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Albuterol Sulfate HFA 90 ug Aerosol, Metered — NDC 80425-0359-01 package photo

Albuterol Sulfate HFA 90 ug Aerosol, Metered

by Advanced Rx of Tennessee, LLC · 1 INHALER in 1 CARTON (80425-0359-1) / 200 AEROSOL, METERED in 1 INHALER
NDC 80425-0359-01
🏷️ FDA NDC (as labeled) 80425-0359-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

⚠️
Other active recalls for Albuterol Sulfate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jul 24, 2025 — Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. (Cipla USA, Inc.) · FDA recall D-0593-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 80425-0359-1
Product NDC 80425-0359
11-digit billing NDC 80425035901
NCPDP billing unit GM — per gram (weight)
RxCUI 2123076
UNII 021SEF3731
Application # NDA020983
SPL Set ID 04c8a345-0a0d-5a01-e063-6294a90a40d2
Established class (EPC) beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-07
Route RESPIRATORY (INHALATION)
Dosage form AEROSOL, METERED
Substance ALBUTEROL SULFATE
TE code (Orange Book) AB3 · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0359-1 — 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 → 80425-0359-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor agonists
How it works Adrenergic beta2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvanced Rx of Tennessee, LLC
Application holderGLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
FDA applicationNDA020983 (NDA AUTHORIZED GENERIC)
Labeler code80425
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio280 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

📖 What it is MedlinePlus · NLM

Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 ye...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
  • What exactly does albuterol do, and when should I use it?
  • That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
  • The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
📖 Read our full Albuterol guide →
2
Nutrient depletion considerations

Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Albuterol Sulfate 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 DH9E53K1Y8
    A synthetic fluorinated hydrocarbon used primarily as a propellant or aerosol dispersant in pressurized inhaler formulations to help deliver medication to the lungs.

1 inactive ingredient 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 eachPer 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 · Q2 2026 $1.71 $342.90 / 200 aerosols
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
Albuterol Sulfate HFA 90 ug 00093-3174-31 Teva 1 inhaler $1.553 AB2 Availability likely —
Albuterol Sulfate 90 ug 17270-0740-00 Armstrong 1 inhaler $1.553 AB2 Availability likely —
albuterol sulfate 90 ug 45802-0088-01 Padagis 1 inhaler $1.553 AB2 Availability likely —
Albuterol sulfate 90 ug 68180-0963-01 Lupin 1 canister $1.553 AB2 Availability likely —
Albuterol Sulfate HFA 90 ug 66993-0019-68 Prasco 1 inhaler $1.819 AB3 Availability likely —
Albuterol 90 ug 69097-0021-60 Cipla 1 inhaler $1.819 AB3 Availability likely —
Albuterol Sulfate 90 ug 76282-0679-42 Exelan 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 00054-0742-87 Hikma 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 60687-0662-91 American 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 69097-0142-60 Cipla 1 canister $2.126 AB1 Availability likely —
Ventolin Hfa 90 ug 00173-0682-20 GlaxoSmithKline 1 inhaler $3.035 AB3 Availability likely —
ProAir Digihaler 90 ug 59310-0117-20 Teva 1 inhaler $86.326 — FDA listed —
Ventolin Hfa 90 ug 50090-1159-00 A-S 1 inhaler — AB3 FDA listed —
albuterol sulfate HFA 90 ug 50090-4137-00 A-S 1 inhaler — AB3 FDA listed —
Ventolin Hfa 90 ug 63187-0026-08 Proficient 60 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 68071-1670-02 NuCare 200 aerosols — AB3 FDA listed —
Albuterol Sulate HFA 90 ug 68071-4777-02 NuCare 200 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 70518-1081-00 REMEDYREPACK 200 aerosols — AB3 FDA listed —
Albuterol Sulate HFA 90 ug 70518-2072-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
Albuterol Sulfate HFA 90 ugthis 80425-0359-01 Advanced 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 51662-1513-01 HF 1 inhaler — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 71205-0211-85 Proficient 1 inhaler — AB2 FDA listed —
albuterol sulfate 90 ug 71205-0441-85 Proficient 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 71205-0732-85 Proficient 1 canister — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 76420-0088-01 Asclemed 1 inhaler — AB2 FDA listed —
Albuterol Sulfate 90 ug 76420-0531-01 Asclemed 200 aerosols — AB1 FDA listed —
Albuterol sulfate 90 ug 85766-0062-90 Sportpharm 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 68071-3902-02 NuCare 1 inhaler — AB2 FDA listed —
Albuterol Sulfate 90 ug 68788-8874-02 Preferred 1 canister — AB1 FDA listed —
Ventolin Hfa 90 ug 50090-1158-00 A-S 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 51662-1267-01 HF 1 inhaler — AB3 FDA listed —
Ventolin Hfa 90 ug 68071-1890-06 NuCare 60 aerosols — AB3 FDA listed —
Albuterol Sulfate HFA 90 ug 68071-4940-02 NuCare 200 aerosols — AB2 FDA listed —
Ventolin Hfa 90 ug 70518-1237-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
albuterol sulfate 90 ug 85766-0055-90 Sportpharm 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 50090-5231-00 A-S 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 50090-5735-01 A-S 96 canisters — AB1 FDA listed —
Albuterol Sulfate 90 ug 68788-4041-02 Preferred 1 inhaler — AB2 FDA listed —
Albuterol Sulfate 90 ug 50090-5179-00 A-S 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 70518-4496-00 REMEDYREPACK 1 inhaler — AB2 FDA listed —
Albuterol Sulfate 90 ug 68788-8787-02 Preferred 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 80425-0266-01 Advanced 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 82804-0189-67 Proficient 1 canister — AB1 FDA listed —
Albuterol sulfate 90 ug 68788-8878-02 Preferred 1 canister — AB2 FDA listed —
Albuterol sulfate 90 ug 70518-3541-00 REMEDYREPACK 1 canister — AB2 FDA listed —
Albuterol sulfate 90 ug 76420-0350-90 Asclemed 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 85766-0020-90 Sportpharm 1 canister — AB1 FDA listed —
Albuterol sulfate 90 ug 68071-2300-02 NuCare 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 85534-0039-00 HAWAII 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 68071-5312-06 NuCare 1 canister — AB1 FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

