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Fluticasone Propionate 50 ug Spray, Metered — NDC 60505-0829-01 package photo

Fluticasone Propionate 50 ug Spray, Metered

by Apotex Corp. · 1 BOTTLE, SPRAY in 1 CARTON (60505-0829-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
NDC 60505-0829-01
🏷️ FDA NDC (as labeled) 60505-0829-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Feb 9, 2024 — CGMP Deviations: potential presence of Burkholderia cepacia complex (Apotex Corp.) · FDA recall D-0326-2024
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Fluticasone Propionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 14, 2024 — CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex (Golden State Medical Supply Inc.) · FDA recall D-0349-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Jan 26, 2022 · Terminated — CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. (CARDINAL HEALTHCARE) · FDA recall D-0182-2024

🆔 Identity & classification

FDA NDC (as labeled) 60505-0829-1
Product NDC 60505-0829
11-digit billing NDC 60505082901
NCPDP billing unit GM — per gram (weight)
Application # ANDA077538
SPL Set ID 3830675d-b45e-fc97-1f73-674b1fc38c80
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-19
Route NASAL
Dosage form SPRAY, METERED
Substance FLUTICASONE PROPIONATE
GCN Seq No 018368
GCN 62263
HICL code 007873
Ingredient (HICL) Fluticasone Propionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7P
Therapeutic class — specific (HIC3) Nasal Anti-Inflammatory Steroids
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name FLUTICASONE PROP 50 MCG SPRAY
FDB brand name Fluticasone Propionate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 60505-0829-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 60505-0829-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA077538 (ANDA)
Labeler code60505
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio306 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FLUTICASONE PROP 50 MCG SPRAY Ingredient Fluticasone Propionate
📖 What it is MedlinePlus · NLM

Nonprescription (over the counter) fluticasone nasal spray is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone nasal spray is used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat chronic rhinosinusitis with or without nasal polyps (ongoing runny nose, sinus swelling and/or nasal co...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
📖 Read our full Fluticasone guide →
8
Nutrient depletion considerations

Fluticasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluticasone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.448 —
Medicaid paysCMS SDUD · 12 mo $0.9539 —
Medicare drug plans payPart D · Q2 2026 $0.7375 —
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.450 $0.263
▲ Up 64% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluticasone Propionate 50 ug 00054-3270-99 Hikma 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ugthis 60505-0829-01 Apotex 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate spray, metered 50 ug 62135-0810-61 Chartwell 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 71085-0090-16 IPG 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 72888-0141-35 Advagen 1 bottle $0.448 AB Availability likely —
good neighbor pharmacy fluticasone propionate 50 ug 46122-0684-29 Amerisource 1 bottle $0.692 — Availability likely +55%
Fluticasone Propionate 50 ug 83324-0294-01 Chain 1 bottle $0.692 — Availability likely +55%
leader fluticasone propionate 50 ug 70000-0703-01 Cardinal 1 bottle $0.813 — Availability likely +82%
Foster and Thrive Allergy Relief 50 ug 70677-1021-01 Strategic 1 bottle $0.813 — Availability likely +82%
Good Sense 24 hour allergy nasal 50 ug 00113-0028-01 L. 1 bottle $0.845 — Discontinued +89%
Rugby Fluticasone Propionate Nasal 50 ug 00536-1183-65 Rugby 1 bottle $0.897 — Availability likely +100%
Fluticasone Propionate 50 ug 60505-6205-03 Apotex 1 bottle $0.897 — Availability likely +100%
Good Sense 24 hour allergy nasal 50 ug 00113-0285-08 L. 1 bottle — — FDA listed —
Flonase Allergy Relief 50 ug 00135-0576-01 Haleon 1 bottle — — FDA listed —
Childrens Flonase Allergy Relief 50 ug 00135-0582-04 Haleon 1 bottle — — FDA listed —
24 Hour Allergy Nasal 50 ug 00363-0024-01 Walgreen 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 00363-0652-01 Walgreens 1 bottle — — FDA listed —
Childrens Allergy Relief 50 ug 00363-4023-08 Walgreen 1 bottle — — FDA listed —
Up and Up Allergy Relief Nasal 50 ug 11673-0103-04 Target 3 bottles — — Discontinued —
Fluticasone Propionate 50 ug 11673-0262-01 Target 1 bottle — — Discontinued —
allergy nasal 50 ug 11822-0901-03 Rite 1 bottle — — FDA listed —
Signature Care Allergy Relief 50 ug 21130-0089-08 Safeway 1 bottle — — Discontinued —
signature care childrens allergy relief 50 ug 21130-0122-08 Safeway 1 bottle — — Discontinued —
childrens allergy relief 50 ug 21130-0607-08 Safeway 1 bottle — — FDA listed —
allergy relief 50 ug 21130-0863-08 Safeway 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 30142-0258-01 The 1 bottle — — FDA listed —
TopCare Childrens Allergy Relief Nasal 24 Hour 50 ug 36800-0128-02 Topco 1 bottle — — Discontinued —
topcare fluticasone propionate nasal 50 ug 36800-0222-01 Topco 1 bottle — — FDA listed —
Nasopro 24 50 ug 37808-0205-02 H 1 bottle — — Discontinued —
Childrens Nasopro 50 ug 37808-0340-08 H 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 37835-0997-31 Bi-Mart 1 bottle — — FDA listed —
Equaline Fluticasone Propionate 50 ug 41163-0023-01 United 1 bottle — — Discontinued —
Allergy Relief 50 ug 41250-0634-08 Meijer 1 bottle — — FDA listed —
careone childrens allergy relief 50 ug 41520-0553-02 American 1 bottle — — FDA listed —
CareOne Allergy Relief 50 ug 41520-0703-01 American 1 bottle — — FDA listed —
allergy relief nasal 50 ug 42507-0710-08 HyVee 1 bottle — — FDA listed —
365 Whole Foods Market Fluticasone Propionate 50 ug 42681-0058-01 Whole 1 bottle — — FDA listed —
equate allergy relief 50 ug 49035-0200-01 Wal-Mart 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 49035-0362-01 Walmart 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 50090-0968-00 A-S 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 50090-2880-00 A-S 1 bottle — AB FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 50090-6823-00 A-S 1 bottle — — FDA listed —
allergy nasal 50 ug 51316-0181-08 CVS 1 bottle — — FDA listed —
Childrens Allergy 50 ug 51316-0197-08 CVS 1 bottle — — FDA listed —
Allergy Relief 50 ug 51316-0497-08 CVS 1 bottle — — FDA listed —
childrens allergy relief 50 ug 51316-0818-08 CVS 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 51407-0871-12 Golden 1 bottle — AB FDA listed —
Allergy Relief 50 ug 53943-0006-01 Discount 1 bottle — — FDA listed —
