IPRATROPIUM BROMIDE 21 ug Spray, Metered
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anticholinergic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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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.
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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.
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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.
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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.
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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?
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
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💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.355 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.9395 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.6490 | — |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ipratropium Bromide 21 ug 00054-0045-44 | Hikma | 1 bottle | $0.355 | AB | Availability likely | — |
| Ipratropium Bromide 21 ug 16714-0526-01 | NORTHSTAR | 1 bottle | $0.355 | AB | Availability likely | — |
| Ipratropium Bromide 21 ug 60505-0826-01 | Apotex | 1 bottle | $0.355 | AB | Availability likely | — |
| Ipratropium Bromide 21 ug 69238-2016-03 | Amneal | 1 bottle | $0.355 | AB | Availability likely | — |
| Ipratropium Bromide 21 ugthis 70748-0336-01 | Lupin | 1 bottle | $0.355 | AB | Availability likely | — |
| Ipratropium Bromide 21 ug 72888-0149-38 | Advagen | 1 bottle | $0.355 | AB | Availability likely | — |
| Ipratropium bromide 21 ug 24208-0398-30 | Bausch | 1 bottle | $0.420 | AB | FDA listed | +18% |
| Ipratroprium Bromide 21 ug 68682-0398-30 | Oceanside | 1 bottle | — | AB | FDA listed | — |
| Ipratropium Bromide 21 ug 72162-2143-03 | Bryant | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70748-0336-01 You're viewing this | 1 BOTTLE, SPRAY in 1 CARTON (70748-336-01) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-07-03 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium bromide 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dose of ipratropium bromide solution, 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient. 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 ▾
CONTRAINDICATIONS Ipratropium bromide nasal solution, 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.
⚠️ Warnings ▾
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 should be stopped at once and alternative treatment should be considered.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reaction information on ipratropium bromide nasal solution, 0.03% in patients with perennial rhinitis was derived from four multicenter, vehicle-controlled clinical trials involving 703 patients (356 patients on ipratropium bromide and 347 patients on vehicle), and a one-year, open-label, follow-up trial. In three of the trials, patients received ipratropium bromide, 0.03% three times daily, for eight weeks. In the other trial, ipratropium bromide, 0.03% was given to patients two times daily for four weeks.
Of the 285 patients who entered the open-label, follow-up trial, 232 were treated for 3 months, 200 for 6 months, and 159 up to one year. The majority (>86%) of patients treated for one year were maintained on 42 mcg per nostril, two or three times daily, of ipratropium bromide, 0.03%. Table 1 shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received ipratropium bromide, 0.03% at the recommended dose of 42 mcg per nostril, or vehicle two or three times daily for four or eight weeks.
Only adverse events reported with an incidence of at least 2.0% in the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group are shown. Table 1: % of Patients Reporting Events + + This table includes adverse events which occurred at an incidence rate of at least 2.0% in the ipratropium bromide group and more frequently in the ipratropium bromide group than in the vehicle group. Ipratropium Bromide Nasal Spray 0.03% (n=356) Vehicle Control (n=347) Incidence % Discontinued % Incidence % Discontinued % Headache 9.8 0.6 9.2
0.0Upper respiratory tract infection 9.8 1.4 7.2
1.4Epistaxis Epistaxis reported by 7.0% of ipratropium bromide patients and 2.3% of vehicle patients, blood-tinged mucus by 2.0% of ipratropium bromide patients and 2.3% of vehicle patients. 9.0 0.3 4.6
0.3Rhinitis All events are listed by their WHO term; rhinitis has been presented by descriptive terms for clarification. Nasal dryness 5.1 0.0 0.9
0.3Nasal irritation Nasal irritation includes reports of nasal itching, nasal burning, nasal irritation, and ulcerative rhinitis. 2.0 0.0 1.7
0.6Other nasal symptoms Other nasal symptoms include reports of nasal congestion, increased rhinorrhea, increased rhinitis, posterior nasal drip, sneezing, nasal polyps, and nasal edema. 3.1 1.1 1.7
0.3Pharyngitis 8.1 0.3 4.6
0.0Nausea 2.2 0.3 0.9
0.0Ipratropium bromide, 0.03% was well tolerated by most patients. The most frequently reported nasal adverse events were transient episodes of nasal dryness or epistaxis. These adverse events were mild or moderate in nature, none was considered serious, none resulted in hospitalization and most resolved spontaneously or following a dose reduction.