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.

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

Medicare Part D (outpatient prescription) spending for Albuterol Sulfate HFA — 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 Albuterol Sulfate HFA. 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
$136.02M
Claims incl. refills
5M
Beneficiaries
3.3M
Spend / beneficiary
$40.82
Spend / claim
$27.21
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 Albuterol Sulfate HFA (this brand).

Top reported reactions

Dyspnoea13,094
Device Delivery System Issue7,965
Drug Dose Omission By Device7,699
Asthma6,886
Cough6,336
Fatigue5,091
Headache4,774

Reporter sex

87,945 reports

Serious outcomes

Death3,997
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14,919 0
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
80425-0359-01 You're viewing this 1 INHALER in 1 CARTON (80425-0359-1) / 200 AEROSOL, METERED in 1 INHALER 2023-09-07 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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) ✓ 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.
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 80425-0359-1, 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: 80425-0359-01, written without dashes as 80425035901. 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 80425-0359-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx of Tennessee, LLC; the middle segment (0359) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx of Tennessee, 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 💬 Information for Patients
🎯 Indications and Usage 110 words ▾

1 INDICATIONS AND USAGE Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 )

1.1Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease.

1.2Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2 ) Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient.

( 2.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. ( 2.2 ) Priming information: Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray.

( 2.3 ) Cleaning information: At least once a week, wash the actuator with warm water and let it air-dry completely. ( 2.3 )

2.1Recommended Dosage for Bronchospasm (Acute Episodes or Symptoms Associated with Bronchospasm) Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a greater number of inhalations is not recommended.

2.2Recommended Dosage for Prevention of Exercise-Induced Bronchospasm Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise.

2.3Administration Information Albuterol Sulfate HFA should be administered by the orally inhaled route only. Priming Priming Albuterol Sulfate HFA is essential to ensure appropriate albuterol content in each actuation. Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped.

To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. Cleaning To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation aerosol: 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece per actuation. Blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister containing 200 metered inhalations and fitted with a counter. Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) per actuation. ( 3 )

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS Albuterol Sulfate HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.6 ), Description ( 11 )] . Hypersensitivity to any ingredient. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue Albuterol Sulfate HFA immediately and institute alternative therapy. ( 5.1 ) Need for more doses of Albuterol Sulfate HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.

