FLUTICASONE- 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:
Unit Dose Services
INN (International Name):
FLUTICASONE PROPIONATE
Composition:
FLUTICASONE PROPIONATE 50 ug
Administration route:
NASAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray 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 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 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 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. Mice and rats at flut
Product summary:
Product: 50436-2640 NDC: 50436-2640-1 120 SPRAY, METERED in a BOTTLE, SPRAY
Authorization status:
Abbreviated New Drug Application
Authorization number:
50436-2640-1

FLUTICASONE- fluticasone propionate spray, metered

Unit Dose Services

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL

SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL

SPRAY.

FLUTICASONE PROPIONATE nasal spray

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 50 mcg per spray 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)

DOSAGE AND ADMINISTRATION

For intranasal use only. Recommended starting dosages:

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)

DOSAGE FORMS AND STRENGTHS

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

CONTRAINDICATIONS

Hypersensitivity to any ingredient. (4)

WARNINGS AND PRECAUTIONS

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. Discontinue Fluticasone Propionate Nasal Spray 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 slowly. (5.5)

Monitor growth of pediatric patients. (5.7)

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 Wockhardt USA, LLC at 1-800-445-4290 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)

USE IN SPECIFIC POPULATIONS

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

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2017

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 50 mcg per spray is indicated for the management of the nasal

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

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

2 DOSAGE AND ADMINISTRATION

Administer Fluticasone Propionate Nasal Spray by the intranasal route only. Prime Fluticasone

Propionate Nasal Spray 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 gently before each use.

Patients should use Fluticasone Propionate Nasal Spray 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 is a nasal spray suspension. Each 100-mg spray delivers 50 mcg of

fluticasone propionate.

4 CONTRAINDICATIONS

Fluticasone Propionate Nasal Spray 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 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 [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. Patients using Fluticasone Propionate Nasal Spray 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 [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 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. Discontinue Fluticasone

Propionate Nasal Spray if such reactions occur [see Contraindications (4)]. Rarely, immediate

hypersensitivity reactions may occur after the administration of Fluticasone Propionate Nasal Spray.

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 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 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. To minimize the systemic effects of intranasal

corticosteroids, including Fluticasone Propionate Nasal Spray, 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:

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)]

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 US 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

with >3% Incidence and More Common than Placebo in Subjects ≥4

Years with Allergic Rhinitis

Adverse Reaction

Fluticas one

Propionate

100 mcg

Once Daily

(n = 167)

%

Fluticas one

Propionate

200 mcg

Once Daily

(n = 782)

%

Placebo

(n = 758)

%

Headache

16.1

14.6

Pharyngitis

Epistaxis

Nasal burning/nasal irritation

Nausea/vomiting

Asthma symptoms

Cough

Other adverse reactions with Fluticasone Propionate Nasal Spray 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 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

50 mcg per spray, 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 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 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.

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/m

basis resulted in measurable radioactivity in milk.

Since there are no data from controlled trials on the use of intranasal Fluticasone Propionate Nasal

Spray by nursing mothers, caution should be exercised when Fluticasone Propionate Nasal Spray is

administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of Fluticasone Propionate Nasal Spray 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 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, 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, 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 (single daily dose of 200 mcg) on growth velocity.

From the primary population receiving Fluticasone Propionate Nasal Spray (n = 56) and placebo (n =

52), the point estimate for growth velocity with Fluticasone Propionate Nasal Spray 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 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 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

Formal pharmacokinetic trials using Fluticasone Propionate Nasal Spray have not been conducted in

subjects with hepatic impairment. Since fluticasone propionate is predominantly cleared by hepatic

metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma.

Therefore, patients with hepatic disease should be closely monitored.

8.7 Renal Impairment

Formal pharmacokinetic trials using Fluticasone Propionate Nasal Spray 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

contains approximately 8 mg of fluticasone propionate.

11 DESCRIPTION

The active component of Fluticasone Propionate Nasal Spray 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, 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 also contains microcrystalline cellulose and

carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and

0.25% w/w phenylethyl alcohol, and has a pH between 5 and 7.

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 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 on the HPA axis were evaluated.

Fluticasone Propionate Nasal Spray 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

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 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

(0–τ)

(0–τ)

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.

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 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 (100

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

with vehicle.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50436-2640

NDC: 50436-2640-1 120 SPRAY, METERED in a BOTTLE, SPRAY

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 may lead to adverse reactions,

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

Fluticasone Propionate Nasal Spray. In addition, Fluticasone Propionate Nasal Spray 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

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 [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. If such

reactions occur, patients should discontinue use of Fluticasone Propionate Nasal Spray [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 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 on a regular basis. Fluticasone

Propionate Nasal Spray, 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 in their eyes and mouth.