exchange select allergy relief 50 ug 55301-0506-01 Army 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55319-0058-01 Family 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55681-0389-14 TWIN 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55700-0714-16 Quality 1 bottle — AB FDA listed —
DG Health childrens allergy relief nasal 50 ug 55910-0607-02 Dolgencorp 1 bottle — — FDA listed —
DG Health Allergy Relief Nasal 50 ug 55910-0773-01 Dolgencorp 1 bottle — — FDA listed —
allergy relief nasal 50 ug 56062-0107-08 Publix 1 bottle — — FDA listed —
Fluticare 50 ug 57483-0180-11 INNOVUS 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 58602-0017-42 Aurohealth 1 bottle — — FDA listed —
Childrens Fluticasone Propionate 50 ug 58602-0018-04 Aurohealth 3 bottles — — FDA listed —
Allergy Relief 50 ug 59726-0203-38 P 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 60429-0195-15 Golden 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 60505-0955-01 Apotex 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 63187-0638-16 Proficient 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 63187-0806-16 Proficient 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 63654-0380-01 Selder, 1 bottle — — FDA listed —
Kirkland Signature Aller Flo 50 ug 63981-0001-01 Costco 120 sprays — — FDA listed —
Welby Fluticasone 50 ug 64024-0007-02 Aldi 1 bottle — — FDA listed —
Allergy Relief 50 ug 64525-6560-02 Quality 1 bottle — — FDA listed —
Good Sense 24 hour allergy nasal 50 ug 67296-1463-01 RedPharm 11 sprays — — FDA listed —
Fluticasone 50 ug 68071-1638-05 NuCare 16 sprays — AB FDA listed —
Fluticasone Propionate 50 ug 68071-3949-05 NuCare 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68071-4868-05 NuCare 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68196-0210-01 Sam's 6 bottles — — Discontinued —
Fluticasone Propionate 50 ug 68196-0503-01 Sam's 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68788-4120-01 Preferred 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68788-8446-01 Preferred 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68788-9678-01 Preferred 1 bottle — AB FDA listed —
Allergy Relief Nasal 50 ug 68998-0452-01 Marc 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68998-0600-01 Marc 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 69168-0014-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0380-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0448-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0452-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate Nasal 50 ug 69842-0900-01 CVS 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 70518-0880-00 REMEDYREPACK 1 spray — AB FDA listed —
Fluticasone Propionate 50 ug 70518-1655-00 REMEDYREPACK 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 72189-0004-01 Direct_RX 1 spray — AB FDA listed —
basic care allergy relief nasal 50 ug 72288-0119-04 Amazon.com 3 bottles — — Discontinued —
basic care childrens allergy relief nasal 50 ug 72288-0333-08 Amazon.com 1 bottle — — FDA listed —
Fluticasone Propionate ALLERGY RELIEF 50 ug 72657-0159-12 GLENMARK 1 bottle — — FDA listed —
Mucinex Nasal Congestion and Allergy Relief 50 ug 72854-0227-60 Reckitt 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 72888-0248-01 Advagen 1 bottle — — FDA listed —
Topcare Allergy Relief Nasal 50 ug 76162-0121-08 Topco 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug/.1g 76420-0106-16 Asclemed 16 g — — FDA listed —
Fluticasone Propionate 50 ug 76420-0329-50 Asclemed 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 76420-0903-01 Asclemed 1 bottle — AB FDA listed —
Equate Allergy Relief 50 ug 79903-0071-10 WALMART 2 bottles — — FDA listed —
Equate Childrens Allergy Relief 50 ug 79903-0295-72 WALMART 1 bottle — — FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 85766-0161-12 Sportpharm 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 85828-0448-01 Grocery 1 bottle — — FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 87063-0114-12 ASCLEMED 1 bottle — — FDA listed —
Childrens Fluticasone Propionate ALLERGY RELIEF 50 ug 72657-0166-72 GLENMARK 1 bottle — — FDA listed —
Allergy Relief Nasal 50 ug 72288-0349-09 Amazon.com 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 59726-0350-38 P 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68462-0918-20 Glenmark 1 bottle — — FDA listed —