( 5.2 ) Albuterol Sulfate HFA is not a substitute for corticosteroids. ( 5.3 ) Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders.

( 5.4 , 5.7 ) Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) Immediate hypersensitivity reactions may occur.

Discontinue Albuterol Sulfate HFA immediately. ( 5.6 ) Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 )

5.1Paradoxical Bronchospasm Albuterol Sulfate HFA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Albuterol Sulfate HFA, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

5.2Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Sulfate HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3Use of Anti-inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

5.4Cardiovascular Effects Albuterol Sulfate HFA, like all other beta 2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, Albuterol Sulfate HFA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.

The clinical relevance of these findings is unknown. Therefore, Albuterol Sulfate HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6Hypersensitivity Reactions, including Anaphylaxis Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Albuterol Sulfate HFA [see Contraindications ( 4 )] .

5.7Coexisting Conditions Albuterol Sulfate HFA, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8Hypokalemia Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology ( 12.1 )] . The decrease in serum potassium is usually transient, not requiring supplementation.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )] Cardiovascular effects [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions, including anaphylaxis [see Warnings and Precautions ( 5.6 )] Hypokalemia [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 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. The safety data described below reflects exposure to albuterol sulfate HFA in 248 subjects treated with albuterol sulfate HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents is based upon 2 clinical trials in which 202 subjects with asthma aged 12 years and older were treated with albuterol sulfate HFA 2 inhalations 4 times daily for 12 weeks’ duration.

The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other. The data from pediatric subjects are based upon 1 clinical trial in which 46 subjects with asthma aged 4 to 11 years were treated with albuterol sulfate HFA 2 inhalations 4 times daily for 2 weeks’ duration. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.

Adult and Adolescent Subjects Aged 12 Years and Older The two 12-week, randomized, double-blind trials in 610 adult and adolescent subjects with asthma that compared albuterol sulfate HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. Overall, the incidence and nature of the adverse reactions reported for albuterol sulfate HFA and a CFC 11/12‑propelled albuterol inhaler were comparable. Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of ≥3% in the group treated with albuterol sulfate HFA and more frequently in the group treated with albuterol sulfate HFA than in the HFA-134a placebo inhaler group.

Table 1. Adverse Reactions with Albuterol Sulfate HFA with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects Adverse Reaction Percent of Subjects Albuterol Sulfate HFA (n = 202) % CFC 11/12-Propelled Albuterol Inhaler (n = 207) % Placebo HFA-134a (n = 201) % Ear, nose, and throat Throat irritation 10 6 7 Upper respiratory inflammation 5 5 2 Lower respiratory Viral respiratory infections 7 4 4 Cough 5 2 2 Musculoskeletal Musculoskeletal pain 5 5 4 Adverse reactions reported by <3% of the adult and adolescent subjects receiving albuterol sulfate HFA and by a greater proportion of subjects receiving albuterol sulfate HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to albuterol sulfate HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles.

Palpitations and dizziness have also been observed with albuterol sulfate HFA. Pediatric Subjects Aged 4 to 11 Years Results from the 2-week clinical trial in pediatric subjects with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations. Three trials have been conducted to evaluate the safety and efficacy of albuterol sulfate HFA in subjects between birth and 4 years of age.

The results of these trials did not establish the efficacy of albuterol sulfate HFA in this age group [see Use…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Beta-blockers: Use with caution.

May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.1 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.

( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.3 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution.

May potentiate effect of albuterol on vascular system. ( 7.4 )

7.1Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as albuterol sulfate HFA, 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.

7.2Non–Potassium-Sparing Diuretics The ECG changes and/or hypokalemia that may result from the administration of non—potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Albuterol Sulfate HFA with non–potassium-sparing diuretics.

7.3Digoxin Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical relevance of these findings for patients with obstructive airway disease who are receiving inhaled albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

7.4Monoamine Oxidase Inhibitors and Tricyclic Antidepressants Albuterol Sulfate HFA 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 albuterol on the vascular system may be potentiated.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more information, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Risk Summary There are no randomized clinical studies of use of albuterol sulfate during pregnancy.

Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are, however, clinical considerations in pregnant women with asthma. (See Clinical Considerations.) Administration of albuterol sulfate HFA to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (MRHDID).

(See Data.) The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 Embryofetal 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. Labor or Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of Albuterol Sulfate HFA during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Albuterol sulfate HFA has not been approved for the management of pre-term labor.

Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiological studies and case reports have not consistently demonstrated an association with use of albuterol sulfate HFA during pregnancy and major birth defects, specific birth defects, or miscarriage. The available studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact.

Animal Data: In a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta 2 -agonist. In a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m 2 basis at a maternal dose of 50 mg/kg).

In a study in pregnant rabbits, an albuterol/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHDID on a mg/m 2 basis. A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

8.2Lactation Risk Summary There are no available data on the presence of albuterol or the components of A…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more information, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Risk Summary There are no randomized clinical studies of use of albuterol sulfate during pregnancy.

Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are, however, clinical considerations in pregnant women with asthma. (See Clinical Considerations.) Administration of albuterol sulfate HFA to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (MRHDID).

(See Data.) The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 Embryofetal 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. Labor or Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of Albuterol Sulfate HFA during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Albuterol sulfate HFA has not been approved for the management of pre-term labor.

Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiological studies and case reports have not consistently demonstrated an association with use of albuterol sulfate HFA during pregnancy and major birth defects, specific birth defects, or miscarriage. The available studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact.

Animal Data: In a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta 2 -agonist. In a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m 2 basis at a maternal dose of 50 mg/kg).

In a study in pregnant rabbits, an albuterol/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHDID on a mg/m 2 basis. A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of albuterol sulfate HFA for treatment or prevention of bronchospasm and for prevention of exercised-induced bronchospasm in pediatric patients aged 4 years and older have been established. Use of albuterol sulfate HFA for this indication is supported by evidence from adequate and well-controlled studies of two 12-week clinical trials in subjects aged 12 years and older with asthma and one 2-week clinical trial in subjects aged 4 to 11 years with asthma [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] .

The safety and effectiveness of albuterol sulfate HFA in pediatric patients younger than 4 years have not been established. Three trials have been conducted to evaluate the safety and efficacy of albuterol sulfate HFA in subjects younger than 4 years and the findings are described below. Two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness).

Albuterol sulfate HFA or placebo HFA was delivered with either an AeroChamber Plus Valved Holding Chamber or an Optichamber Valved Holding Chamber with mask 3 times daily. In one trial, albuterol sulfate HFA 90 mcg (n = 26), albuterol sulfate HFA 180 mcg (n = 25), and placebo HFA (n = 26) were administered to children aged between 24 and 48 months. In the second trial, albuterol sulfate HFA 90 mcg (n = 29), albuterol sulfate HFA 180 mcg (n = 29), and placebo HFA (n = 28) were administered to children aged between birth and 24 months.

Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving albuterol sulfate HFA 90 mcg, albuterol sulfate HFA 180 mcg, and placebo in either trial. In a third trial, albuterol sulfate HFA was evaluated in 87 pediatric subjects younger than 24 months for the treatment of acute wheezing. Albuterol sulfate HFA was delivered with an AeroChamber Plus Valved Holding Chamber in this trial.

There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between albuterol sulfate HFA 180 mcg and albuterol sulfate HFA 360 mcg. In vitro dose characterization studies were performed to evaluate the delivery of albuterol sulfate HFA via holding chambers with attached masks. The studies were conducted with 2 different holding chambers with masks (small and medium size).

The in vitro study data when simulating patient breathing suggest that the dose of albuterol sulfate HFA presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weight ( Table 2 ). However, clinical trials in children younger than 4 years described above suggest that either the optimal dose of albuterol sulfate HFA has not been defined in this age group or albuterol sulfate HFA is not effective in this age group.

The safety and effectiveness of albuterol sulfate HFA administered with or without a spacer device in children younger than 4 years have not been demonstrated. Table 2. In Vitro Medication Delivery through AeroChamber Plus Valved Holding Chamber with a Mask a Centers for Disease Control growth charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion (2000).

