasal Septal Perforation

Postmarketing cases of nasal septal perforation have been reported in patients treated with fluticasone

propionate nasal spray, USP [see Adverse Reactions (6.2)].

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced

recent nasal ulcers, nasal surgery, or nasal trauma should avoid using fluticasone propionate nasal

spray, USP until healing has occurred.

5.2 Glaucoma and Cataracts

Use of intranasal and inhaled corticosteroids may result in the development of glaucoma and/or

cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history

of increased intraocular pressure, glaucoma, and/or cataracts.

5.3 Hypersensitivity Reactions including Anaphylaxis

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have

been reported after administration of fluticasone propionate nasal spray, USP. Discontinue fluticasone

propionate nasal spray, USP if such reactions occur [see Contraindications (4)]. Rarely, immediate

hypersensitivity reactions may occur after the administration of fluticasone propionate nasal spray, USP.

5.4 Immunosuppression

Persons who are using drugs that suppress the immune system are more susceptible to infections than

healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course

in susceptible children or adults using corticosteroids. In such children or adults who have not had

these diseases or been properly immunized, particular care should be taken to avoid exposure. How the

dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated

infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment

to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster

immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled

intramuscular immunoglobulin (IG) may be indicated. (See the complete prescribing information for

VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered.

Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent

tuberculous infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections;

or ocular herpes simplex.

5.5 Hypercorticism and Adrenal Suppression

When intranasal corticosteroids are used at higher than recommended dosages or in susceptible

individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and

adrenal suppression may appear. If such changes occur, the dosage of fluticasone propionate nasal

spray, USP should be discontinued slowly consistent with accepted procedures for discontinuing oral

corticosteroid therapy.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by

signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid

withdrawal (e.g., joint and/or muscular pain, lassitude, depression). Patients previously treated for

prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be

carefully monitored for acute adrenal insufficiency in response to stress. In patients who have asthma or

other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in

systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

5.6 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir,

clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin,

conivaptan, lopinavir, nefazodone, voriconazole) with fluticasone propionate nasal spray, USP is not

recommended because increased systemic corticosteroid adverse effects may occur [see Drug

Interactions (7.1), Clinical Pharmacology (12.3)].

5.7 Effect on Growth

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric

patients [see Use in Specific Populations (8.4)]. Monitor the growth routinely of pediatric patients

receiving fluticasone propionate nasal spray, USP. To minimize the systemic effects of intranasal

corticosteroids, including fluticasone propionate nasal spray, USP, titrate each patient’s dose to the

lowest dosage that effectively controls his/her symptoms [see Dosage and Administration (2), Use in

Specific Populations (8.4)].

6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another

drug and may not reflect the rates observed in practice.

In controlled U.S. clinical trials, more than 3,300 subjects with allergic and nonallergic rhinitis

received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical trials

have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions

were reported with approximately the same frequency by subjects treated with placebo. Less than 2% of

subjects in clinical trials discontinued because of adverse reactions; this rate was similar for vehicle

placebo and active comparators.

The safety data described below are based on 7 placebo-controlled clinical trials in subjects with

allergic rhinitis. The 7 trials included 536 subjects (57 girls and 108 boys aged 4 to 11 years, 137

female and 234 male adolescents and adults) treated with fluticasone propionate 200 mcg once daily

over 2 to 4 weeks and 2 placebo-controlled clinical trials which included 246 subjects (119 female and

127 male adolescents and adults) treated with fluticasone propionate 200 mcg once daily over 6 months

(Table 1). Also included in Table 1 are adverse reactions from 2 trials in which 167 children (45 girls

and 122 boys aged 4 to 11 years) were treated with fluticasone propionate 100 mcg once daily for 2 to

4 weeks.

