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AirDuo RespiClick Fluticasone Propionate and Salmeterol 55 ug; 14 ug Powder, Metered — NDC 59310-0805-08 package photo

AirDuo RespiClick Fluticasone Propionate and Salmeterol 55 ug; 14 ug Powder, Metered

by Teva Respiratory, LLC · 1 POUCH in 1 CARTON (59310-805-08) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
NDC 59310-0805-08
🏷️ FDA NDC (as labeled) 59310-805-08 billing pads the product segment with a zero
This package
Contains60 powder, metered in 1 inhaler Pack sizes2 compare ↓
Also comes in: 1 pouch 59310-0805-06
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 59310-805-08
Product NDC 59310-805
11-digit billing NDC 59310080508
Application # NDA208799
SPL Set ID 9c122b91-a11f-49ca-80bb-3eec5112db87
Established class (EPC) Corticosteroid; beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists; Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2017-04-12
Route RESPIRATORY (INHALATION)
Dosage form POWDER, METERED
Substance FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Why two NDCs? The FDA registers this code as 59310-805-08 — a 5-3-2 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 product segment → 59310-0805-08. 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

LabelerTeva Respiratory, LLC
Application holderTEVA PHARMACEUTICAL INDUSTRIES LTD
FDA applicationNDA208799 (NDA)
Labeler code59310
First marketedApr 2017
Product typeHuman Prescription Drug
Portfolio10 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

