Drug Catalog - Product Detail
ALBUTEROL SULFATE INH SOL USP INDIVIDUALLY FOIL WRAPPED 0.005 SOL 30X0.5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00487-9901-30 | NEPHRON PHARMACEUTICALS CORP. | 1 | 2.5MG/0.5ML | NEBULIZER SOLUTION |
PACKAGE FILES
Generic Name
ALBUTEROL SULFATE
Substance Name
ALBUTEROL SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
RESPIRATORY (INHALATION)
Application Number
ANDA075664
Description
DESCRIPTION Albuterol Sulfate Inhalation Solution, 0.5% 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 chemical structure: (C 13 H 21 NO 3 ) 2 • H 2 SO 4 Mol. Wt. 576.7 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 0.5 mL of the solution to 3 mL with sterile normal saline solution prior to administration by nebulization (see DOSAGE AND ADMINISTRATION ). Each 0.5 mL Unit-of-Use Vial Contains: ACTIVE: 2.5 mg of albuterol (equivalent to 3 mg of albuterol sulfate, USP) in a sterile, aqueous solution; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution contains no sulfiting agents or preservatives. It is supplied in 0.5 mL sterile Unit-of-Use Vials. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. b88244c6-figure-01
How Supplied
HOW SUPPLIED Albuterol Sulfate Inhalation Solution, 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches: NDC 0487-9901-30: 30 vials, each in an individual pouch. Storage and Handling Store between 2°C and 25°C (36°F - 77°F). Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
Indications & Usage
INDICATIONS AND USAGE Albuterol sulfate 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
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 sulfate inhalation solution will be delivered over approximately 5 to 15 minutes. 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. The use of albuterol sulfate 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.