Table 1. Adverse Reactions with Fluticasone Propionate Nasal Spray, USP with >3% Incidence

and More Common than Placebo in Subjects ≥4 Years with Allergic Rhinitis

Adverse Reaction

Fluticas one

Propionate 100 mcg

Fluticas one

Propionate 200

Placebo

(n = 758)

Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired

wound healing [see Warnings and Precautions (5.1)]

Cataracts and glaucoma [see Warnings and Precautions (5.2)]

Immunosuppression [see Warnings and Precautions (5.4)]

Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5)]

Effect on growth [see Warnings and Precautions (5.7)]

Once Daily

(n = 167)

%

mcg

Once Daily

(n = 782)

%

%

Headache

Pharyngitis

Epistaxis

Nasal burning/nasal irritation

Nausea/vomiting

Asthma symptoms

Cough

16.1

14.6

Other adverse reactions with fluticasone propionate nasal spray, USP observed with an incidence less

than or equal to 3% but greater than or equal to 1% and more common than with placebo included: blood

in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains,

dizziness, and bronchitis.

6.2 Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse events have been

identified during postapproval use of intranasal fluticasone propionate. 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. These events have been chosen for

inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone

propionate or a combination of these factors.

General Disorders and Administration Site Conditions

Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus,

urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare

instances were severe.

Ear and Labyrinth Disorders

Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore

throat, throat irritation and dryness, cough, hoarseness, and voice changes.

Eye Disorders

Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and

cataracts.

Cases of growth suppression have been reported for intranasal corticosteroids, including fluticasone

propionate [see Warnings and Precautions (5.7)].

7 DRUG INTERACTIONS

7.1 Inhibitors of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir,

atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole,

telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with fluticasone propionate nasal spray,

USP is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir

A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown

that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate

exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology

(12.3)]. During postmarketing use, there have been reports of clinically significant drug interactions in

patients receiving fluticasone propionate products, including fluticasone propionate nasal spray, USP,

with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal

suppression.

Ketoconazole

Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once

daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in

plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects

Pregnancy Category C. There are no adequate and well-controlled trials with fluticasone propionate

nasal spray, USP in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory

animals when administered systemically at relatively low dosage levels. Because animal reproduction

studies are not always predictive of human response, fluticasone propionate nasal spray, USP should be

used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should

be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal

spray, USP.

Mice and rats at fluticasone propionate doses approximately 1 and 4 times, respectively, the maximum

recommended human daily intranasal dose (MRHDID) for adults (on a mg/m basis at maternal

subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of

potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate,

and retarded cranial ossification. No teratogenicity was seen in rats at doses up to 3 times the MRHDID

(on a mg/m basis at maternal inhalation doses up to 68.7 mcg/kg/day).

In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose

approximately 0.3 times the MRHDID for adults (on a mg/m basis at a maternal subcutaneous dose of 4

mcg/kg/day). However, no teratogenic effects were reported at fluticasone propionate doses up to

approximately 20 times the MRHDID for adults (on a mg/m basis at a maternal oral dose up to 300

mcg/kg/day). No fluticasone propionate was detected in the plasma in this study, consistent with the

established low bioavailability following oral administration [see Clinical Pharmacology (12.3)].

Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and

oral administration to rabbits.

Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to

physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids

than humans. In addition, because there is a natural increase in corticosteroid production during

pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need

corticosteroid treatment during pregnancy.

Nonteratogenic Effects

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such

infants should be carefully monitored.

8.3 Nursing Mothers

It is not known whether fluticasone propionate is excreted in human breast milk. However, other

corticosteroids have been detected in human milk. Subcutaneous administration to lactating rats of

tritiated fluticasone propionate at a dose approximately 0.4 times the MRHDID for adults on a mg/m2

basis resulted in measurable radioactivity in milk.

Since there are no data from controlled trials on the use of intranasal fluticasone propionate nasal spray,

USP by nursing mothers, caution should be exercised when fluticasone propionate nasal spray, USP is

administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of fluticasone propionate nasal spray, USP in children aged 4 years and

older have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)].Six hundred

fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in US clinical

trials with fluticasone propionate nasal spray. The safety and effectiveness of fluticasone propionate

nasal spray, USP in children younger than 4 years have not been established.

Effects on Growth

Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth

velocity when administered to pediatric patients. This effect was observed in the absence of laboratory

evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is

a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some

commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity

associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The

potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids

has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids,

including fluticasone propionate nasal spray, USP, should be monitored routinely (e.g., via stadiometry).