📗 Our plain-language guide HelloPharmacist
  • No — and this is really important. This inhaler is a long-term controller, not a rescue inhaler. It won't work fast enough in an emergency. If you're having a sudden attack, use yo...
  • Can I use this inhaler when I'm having an asthma attack right now?
  • The corticosteroid (fluticasone) can settle in your mouth and throat and encourage a fungal infection called oral thrush — you'd notice it as white patches or soreness. Rinsing wit...
  • Why do I need to rinse my mouth after using this inhaler?
📖 Read our full Fluticasone and Salmeterol Oral Inhalation guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 pouch
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 and Salmeterol 55 ug/1; 14 ug 00093-3607-82 Teva 1 pouch $113.787 — Availability likely —
Fluticasone Propionate and Salmeterol 55 ug/1; 14 ug 50090-3272-00 A-S 1 pouch — — FDA listed —
AirDuo RespiClick 55 ug/1; 14 ugthis 59310-0805-08 Teva 1 pouch — — Discontinued —
Fluticasone Propionate and Salmeterol 55 ug/1; 14 ug 63629-8811-01 Bryant 1 pouch — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2017
First FDA approval
Jan 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 27, 2017 RLD RS ⏳ ~14.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9066957 — method of use (U-645)
US 9415008 — method of use (U-645)
US 9066957 — method of use (U-645)
US 9066957 — method of use (U-645)
US 9066957 — method of use (U-645)
US 9415008 — method of use (U-645)
US 9066957 — method of use (U-645)
US 9066957 — method of use (U-645)
US 11969544 — drug product
US 10195375 — drug product
US 11344685 — drug product
US 11173259 — drug product
US 11173259 — drug product
US 10195375 — drug product
US 10195375 — drug product
US 11969544 — drug product
US 10195375 — drug product
US 11969544 — drug product
US 10918816 — drug product
US 11969544 — drug product
US 11969544 — drug product
US 10195375 — drug product
US 10918816 — drug product
US 11344685 — drug product
US 11344685 — drug product
US 11173259 — drug product
US 10918816 — drug product
US 11969544 — drug product
US 10195375 — drug product
US 9415008*PED — drug product
US 9066957*PED — drug product
US 9066957*PED — drug product
US 9066957*PED — drug product
US 10195375*PED — drug product
US 10195375*PED — drug product
US 10195375*PED — drug product
US 11173259*PED — drug product
US 11173259*PED — drug product
US 11173259*PED — drug product
US 11344685*PED — drug product
US 11344685*PED — drug product
US 11344685*PED — drug product
US 9415008*PED — drug product
US 9066957*PED — drug product
US 9066957*PED — drug product
US 9066957*PED — drug product
US 10195375*PED — drug product
US 10195375*PED — drug product
US 10195375*PED — drug product
US 11969544*PED — drug product
US 11969544*PED — drug product
US 11969544*PED — drug product
US 11969544*PED — drug product
US 11969544*PED — drug product
US 11969544*PED — drug product
US 10918816*PED — drug product
US 10918816*PED — drug product
US 10918816*PED — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (58)
PatentTypeUse codeExpires
US 9066957 ↗ Method of use U-645 Oct 6, 2034
US 9415008 ↗ Method of use U-645 Oct 6, 2034
US 9066957 ↗ Method of use U-645 Oct 6, 2034
US 9066957 ↗ Method of use U-645 Oct 6, 2034
US 9066957 ↗ Method of use U-645 Oct 6, 2034
US 9415008 ↗ Method of use U-645 Oct 6, 2034
US 9066957 ↗ Method of use U-645 Oct 6, 2034
US 9066957 ↗ Method of use U-645 Oct 6, 2034
US 11969544 ↗ Drug product — Aug 20, 2039
US 10195375 ↗ Drug product — Feb 14, 2031
US 11344685 ↗ Drug product — Sep 26, 2039
US 11173259 ↗ Drug product — Jul 6, 2040
US 11173259 ↗ Drug product — Jul 6, 2040
US 10195375 ↗ Drug product — Feb 14, 2031
US 10195375 ↗ Drug product — Feb 14, 2031
US 11969544 ↗ Drug product — Aug 20, 2039
US 10195375 ↗ Drug product — Feb 14, 2031
US 11969544 ↗ Drug product — Aug 20, 2039
US 10918816 ↗ Drug product — Dec 14, 2035
US 11969544 ↗ Drug product — Aug 20, 2039
US 11969544 ↗ Drug product — Aug 20, 2039
US 10195375 ↗ Drug product — Feb 14, 2031
US 10918816 ↗ Drug product — Dec 14, 2035
US 11344685 ↗ Drug product — Sep 26, 2039
US 11344685 ↗ Drug product — Sep 26, 2039
US 11173259 ↗ Drug product — Jul 6, 2040
US 10918816 ↗ Drug product — Dec 14, 2035
US 11969544 ↗ Drug product — Aug 20, 2039
US 10195375 ↗ Drug product — Feb 14, 2031
US 9415008*PED ↗ Drug product — Apr 6, 2035
US 9066957*PED ↗ Drug product — Apr 6, 2035
US 9066957*PED ↗ Drug product — Apr 6, 2035
US 9066957*PED ↗ Drug product — Apr 6, 2035
US 10195375*PED ↗ Drug product — Aug 14, 2031
US 10195375*PED ↗ Drug product — Aug 14, 2031
US 10195375*PED ↗ Drug product — Aug 14, 2031
US 11173259*PED ↗ Drug product — Jan 6, 2041
US 11173259*PED ↗ Drug product — Jan 6, 2041
US 11173259*PED ↗ Drug product — Jan 6, 2041
US 11344685*PED ↗ Drug product — Mar 26, 2040
US 11344685*PED ↗ Drug product — Mar 26, 2040
US 11344685*PED ↗ Drug product — Mar 26, 2040
US 9415008*PED ↗ Drug product — Apr 6, 2035
US 9066957*PED ↗ Drug product — Apr 6, 2035
US 9066957*PED ↗ Drug product — Apr 6, 2035
US 9066957*PED ↗ Drug product — Apr 6, 2035
US 10195375*PED ↗ Drug product — Aug 14, 2031
US 10195375*PED ↗ Drug product — Aug 14, 2031
US 10195375*PED ↗ Drug product — Aug 14, 2031
US 11969544*PED ↗ Drug product — Feb 20, 2040
US 11969544*PED ↗ Drug product — Feb 20, 2040
US 11969544*PED ↗ Drug product — Feb 20, 2040
US 11969544*PED ↗ Drug product — Feb 20, 2040
US 11969544*PED ↗ Drug product — Feb 20, 2040
US 11969544*PED ↗ Drug product — Feb 20, 2040
US 10918816*PED ↗ Drug product — Jun 14, 2036
US 10918816*PED ↗ Drug product — Jun 14, 2036
US 10918816*PED ↗ Drug product — Jun 14, 2036
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 pouch59310-0805-06 156 Rx · $69,169
1 pouch this page59310-0805-08 No Medicaid data
Drug total (last 4 qtrs): 156 Rx · 75 units · $69,169 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Airduo Respiclick — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Airduo Respiclick. 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.
Total Part D spend
$102.5K
Claims incl. refills
242
Beneficiaries
186
Spend / beneficiary
$551.32
Spend / claim
$423.74
💵 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59310-0805-06 1 POUCH in 1 CARTON (59310-805-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER 2017-04-24 Active
59310-0805-08 You're viewing this 1 POUCH in 1 CARTON (59310-805-08) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER 2017-04-12 Discontinued by firm

