Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Direct_Rx
INTRABRONCHIAL
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 any of its components.
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. carton of 25 vials. carton of 30 vials. carton of 60 vials.
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION DIRECT_RX ---------- ALBUTEROL SULFATE Albuterol Sulfate Inhalation Solution 0.083%* (*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate) PRESCRIBING INFORMATION FOR INHALATION USE ONLY-NOT FOR INJECTION. Albuterol sulfate inhalation solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α1-[(tert-Butylamino)methyl]-4- hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula: [Albuterol Sulfate Structural Formula] Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C13H21NO3)2 • H2SO4. 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. The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3’,5’-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, 10% to 50% of the beta-receptors in the Baca dokumen lengkap