The potential growth effects of prolonged treatment should be weighed against the clinical benefits

obtained and the risks associated with alternative therapies. To minimize the systemic effects of

intranasal corticosteroids, including fluticasone propionate nasal spray, USP, each patient’s dosage

should be titrated to the lowest dosage that effectively controls his/her symptoms.

A 1-year placebo-controlled trial was conducted in 150 pediatric subjects (aged 3 to 9 years) to assess

the effect of fluticasone propionate nasal spray, USP (single daily dose of 200 mcg) on growth

velocity. From the primary population receiving fluticasone propionate nasal spray, USP (n = 56) and

placebo (n = 52), the point estimate for growth velocity with fluticasone propionate nasal spray, USP

was 0.14 cm/year lower than placebo (95% CI: -0.54, 0.27 cm/year). Thus, no statistically significant

effect on growth was noted compared with placebo. No evidence of clinically relevant changes in HPA

axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion

and dual-energy x-ray absorptiometry, respectively.

The potential for fluticasone propionate nasal spray, USP to cause growth suppression in susceptible

patients or when given at higher than recommended dosages cannot be ruled out.

8.5 Geriatric Use

A limited number of subjects aged 65 years and older (n = 129) or 75 years and older (n = 11) have been

treated with fluticasone propionate nasal spray, USP in clinical trials. While the number of subjects is

too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this

population were similar to those reported by 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.

8.6 Hepatic Impairment

A limited number of subjects aged 65 years and older (n = 129) or 75 years and older (n = 11) have been

treated with fluticasone propionate nasal spray, USP in clinical trials. While the number of subjects is

too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this

population were similar to those reported by 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.

8.7 Renal Impairment

Formal pharmacokinetic trials using fluticasone propionate nasal spray, USP have not been conducted in

subjects with renal impairment.

10 OVERDOSAGE

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions

(5.5)]. Intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate

twice daily for 7 days was administered to healthy human volunteers. Adverse events reported with

fluticasone propionate were similar to placebo, and no clinically significant abnormalities in laboratory

safety tests were observed. Single oral doses up to 16 mg have been studied in human volunteers with

no acute toxic effects reported. Repeat oral doses up to 80 mg daily for 10 days in volunteers and

repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were

of mild or moderate severity, and incidences were similar in active and placebo treatment groups. Acute

overdosage with this dosage form is unlikely since 1 bottle of fluticasone propionate nasal spray, USP

contains approximately 8 mg of fluticasone propionate.

11 DESCRIPTION

The active component of Fluticasone Propionate Nasal Spray, USP is fluticasone propionate, a

corticosteroid having the chemical name S- (fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-

methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:

Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula

is C

H F O S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and

dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Fluticasone Propionate Nasal Spray, USP, 50 mcg is an aqueous suspension of microfine fluticasone

propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump.

Fluticasone Propionate Nasal Spray, USP also contains benzalkonium

chloride (0.02% w/w), carboxymethylcellulose sodium, dextrose, microcrystalline cellulose,

phenylethyl alcohol (0.25% w/w), polysorbate 80, and purified water and has a pH between 5.8 and 6.8.

After initial priming, each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation

through the nasal adapter.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.

Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid

receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-

monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of

budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The

clinical significance of these findings is unknown.

The precise mechanism through which fluticasone propionate affects rhinitis symptoms is not known.

Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast

cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids,

leukotrienes, cytokines) involved in inflammation. In 7 trials in adults, fluticasone propionate nasal spray,

USP has decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in

39% of patients (28% for placebo). The direct relationship of these findings to long-term symptom

relief is not known.

12.2 Pharmacodynamics

HPA Axis Effect

The potential systemic effects of fluticasone propionate nasal spray, USP on the HPA axis were

evaluated. fluticasone propionate nasal spray, USP given as 200 mcg once daily or 400 mcg twice daily

was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. Fluticasone

propionate nasal spray, USP at either dosage for 4 weeks did not affect the adrenal response to 6-hour

cosyntropin stimulation, while both dosages of oral prednisone significantly reduced the response to

cosyntropin.

Cardiac Electrophysiology

A study specifically designed to evaluate the effect of fluticasone propionate on the QT interval has not

been conducted.