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 59310-0805-08?
NDC 59310-0805-08 is listed by the FDA — 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder, metered in 1 inhaler.
What NDC number is used to bill for this package of AirDuo RespiClick Fluticasone Propionate and Salmeterol 55 ug; 14 ug Powder, Metered?
Bill NDC 59310-0805-08 — the 11-digit billing format is 59310080508. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59310-805-08, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59310-0805-08, written without dashes as 59310080508. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59310-0805-08, the first segment (59310) is the labeler code FDA assigned to Teva Respiratory, LLC; the middle segment (0805) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 pouch (59310-0805-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Teva Respiratory, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 176 words ▾

1 INDICATIONS AND USAGE AIRDUO ® RESPICLICK ® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). Limitations of Use : AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm.

AIRDUO RESPICLICK is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) 1 inhalation of AIRDUO RESPICLICK 55 mcg/14 mcg, 113 mcg/14 mcg or 232 mcg/14 mcg twice daily. ( 2.2 ) Do not use with a spacer or volume holding chamber. ( 2.2 )

2.1Administration Instructions AIRDUO RESPICLICK is for oral inhalation and does not require priming. Do not use AIRDUO RESPICLICK with a spacer or volume holding chamber. Do not use more than two times every 24 hours.

More frequent administration or a greater number of daily inhalations (more than one inhalation twice daily) is not recommended as some patients are more likely to experience adverse reactions with higher salmeterol dosages. Avoid the concomitant use of other long acting beta 2 -adrenergic agonist (LABAs) [see Warnings and Precautions ( 5.3 , 5.11 )]. If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.

2.2Recommended Dosage Administer 1 inhalation of AIRDUO RESPICLICK twice daily by oral inhalation (approximately 12 hours apart at the same time every day). Rinse the mouth with water without swallowing after each inhalation. Dosage Selection The recommended starting dosage for AIRDUO RESPICLICK is based on asthma severity and current inhaled corticosteroid use and strength.

Patients not taking inhaled corticosteroids (ICS) (with less severe asthma): 1 inhalation of 55 mcg/14 mcg AIRDUO RESPICLICK dose strength (55 mcg of fluticasone propionate and 14 mcg of salmeterol), twice daily by oral inhalation. Patients with greater asthma severity, use the higher dose strengths: 1 inhalation of 113 mcg/14 mcg AIRDUO RESPICLICK (113 mcg of fluticasone propionate and 14 mcg of salmeterol) twice daily; or 1 inhalation of 232 mcg/14 mcg AIRDUO RESPICLICK (232 mcg of fluticasone propionate and 14 mcg of salmeterol) twice daily Patients switching to AIRDUO RESPICLICK from another inhaled corticosteroid or combination product: 1 inhalation of low (55 mcg/14 mcg), medium (113 mcg/14 mcg) or high (232 mcg/14 mcg) AIRDUO RESPICLICK twice daily by oral inhalation based on the strength of the previous inhaled corticosteroid product, or the strength of the inhaled corticosteroid from a combination product, and disease severity.

The maximum recommended dosage of AIRDUO RESPICLICK is 232 mcg/14 mcg twice daily. General Dosing Information Improvement in asthma control following AIRDUO RESPICLICK administration can occur within 15 minutes of beginning treatment; although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose of AIRDUO RESPICLICK after 2 weeks of therapy, consider increasing the strength (replace with higher strength) to possibly provide additional improvement in asthma control. If a previously effective dosage regimen fails to provide adequate improvement in asthma control, re-evaluate the therapeutic regimen, including patient compliance and inhaler technique, and consider additional therapeutic options (e.g., increasing the dose of AIRDUO RESPICLICK with a higher strength, adding additional controller therapies).

