HomeNDC LookupIngredientsIpratropium Bromide › 76204-0100-60
Ipratropium Bromide .5 mg/2.5mL Solution — NDC 76204-0100-60 package photo

Ipratropium Bromide .5 mg/2.5mL Solution

by Ritedose Pharmaceuticals, LLC · 2 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
NDC 76204-0100-60
🏷️ FDA NDC (as labeled) 76204-100-60 billing pads the product segment with a zero
This package
Contains2.5 mL in 1 ampule Cost per mL$0.1089 NADAC Per package$16.34 / 150 ml Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1548/unit · Part D plans $0.1185/unit — full pricing hub ↓
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) 76204-100-60
Product NDC 76204-100
11-digit billing NDC 76204010060
NCPDP billing unit ML — per mL (volume)
RxCUI 836358
UNII J697UZ2A9J
UPC 0376204100250, 0376204100014
Application # ANDA075693
SPL Set ID 22479633-624a-4251-ad3c-1dcba5d503fb
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 2011-02-01
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance IPRATROPIUM BROMIDE
GPI-14 44100030102020
GPI class Ipratropium Bromide
GCN Seq No 021700
GCN 42235
HICL code 000057
Ingredient (HICL) Ipratropium Bromide
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B60
Therapeutic class — specific (HIC3) Anticholinergics, Orally Inhaled Short Acting
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name IPRATROPIUM BR 0.02% SOLN
FDB brand name Ipratropium Bromide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AN · RLD · RS
Why two NDCs? The FDA registers this code as 76204-100-60 — 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 → 76204-0100-60. 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

LabelerRitedose Pharmaceuticals, LLC
Application holderTHE RITEDOSE CORP
FDA applicationANDA075693 (ANDA)
Labeler code76204
First marketedFeb 2011
Product typeHuman Prescription Drug
Portfolio14 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 BR 0.02% SOLN Ingredient Ipratropium Bromide
📗 Our plain-language guide HelloPharmacist
  • It depends on the form you were prescribed. The inhaler (like Atrovent HFA) and the nebulizer solution are used every day to help keep the airways open if you have COPD — condition...
  • What is ipratropium actually used for — is it for my COPD or my runny nose?
  • No — the inhaler is a maintenance medication, meaning it's meant to be used on a regular schedule to prevent breathing problems, not to rescue you during a sudden flare-up. If you'...
  • Can I use my ipratropium inhaler during a sudden asthma or COPD attack when I can't breathe?
📖 Read our full Ipratropium 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 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 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.

3 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 $0.109 $16.34 / 150 ml
Medicaid paysCMS SDUD · 12 mo $0.1548 $23.22 / 150 ml
Medicare drug plans payPart D · Q2 2026 $0.1185 $17.78 / 150 ml
Medicare Part B allowsASP · J7644 $0.444 / J7644 unit
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.115 $0.057
▲ Up 87% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)76204-100-60
11-digit billing NDC76204-0100-60
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7644
DescriptorIPRATROPIUM BROMIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
Billing units / pkg0.2 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ipratropium Bromide .5 mg/2.5mL 47335-0706-49 Sun 5 pouches $0.095 FDA listed save 13%
Ipratropium Bromide .5 mg/2.5mL 00378-7970-52 Mylan 1 pouch $0.106 AN Availability likely save 2%
Ipratropium Bromide .5 mg/2.5mL 64980-0640-02 Rising 1 pouch $0.106 AN Availability likely save 2%
Ipratropium Bromide .5 mg/2.5mLthis 76204-0100-60 Ritedose 2 pouches $0.109 AN Availability likely
Ipratropium Bromide .5 mg/2.5mL 00487-9801-01 Nephron 30 pouches $0.114 AN Availability likely +5%
Ipratropium Bromide .5 mg/2.5mL 60687-0394-83 American 30 pouches $0.114 AN Availability likely +5%
Ipratropium Bromide .5 mg/2.5mL 62135-0830-84 Chartwell 6 pouches $0.114 AN Availability likely +5%
Ipratropium Bromide .5 mg/2.5mL 50090-0668-00 A-S 1 pouch AN FDA listed
Ipratropium Bromide .5 mg/2.5mL 50090-6373-00 A-S 25 pouches AN FDA listed
Ipratropium Bromide .5 mg/2.5mL 55154-2134-05 Cardinal 5 pouches AN FDA listed
Ipratropium bromide .5 mg/2.5mL 65862-0905-03 Aurobindo 30 pouches AN FDA listed
Ipratropium Bromide .5 mg/2.5mL 67296-2246-01 Redpharm 1 pouch AN FDA listed
Ipratropium Bromide .5 mg/2.5mL 68071-3769-02 NuCare 25 ampules AN FDA listed
Ipratropium Bromide .5 mg/2.5mL 55154-4411-05 Cardinal 5 pouches AN 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

🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 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 76204-0100-60, 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
22.7K
Units reimbursed last 4 qtrs
3.7M
Gross reimbursed last 4 qtrs
$575.7K
Avg / prescription
$25.41
Avg / unit
$0.1548
Latest quarter Q4 2025
5KRx
Medicaid pays / mL
$0.1548
gross reimbursed
vs
NADAC / mL
$0.1089
acquisition cost
=
Spread
+$0.0459
+42% 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
24% FFS 76% MCO
Fee-for-service · 5,361 Rx Managed care · 17,295 Rx
State Medicaid map
Alaska: no data reported AK Maine: 9,600 units · 688 per 100k residents ME Washington: 10,950 units · 140 per 100k residents WA Idaho: no data reported ID Montana: 1,398 units · 123 per 100k residents MT North Dakota: no data reported ND Minnesota: 3,900 units · 68.0 per 100k residents MN Wisconsin: 30,455 units · 515 per 100k residents WI Michigan: 91,418 units · 911 per 100k residents MI New York: 98,583 units · 504 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,985 units · 46.9 per 100k residents OR Nevada: 34,275 units · 1,073 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 10,725 units · 334 per 100k residents IA Illinois: 131,300 units · 1,046 per 100k residents IL Indiana: 85,065 units · 1,240 per 100k residents IN Ohio: 98,828 units · 839 per 100k residents OH Pennsylvania: 96,815 units · 747 per 100k residents PA New Jersey: 46,283 units · 498 per 100k residents NJ Massachusetts: 18,907 units · 270 per 100k residents MA California: 333,673 units · 856 per 100k residents CA Utah: no data reported UT Colorado: 29,925 units · 509 per 100k residents CO Nebraska: 15,600 units · 789 per 100k residents NE Missouri: 69,601 units · 1,123 per 100k residents MO Kentucky: 66,104 units · 1,461 per 100k residents KY West Virginia: 32,343 units · 1,827 per 100k residents WV Virginia: 36,075 units · 414 per 100k residents VA Maryland: 25,433 units · 412 per 100k residents MD Connecticut: 24,150 units · 668 per 100k residents CT Rhode Island: no data reported RI Arizona: 71,135 units · 957 per 100k residents AZ New Mexico: 52,666 units · 2,491 per 100k residents NM Kansas: 12,975 units · 441 per 100k residents KS Arkansas: 33,510 units · 1,093 per 100k residents AR Tennessee: 88,378 units · 1,240 per 100k residents TN North Carolina: 70,870 units · 654 per 100k residents NC South Carolina: no data reported SC Delaware: 38,025 units · 3,688 per 100k residents DE Oklahoma: 47,313 units · 1,167 per 100k residents OK Louisiana: 26,258 units · 574 per 100k residents LA Mississippi: 35,820 units · 1,218 per 100k residents MS Alabama: 23,225 units · 455 per 100k residents AL Georgia: 79,520 units · 721 per 100k residents GA D.C.: 22,500 units · 3,314 per 100k residents DC Hawaii: no data reported HI Texas: 192,600 units · 631 per 100k residents TX Florida: 208,725 units · 923 per 100k residents FL
Units reimbursed · per 100k residents
46.93,688
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 Delaware 3,688 /100k
2 D.C. 3,314 /100k
3 New Mexico 2,491 /100k
4 West Virginia 1,827 /100k
5 Kentucky 1,461 /100k
6 Tennessee 1,240 /100k
7 Indiana 1,240 /100k
8 Mississippi 1,218 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 pouch76204-0100-25 30,867 Rx · $561,782
2 pouches this page76204-0100-60 22,656 Rx · $575,673
1 pouch76204-0100-30 10,147 Rx · $197,389
30 pouches76204-0100-01 5,479 Rx · $112,328
Drug total (last 4 qtrs): 69,149 Rx · 8,553,568 units · $1,447,171 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 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 Per unit Per pack Marketing startStatus
76204-0100-01 30 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE $0.1139 / mL $8.54 2011-11-21 Active
76204-0100-25 1 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE $0.1063 / mL $6.65 2011-11-21 Active
76204-0100-30 1 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE $0.1139 / mL $8.54 2011-11-21 Active
76204-0100-60 You're viewing this 2 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE $0.1089 / mL $16.33 2011-11-21 Active

This pack accounts for about 33% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 76204-0100-60?
NDC 76204-0100-60 is listed by the FDA — 2 pouch in 1 carton / 30 ampule in 1 pouch / 2.5 ml in 1 ampule.
What NDC number is used to bill for this package of Ipratropium Bromide .5 mg/2.5mL Solution?
Bill NDC 76204-0100-60 — the 11-digit billing format is 76204010060. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 38 words

INDICATIONS AND USAGE Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

⏱️ Dosage and Administration 92 words

DOSAGE AND ADMINISTRATION The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium bromide inhalation solution unit-dose vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline. Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour.

Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

Contraindications 21 words

CONTRAINDICATIONS Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

⚠️ Warnings 92 words

WARNINGS The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of ipratropium bromide and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation.

Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature. All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.

Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis, and acute eye pain have been reported. Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials.

Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg. Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.