12.3 Pharmacokinetics

The activity of fluticasone propionate nasal spray, USP is due to the parent drug, fluticasone

propionate. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic

data was obtained via other routes of administration.

Absorption

Indirect calculations indicate that fluticasone propionate delivered by the intranasal route has an

absolute bioavailability averaging less than 2%. Trials using oral dosing of labeled and unlabeled drug

have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (<1%),

primarily due to incomplete absorption and presystemic metabolism in the gut and liver. After intranasal

treatment of patients with rhinitis for 3 weeks, fluticasone propionate plasma concentrations were above

the level of detection (50 pg/mL) only when recommended doses were exceeded and then only in

occasional samples at low plasma levels.

Distribution

Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid

and consistent with its high lipid solubility and tissue binding. The volume of distribution averaged 4.2

L/kg.

The percentage of fluticasone propionate bound to human plasma proteins averaged 99%. Fluticasone

propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human

transcortin.

Elimination

Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a

terminal elimination half-life of approximately 7.8 hours. The total blood clearance of fluticasone

propionate is high (average: 1,093 mL/min), with renal clearance accounting for less than 0.02% of the

total.

Metabolism: The only circulating metabolite detected in man is the 17β-carboxylic acid derivative of

fluticasone propionate, which is formed through the CYP3A4 pathway. This metabolite had less affinity

(approximately 1/2,000) than the parent drug for the glucocorticoid receptor of human lung cytosol in

vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using

cultured human hepatoma cells have not been detected in man.

Excretion: Less than 5% of a radiolabeled oral dose was excreted in the urine as metabolites, with the

remainder excreted in the feces as parent drug and metabolites.

Special Populations

Fluticasone propionate nasal spray was not studied in any special populations, and no gender-specific

pharmacokinetic data have been obtained.

Drug Interactions

Inhibitors of Cytochrome P450 3A4: Ritonavir: Fluticasone propionate is a substrate of CYP3A4.

Coadministration of fluticasone propionate and the strong CYP3A4 inhibitor, ritonavir, is not

recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects.

Fluticasone propionate aqueous nasal spray (200 mcg once daily) was coadministered for 7 days with

ritonavir (100 mg twice daily). Plasma fluticasone propionate concentrations following fluticasone

propionate aqueous nasal spray alone were undetectable (<10 pg/mL) in most subjects, and when

concentrations were detectable, peak levels (C

) averaged 11.9 pg/mL (range: 10.8 to 14.1 pg/mL)

and AUC

averaged 8.43 pgh/mL (range: 4.2 to 18.8 pgh/mL). Fluticasone propionate C

increased to 318 pg/mL (range: 110 to 648 pg/mL) and 3,102.6 pgh/mL (range: 1,207.1 to

5,662.0 pgh/mL), respectively, after coadministration of ritonavir with fluticasone propionate aqueous

nasal spray. This significant increase in plasma fluticasone propionate exposure resulted in a significant

decrease (86%) in serum cortisol AUC.

Ketoconazole: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole

(200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a

45% decrease in plasma cortisol AUC, but had no effect on urinary excretion of cortisol.

Erythromycin: In a multiple-dose drug interaction study, coadministration of orally inhaled fluticasone

propionate (500 mcg twice daily) and erythromycin (333 mg 3 times daily) did not affect fluticasone

propionate pharmacokinetics.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg

(approximately 20 times the MRHDID in adults and approximately 10 times the MRHDID in children on

a mcg/m basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately 2 times the

MRHDID in adults and approximately equivalent to the MRHDID in children on a mcg/m basis) for 104

weeks.

Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No

significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the

mouse micronucleus test.

No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up

to 50 mcg/kg (approximately 2 times the MRHDID in adults on a mcg/m basis). Prostate weight was

significantly reduced at a subcutaneous dose of 50 mcg/kg.

(0-τ)

(0-τ)

14 CLINICAL STUDIES

Perennial Nonallergic Rhinitis: Three randomized, double-blind, parallel-group, vehicle placebo-

controlled trials were conducted in 1,191 subjects to investigate regular use of fluticasone propionate

nasal spray, USP in subjects with perennial nonallergic rhinitis. These trials evaluated subject-rated

total nasal symptom scores (TNSS) that included nasal obstruction, postnasal drip, rhinorrhea in subjects

treated for 28 days of double-blind therapy and in 1 of the 3 trials for 6 months of open-label treatment.

