Drug Catalog - Product Detail
ALBUTEROL SULFATE INH SOL USP 0.08% 25X3ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00487-9501-25 | NEPHRON PHARMACEUTICALS CORP. | 3 | (2.5 MG/3ML)0.083% | NEBULIZER SOLUTION |
PACKAGE FILES
Generic Name
ALBUTEROL SULFATE
Substance Name
ALBUTEROL SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
RESPIRATORY (INHALATION)
Application Number
ANDA074880
Description
DESCRIPTION Albuterol inhalation solution, USP is a relatively selective beta 2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate USP, the racemic form of albuterol, 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 576.7, and the molecular formula is (C 13 H 21 NO 3 ) 2 • H 2 SO 4 . Albuterol sulfate, USP is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol inhalation solution, USP 0.083% requires no dilution before administration. Each mL of albuterol inhalation solution, USP (0.083%) contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate USP) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol inhalation solution, USP (0.083%) contains no sulfiting agents. Albuterol inhalation solution, USP is a clear, colorless to light yellow solution. F:\daisy assignment\6月份\06.20\albuterol-sulfate-inhalation-solution-6-20-2008\figure-01.jpg
How Supplied
HOW SUPPLIED Albuterol Inhalation Solution, USP 0.083% is contained in plastic, sterile, unit dose vials of 3 mL each, supplied in foil pouches: NDC 76420-087-25: carton of 25 vials (relabeled from NDC 0487-9501-25) Storage and Handling PROTECT FROM LIGHT. Store vials in pouch until time of use. Store between 20°C to 25° C (68°F to 77° F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Rx Only Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
Indications & Usage
INDICATIONS AND USAGE Albuterol 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 Adults and Children 2 to 12 Years of Age: The usual dosage for adults and for children weighing at least 15 kg is 2.5 mg of albuterol (one vial) administered three to four times daily by nebulization. Children weighing < 15 kg who require < 2.5 mg/dose (i.e., less than a full vial) should use albuterol inhalation solution, 0.5% instead of albuterol inhalation solution, 0.083%. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the entire contents of one sterile unit-dose vial (3 mL of 0.083% inhalation solution) 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. 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. 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.