All Adverse Events, from a Double-blind, Parallel, 12-week Study of patients with COPD All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials. PERCENT OF PATIENTS Ipratropium Metaproterenol Ipratropium/ Metaproterenol Albuterol Ipratropium/ Albuterol (500 mcg t.i.d.) (15 mg t.i.d.) (500 mcg t.i.d./ 15 mg t.i.d.) (2.5 mg t.i.d.) (500 mcg t.i.d./ 2.5 mg t.i.d.) n = 219 n = 212 n = 108 n = 205 n = 100 Body as a Whole-General Disorders Headache 6.4 5.2 6.5 6.3

9.0Pain 4.1 3.3 0.9 2.9

5.0Influenza-like symptoms 3.7 4.7 6.5 0.5

1.0Back Pain 3.2 1.9 1.9 2.4

0.0Chest Pain 3.2 4.2 5.6 2.0

1.0Cardiovascular Disorders Hypertension/Hypertension Aggravated 0.9 1.9 0.9 1.5

4.0Central & Peripheral Nervous System Dizziness 2.3 3.3 1.9 3.9

4.0Insomnia 0.9 0.5 4.6 1.0

1.0Tremor 0.9 7.1 8.3 1.0

0.0Nervousness 0.5 4.7 6.5 1.0

1.0Gastrointestinal System Disorders Mouth Dryness 3.2 0.0 1.9 2.0

3.0Nausea 4.1 3.8 1.9 2.9

2.0Constipation 0.9 0.0 3.7 1.0

1.0Musculo-skeletal System Disorders Arthritis 0.9 1.4 0.9 0.5

3.0Respiratory System Disorders (Lower) Coughing 4.6 8.0 6.5 5.4

6.0Dyspnea 9.6 13.2 16.7 12.7

9.0Bronchitis 14.6 24.5 15.7 16.6

20.0Bronchospasm 2.3 2.8 4.6 5.4

5.0Sputum Increased 1.4 1.4 4.6 3.4

0.0Respiratory Disorder 0.0 6.1 6.5 2.0

4.0Respiratory System Disorders (Upper) Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2

16.0Pharyngitis 3.7 4.2 5.6 2.9

4.0Rhinitis 2.3 4.2 1.9 2.4

0.0Sinusitus 2.3 2.8 0.9 5.4 4.0

🔄 Drug Interactions 40 words

Drug Interactions Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.

🤰 Pregnancy 98 words

Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 18 words

Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 have not been established.

🆘 Overdosage 66 words

OVERDOSAGE Acute systemic overdosage by inhalation solution is unlikely since ipratropium bromide is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose. The oral LD 50 of ipratropium bromide ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 mg/kg in dogs.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Ipratropium bromide is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one.

Much of an administered dose is swallowed but not absorbed, as shown by fecal excretion studies. Following nebulization of a 2 mg dose, a mean 7% of the dose was absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract. The half-life of elimination is about 1.6 hours after intravenous administration.

Ipratropium bromide is minimally (0 to 9% in vitro ) bound to plasma albumin and a 1 -acid glycoproteins. It is partially metabolized. Autoradiographic studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier.

Ipratropium bromide has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations. In controlled 12-week studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function (FEV 1 increases of 15% or more) occurred within 15 to 30 minutes, reached a peak in 1 to 2 hours, and persisted for periods of 4 to 5 hours in the majority of patients, with about 25% to 38% of the patients demonstrating increases of 15% or more for at least 7 to 8 hours.

Continued effectiveness of ipratropium bromide inhalation solution was demonstrated throughout the 12-week period. In addition, significant increases in forced vital capacity (FVC) have been demonstrated. However, ipratropium bromide did not consistently produce significant improvement in subjective symptom scores nor in quality of life scores over the 12-week duration of study.

Additional controlled 12-week studies were conducted to evaluate the safety and effectiveness of ipratropium bromide inhalation solution administered concomitantly with the beta adrenergic bronchodilator solutions metaproterenol and albuterol compared with the administration of each of the beta agonists alone. Combined therapy produced significant additional improvement in FEV 1 and FVC. On combined therapy, the median duration of 15% improvement in FEV 1 was 5 to 7 hours, compared with 3 to 4 hours in patients receiving a beta agonist alone.

📦 How Supplied / Storage and Handling 103 words

HOW SUPPLIED Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 76204-100-25, 25 vials per carton / 25 vials per foil pouch NDC 76204-100-30, 30 vials per carton / 30 vials per foil pouch NDC 76204-100-01, 30 vials per carton / 1 vial per foil pouch NDC 76204-100-60, 60 vials per carton / 30 vials per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch.

Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

📦 Storage and Handling 17 words

Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

📋 Description 125 words

DESCRIPTION The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C 20 H 30 BrNO 3 •H 2 O Mol.Wt. 430.4 Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols.

It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer.

It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid. Chemical Structure

💬 Information for Patients 122 words

Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour.

Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that ipratropium bromide inhalation solution should be used consistently as prescribed throughout the course of therapy.

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.