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the risk of adverse reactions.

2.3Storing and Cleaning the Inhaler Keep the inhaler in a cool dry place. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water.

2.4Dose Counter The AIRDUO RESPICLICK inhaler has a dose counter: The number 60 is displayed (prior to use). The dose counter will count down each time the mouthpiece is opened and closed [see Patient Counseling Information ( 17 )].

2.1 Administration In…

💊 Dosage Forms and Strengths 111 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation powder: an inhalation-driven, multidose dry powder inhaler (MDPI) for oral inhalation that meters 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate with 14 mcg of salmeterol from the device reservoir and delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate with 12.75 mcg of salmeterol, respectively, from the mouthpiece per actuation. The AIRDUO RESPICLICK is a white inhaler with a yellow cap, and is provided in a sealed foil pouch with desiccant [see How Supplied/Storage and Handling ( 16 )].

Inhalation powder: 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg of fluticasone propionate/salmeterol in each actuation. ( 3 )

⛔ Contraindications 95 words ▾

4 CONTRAINDICATIONS AIRDUO RESPICLICK is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions ( 5.10 ) and Description ( 11 )]. Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.

( 4 ) Severe hypersensitivity to milk proteins or any ingredients of AIRDUO RESPICLICK. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma.

( 5.2 ) Do not use in combination with an additional medicine containing LABA because of risk of overdose. ( 5.3 ) Localized infections: Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically.

Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.4 ) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or 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. ( 5.5 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to AIRDUO RESPICLICK.

( 5.6 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue AIRDUO RESPICLICK slowly. ( 5.7 ) Paradoxical bronchospasm: Discontinue AIRDUO RESPICLICK and institute alternative therapy if paradoxical bronchospasm occurs.

( 5.9 ) Use with caution in patients with cardiovascular or central nervous system disorders because of beta adrenergic stimulation. ( 5.11 ) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. ( 5.12 ) Monitor growth of pediatric patients.

( 5.13 ) Close monitoring for glaucoma and cataracts is warranted. ( 5.14 ) Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. ( 5.15 , 5.17 ) Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

( 5.16 )

5.1Serious Asthma-Related Events – Hospitalizations, Intubations, Deat h Use of LABA as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)] . Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy.

When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone [see Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta 2 -adrenergic Agonists] . Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta 2 -adrenergic Agonists Four large, 26-week, randomized, blinded, active-controlled clinical safety trials were conducted to evaluate the risk of serious asthma-related events when LABA were used in fixed-dose combination with ICS compared with ICS alone in subjects with asthma.

Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol to budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol to mometasone furoate. The fourth trial included pediatric subjects aged 4 to 11 years and compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder. The primary safety endpoint for all 4 trials was serious asthma-related events (hospitalizations, intubations, death).

A blinded adjudication committee determined whether events were asthma-related. The 3 adult and adolescent trials were desi…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] Oropharyngeal candidiasis [see Warnings and Precautions ( 5.4 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.5 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.11 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.12 )] Growth effects in pediatrics [see Warnings and Precautions ( 5.13 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (greater than or equal to 3%): nasopharyngitis, oral candidiasis, headache, cough and back pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience in Asthma Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two placebo-controlled, 12-week, clinical studies (Trials 1 and 2) [see Clinical Studies ( 14 )] , a total of 1,364 adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy were treated twice daily with either placebo; fluticasone propionate MDPI 55 mcg, 113 mcg, or 232 mcg (ARMONAIR RESPICLICK, hereafter referred to as fluticasone propionate MDPI); or AIRDUO RESPICLICK 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg.

Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 to 84 days in the fluticasone propionate MDPI and AIRDUO RESPICLICK treatment groups compared with 75 days in the placebo group. Table 2 displays the incidence of most common adverse reactions in pooled Trials 1 and 2.

