Ipratropium Bromide 42 ug Spray, Metered — NDC 24208-399-15 (Billing 24208-0399-15)
This is a package of Ipratropium Bromide 42 ug Spray, Metered from Bausch & Lomb Incorporated, marketed since Mar 2003 and currently FDA-listed; retail pharmacies pay about $0.8711 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 24208-399-15 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 24208 labeler · 399 product · 15 package
- Package marketed since
- Mar 31, 2003
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 2420839915 6
- Medicaid fills, this package
- 48,995 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 024456
- GCN: 42238
- GPI-14 (Medi-Span): 42300040102020
- HICL (First Databank): 000057
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 1797844
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 dries up a runny nose caused by the common cold or seasonal allergies. It won't help with stuffiness or sneezing, so you may still need something else for those.
- Spray it into each nostril, several times a day as your prescriber directs. Prime a new pump with seven sprays first. Keep it out of your eyes.
- For a cold, safety and effectiveness haven't been shown beyond four days. For seasonal allergies, they haven't been shown beyond three weeks. Check in with your doctor if symptoms...
- Nosebleeds, a dry nose, headache and a sore throat are the most common. Nasal dryness or nosebleeds were usually mild and often settled on their own. A moisturizing agent such as s...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.871 | — |
| Medicaid paysCMS SDUD · 12 mo | $1.52 | — |
| Medicare drug plans payPart D · Q2 2026 | $1.17 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 18, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 24208-0399-15 You're viewing this Main listing | 1 BOTTLE, SPRAY in 1 CARTON / 165 SPRAY, METERED in 1 BOTTLE, SPRAY | 2003-03-31 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ipratropium Bromide 42 ug 00054-0046-41 | Hikma | 1 bottle | $0.778 | AB | Availability likely | save 11% |
| Ipratropium Bromide 42 ug 16714-0527-01 | NORTHSTAR | 1 bottle | $0.778 | AB | Availability likely | save 11% |
| Ipratropium Bromide 42 ug 60505-0827-01 | Apotex | 1 bottle | $0.778 | AB | Availability likely | save 11% |
| Ipratropium Bromide 42 ug 69238-2017-02 | Amneal | 1 bottle | $0.778 | AB | Availability likely | save 11% |
| Ipratropium Bromide 42 ug 70748-0337-01 | Lupin | 1 bottle | $0.778 | AB | Availability likely | save 11% |
| Ipratropium Bromide 42 ug 72888-0148-37 | Advagen | 1 bottle | $0.778 | AB | Availability likely | save 11% |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 18, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Ipratropium Nasal Spray inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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.
-
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Bausch & Lomb Incorporated labeler code 24208
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- Zylet loteprednol etabonate and tobramycin 5 mg/mL; 3 mg/mL Suspension/ Drops NDC 24208-358-01
- MIEBO Perfluorohexyloctane 1 mg/mg Solution NDC 24208-377-01
- Muro 128 sodium chloride 50 mg/g Ointment NDC 24208-385-01
- Ipratropium bromide 21 ug Spray, Metered NDC 24208-398-30
- Ofloxacin 3 mg/mL Solution NDC 24208-410-05
- Brimonidine Tartrate 2 mg/mL Solution/ Drops NDC 24208-411-05
- Retisert Fluocinolone Acetonide .59 mg Implant NDC 24208-416-01
- Opcon-A Naphazoline hydrochloride and Pheniramine maleate .2675 mg/mL; 3.15 mg/mL Solution/ Drops NDC 24208-430-03
- Opcon-A Naphazoline hydrochloride and Pheniramine maleate .2675 mg/mL; 3.15 mg/mL Solution/ Drops NDC 24208-431-15
- Ofloxacin 3 mg/mL Solution/ Drops NDC 24208-434-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
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 ▾
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… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
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 ▾
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 ▾
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 ▾
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 ▾
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… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
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 ▾
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 ▾
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 ▾
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 ▾
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.
⚠️ Precautions ▾
PRECAUTIONS: General: 1. Effects Seen with Anticholinergic Drugs: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder neck obstruction, particularly if they are receiving an anticholinergic by another route. 2.
Use in Hepatic or Renal Disease: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations. 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. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg. This dose corresponds in rats and mice to approximately 70 and 35 times the maximum recommended daily intranasal dose in adults, respectively, and approximately 35 and 15 times the maximum recommended daily intranasal dose in children, respectively, on a mg/m 2 basis.
Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test, and chromosome aberration of bone marrow in Chinese hamsters) were negative. Fertility of male or female rats at oral doses up to 50 mg/kg (approximately 600 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 16,000 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis), ipratropium bromide produced a decrease in the conception rate.
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 demonstrate… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers: It is known that some ipratropium bromide is systemically absorbed following nasal administration; however the portion which may be excreted in human milk is unknown. Because lipid-insoluble quaternary cations pass into breast milk, caution should be exercised when Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is administered to a nursing mother.
🧬 Pharmacokinetics ▾
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 Studies ▾
Clinical Trials: The clinical trials for Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) were conducted in patients with rhinorrhea associated with naturally occurring common colds. In two controlled four day comparisons of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) (84 mcg per nostril, administered three or four times daily; n=352) with its vehicle (n=351), there was a statistically significant reduction of rhinorrhea, as measured by both nasal discharge weight and the patients’ subjective assessment of severity of rhinorrhea using a visual analog scale.
These significant differences were evident within one hour following dosing. There was no effect of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) on degree of nasal congestion or sneezing. The response to Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) did not appear to be affected by age or gender.
No controlled clinical trials directly compared the efficacy of three times daily versus four times daily treatment. One clinical trial was conducted with Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray), administered four times daily for three weeks, in 218 patients with rhinorrhea associated with Seasonal Allergic Rhinitis (SAR), compared to its vehicle in 211 patients. Patients in this trial were adults and adolescents 12 years of age and above.
Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) was significantly more effective in reducing the severity and duration of rhinorrhea over the three weeks of the study, as measured by daily patient symptom scores. There was no difference between treatment groups in the effect on nasal congestion, sneezing or itching eyes.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg. This dose corresponds in rats and mice to approximately 70 and 35 times the maximum recommended daily intranasal dose in adults, respectively, and approximately 35 and 15 times the maximum recommended daily intranasal dose in children, respectively, on a mg/m 2 basis. Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test, and chromosome aberration of bone marrow in Chinese hamsters) were negative.
Fertility of male or female rats at oral doses up to 50 mg/kg (approximately 600 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 16,000 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis), ipratropium bromide produced a decrease in the conception rate.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - Carton NDC 24208-399-15 Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) (165 metered sprays) 42 mcg/spray FOR INTRANASAL USE ONLY Rx only 15 mL BAUSCH + LOMB 9681701 carton