HomeNDC LookupIngredientsIpratropium Bromide › 24208-0399-15
Ipratropium Bromide 42 ug Spray, Metered — NDC 24208-0399-15 package photo

Ipratropium Bromide 42 ug Spray, Metered

by Bausch & Lomb Incorporated · 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY
NDC 24208-0399-15
🏷️ FDA NDC (as labeled) 24208-399-15 billing pads the product segment with a zero
Rx only Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 24208-399-15
Product NDC 24208-399
11-digit billing NDC 24208039915
NCPDP billing unit ML — per mL (volume)
RxCUI 1797844
UNII J697UZ2A9J
Application # ANDA076103
SPL Set ID 3fd850a2-af0f-4291-af5d-52c8d6094e64
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-03-31
Route NASAL
Dosage form SPRAY, METERED
Substance IPRATROPIUM BROMIDE
GPI-14 42300040102020
GPI class Ipratropium Bromide
GCN Seq No 024456
GCN 42238
HICL code 000057
Ingredient (HICL) Ipratropium Bromide
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7A
Therapeutic class — specific (HIC3) Nose Preparations, Miscellaneous (Rx)
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name IPRATROPIUM 0.06% SPRAY
FDB brand name Ipratropium Bromide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 24208-399-15 — 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 → 24208-0399-15. 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 Anticholinergic class.

Pharmacologic class Anticholinergic
Drug family (ATC) Other nasal preparations, Anticholinergics
How it works Cholinergic Antagonists
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

LabelerBausch & Lomb Incorporated
Application holderBAUSCH HEALTH US LLC
FDA applicationANDA076103 (ANDA)
Labeler code24208
First marketedMar 2003
Product typeHuman Prescription Drug
Portfolio92 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IPRATROPIUM 0.06% SPRAY Ingredient Ipratropium Bromide
📖 What it is MedlinePlus · NLM