Table 2: Adverse Reactions with ≥3% Incidence with AIRDUO RESPICLICK, and More Common than Placebo in Subjects with Asthma (Trials 1 and 2) Adverse Reaction Fluticasone Propionate MDPI55 mcg (n=129)% Fluticasone Propionate MDPI113 mcg (n=274)% Fluticasone Propionate MDPI232 mcg (n=146)% AIRDUO RESPICLICK 55 mcg/14 mcg (n=128)% AIRDUO RESPICLICK 113 mcg/14 mcg (n=269)% AIRDUO RESPICLICK 232 mcg/14 mcg (n=145)% Placebo (n=273)% Nasopharyngitis 5.4 5.8 4.8 8.6 4.8 6.9

4.4Oral candidiasis* 3.1 2.9 4.8 1.6 2.2 3.4

0.7Headache 1.6 7.3 4.8 5.5 4.8 2.8

4.4Cough 1.6 1.8 3.4 2.3 3.7 0.7

2.6Back pain 0 1.5 1.4 3.1 0.7 0 1.8 *Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, and oropharyngitis fungal Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on AIRDUO RESPICLICK) that were reported more frequently by patients with asthma treated with AIRDUO RESPICLICK compared with patients treated with placebo include the following: Sinusitis, oropharyngeal pain, pharyngitis, dizziness, influenza, rhinitis allergic, respiratory tract infection, rhinitis, nasal congestion, abdominal pain upper, myalgia, pain in extremity, dyspepsia, laceration, dermatitis contact, and palpitations.

Long Term Safety Study: This was a 26-week, open labeled study of 674 patients previously treated with ICS who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232 mcg; AIRDUO RESPICLICK 113 mcg/14 mcg or 232 mcg/14 mcg; fluticasone propionate inhalation aerosol 110 mcg or 220 mcg; fluticasone propionate and salmeterol inhalation powder (250 mcg/50 mcg), or fluticasone propionate and salmeterol inhalation powder (500 mcg/50 mcg). The types of adverse reactions were similar to those reported above in placebo-controlled studies.

6.2 Postmarketing Experience In addition to adverse reactions…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS AIRDUO RESPICLICK has been used concomitantly with other drugs, including short‑acting beta 2 ‑agonists, and intranasal corticosteroids, commonly used in patients with asthma without adverse drug reactions [see Clinical Pharmacology ( 12.2 )] . No formal drug interaction trials have been performed with AIRDUO RESPICLICK. Avoid strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase risk of systemic corticosteroid and cardiovascular effects.

( 7.1 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. ( 7.2 ) Beta‑blockers: Use with caution.

May block bronchodilatory effects of beta‑agonists and produce severe bronchospasm. ( 7.3 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non‑potassium‑sparing diuretics may worsen with concomitant beta‑agonists.

( 7.4 )

7.1Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of AIRDUO RESPICLICK, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with AIRDUO RESPICLICK is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. Ritonavir : Fluticasone Propionate: 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 and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole : Fluticasone Propionate: 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.

Salmeterol: In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16‑fold and C max increased 1.4‑fold). Three (3) subjects were withdrawn due to beta 2 ‑agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration [see Clinical Pharmacology ( 12.3 )] .

7.2Monoamine Oxidase Inhibitors and Tricyclic Antidepressants AIRDUO RESPICLICK should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol, a component of AIRDUO RESPICLICK, on the vascular system may be potentiated by these agents.

7.3Beta-Adrenergic Receptor Blocking Agents Beta‑blockers not only block the pulmonary effect of beta‑agonists, such as salmeterol, a component of AIRDUO RESPICLICK, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta‑blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta‑adrenergic blocking agents for these patients; cardioselective beta‑blockers could be considered, although they should be administered with caution.

7.4 N…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Monitor for systemic corticosteroid effects. ( 8.6 )

8.1Pregnancy Risk Summary There are no randomized clinical studies of AIRDUO RESPICLICK or individual monoproducts, fluticasone propionate and salmeterol, in pregnant women. There are clinical considerations with the use of AIRDUO RESPICLICK in pregnant women [see Clinical Considerations] . Animal reproduction studies are available with the combination of fluticasone propionate and salmeterol as well as individual components.

In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis [see Data] . However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis [see Data] .

Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 700 times the MRHDID on a mcg/m 2 basis. These adverse effects generally occurred at large multiples of the MRHDID when salmeterol was administered by the oral route to achieve high systemic exposures.

