Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Rebel Distributors Corp.
ALBUTEROL SULFATE
ALBUTEROL 5 mg in 1 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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. Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components. Albuterol Sulfate Inhalation Solution, 0.5%* *Potency expressed as albuterol Note: The Albuterol Sulfate Inhalation Solution contained in the 20 mL multiple-dose bottles is concentrated and must be diluted. Read complete instructions carefully before using. 1. Draw the appropriate volume of Albuterol SulfateInhalation Solution, 0.5% into the specially marked dropper that comes with each multidose bottle (Figure 1). For children 12 years of age and under, the volume is based upon body weight. Use the dropper volume prescribed by your doctor. Figure 1 2 . Squeeze the solution into the nebulizer reservoir through the appropriate opening, taking care not to touch the tip of the
Albuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless to light yellow sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 21695-245-20) with accompanying calibrated dropper; boxes of one. Store between 2° and 25°C ( 36° and 77°F). KEEP OUT OF REACH OF CHILDREN. PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENT
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION REBEL DISTRIBUTORS CORP. ---------- ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%* STERILE (*POTENCY EXPRESSED AS ALBUTEROL) 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 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGYsection below). Albuterol sulfate has the chemical name α -[(_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 H NO ) •H SO . 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 (3.0-5.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate inhalation solution contains no sulfiting agents. It is supplied in 20 mL bottles. Albuterol Aulfate Inhalation Solution is a clear, colorless to light yellow solution. CLINICAL PHARMACOLOGY _In vitro _studies and _in vivo _pharmacologic studies have demonstrated that albuterol has a preferential effect on beta -adrenergic receptors compared with isoproterenol. While it is recognized that beta - adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta -receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established (see WARNINGS). The pharmacologic effects of bet Læs hele dokumentet