Ipratropium nasal spray is available in two strengths that are used to treat different conditions. Ipratropium nasal spray 0.06% is used to relieve a runny nose caused by the common cold or seasonal allergies (hay fever) in adults and children age 5 and older. Ipratropium nasal spray 0.03% is used to relieve a runny nose caused by year-round allergic and nonallergic rhinitis (runny nose and stuffiness) in adults and children age 6 and older. Ipratropium nasal spray does not relieve nasal congestion, sneezing, or postnasal drip caused by these conditions. Ipratropium nasal spray is in a class o...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Unfortunately, no. Ipratropium nasal spray is designed specifically to reduce a runny nose — it blocks the glands that produce nasal fluid. It doesn't do anything for congestion or...
  • Will this spray help with my stuffiness and sneezing too?
  • You can expect to notice a reduction in nasal dripping within about an hour of your first dose — that's what clinical studies showed. Use it consistently as directed throughout the...
  • That depends on why you're using it. For a cold, safety and effectiveness have only been established for up to four days. For seasonal allergies, it's been studied for up to three...
📖 Read our full Ipratropium Nasal Spray guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 mLPer package
Retail pharmacies payNADAC · weekly $0.871
Medicaid paysCMS SDUD · 12 mo $1.52
Medicare drug plans payPart D · Q2 2026 $1.17
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 May 2022 Nov 2022 Feb 2026 $1.612 $0.871
▼ Down 36% over the last 18 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ipratropium Bromide 42 ug 00054-0046-41 Hikma 1 bottle $0.810 AB Availability likely save 7%
Ipratropium Bromide 42 ug 16714-0527-01 NORTHSTAR 1 bottle $0.810 AB Availability likely save 7%
Ipratropium Bromide 42 ug 60505-0827-01 Apotex 1 bottle $0.810 AB Availability likely save 7%
Ipratropium Bromide 42 ug 69238-2017-02 Amneal 1 bottle $0.810 AB Availability likely save 7%
Ipratropium Bromide 42 ug 70748-0337-01 Lupin 1 bottle $0.810 AB Availability likely save 7%
Ipratropium Bromide 42 ug 72888-0148-37 Advagen 1 bottle $0.810 AB Availability likely save 7%
Ipratropium Bromide 42 ugthis 24208-0399-15 Bausch 1 bottle $0.871 AB FDA listed
Ipratropium Bromide 42 ug 50090-5968-00 A-S 1 bottle AB FDA listed
Ipratropium Bromide 42 ug 68682-0399-15 Oceanside 1 bottle AB FDA listed
Ipratropium Bromide 42 ug 72162-2144-02 Bryant 1 bottle AB FDA listed
Ipratropium Bromide 42 ug 85766-0242-15 Sportpharm 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2003
On the market since
Mar 2003
📍
2026
Currently FDA-listed
23 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 24208-0399-15, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
65.6K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$1.68M
Avg / prescription
$25.60
Avg / unit
$1.5188
Latest quarter Q4 2025
10.8KRx
Medicaid pays / mL
$1.5188
gross reimbursed
vs
NADAC / mL
$0.8711
acquisition cost
=
Spread
+$0.6477
+74% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
38% FFS 62% MCO
Fee-for-service · 24,988 Rx Managed care · 40,619 Rx
State Medicaid map
Alaska: 255 units · 34.8 per 100k residents AK Maine: 1,215 units · 87.1 per 100k residents ME Washington: 10,395 units · 133 per 100k residents WA Idaho: 1,605 units · 81.7 per 100k residents ID Montana: 1,125 units · 99.4 per 100k residents MT North Dakota: 660 units · 84.3 per 100k residents ND Minnesota: 15,600 units · 272 per 100k residents MN Wisconsin: 13,530 units · 229 per 100k residents WI Michigan: 55,365 units · 552 per 100k residents MI New York: 128,160 units · 655 per 100k residents NY Vermont: 1,620 units · 250 per 100k residents VT New Hampshire: 3,030 units · 216 per 100k residents NH Oregon: 1,365 units · 32.2 per 100k residents OR Nevada: 18,840 units · 590 per 100k residents NV Wyoming: no data reported WY South Dakota: 390 units · 42.4 per 100k residents SD Iowa: 675 units · 21.0 per 100k residents IA Illinois: 5,640 units · 44.9 per 100k residents IL Indiana: 39,570 units · 577 per 100k residents IN Ohio: 55,155 units · 468 per 100k residents OH Pennsylvania: 72,253 units · 557 per 100k residents PA New Jersey: 39,840 units · 429 per 100k residents NJ Massachusetts: 58,005 units · 829 per 100k residents MA California: 121,815 units · 313 per 100k residents CA Utah: 1,035 units · 30.3 per 100k residents UT Colorado: 21,330 units · 363 per 100k residents CO Nebraska: 2,715 units · 137 per 100k residents NE Missouri: 16,785 units · 271 per 100k residents MO Kentucky: 19,110 units · 422 per 100k residents KY West Virginia: 9,360 units · 529 per 100k residents WV Virginia: 20,175 units · 231 per 100k residents VA Maryland: 28,757 units · 465 per 100k residents MD Connecticut: 28,605 units · 791 per 100k residents CT Rhode Island: 10,635 units · 971 per 100k residents RI Arizona: 32,625 units · 439 per 100k residents AZ New Mexico: 17,790 units · 842 per 100k residents NM Kansas: 2,235 units · 76.0 per 100k residents KS Arkansas: 2,295 units · 74.8 per 100k residents AR Tennessee: 25,740 units · 361 per 100k residents TN North Carolina: 61,965 units · 572 per 100k residents NC South Carolina: 24,630 units · 458 per 100k residents SC Delaware: 8,820 units · 855 per 100k residents DE Oklahoma: 6,478 units · 160 per 100k residents OK Louisiana: 44,490 units · 973 per 100k residents LA Mississippi: 6,720 units · 229 per 100k residents MS Alabama: 4,455 units · 87.2 per 100k residents AL Georgia: 24,255 units · 220 per 100k residents GA D.C.: 3,285 units · 484 per 100k residents DC Hawaii: 6,330 units · 441 per 100k residents HI Texas: 24,555 units · 80.5 per 100k residents TX Florida: 4,485 units · 19.8 per 100k residents FL
Units reimbursed · per 100k residents
19.8973
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 973 /100k
2 Rhode Island 971 /100k
3 Delaware 855 /100k
4 New Mexico 842 /100k
5 Massachusetts 829 /100k
6 Connecticut 791 /100k
7 New York 655 /100k
8 Nevada 590 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Ipratropium Bromide — the program that covers self-administered drugs. 13 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 Ipratropium Bromide. 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
$19.15M
Claims incl. refills
666.7K
Beneficiaries
481.7K
Spend / beneficiary
$39.75
Spend / claim
$28.72
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 Ipratropium Bromide — the ingredient across all brands.