No such effects occurred at an oral salmeterol dose approximately 420 times the MRHDID [see Data] . The estimated risk of major birth defects and miscarriage for the indicated population is unknown. 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.

Clinical Considerations Disease‑Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. Data Animal Data Fluticasone Propionate and Salmeterol: In an embryo/fetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1000, 30/0, 10/100, 30/1000, and 100/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects.

Omphalocele, increased embryo/fetal deaths, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, when combining fluticasone propionate at a dose approximately 2 times the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and a dose of salmeterol at approximately 3500 times the MRHDID (on a mcg/m 2 basis at a maternal oral dose of 10,000 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed when combining fluticasone propionate at a dose 0.6 times the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 30 mcg/kg/day) and a dose of salmeterol at approximately 350 times the MRHDID (on a mcg/m 2 basis at a maternal oral dose of 1000 mcg/kg/day).

In an embryo/fetal development study with pregnant mice that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1400, 40/0, 10/200, 40/1400, or 150/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were genera…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no randomized clinical studies of AIRDUO RESPICLICK or individual monoproducts, fluticasone propionate and salmeterol, in pregnant women. There are clinical considerations with the use of AIRDUO RESPICLICK in pregnant women [see Clinical Considerations] . Animal reproduction studies are available with the combination of fluticasone propionate and salmeterol as well as individual components.

In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis [see Data] . However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis [see Data] .

Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 700 times the MRHDID on a mcg/m 2 basis. These adverse effects generally occurred at large multiples of the MRHDID when salmeterol was administered by the oral route to achieve high systemic exposures.

No such effects occurred at an oral salmeterol dose approximately 420 times the MRHDID [see Data] . The estimated risk of major birth defects and miscarriage for the indicated population is unknown. 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.

Clinical Considerations Disease‑Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. Data Animal Data Fluticasone Propionate and Salmeterol: In an embryo/fetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1000, 30/0, 10/100, 30/1000, and 100/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects.

Omphalocele, increased embryo/fetal deaths, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, when combining fluticasone propionate at a dose approximately 2 times the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and a dose of salmeterol at approximately 3500 times the MRHDID (on a mcg/m 2 basis at a maternal oral dose of 10,000 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed when combining fluticasone propionate at a dose 0.6 times the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 30 mcg/kg/day) and a dose of salmeterol at approximately 350 times the MRHDID (on a mcg/m 2 basis at a maternal oral dose of 1000 mcg/kg/day).

In an embryo/fetal development study with pregnant mice that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1400, 40/0, 10/200, 40/1400, or 150/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of AIRDUO RESPICLICK have been established for the treatment of asthma in pediatric patients aged 12 years and older whose asthma (1) is inadequately controlled on a long term asthma control medication or (2) warrants initiation of treatment with both an ICS and a LABA. Use of AIRDUO RESPICLICK in pediatric patients aged 12 to 17 years for this indication is supported by evidence from two adequate and well-controlled trials in pediatric patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2) [see Clinical Studies ( 14 )].

In these trials, 58 adolescents received AIRDUO RESPICLICK one inhalation twice daily. The safety and effectiveness of AIRDUO RESPICLICK have not been established in pediatric patients younger than 12 years of age for the treatment of asthma. Effectiveness was not demonstrated in one adequate and well-controlled study conducted in 211 patients aged 4 to 11 years with persistent asthma on a stable asthma regimen who were treated with AIRDUO RESPICLICK 55 mcg/14 mcg one inhalation twice daily.

Effect on Growth Inhaled corticosteroids, including fluticasone propionate, a component of AIRDUO RESPICLICK, may cause a reduction in growth velocity in adolescents [see Warning and Precautions ( 5.13 )] . The growth of pediatric patients receiving ICS, including AIRDUO RESPICLICK, should be monitored. If an adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered.

In such patients, the potential growth effects of prolonged ICS treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of ICS, including AIRDUO RESPICLICK, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see Dosage and Administration ( 2 )].

🧓 Geriatric Use 40 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness were observed in data collected in 54 subjects aged 65 years and older versus younger subjects who were treated with AIRDUO RESPICLICK in placebo-controlled Phase 2 and 3 asthma studies.