Fluticasone 50 ug 73581-0535-01 YYBA 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 73581-0510-01 YYBA 1 bottle — — FDA listed —
Fluticasone Propionate ALLERGY RELIEF 50 ug 73581-0530-01 YYBA 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 60505-0829-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.7M
Units reimbursed last 4 qtrs
74.4M
Gross reimbursed last 4 qtrs
$70.92M
Avg / prescription
$15.02
Avg / unit
$0.9539
Latest quarter Q4 2025
1.1MRx
Medicaid pays / g
$0.9539
gross reimbursed
vs
NADAC / g
$0.4478
acquisition cost
=
Spread
+$0.5061
+113% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
40% FFS 60% MCO
Fee-for-service · 1,902,735 Rx Managed care · 2,820,505 Rx
State Medicaid map
Alaska: 132,065 units · 18,017 per 100k residents AK Maine: 193,537 units · 13,874 per 100k residents ME Washington: 1,016,429 units · 13,011 per 100k residents WA Idaho: 304,080 units · 15,483 per 100k residents ID Montana: 9,294 units · 821 per 100k residents MT North Dakota: 59,750 units · 7,631 per 100k residents ND Minnesota: 1,036,612 units · 18,069 per 100k residents MN Wisconsin: 1,291,297 units · 21,849 per 100k residents WI Michigan: 4,663,687 units · 46,465 per 100k residents MI New York: 10,925,800 units · 55,826 per 100k residents NY Vermont: 89,093 units · 13,770 per 100k residents VT New Hampshire: 107,712 units · 7,683 per 100k residents NH Oregon: 555,753 units · 13,129 per 100k residents OR Nevada: 392,203 units · 12,279 per 100k residents NV Wyoming: 31,776 units · 5,441 per 100k residents WY South Dakota: 108,404 units · 11,796 per 100k residents SD Iowa: 681,160 units · 21,240 per 100k residents IA Illinois: 2,315,256 units · 18,450 per 100k residents IL Indiana: 1,219,526 units · 17,772 per 100k residents IN Ohio: 4,267,072 units · 36,208 per 100k residents OH Pennsylvania: 3,236,935 units · 24,974 per 100k residents PA New Jersey: 2,201,078 units · 23,693 per 100k residents NJ Massachusetts: 787,186 units · 11,244 per 100k residents MA California: 7,540,841 units · 19,353 per 100k residents CA Utah: 221,628 units · 6,486 per 100k residents UT Colorado: 889,040 units · 15,125 per 100k residents CO Nebraska: 21,337 units · 1,079 per 100k residents NE Missouri: 101,732 units · 1,642 per 100k residents MO Kentucky: 3,305,095 units · 73,025 per 100k residents KY West Virginia: 834,528 units · 47,148 per 100k residents WV Virginia: 1,460,953 units · 16,762 per 100k residents VA Maryland: 70,698 units · 1,144 per 100k residents MD Connecticut: 1,028,768 units · 28,443 per 100k residents CT Rhode Island: 229,408 units · 20,951 per 100k residents RI Arizona: 1,013,498 units · 13,639 per 100k residents AZ New Mexico: 787,223 units · 37,239 per 100k residents NM Kansas: 328,946 units · 11,189 per 100k residents KS Arkansas: 926,657 units · 30,214 per 100k residents AR Tennessee: 1,979,186 units · 27,774 per 100k residents TN North Carolina: 2,952,038 units · 27,245 per 100k residents NC South Carolina: 903,171 units · 16,809 per 100k residents SC Delaware: 323,787 units · 31,405 per 100k residents DE Oklahoma: 57,215 units · 1,412 per 100k residents OK Louisiana: 2,790,761 units · 61,014 per 100k residents LA Mississippi: 717,654 units · 24,410 per 100k residents MS Alabama: 739,632 units · 14,480 per 100k residents AL Georgia: 1,677,617 units · 15,211 per 100k residents GA D.C.: 179,266 units · 26,401 per 100k residents DC Hawaii: 43,073 units · 3,002 per 100k residents HI Texas: 4,459,598 units · 14,620 per 100k residents TX Florida: 1,758,894 units · 7,779 per 100k residents FL
Units reimbursed · per 100k residents
82173,025
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 73,025 /100k
2 Louisiana 61,014 /100k
3 New York 55,826 /100k
4 West Virginia 47,148 /100k
5 Michigan 46,465 /100k
6 New Mexico 37,239 /100k
7 Ohio 36,208 /100k
8 Delaware 31,405 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fluticasone Propionate — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fluticasone Propionate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$55.37M
Claims incl. refills
3.4M
Beneficiaries
2.6M
Spend / beneficiary
$21.45
Spend / claim
$16.15
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluticasone Propionate — the ingredient across all brands.