Top reported reactions

Dyspnoea6,721
Asthma4,204
Pneumonia3,446
Cough3,300
Wheezing2,775
Fatigue2,488
Nausea2,200

Age at onset

Neonate17
Infant36
Child135
Adolescent91
Adult2,880
Elderly3,373

Reporter sex

39,628 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization16,882
Death5,048
Life-threatening2,321
Disabling1,140
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,106 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
24208-0399-15 You're viewing this 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY 2003-03-31 Active

📄 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 97 words

INDICATIONS AND USAGE: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION: For Symptomatic Relief of Rhinorrhea Associated with the Common Cold: The recommended dose of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) for children age 5-11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day).

The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold have not been established. For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic Rhinitis: The recommended dose of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond three weeks in patients with seasonal allergic rhinitis have not been established.

Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime.

Avoid spraying into eyes.

Contraindications 29 words

CONTRAINDICATIONS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.

⚠️ Warnings 47 words

WARNINGS: Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) should be stopped at once and alternative treatment should be considered.

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS: Adverse reaction information on Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in patients with the common cold was derived from two multicenter, vehicle-controlled clinical trials involving 1,276 patients (195 patients on Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray), 352 patients on Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray), 189 patients on Ipratropium Bromide Nasal Solution 0.12% (Nasal Spray), 351 patients on vehicle and 189 patients receiving no treatment). Table 1 shows adverse events reported for patients who received Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) at the recommended dose of 84 mcg per nostril, or vehicle, administered three or four times daily, where the incidence is 1% or greater in the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group.

Table 1 % of Patients with Common Cold Reporting Events This table includes adverse events for which the incidence was 1% or greater in the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) Vehicle Control No. of Patients 352 351 Epistaxis Epistaxis reported by 5.4% of ipratropium bromide patients and 1.4% of vehicle patients, blood-tinged nasal mucus by 2.8% of ipratropium bromide patients and 0.9% of vehicle patients.

8.2% 2.3% Nasal Dryness 4.8% 2.8% Dry Mouth/Throat 1.4% 0.3% Nasal Congestion 1.1% 0.0% Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) was well tolerated by most patients. The most frequently reported adverse events were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate in nature, none was considered serious, and none resulted in hospitalization.

No patient required treatment for nasal dryness, and only three patients (<1%) required treatment for epistaxis, which consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly). No patient receiving Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) was discontinued from the trial due to either nasal dryness or bleeding. Adverse events reported by less than 1% of the patients receiving Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) during the controlled clinical trials that are potentially related to ipratropium bromide’s local effects or systemic anticholinergic effects include: taste perversion, nasal burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation, pharyngitis, tachycardia, thirst, tinnitus and blurred vision.

No controlled trial was conducted to address the relative incidence of adverse events for three times daily versus four times daily therapy. Nasal adverse events seen in the clinical trial with seasonal allergic rhinitis (SAR) patients (see Table 2 ) were similar to those seen in the common cold trials. Additional events were reported at a higher rate in the SAR trial due in part to the longer duration of the trial and the inclusion of Upper Respiratory Tract Infection (URI) as an adverse event.

In common cold trials, URI was the disease under study and not an adverse event. Table 2 % of Patients with SAR Reporting Events This table includes adverse events for which the incidence was 1% or greater in ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) Vehicle Control No. of Patients 218 211 Epistaxis Epistaxis reported by 3.7% of ipratropium bromide patients and 2.4% of vehicle patients, blood-tinged nasal mucus by 2.3% of ipratropium bromide patients and 1.9% of vehicle patients.

6.0% 3.3% Pharyngitis 5.0% 3.8% URI 5.0% 3.3% Nasal Dryness 4.6% 0.9% Headache 4.1% 0.5% Dry Mouth/Throat 4.1% 0.0% Taste Perversion 3.7% 1.4% Sinusitis 2.8% 2.8% Pain 1.8% 0.9% Diarrhea 1.8% 0.5% There were no reports of allergic-type reactions in the controlled clinical common cold and SA…

🔄 Drug Interactions 39 words

Drug Interactions: No controlled clinical trials were conducted to investigate potential drug-drug interactions. There is potential for an additive interaction with other concomitantly administered medications with anticholinergic properties, including Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) for oral inhalation.