🆘 Overdosage 191 words ▾

10 OVERDOSAGE AIRDUO RESPICLICK contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to AIRDUO RESPICLICK. Treatment of overdosage consists of discontinuation of AIRDUO RESPICLICK together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta‑receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.

Cardiac monitoring is recommended in cases of overdosage. Fluticasone propionate Chronic overdosage of fluticasone propionate may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.7 )] . Salmeterol The expected signs and symptoms with overdosage of salmeterol are those of excessive beta‑adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta‑adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).

Overdosage with salmeterol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias. As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of salmeterol.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action AIRDUO RESPICLICK : AIRDUO RESPICLICK contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to AIRDUO RESPICLICK. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices.

Fluticasone Propionate : 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 humans are consistent with these results.

The clinical significance of these findings is unknown. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

These anti-inflammatory actions of corticosteroids contribute to their efficacy in the treatment of asthma. Salmeterol : Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 ‑adrenoceptors than albuterol.

Although beta 2 ‑adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 ‑adrenoceptors are the predominant receptors in the heart, there are also beta 2 ‑adrenoceptors in the human heart comprising 10% to 50% of the total beta‑adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta 2 ‑agonists may have cardiac effects. The pharmacologic effects of beta 2 ‑adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP).

Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long‑lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D 2 , from human lung. Salmeterol inhibits histamine‑induced plasma protein extravasation and inhibits platelet‑activating factor‑induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route.

In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen‑induced bronchial hyperresponsiveness.

12.2Pharmacodynamics Hypothalamic Pituitary Adrenal Axis Effects (HPA) There are no HPA data from controlled trials of the AIRDUO RESPICLICK in healthy subjects or subjects with asthma. Cardiovascular Effects and Effects on Potassium and Glucose AIRDUO RESPICLICK in Healthy Subjects There were no clinical trials conducted with AIRDUO RESPICLICK that assessed cardiovascular (CV) effects in healthy subjects. Other Fluticasone Propionate and Salmeterol Dry Powder Inhaler (DPI) Products in Healthy Subjects Since systemic pharmacodynamic effects of salmeterol are not normally seen at the maximum approved salmeterol dosage, higher doses were used to produce measurable effects.

Four trials were conducted with healthy adult subjects to assess CV effects: Single‑dose crossover trial using 2 inhalations of fluticasone propionate and salmeterol DPI (500 mcg/50 mcg) (two times the maximum approved salmeterol dosage for that DPI per dosing interval…

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action AIRDUO RESPICLICK : AIRDUO RESPICLICK contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to AIRDUO RESPICLICK. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices.

Fluticasone Propionate : 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 humans are consistent with these results.

The clinical significance of these findings is unknown. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

These anti-inflammatory actions of corticosteroids contribute to their efficacy in the treatment of asthma. Salmeterol : Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 ‑adrenoceptors than albuterol.

Although beta 2 ‑adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 ‑adrenoceptors are the predominant receptors in the heart, there are also beta 2 ‑adrenoceptors in the human heart comprising 10% to 50% of the total beta‑adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta 2 ‑agonists may have cardiac effects. The pharmacologic effects of beta 2 ‑adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP).

Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long‑lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D 2 , from human lung. Salmeterol inhibits histamine‑induced plasma protein extravasation and inhibits platelet‑activating factor‑induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route.

In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen‑induced bronchial hyperresponsiveness.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied AIRDUO RESPICLICK inhalation powder: a multidose, dry-powder inhaler (MDPI) each inhaler is white, has a yellow cap and is packaged individually in a foil pouch with a dessicant, each pouch is packed in a carton each inhaler contains 0.45 grams of the formulation and provides 60 actuations available in 3 strengths STRENGTH NDC CODE AIRDUO RESPICLICK 55 mcg/14 mcg (low) NDC 59310-805-06 AIRDUO RESPICLICK 113 mcg/14 mcg (medium) NDC 59310-812-06 AIRDUO RESPICLICK 232 mcg/14 mcg (high) NDC 59310-822-06 Each AIRDUO RESPICLICK inhaler has a dose counter attached to the actuator.

Patients should never try to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Patient Counseling Information (17 )] .