Top reported reactions

Dyspnoea21,832
Asthma12,800
Cough11,446
Fatigue11,026
Headache10,628
Pneumonia10,087
Nausea9,027

Age at onset

Neonate22
Infant24
Child935
Adolescent723
Adult16,314
Elderly10,793

Reporter sex

192,102 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization45,985
Life-threatening3,495
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 11,910 6,070
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 63 words ▾

1 INDICATIONS AND USAGE Fluticasone propionate nasal 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 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 ~2 min read ▾

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. 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 )

2.1Adults 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.

2.2Adolescents 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.

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Fluticasone propionate nasal spray, USP is an aqueous suspension. Each 100-mg spray delivers 50 mcg of fluticasone propionate. Nasal spray: 50 mcg of fluticasone propionate in each 100-mg spray. ( 3 )

⛔ Contraindications 36 words ▾

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 )] . Hypersensitivity to any ingredient. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 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 ) Glaucoma and cataracts: Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone long-term. ( 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 )

5.1Local 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.

5.2Glaucoma 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. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone long-term.

5.3Hypersensitivity 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.

5.4Immunosuppression 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 af…

🤒 Adverse Reactions ~3 min read ▾

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 )] Glaucoma and cataracts [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 )] 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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 Fluticasone propionate 100 mcg Once Daily (n = 167) % Fluticasone propionate 200 mcg Once Daily (n = 782) % Placebo (n=758) % Headache 6.6 16.1

14.6Pharyngitis 6.0 7.8

7.2Epistaxis 6.0 6.9

5.4Nasal burning/nasal irritation 2.4 3.2

2.6Nausea/vomiting 4.8 2.6

2.0Asthma symptoms 7.2 3.3

2.9Cough 3.6 3.8

2.8Other 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.

6.2Postmarketing 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 inst…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 )

7.1Inhibitors 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, 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.

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 max ) averaged 11.9 pg/mL (range: 10.8 to 14.1 pg/mL) and AUC (0-τ) averaged 8.43 pg•h/mL (range: 4.2 to 18.8 pg•h/mL). Fluticasone propionate C max and AUC (0-τ) increased to 318 pg/mL (range: 110 to 648 pg/mL) and 3,102.6 pg•h/mL (range: 1,207.1 to 5,662.0 pg•h/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.

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary There are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (MRHDID) on a mcg/m2 basis, respectively.

(See Animal Data.) However, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose equivalent to the MRHDID on a mcg/m2 basis. (See Animal Data.) Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. The estimated risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data: Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.

Animal Data: In embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species. Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 5 times the MRHDID of 200 mcg/day (on a mcg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed at approximately equivalent to the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 30 mcg/kg/day).

Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately equivalent to the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). The mouse NOAEL was observed with a dose approximately 0.3 times the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). In an embryofetal development study with pregnant rats dosed by the nose-only inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately equivalent to the MRHDID (on a mcg/m2 basis with a maternal nose-only inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity.

The NOAEL was observed with a dose approximately 0.25 times the MRHDID (on a mcg/m2 basis with a maternal nose only inhalation dose of 5.5 mcg/kg/day). In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.06 times the MRHDID and higher (on a mcg/m2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose 0.39 times the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 4 mcg/kg/day).

The NOAEL was observed in rabbit fetuses with a dose approximately 0.01 times the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. In a pre- and post-natal development study in pregnant rats dosed from late gestation…

🆘 Overdosage 153 words ▾

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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics 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.

12.3Pharmacokinetics 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

4.2L/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 usin…

🧬 Mechanism of Action 166 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Propionate Nasal Spray USP, 50 mcg, is supplied in an amber glass bottle fitted with a silver metering nasal pump, white plastic actuator, and translucent cap in a box of 1 (NDC 60505-0829-1) with a package insert (prescribing information and patient leaflet). 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°C to 30°C (39°F to 86°F).

Shake gently before each use.

📋 Description ~1 min read ▾

11 DESCRIPTION Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray USP, is a synthetic 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 or almost white, crystalline powder with a molecular weight of 500.6, and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and in dichloromethane and slightly soluble in ethanol (95%).

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 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water, and has a pH between 5 and 7. It is necessary to prime the pump before first use or after a period of non-use (1 week or more).

After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each 16 g bottle of Fluticasone Propionate Nasal Spray USP provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded.

💬 Information for Patients ~2 min read ▾

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.

APOTEX INC. FLUTICASONE PROPIONATE NASAL SPRAY USP 50 mcg Manufactured by Manufactured for Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, FL Canada M9L 1T9 33326 January 2021

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.