🤰 Pregnancy 196 words

Pregnancy: Teratogenic Effects: There are no adequate and well-controlled studies for Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in pregnant women. Because animal reproduction studies are not always predictive of human response, Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) should be used during pregnancy only if clearly needed. Oral reproduction studies were performed at ipratropium doses of 10 mg/kg in mice, 1,000 mg/kg in rats and 125 mg/kg in rabbits.

These doses correspond, in each species respectively, to approximately 60, 12,000, and 3,000 times the maximum recommended daily intranasal dose (MRDID) in adults on a mg/m 2 basis. Inhalation reproduction studies were conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg, respectively (approximately 20 and 45 times, respectively, the MRDID in adults on a mg/m 2 basis). These studies demonstrated no evidence of teratogenic effects as a result of ipratropium bromide.

At oral doses above 90 mg/kg in rats (approximately 1,100 times the MRDID in adults on a mg/m 2 basis), embryotoxicity was observed as increased resorption. This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration.

🧒 Pediatric Use ~2 min read

Pediatric Use: The safety of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) at a dose of two sprays (84 mcg) per nostril three times a day (total dose 504 mcg/day) for two to four days has been demonstrated in two clinical trials involving 362 pediatric patients 5-11 years of age with naturally acquired common colds. In this pediatric population, Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) had an adverse event profile similar to that observed in adolescent and adult patients. When Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) was concomitantly administered with an oral decongestant (pseudoephedrine HCl) in 122 children ages 5-12 years, and concomitantly administered with an oral decongestant/antihistamine combination (pseudoephedrine HCl/chlorpheniramine maleate) in 123 children ages 5-12 years, adverse event profiles were similar to Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) alone.

The safety of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) at a dose of two sprays (84 mcg) per nostril four times a day (total dose 672 mcg/day) for three weeks in pediatric seasonal allergic rhinitis patients down to 5 years is based upon the safety demonstrated in the pediatric common cold trials and the trial in adult and adolescent patients 12 to 75 years of age with seasonal allergic rhinitis. The effectiveness of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) for the treatment of rhinorrhea associated with the common cold and seasonal allergic rhinitis in this pediatric age group is based on extrapolation of the demonstrated efficacy of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in adolescents and adults with the conditions and the likelihood that the disease course, pathophysiology, and the drug’s effects are substantially similar to that of adults.

The recommended dose for common cold for the pediatric population is based on cross-study comparisons of the efficacy of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in adult and pediatric patients and on its safety profile in both adults and pediatric common cold patients. The recommended dose for seasonal allergic rhinitis for the pediatric population down to 5 years is based upon the efficacy and safety of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in adults and adolescents 12 years of age and above with seasonal allergic rhinitis and the safety profile of this dose in both adult and pediatric common cold patients.

The safety and effectiveness of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in pediatric patients under 5 years of age have not been established.

🆘 Overdosage 124 words

OVERDOSAGE: Acute overdosage by intranasal administration is unlikely since ipratropium bromide is not well absorbed systemically after intranasal or oral administration. Following administration of a 20 mg oral dose (equivalent to ingesting more than two bottles of Ipratropium Bromide Nasal Solution 0.06% [Nasal Spray]) to 10 male volunteers, no change in heart rate or blood pressure was noted. Following a 2 mg intravenous infusion over 15 minutes to the same 10 male volunteers, plasma ipratropium concentrations of 22-45 ng/mL were observed (>100 times the concentrations observed following intranasal administration).

Following intravenous infusion, these 10 volunteers had a mean increase of heart rate of 50 bpm and less than 20 mmHg change in systolic or diastolic blood pressure at the time of peak ipratropium levels.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY: Mechanism of Action: Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. In humans, ipratropium bromide has anti-secretory properties and, when applied locally, inhibits secretions from the serous and seromucous glands lining the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal and gastrointestinal membranes and the blood-brain barrier, resulting in a reduction of the systemic anticholinergic effects (e.g., neurologic, ophthalmic, cardiovascular, and gastrointestinal effects) that are seen with tertiary anticholinergic amines.

Pharmacokinetics: Absorption : Ipratropium bromide is poorly absorbed into the systemic circulation following oral administration (2-3%). Less than 20% of an 84 mcg per nostril dose was absorbed from the nasal mucosa of normal volunteers, induced-cold adult volunteers, naturally acquired common cold pediatric patients, or perennial rhinitis adult patients. Distribution : Ipratropium bromide is minimally bound (0 to 9% in vitro) to plasma albumin and α 1 -acid glycoprotein.

