Drug Catalog - Product Detail
ALBUTEROL SULFATE INH SOL USP (STERILE) SOL 0.005 20ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50383-0741-20 | AKORN | 20 | (5 MG/ML)0.5% | NEBULIZER SOLUTION |
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Description
DESCRIPTION Albuterol Sulfate Inhalation Solution, 0.5% is a sterile solution that contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate has the chemical name α 1 -[( tert -Butylamino) methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula: Albuterol sulfate has a molecular weight of 576.71 and the molecular formula (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization's recommended name for albuterol base is salbutamol. Albuterol Sulfate Inhalation Solution, 0.5% is in concentrated form. Dilute the appropriate volume of the solution (see DOSAGE AND ADMINISTRATION ) with sterile normal saline solution to a total volume of 3 mL and administer by nebulization. Each mL Contains: ACTIVE: Albuterol sulfate equivalent to 5 mg of albuterol in an aqueous solution. Sulfuric Acid may be added to adjust pH (3.5-4.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate inhalation solution contains no sulfiting agents. It is supplied in 20 mL bottles. Albuterol Sulfate Inhalation Solution is a clear, colorless sterile solution. Chemical Structure
How Supplied
HOW SUPPLIED Albuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 50383-741-20) with accompanying calibrated dropper; boxes of one. Store between 2° and 25°C (36° and 77°F). KEEP OUT OF REACH OF CHILDREN. Rx only. FOR ORAL INHALATION ONLY. Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev.741:04 02/17 PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENT
Indications & Usage
INDICATIONS AND USAGE Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
Dosage and Administration
DOSAGE AND ADMINISTRATION To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used. Children 2 to 12 Years of Age For children 2 to 12 years of age, initial dosing should be based upon body weight (0.1 to 0.15 mg/kg per dose), with subsequent dosing titrated to achieve the desired clinical response. Dosing should not exceed 2.5 mg three to four times daily by nebulization. The following table outlines approximate dosing according to body weight. Approximate Weight (kg) Approximate Weight (lb) Dose (mg) Volume of Inhalation Solution 10-15 22-33 1.25 0.25 mL >15 >33 2.5 0.5 mL The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total volume of 3 mL prior to administration via nebulization. Adults and Children Over 12 Years of Age The usual dosage for adults and children 12 years of age and older is 2.5 mg of albuterol administered three to four 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% inhalation solution with 2.5 mL of sterile normal saline solution. The flow rate is regulated to suit the particular nebulizer so that albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes. The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation 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 that would require reassessment of therapy. Drug compatibility (physical and chemical), efficacy, and safety of albuterol sulfate inhalation solution when mixed with other drugs in a nebulizer have not been established. In patients who receive high doses (e.g., continuous nebulization) of Albuterol Sulfate Inhalation Solution and bronchospasm does not resolve, consider a trial of short acting bronchodilator that does not contain the preservative benzalkonium chloride [see WARNINGS – Paradoxical Bronchospasm ].