Storage and Handling Store at room temperature (between 15ºC and 25ºC; 59ºF and 77ºF) in a dry place; excursions permitted from 59º F to 86º F (15ºC to 30ºC). Avoid exposure to extreme heat, cold, or humidity. Store AIRDUO RESPICLICK inside the unopened moisture‑protective foil pouch until initial use.

Discard AIRDUO RESPICLICK 30 days after opening the foil pouch or when the counter reads 0, whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

📋 Description ~2 min read ▾

11 DESCRIPTION AIRDUO RESPICLICK 55 mcg/14 mcg, AIRDUO RESPICLICK 113 mcg/14 mcg and AIRDUO RESPICLICK 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate One active component of AIRDUO RESPICLICK is fluticasone propionate, a corticosteroid having the chemical name S -(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-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 25 H 31 F 3 O 5 S.

It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate The other active component of AIRDUO RESPICLICK is salmeterol xinafoate, a beta 2 –adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol.

It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure: Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C 25 H 37 NO 4 •C 11 H 8 O 3 . It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AIRDUO RESPICLICK AIRDUO RESPICLICK is a multidose dry powder inhaler (MDPI) for oral inhalation only.

It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device.

This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AIRDUO RESPICLICK inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles.

In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min). FP chem structure Salmeterol chem structure

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION AIRDUO ® RESPICLICK ® (ayr´ due oh res-pē-klik) (fluticasone propionate and salmeterol) inhalation powder 55 mcg/14 mcg AIRDUO ® RESPICLICK ® (ayr´ due oh res-pē-klik) (fluticasone propionate and salmeterol) inhalation powder 113 mcg/14 mcg AIRDUO ® RESPICLICK ® (ayr´ due oh res-pē-klik) (fluticasone propionate and salmeterol) inhalation powder 232 mcg/14 mcg for oral inhalation use What is AIRDUO RESPICLICK? AIRDUO RESPICLICK combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the LABA medicine salmeterol.

ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. AIRDUO RESPICLICK is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.

AIRDUO RESPICLICK contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AIRDUO RESPICLICK contains an ICS and a LABA.

When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems. AIRDUO RESPICLICK is not for people 12 years of age and older with asthma who are well controlled with an asthma control medicine, such as a low or medium dose of an inhaled corticosteroid medicine. AIRDUO RESPICLICK is for people 12 years of age and older with asthma who need both an ICS and LABA medicine.

AIRDUO RESPICLICK is not used to relieve sudden breathing problems and will not replace a rescue inhaler. It is not known if AIRDUO RESPICLICK is safe and effective in children younger than 12 years of age. Do not use AIRDUO RESPICLICK: to treat sudden, severe symptoms of asthma. if you have a severe allergy to milk proteins.

Ask your healthcare provider if you are not sure. if you are allergic to fluticasone propionate or any of the inactive ingredients in AIRDUO RESPICLICK. See the end of this leaflet for a complete list of ingredients in AIRDUO RESPICLICK. Tell your healthcare provider about all of your medical conditions, including if you: have heart problems. have high blood pressure. have seizures. have thyroid problems. have diabetes. have liver problems. have weak bones (osteoporosis). have an immune system problem. have eye problems, such as glaucoma or cataracts. are allergic to milk proteins. have any type of viral, bacterial, fungal, or parasitic infection. are exposed to chickenpox or measles. are pregnant or plan to become pregnant.

It is not known if AIRDUO RESPICLICK may harm your unborn baby. are breastfeeding. It is not known if the medicines in AIRDUO RESPICLICK pass into your breast milk and if they 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.

AIRDUO RESPICLICK 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.

How should I use AIRDUO RESPICLICK? Read the step-by-step instructions for using AIRDUO RESPICLICK at the end of this Patient Information leaflet. AIRDUO RESPICLICK is for oral inhalation only.

Rinse your mouth with water without swallowing after each dose of AIRDUO RESPICLICK. AIRDUO RESPICLICK comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.

Use AIRDUO RESPICLICK exactly as your healthcare provider tells you to use it. Do not use AIRDUO RESPICLICK more often than prescribed. Use 1 inhalation of AIRDUO RESPICLICK 2 times each d…

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.