Its blood/plasma concentration ratio was estimated to be about 0.89. Studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier. Metabolism : Ipratropium bromide is partially metabolized to ester hydrolysis products, tropic acid, and tropane.

These metabolites appear to be inactive based on in vitroreceptor affinity studies using rat brain tissue homogenates. Elimination : After intravenous administration of 2 mg ipratropium bromide to 10 healthy volunteers, the terminal half-life of ipratropium bromide was approximately 1.6 hours. The total body clearance and renal clearance were estimated to be 2,505 and 1,019 mL/min, respectively.

The amount of the total dose excreted unchanged in the urine (Ae) within 24 hours was approximately one-half of the administered dose. Pediatrics : Following administration of 84 mcg of ipratropium bromide per nostril three times a day in patients 5-18 years old (n=42) with a naturally acquired common cold, the mean amount of the total dose excreted unchanged in the urine of 7.8% was comparable to 84 mcg per nostril four times a day in an adult induced common cold population (n=22) of 7.3 to 8.1%. Plasma ipratropium concentrations were relatively low (ranging from undetectable up to 0.62 ng/mL).

No correlation of the amount of the total dose excreted unchanged in the urine (Ae) with age or gender was observed in the pediatric population. Special Populations : Gender does not appear to influence the absorption or excretion of nasally administered ipratropium bromide. The pharmacokinetics of ipratropium bromide have not been studied in patients with hepatic or renal insufficiency or in the elderly.

Drug-Drug Interactions : No specific pharmacokinetic studies were conducted to evaluate potential drug-drug interactions. Pharmacodynamics: In two single dose trials (n=17), doses up to 336 mcg of ipratropium bromide did not significantly affect pupillary diameter, heart rate, or systolic/diastolic blood pressure. Similarly, Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in adult patients (n=22) with induced-colds, (84 mcg/nostril four times a day) and in pediatric patients (n=45) with naturally acquired common cold (84 mcg/nostril three times a day) had no significant effects on pupillary diameter, heart rate, or systolic/diastolic blood pressure.

Controlled clinical trials demonstrated that intranasal fluorocarbon-propelled ipratropium bromide does not alter physiologic nasal functions (e.g., sense of smell, ciliary beat frequency, mucociliary clearance, or the air conditioning capacity of the nose). Clinical Trials: The clinical trials for Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) wer…

🧬 Mechanism of Action 101 words

Mechanism of Action: Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. In humans, ipratropium bromide has anti-secretory properties and, when applied locally, inhibits secretions from the serous and seromucous glands lining the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal and gastrointestinal membranes and the blood-brain barrier, resulting in a reduction of the systemic anticholinergic effects (e.g., neurologic, ophthalmic, cardiovascular, and gastrointestinal effects) that are seen with tertiary anticholinergic amines.

📦 How Supplied / Storage and Handling 86 words

HOW SUPPLIED: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is supplied in a white high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 16.6 g of product formulation, 165 sprays, each delivering 42 mcg of ipratropium bromide per spray (70 microliters), or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day). NDC 24208-399-15 Bottle of 15 mL

📦 Storage and Handling 60 words

STORAGE: Store at 20° to 25°C (68° to 77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children. Do not spray in the eyes. Patients should be reminded to read and follow the accompanying PATIENT'S INSTRUCTIONS FOR USE , which should be dispensed with the product.

📋 Description 147 words

DESCRIPTION: The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: ipratropium bromide monohydrate Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media.

In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 microliters) in an isotonic, aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water.

Each bottle contains 165 sprays. chem_structure

💬 Information for Patients 176 words

Information for Patients: Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, visual halos or colored images in association with red eyes from conjunctival and corneal congestion may result if Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) comes into direct contact with the eyes. Patients should be instructed to avoid spraying Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in or around the eyes.

Patients who experience eye pain, blurred vision, excessive nasal dryness or episodes of nasal bleeding should be instructed to contact their doctor. To ensure proper dosing, patients should be advised not to alter the size of the nasal spray opening. Patients should be reminded to carefully read and follow the accompanying PATIENT'S INSTRUCTIONS FOR USE.

Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray), patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances, machinery, etc.

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