Ranges correspond to the average of the 50 th percentile weight for boys and girls at the ages indicated. b A single inhalation of albuterol sulfate HFA in a 70-kg adult without use of a valved holding chamber and mask delivers approximately 90 mcg, or 1.3 mcg/kg. Age Mask Flow Rate (L/min) Holding Time (seconds) Mean Medication Delivery through AeroChamber Plus (mcg/actuation) Body Weight 50 th Percentile (kg) a Medication Delivered per Actuation…

🧓 Geriatric Use 87 words ▾

8.5Geriatric Use Clinical trials of albuterol sulfate HFA did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 134 words ▾

10 OVERDOSAGE The expected signs and symptoms with overdosage of albuterol 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). As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of Albuterol Sulfate HFA Inhalation Aerosol.

Treatment consists of discontinuation of Albuterol Sulfate HFA together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Albuterol Sulfate HFA.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. 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.

Activation of beta 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenyl cyclase and to an increase in the intracellular concentration of cyclic-3′,5′-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles.

Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.

Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [see Warnings and Precautions ( 5.4 )] .

12.3Pharmacokinetics The systemic levels of albuterol are low after inhalation of recommended doses. A trial conducted in 12 healthy male and female subjects using a higher dose (1,080 mcg of albuterol base) showed that mean peak plasma concentrations of approximately 3 ng/mL occurred after dosing when albuterol was delivered using propellant HFA-134a. The mean time to peak concentrations (T max ) was delayed after administration of Albuterol Sulfate HFA (T max = 0.42 hours) as compared with CFC-propelled albuterol inhaler (T max = 0.17 hours).

Apparent terminal plasma half-life of albuterol is approximately 4.6 hours. No further pharmacokinetic trials for albuterol sulfate HFA were conducted in neonates, children, or elderly subjects.

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. 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.

Activation of beta 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenyl cyclase and to an increase in the intracellular concentration of cyclic-3′,5′-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles.

Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.

Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [see Warnings and Precautions ( 5.4 )] .

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

16 HOW SUPPLIED/STORAGE AND HANDLING Albuterol Sulfate HFA Inhalation Aerosol is supplied in the following box of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue cap: NDC 80425-0359-01 18-g canister containing 200 actuations Each inhaler is packaged with a Patient Information leaflet. The blue actuator supplied with Albuterol Sulfate HFA should not be used with any other product canisters, and actuators from other products should not be used with an Albuterol Sulfate HFA canister.

Counter Albuterol Sulfate HFA has a counter attached to the canister. The counter starts at 204 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate.

The inhaler should be discarded when the counter reads 000. Contents Under Pressure Do not puncture. Do not use or store near heat or open flame.

Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. Storage Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature].

Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.

📋 Description ~1 min read ▾

11 DESCRIPTION The active component of Albuterol Sulfate HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1 -[( tert -butylamino)methyl]-4-hydroxy- m -xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure: Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . It is soluble in water and slightly soluble in ethanol.

The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA‑134a (1,1,1,2‑tetrafluoroethane).

It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped.

To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. Albuterol Sulfate chemical structure

💬 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). Frequency of Use Inform patients that the action of Albuterol Sulfate HFA should last up to 4 to 6 hours. Do not use Albuterol Sulfate HFA more frequently than recommended.

Instruct patients not to increase the dose or frequency of doses of Albuterol Sulfate HFA without consulting the physician. Instruct patients to seek medical attention immediately if treatment with Albuterol Sulfate HFA becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual. Priming Instruct patients to prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped.

To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. Cleaning To ensure proper dosing and to prevent actuator orifice blockage, instruct patients to wash the actuator with warm water and let it air-dry completely at least once a week.

Inform patients that detailed cleaning instructions are included in the Patient Information leaflet. Paradoxical Bronchospasm Inform patients that Albuterol Sulfate HFA can produce paradoxical bronchospasm. Instruct them to discontinue Albuterol Sulfate HFA if paradoxical bronchospasm occurs [see Warnings and Precautions (5.1)] .

Concomitant Drug Use Advise patients that while they are using Albuterol Sulfate HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician. Common Adverse Effects Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness. Pregnancy Exposure Registry Inform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications, including Albuterol Sulfate HFA, during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/asthma [see Use in Specific Populations ( 8.1 )] .

Manufactured for: Prasco Laboratories Mason, OH 45040 USA Manufactured by: GlaxoSmithKline Research Triangle Park, NC 27709 VNT-PS:4PI

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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