Drug Catalog - Product Detail
ALBUTEROL SULFATE INH USP 0.083 SOL 25X3ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-8270-52 | MYLAN | 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
ANDA077839
Description
DESCRIPTION Albuterol sulfate inhalation solution is a relatively selective beta 2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, 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 576.70, and the molecular formula (C 13 H 21 NO 3 ) 2 • H 2 SO 4 . Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Sulfate Inhalation Solution 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Sulfate Inhalation Solution 0.083% contains no sulfiting agents or preservatives. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. Chemical Structure
How Supplied
HOW SUPPLIED Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL (Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate) . Equivalent to 0.5 mL albuterol (as the sulfate) 0.5% (2.5 mg albuterol) diluted to 3 mL. Supplied in cartons as listed below. NDC 0378-8270-52 25 vials per carton / 25 vials per foil pouch NDC 0378-8270-93 30 vials per carton / 30 vials per foil pouch NDC 0378-8270-91 60 vials per carton / 30 vials per foil pouch NDC 0378-8270-55 30 vials per carton / 1 vial per foil pouch Storage PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F).
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 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 sulfate 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 which would require reassessment of therapy.