Albuterol Sulfate Inhalation Solution .63 mg/3mL
Albuterol Sulfate · SOLUTION · Ritedose Pharmaceuticals, LLC
Albuterol Sulfate Inhalation Solution is a solution containing albuterol sulfate at .63 mg/3mL, taken respiratory (inhalation). Manufactured by Ritedose Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Albuterol Sulfate Inhalation Solution
- Generic Name
- Albuterol Sulfate
- NDC Code (Product)
76204-010- Manufacturer
- Ritedose Pharmaceuticals, LLC
- Strength
- .63 mg/3mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA214531
- Marketing Start
- 01/04/2022
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Nephron SC, LLC
Labelling: Illegible label
Cipla USA, Inc.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Actavis Inc
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
Dosage & Administration
DOSAGE AND ADMINISTRATION The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of Albuterol Inhalation Solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended. To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver Albuterol Inhalation Solution over 5 to 15 minutes. The use of Albuterol Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution. Patients 6 to 12 years of age with more severe asthma (baseline FEV 1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose. Albuterol Inhalation Solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in…
Warnings
WARNINGS Paradoxical Bronchospasm As with other inhaled beta-adrenergic agonists, Albuterol Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Albuterol Inhalation Solution should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. Use of Anti-Inflammatory Agents The use of beta-adrenergic bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids). Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Inhalation Solution than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids). Fatalities have been reported in association with excessive use of …
Contraindications
CONTRAINDICATIONS Albuterol Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components.
Drug Interactions
Drug Interactions Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution. Albuterol Inhalation Solution should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or within 2 weeks of discontinuation of such agents, since the action of albuterol on the vascular system may be potentiated. Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Albuterol Inhalation Solution, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective betablockers should be considered, although they should be administered with caution. The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsene…
Adverse Reactions
ADVERSE REACTIONS Clinical Trial Experience Adverse events reported in >1% of patients receiving Albuterol Inhalation Solution and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table. Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg Albuterol Inhalation Solution (N=115) 0.63 mg Albuterol Inhalation Solution (N=117) Placebo (N=117) Asthma Exacerbation 13 11.1 8.5 Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4 1.7 Gastroenteritis 0.9 3.4 0.9 Cold Symptoms 0 3.4 1.7 Flu Syndrome 2.6 2.6 1.7 Lymphadenopathy 2.6 0.9 1.7 Skin/Appendage Infection 1.7 0 0 Urticaria 1.7 0.9 0 Migraine 0.9 1.7 0 Chest Pain 0.9 1.7 0 Bronchitis 0.9 1.7 0.9 Nausea 1.7 0.9 0.9 There was one case of ST segment depression in the 1.25 mg Albuterol Inhalation Solution treatment group. No clinically relevant laboratory abnormalities related to Albuterol Inhalation Solution administration were seen in this study. Post-marketing Experience Metabolic acidosis has been reported after the use of albuterol inhalation solution. Because …
Frequently Asked Questions
What is Albuterol Sulfate Inhalation Solution used for?
Albuterol Sulfate Inhalation Solution contains Albuterol Sulfate. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is Albuterol Sulfate Inhalation Solution a controlled substance?
Albuterol Sulfate Inhalation Solution is not classified as a controlled substance by the DEA.
What is the generic name for Albuterol Sulfate Inhalation Solution?
The generic name for Albuterol Sulfate Inhalation Solution is Albuterol Sulfate. There are 12 other brand versions of Albuterol Sulfate.
What is the NDC code for Albuterol Sulfate Inhalation Solution .63 mg/3mL?
The NDC (National Drug Code) for Albuterol Sulfate Inhalation Solution .63 mg/3mL is 76204-010, listed by Ritedose Pharmaceuticals, LLC.
Other Albuterol Brands
See all →- Albuterol Sulfate1.25 mg/3mL0487-9904
- ALBUTEROL SULFATE90 ug/176282-679
- Albuterol sulfate90 ug/176420-350
- Albuterol Sulfate HFA90 ug/180425-0359
- Albuterol Sulfate90 ug/182804-189
- Albuterol Sulfate.83 mg/mL47335-703
- VENTOLIN HFA90 ug/150090-1159
- Albuterol sulfate90 ug/150090-5231
- ALBUTEROL SULFATE90 ug/150090-5735
- ALBUTEROL SULFATE90 ug/151662-1513
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)