Treatment for nasal dryness and epistaxis was required infrequently (2% or less) and consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly or saline nasal spray). Patient discontinuation for epistaxis or nasal dryness was infrequent in both the controlled (0.3% or less) and one-year, open-label (2% or less) trials. There was no evidence of nasal rebound (i.e., a clinically significant increase in rhinorrhea, posterior nasal drip, sneezing or nasal congestion severity compared to baseline) upon discontinuation of double-blind therapy in these trials.
Adverse events reported by less than 2% of the patients receiving ipratropium bromide, 0.03% during the controlled clinical trials or during the open-label follow-up trial, which are potentially related to Ipratropium Bromide's local effects or systemic anticholinergic effects include: dry mouth/throat, dizziness, ocular irritation, blurred vision, conjunctivitis, hoarseness, cough, and taste perversion. There were infrequent reports of skin rash in both the controlled and uncontrolled clinical studies. Post-Marketing Experience Allergic type reactions such as skin rash, ang…
🆘 Overdosage ▾
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 four bottles of ipratropium bromide, 0.03%) 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 to 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 ▾
CLINICAL PHARMACOLOGY Mechanism of Action Ipratropium bromide is an anticholinergic (para sympatholytic) 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 membrane 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 to 3%). Less than 20% of an 84 mcg per nostril dose was absorbed from the nasal mucosa of normal volunteers, induced-cold patients, or perennial rhinitis 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 vitro receptor 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 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 42 mcg of ipratropium bromide per nostril two or three times a day in perennial rhinitis patients 6 to 18 years old, the mean amounts of the total dose excreted unchanged in the urine (8.6 to 11.1%) were higher than those reported in adult volunteers or adult perennial rhinitis patients (3.7 to 5.6%). Plasma ipratropium concentrations were relatively low (ranging from undetectable up to 0.49 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 Interaction 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, in patients with induced-colds, ipratropium bromide nasal solution 0.06% (84 mcg/nostril four times a day), had no significant effects on pupillary diameter, heart rate or systolic/diastolic blood pressure.
Two nasal provocation trials in perennial rhinitis patients (n=44) using ipratropium bromide nasal spray showed a dose dependent increase in inhibition of methacholine induced nasal secretion with an onset of action within 15 minutes (time of first observation). 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, 0.03% were conduct…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ipratropium Bromide Nasal Solution, 0.03% is supplied as a clear, colorless solution in a white high density polyethylene (HDPE) bottle fitted with a white and clear metered nasal spray pump, a white safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 31.1 g of product formulation, 345 sprays, each delivering 21 mcg (70 mcL) of ipratropium per spray, or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day). Ipratropium Bromide Nasal Solution, 0.03% Nasal Spray, 21 mcg/spray NDC 70748-336-01: Bottle of 30 mL (345 metered sprays) in a carton.
Storage Store tightly closed at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid freezing. Keep out of reach of children. Do not spray in the eyes.
Address medical inquiries to Lupin Pharmaceuticals, Inc. at 1-800-399-2561. Patients should be reminded to read and follow the accompanying " Patient's Instructions for Use ", which should be dispensed with the product.
📋 Description ▾
DESCRIPTION The active ingredient in ipratropium bromide nasal solution is ipratropium bromide, USP (as the 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. The structural formula is: Ipratropium bromide, USP is a white to off-white, crystalline powder.
It is soluble in water, freely soluble in methanol and slightly soluble in ethanol (96%). Ipratropium bromide nasal solution, 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70 mcL) ipratropium bromide, USP (on an anhydrous basis) per spray (70 mcL) in an isotonic, aqueous solution with pH-adjusted to 4.7 with hydrochloric acid and sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, purified water and sodium chloride.
Each bottle contains 345 metered sprays. Ipratropium Bromide Monohydrate