Albuterol Sulfate Inhalation Solution, 0.5%

Albuterol Sulfate Inhalation Solution, 0.5% is an FDA-registered drug product whose active ingredient is ALBUTEROL SULFATE. It is labelled by Ritedose Pharmaceuticals, LLC taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 76204-027, application ANDA218386, label effective 20260430. It is one of 36 FDA drug label records sharing the active ingredient ALBUTEROL SULFATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ALBUTEROL SULFATE are most often described in connection with: usage albuterol, inhalation solution, relief bronchospasm, patients years, reversible obstructive, airway disease, acute attacks. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

DOSAGE AND ADMINISTRATION The usual dosage for adults and pediatric patients 12 years of age and older is 2.5 mg of albuterol (one unit-of-use vial) administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% solution for inhalation to a total volume of 3 mL with sterile normal saline solution and administer by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes. Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution when mixed with other drugs in a nebulizer have not been established. The use of albuterol inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During treatment, most patients gain optimum benefit from regular use of the nebulizer solution. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy. The nebulizer should be cleaned in accordance with the manufacturer’s instructions. Failure to do so could lead to bacterial contamination of the nebulizer and possible infection.

CONTRAINDICATIONS Albuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

WARNINGS 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 treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. USE OF ANTI-INFLAMMATORY AGENTS The use of beta-adrenergic agonist 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. PARADOXICAL BRONCHOSPASM 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 recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial. CARDIOVASCULAR EFFECTS Albuterol inhalation solution, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of albuterol inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol inhalation solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. IMMEDIATE HYPERSENSITIVITY REACTIONS Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

ADVERSE REACTIONS The results of clinical trials with albuterol inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related: Percent Incidence of Adverse Reactions Reaction Percent Incidence (N=135) Central Nervous System Tremors 20 Dizziness 7 Nervousness 4 Headache 3 Insomnia 1 Gastrointestinal Nausea 4 Dyspepsia 1 Ear, nose and throat Nasal congestion 1 Pharyngitis <1 Cardiovascular Tachycardia 1 Hypertensions 1 Respiratory Bronchospasm 8 Cough 4 Bronchitis 4 Wheezing 1 No clinically relevant laboratory abnormalities related to albuterol inhalation solution were determined in these studies. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been reported after the use of inhaled albuterol. To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

FDA lists 36 drug label records with ALBUTEROL SULFATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Albuterol Sulfate Inhalation Solution, 0.5% used for?
INDICATIONS AND USAGE Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

Who makes Albuterol Sulfate Inhalation Solution, 0.5%?
Ritedose Pharmaceuticals, LLC is the labeler of record for Albuterol Sulfate Inhalation Solution, 0.5%. 36 FDA label records share the active ingredient ALBUTEROL SULFATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Albuterol Sulfate Inhalation Solution, 0.5% come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Albuterol Sulfate Inhalation Solution, 0.5% prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ALBUTEROL SULFATE?
Yes. 36 FDA drug label records list ALBUTEROL SULFATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Albuterol Sulfate Inhalation Solution, 0.5% been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.