IPRATROPIUM BROMIDE 42 ug Spray, Metered
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
🏭 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 | $0.810 | — |
| Medicaid paysCMS SDUD · 12 mo | $1.48 | — |
| Medicare drug plans payPart D · Q2 2026 | $1.17 | — |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ipratropium Bromide 42 ug 00054-0046-41 | Hikma | 1 bottle | $0.810 | AB | Availability likely | — |
| Ipratropium Bromide 42 ug 16714-0527-01 | NORTHSTAR | 1 bottle | $0.810 | AB | Availability likely | — |
| Ipratropium Bromide 42 ug 60505-0827-01 | Apotex | 1 bottle | $0.810 | AB | Availability likely | — |
| Ipratropium Bromide 42 ug 69238-2017-02 | Amneal | 1 bottle | $0.810 | AB | Availability likely | — |
| Ipratropium Bromide 42 ugthis 70748-0337-01 | Lupin | 1 bottle | $0.810 | AB | Availability likely | — |
| Ipratropium Bromide 42 ug 72888-0148-37 | Advagen | 1 bottle | $0.810 | AB | Availability likely | — |
| Ipratropium Bromide 42 ug 24208-0399-15 | Bausch | 1 bottle | $0.871 | AB | FDA listed | +7% |
| 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 | — |
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
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70748-0337-01 You're viewing this | 1 BOTTLE, SPRAY in 1 CARTON (70748-337-01) / 165 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, 0.06% 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 0.06% 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 0.06% 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 ▾
DOSAGE AND ADMINISTRATION For Symptomatic Relief of Rhinorrhea Associated with the Common Cold The recommended dose of ipratropium bromide nasal solution, 0.06% 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% for children age 5 to 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% 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% 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% 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 ▾
CONTRAINDICATIONS Ipratropium bromide nasal solution, 0.06% 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 0.06% in patients with the common cold was derived from two multicenter, vehicle-controlled clinical trials involving 1,276 patients (195 patients on ipratropium bromide 0.03%, 352 patients on ipratropium bromide, 0.06%, 189 patients on ipratropium bromide 0.12%, 351 patients on vehicle and 189 patients receiving no treatment). Table 1 shows adverse events reported for patients who received ipratropium bromide 0.06% 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, 0.06% 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 0.06% 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 0.06% 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 0.06% 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 the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group. Ipratropium Bromide, 0.06% 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 SAR trials. Post-Marketing Experience Allergic type reactions such as skin rash, angioedema, including that of the throat, tongue, lips and face, generalized urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported with ipratropium bromide 0.…
🆘 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 two bottles of ipratropium bromide, 0.06%) 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 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 to 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 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 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 to 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% 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 Clinical trials for ipratropium bromide, 0.06% were conducted in patients with rhinorrhea associated with n…
🧬 Mechanism of Action ▾
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 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 ▾
HOW SUPPLIED Ipratropium Bromide Nasal Solution, 0.06% is supplied as a clear, colorless solution in a white high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a white 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 mcL), or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day). Ipratropium Bromide Nasal Solution, 0.06% Nasal Spray, 42 mcg/spray NDC 70748-337-01: Bottle of 15 mL (165 metered sprays) in a carton.
Storage Store tightly closed at 20° to 25°C (68° 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 ( endo,syn )-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its 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, 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg 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 165 metered sprays. Ipratropium Bromide Monohydrate