Ipratroprium Bromide 21 ug/1
Ipratroprium Bromide · SPRAY, METERED · Oceanside Pharmaceuticals
Ipratroprium Bromide is a spray, metered containing ipratroprium bromide at 21 ug/1, taken nasal. Manufactured by Oceanside Pharmaceuticals.
Key Facts
- Brand Name
- Ipratroprium Bromide
- Generic Name
- Ipratroprium Bromide
- NDC Code (Product)
68682-398- Manufacturer
- Oceanside Pharmaceuticals
- Strength
- 21 ug/1
- Dosage Form
- SPRAY, METERED
- Route
- NASAL
- Marketing Status
- Application #
- ANDA076025
- Marketing Start
- 06/01/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) 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 Nasal Solution 0.03% (Nasal Spray) does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION: The recommended dose of Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) 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.
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 0.03% (Nasal Spray) should be stopped at once and alternative treatment should be considered.
Contraindications
CONTRAINDICATIONS: Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.
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 0.03% (Nasal Spray) for oral inhalation.
Adverse Reactions
ADVERSE REACTIONS: Adverse reaction information on Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) 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 Nasal Solution 0.03% (Nasal Spray) three times daily, for eight weeks. In the other trial, Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) 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 Nasal Solution 0.03% (Nasal Spray). 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 Nasal Solution 0.03% (Nasal Spray) at the recommended dose of 42 mcg per nostril, or vehicle two or three …
Frequently Asked Questions
What is Ipratroprium Bromide used for?
Ipratroprium Bromide contains Ipratroprium Bromide. It is a spray, metered taken nasal. Consult your doctor for specific uses.
Is Ipratroprium Bromide a controlled substance?
Ipratroprium Bromide is not classified as a controlled substance by the DEA.
What is the generic name for Ipratroprium Bromide?
The generic name for Ipratroprium Bromide is Ipratroprium Bromide. There are no other listed brand versions of Ipratroprium Bromide.
What is the NDC code for Ipratroprium Bromide 21 ug/1?
The NDC (National Drug Code) for Ipratroprium Bromide 21 ug/1 is 68682-398, listed by Oceanside Pharmaceuticals.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)