Two of these trials demonstrated that subjects treated with fluticasone propionate nasal spray, USP (100

mcg twice daily) exhibited statistically significant decreases in TNSS compared with subjects treated

with vehicle.

16 HOW SUPPLIED/STORAGE AND HANDLING

Fluticasone Propionate Nasal Spray, USP 50 mcg is supplied in an amber glass bottle fitted with a white

metering atomizing pump, white nasal adapter, in a box of 1 with FDA-approved Patient Labeling (see

Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of

16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100

mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be

assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded

when the labeled number of actuations has been used.

Store between 4° and 30°C (39° and 86°F).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Local Nasal Effects

Inform patients that treatment with fluticasone propionate nasal spray, USP may lead to adverse

reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment

with fluticasone propionate nasal spray, USP. In addition, fluticasone propionate nasal spray, USP has

been associated with nasal septal perforation and impaired wound healing. Patients who have

experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use fluticasone propionate

nasal spray, USP until healing has occurred [see Warnings and Precautions (5.1)].

Glaucoma and Cataracts

Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use.

Advise patients to notify their healthcare providers if a change in vision is noted while using

fluticasone propionate nasal spray, USP [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions, including Anaphylaxis

Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact

dermatitis, and rash, may occur after administration of fluticasone propionate nasal spray, USP. If such

reactions occur, patients should discontinue use of fluticasone propionate nasal spray, USP [see

Warnings and Precautions (5.3)].

Immunosuppression

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox

or measles and if they are exposed to consult their healthcare provider without delay. Inform patients of

potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular

herpes simplex [see Warnings and Precautions (5.4)].

Reduced Growth Velocity

Advise parents that fluticasone propionate nasal spray, USP may cause a reduction in growth velocity

when administered to pediatric patients. Physicians should closely follow the growth of children and

adolescents taking corticosteroids by any route [see Warnings and Precautions (5.7), Pediatric Use

(8.4)].

Use Daily for Best Effect

Inform patients that they should use fluticasone propionate nasal spray, USP on a regular basis.

Fluticasone propionate nasal spray, USP, like other corticosteroids, does not have an immediate effect

on rhinitis symptoms. Maximum benefit may not be reached for several days. Patients should not

increase the prescribed dosage but should contact their healthcare providers if symptoms do not

improve or if the condition worsens.

Keep Spray Out of Eyes and Mouth

Inform patients to avoid spraying fluticasone propionate nasal spray, USP in their eyes and mouth.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Made in USA

Rev. 700:04 08/15

Patient Information

Fluticasone Propionate Nasal Spray, 50 mcg

(floo-T IK-a-s one)

Read the Patient Information that comes with fluticasone propionate nasal spray before you start using it

and each time you get a refill. There may be new information. This Patient Information does not take the

place of talking to your healthcare provider about your medical condition or treatment.

What is fluticasone propionate nasal spray?

Fluticasone propionate nasal spray is a prescription medicine used to treat non-allergy nasal symptoms

such as runny nose, stuffy nose, sneezing, and nasal itching in adults and children aged 4 years and

older.

It is not known if fluticasone propionate nasal spray is safe and effective in children younger than 4

years of age.

Who should not use fluticasone propionate nasal spray?

Do not use fluticasone propionate nasal spray if you are allergic to fluticasone propionate or any of the

ingredients in fluticasone propionate nasal spray. See “What are the ingredients in fluticasone

propionate nasal spray?” below for a complete list of ingredients.

What should I tell my healthcare provider before using fluticasone propionate nasal sp Tell your

healthcare provider about all of your health conditions, including if you:

have or have had nasal sores, nasal surgery, or nasal injury.

have eye problems, such as cataracts or glaucoma.

have an immune system problem.

are allergic to any of the ingredients in fluticasone propionate nasal spray, any other medicines, or

food products. See “What are the ingredients in fluticasone propionate nasal spray?” below

for a complete list of ingredients.

have any type of viral, bacterial, or fungal infection.

are exposed to chickenpox or measles.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-

counter medicines, vitamins, and herbal supplements. Fluticasone propionate nasal spray and certain

other medicines may interact with each other. This may cause serious side effects. Especially, tell your

healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist

when you get a new medicine.

