Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Teva Pharmaceuticals USA Inc
ALBUTEROL SULFATE
ALBUTEROL 2 mg in 5 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP TEVA PHARMACEUTICALS USA INC ---------- ALBUTEROL SULFATE SYRUP 0661 RX ONLY DESCRIPTION Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta -adrenergic bronchodilator. Albuterol sulfate has the chemical name α -[(_tert_- butylamino)methyl]-4-hydroxy-_m_-xylene-α,α'-diol sulfate (2:1) (salt) and the following chemical structure: (C H NO ) •H SO M.W. 576.7 Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Citric Acid, FD&C Yellow No. 6, Hypromellose, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, and Strawberry Flavor. The pH of the syrup is 3.3 to 4.0. 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 beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of media Aqra d-dokument sħiħ