Product No.: 7264

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

27264

REV. 03/16

Patient Information

Fluticasone Propionate Nasal Spray, USP

50 mcg per spray

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 Spray?

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.

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.

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.

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.

What are the possible side effects of Fluticasone Propionate Nasal Spray? Fluticasone Propionate

Nasal Spray may cause serious side effects, including:

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).

Symptoms of nasal septal perforation may include:

crusting in the nose

nose bleeds

runny nose

whistling sound when you breathe

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:

rash

hives

swelling of your face, mouth, and tongue

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:

fever

pain

aches

chills

feeling tired

nausea

vomiting

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:

feeling tired

lack of energy

weakness

nausea and vomiting

low blood pressure

slowed growth in children. A child's growth should be checked often.

The most common side effects of Fluticasone Propionate Nasal Spray include:

headache

sore throat

nose bleeds

nose burning or itching

nausea and vomiting

trouble breathing

cough

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 FDA at 1-800-

FDA-1088.

How do I store Fluticasone Propionate Nasal Spray?

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

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.

For more information about Fluticasone Propionate Nasal Spray, call 1-800-346-6854.

What are the ingredients in Fluticasone Propionate Nasal Spray?

Active ingredient: fluticasone propionate.

Inactive ingredients: microcrystalline cellulose, carboxymethylcellulose sodium, dextrose, 0.02% w/w

benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol.

Instructions for Use

Fluticasone Propionate Nasal Spray

USP 50 mcg per spray

Fluticasone Propionate Nasal Spray is for use in your nose only.

Read this information before you start using your Fluticasone Propionate Nasal Spray.

FIGURE A

FIGURE B

Your Fluticasone Propionate Nasal Spray

must be primed before you use it for the

first time and when you have not used it for

a week or more.

How to prime your Fluticasone Propionate

Nasal Spray

Shake the bottle gently and then remove

the dust cover (See Figure A).

Hold the bottle as shown (See Figure B)

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.

Press down and release 6 times until a fine

spray appears (See Figure B). The pump is

now ready for use.

FIGURE C

Using your Fluticasone Propionate Nasal

Spray:

Step 1. Blow your nose to clear your nostrils

Step 2. Close 1 nostril. Tilt your head

forward slightly and, keeping the bottle

upright, carefully insert the nasal applicator

into the other nostril (See Figure C).

Step 3. Start to breathe in through your nose,

and while breathing in press firmly and

quickly down 1 time on the applicator to

release the spray. To get a full dose, use your

forefinger and middle finger to spray while

supporting the base of the bottle with your

thumb. Avoid spraying in your eyes. Breathe

FIGURE D

in gently through the nostril.

Step 4. Breathe out through your mouth.

Step 5. If a second spray is required in that

nostril, repeat steps 2 through 4.

Step 6. Repeat steps 2 through 5 in the other

nostril.

Step 7. Wipe the nasal applicator with a clean

tissue and replace the dust cover (See Figure

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 talk to your healthcare provider to see if a refill is needed. Do not

take extra doses or stop taking Fluticasone Propionate Nasal Spray without

talking to your healthcare provider.

Cleaning your Fluticasone Propionate Nasal Spray:

Your nasal spray should be cleaned at least 1 time each week.

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

2. Wash the applicator and dust cover under warm tap water. Allow to dry at room temperature.

3. Place the applicator and dust cover back on the bottle.

4. If the nasal applicator becomes blocked, it can be removed and left to soak in warm water. Rinse the

nasal applicator with cold tap water. Dry the nasal applicator and place it back on the bottle. Do not

try to unblock the nasal applicator by inserting a pin or other sharp object.

Storing your Fluticasone Propionate Nasal Spray:

Store Fluticasone Propionate Nasal Spray between 39°F and 86°F (4°C and 30°C).

Do not use your Fluticasone Propionate Nasal Spray after the date shown as "EXP" on the label or

box.

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

Administration.

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

27264A REV. 03-16

FLUTICASONE 50MCG SPY 16 GM

FLUTICASONE

fluticasone propionate spray, metered

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 436 -26 40 (NDC:6 0 432-26 4)

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

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

Anhydro us Dextro se (UNII: 5SL0 G7R0 OK)

Benza lko nium Chlo ride (UNII: F5UM2KM3W7)

Phenylethyl Alco ho l (UNII: ML9 LGA746 8 )

ca rbo xymethylcellulo se so dium, unspecified fo rm (UNII: K6 79 OBS311)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 436 -26 40 -

1 in 1 BOX

0 7/0 4/20 16

1

120 in 1 BOTTLE, SPRAY ; 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 78 49 2

0 1/0 9 /20 12

Unit Dose Services

Labeler -

Unit Dose Services (831995316)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Unit Do se Services

8 319 9 5316

RELABEL(50 436 -26 40 )

Revised: 3/2017

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