How should I use fluticasone propionate nasal spray?

Read the step-by-step instructions for using fluticasone propionate nasal spray at the end of this

Patient Information.

What are the possible side effects of fluticasone propionate nasal spray?

Fluticasone propionate nasal spray may cause serious side effects, including:

Symptoms of nasal septal perforation may include:

crusting in the nose

nose bleeds

whistling sound when you breathe

have any other medical conditions.

are pregnant or planning to become pregnant. It is not known if fluticasone propionate nasal spray

may harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if fluticasone propionate nasal spray passes

into your breast milk and if it can harm your baby.

Fluticasone propionate nasal spray is for use in your nose only. Do not spray it in your eyes or

mouth.

Children should use fluticasone propionate nasal spray with an adult’s help, as instructed by the

child’s healthcare provider.

Use fluticasone propionate nasal spray exactly as your healthcare provider tells you. Do not use

fluticasone propionate nasal spray more often than prescribed.

Fluticasone propionate nasal spray may take several days of regular use for your rhinitis

symptoms to get better. If your symptoms do not improve or get worse, call your healthcare

provider.

You will get the best results if you keep using fluticasone propionate nasal spray regularly each

day without missing a dose. After you begin to feel better, your healthcare provider may decrease

your dose. Do not stop using fluticasone propionate nasal spray unless your healthcare provider

tells you to do so.

nose problems. Nose problems may include:

nose bleeds.

sores (ulcers) in your nose.

a certain fungal infection in your nose, mouth, and/or throat (thrush).

hole in the cartilage of your nose (nasal septal perforation).

runny nose

o nausea

o vomiting

The most common side effects of fluticasone propionate nasal spray include:

slow wound healing. You should not use fluticasone propionate nasal spray until your nose has

healed if you have a sore in your nose, have had surgery on your nose, or if your nose has been

injured.

eye problems including glaucoma and cataracts. You should have regular eye exams while

you use fluticasone propionate nasal spray.

serious allergic reactions. Call your healthcare provider or get emergency medical care if you

get any of the following signs of a serious allergic reaction:

o rash

o hives

o swelling of your face, mouth, and tongue

o breathing problems

weakened immune system and increased chance of getting infections

(immunosuppression). Taking medicines that weaken your immune system makes you more

likely to get infections and can make certain infections worse. These infections may include

tuberculosis (TB), ocular herpes simplex infections, and infections caused by fungi, bacteria,

viruses, and parasites. Avoid contact with people who have a contagious disease such as

chickenpox or measles while using fluticasone propionate nasal spray. If you come in contact with

someone who has chickenpox or measles call your healthcare provider right away. Symptoms of

an infection may include:

o fever

o pain

o aches

o chills

o feeling tired

lowered steroid hormone levels (adrenal insufficiency). Adrenal insufficiency happens when

your adrenal glands do not make enough steroid hormones. This can happen when you stop taking

oral corticosteroid medicines (such as prednisone) and start taking medicine containing an inhaled

steroid (such as fluticasone propionate nasal spray). Symptoms of adrenal insufficiency may

include:

o feeling tired

o lack of energy

o weakness

o nausea and vomiting

o low blood pressure

headache

sore throat

nose bleeds

nose burning or itching

nausea and vomiting

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

These are not all the side effects with fluticasone propionate nasal spray. Ask your healthcare provider

or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to Hi-Tech

Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088.

How do I store fluticasone propionate nasal spray?

Keep fluticasone propionate nasal spray and all medicines out of the reach of children.

General information about the safe and effective use of fluticasone propionate nasal spray.

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not

use fluticasone propionate nasal spray for a condition for which it was not prescribed. Do not give your

fluticasone propionate nasal spray to other people, even if they have the same condition that you have. It

may harm them.

This Patient Information leaflet summarizes the most important information about fluticasone propionate

nasal spray. If you would like more information, talk with your healthcare provider. You can ask your

pharmacist or healthcare provider for information about fluticasone propionate nasal spray that was

written for healthcare professionals.

What are the ingredients in fluticasone propionate nasal spray?

Active ingredient: fluticasone propionate.

Inactive ingredients: benzalkonium chloride (0.02% w/w), carboxymethylcellulose sodium, dextrose,

microcrystalline cellulose, phenylethyl alcohol (0.25% w/w), polysorbate 80, and purified water.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Made in USA

Rev. 700:04 08/15

FLUTICASONE PROPIONATE

NASAL SPRAY, USP, 50 mcg

Rx Only

Rev. 700:00 5/14

Please read this leaflet carefully before you start to take your medicine. It provides a summary of

information on your medicine.

For further information ask your doctor or pharmacist.

WHAT YOU SHOULD KNOW ABOUT RHINITIS

Rhinitis is a word that means inflammation of the lining of the nose. If you suffer from rhinitis, your

nose becomes stuffy and runny. Rhinitis can also make your nose itchy, and you may sneeze a lot.

Rhinitis can be caused by allergies to pollen, animals, molds, or other materials-or it may have a

nonallergic cause.

trouble breathing

cough

Store fluticasone propionate nasal spray between 39°F and 86°F (4°C and 30°C).

WHAT YOU SHOULD KNOW ABOUT FLUTICASONE PROPIONATE NASAL SPRAY, USP

Your doctor has prescribed Fluticasone Propionate Nasal Spray, USP, a medicine that can help treat

your rhinitis. Fluticasone Propionate Nasal Spray, USP, contains fluticasone propionate, which is a

synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight

inflammation. When you spray Fluticasone Propionate Nasal Spray, USP, into your nose, it helps to

reduce the symptoms of allergic reactions and the stuffiness, runniness, itching, and sneezing that can

bother you.

THINGS TO REMEMBER ABOUT FLUTICASONE PROPIONATE NASAL SPRAY, USP

BEFORE USING YOUR NASAL SPRAY

TELL YOUR DOCTOR BEFORE STARTING TO TAKE THIS MEDICINE. In some

circumstances, this medicine may not be suitable and your doctor may wish to give you a different

medicine. Make sure that your doctor knows what other medicines you are taking.

USING YOUR NASAL SPRAY

DOSAGE

For ADOLESCENTS and CHILDREN (4 years of age and older), the usual starting dosage is 1

spray in each nostril once daily. Sometimes your doctor may recommend using 2 sprays in each nostril

daily. Then, after you have begun to feel better, 1 spray in each nostril daily may be adequate for you.

1. Shake gently before using.

2. Use your nasal spray as directed by your doctor. The directions are on the pharmacy label.

3. Keep your nasal spray out of the reach of children.

If you are pregnant (or intending to become pregnant),

If you are breastfeeding a baby,

If you are allergic to Fluticasone Propionate Nasal Spray, USP, or any other nasal corticosteroid,

If you are taking a medicine containing ritonavir (commonly used to treat HIV infection or AIDS).

Follow the instructions shown in the rest of this leaflet. If you have any problems, tell your doctor

or pharmacist.

It is important that you use it as directed by your doctor. The pharmacist’s label will usually tell

you what dose to take and how often. If it doesn’t, or you are not sure, ask your doctor or

pharmacist.

For ADULTS, the usual starting dose is 2 sprays in each nostril once daily. Sometimes your

doctor may recommend using 1 spray in each nostril twice a day (morning and evening). You

should not use more than a total of 2 sprays in each nostril daily. After you have begun to feel

better, 1 spray in each nostril daily may be adequate for you.

DO NOT use more of your medicine or take it more often than your doctor advises.

Fluticasone Propionate Nasal Spray, USP, may begin to work within 12 hours of the first dose, but

it takes several days of regular use to reach its greatest effect. It is important that you use

Fluticasone Propionate Nasal Spray, USP, as prescribed by your doctor. Best results will be

obtained by using the spray on a regular basis. If symptoms disappear, contact your doctor for

further instructions.

If you also have itchy, watery eyes, you should tell your doctor. You may be given an additional

medicine to treat your eyes. Be careful not to confuse them, particularly if the second medicine is

HOW TO USE YOUR NASAL SPRAY

Read the complete instructions carefully and use only as directed.

BEFORE USING

Figure 1

an eye drop.

If you miss a dose, just take your regularly scheduled next dose when it is due. DO NOT

DOUBLE the dose.

Shake the bottle gently and then remove the cap (Figure 1).

It is necessary to prime the pump into the air the first time it is used, or when you have not used it

for a week or more. To prime the pump, hold the bottle as shown with the nasal applicator pointing

away from you and with your forefinger and middle finger on either side of the nasal applicator

and your thumb underneath the bottle. When you prime the pump for the first time, press down and

release the pump 6 times (Figure 2). The pump is now ready for use. If the pump is not used for 7

days, prime until a fine spray appears.

Figure 2

USING THE SPRAY

4. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the

nasal applicator into the other nostril (Figure 3).

5. Start to breathe in through your nose, and WHILE BREATHING IN press firmly and quickly down

once on the applicator to release the spray. To get a full actuation, use your forefinger and middle

finger to spray while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe

3. Blow your nose to clear your nostrils

gently inwards through the nostril (Figure 4).

Figure 4

6. Breathe out through your mouth.

7. If a second spray is required in that nostril, repeat steps 4 through 6.

8. Repeat steps 4 through 7 in the other nostril.

9. Wipe the nasal applicator with a clean tissue and replace the cap (Figure 5).

Figure 5

10. Do not use this bottle for more than the labeled number of sprays even though the bottle is not

completely empty. Before you throw the bottle away, you should consult your doctor to see if a refill is

needed. Do not take extra doses or stop taking Fluticasone Propionate Nasal Spray, USP, without

consulting your doctor.

CLEANING

Your nasal spray should be cleaned at least once a week. To do this:

1. Remove the cap and then gently pull upwards to free the nasal applicator.

2. Wash the applicator and cap under warm tap water. Allow to dry at room temperature, then place the

applicator and cap back on the bottle.

3. If the nasal applicator becomes blocked, it can be removed as above and left to soak in warm water.

Rinse with cold tap water, dry, and refit. Do not try to unblock the nasal applicator by inserting a pin or

other sharp object.

STORING YOUR NASAL SPRAY

REMEMBER: This medicine has been prescribed for you by your doctor. DO NOT give this

medicine to anyone else.

FURTHER INFORMATION

The leaflet does not contain the complete information about your medicine. If you have any questions, or

are not sure about something, then you should ask your doctor or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished

your medicine.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-

9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, N.Y. 11701

Made in U.S.A.

Package/Label Display Panel

Keep your Fluticasone Propionate Nasal Spray, USP, out of the reach of children.

Avoid spraying in eyes.

Store between 4° and 30°C (39° and 86° F).

Do not use your Fluticasone Propionate Nasal Spray, USP, after the expiration date shown on the

label and box.

AKORN

NDC 50383-700-16

Fluticasone Propionate Nasal Spray, USP, 50 mcg

120 Metered Sprays

Rx Only

50 mcg per spray

Spray- For intranasal use only

ATTENTION PHARMACIST:

Dispense with enclosed patient’s instructions for use.

Important:

Read accompanying directions carefully.

16 g net fill weight

FLUTICASONE PROPIONATE

fluticasone propionate spray, metered

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 38 3-70 0

Route of Administration

NASAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FLUTICASO NE PRO PIO NATE (UNII: O2GMZ0 LF5W) (FLUTICASONE -

UNII:CUT2W21N7U)

FLUTICASONE

PROPIONATE

50 ug

in 0 .1 g

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PHENYLETHYL ALCO HO L (UNII: ML9 LGA746 8 )

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 38 3-70 0 -16

1 in 1 CARTON

0 1/16 /20 0 8

1

16 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

NDC:50 38 3-70 0 -

Hi-Tech Pharmacal Co., Inc.

2

NDC:50 38 3-70 0 -

1 in 1 BOTTLE, PUMP

0 1/0 8 /20 16

2

9 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 77570

0 1/16 /20 0 8

Labeler -

Hi-T ech Pharmacal Co., Inc. (101196749)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hi-Tech Pharmacal Co ., Inc.

10 119 6 749

MANUFACTURE(50 38 3-70 0 )

Revised: 5/2018

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