Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Dispensing Solutions, Inc.
ALBUTEROL SULFATE
ALBUTEROL SULFATE 2 mg in 5 mL
OCCLUSIVE DRESSING TECHNIQUE
PRESCRIPTION DRUG
Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease. Albuterol Sulfate Syrup is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
Albuterol Sulfate Syrup, a yellow-orange liquid with an orange flavor, contains 2 mg albuterol as the sulfate per 5 mL; bottles of 4 fluid ounces, 8 fluid ounces and 16 fluid ounces. Store between 2° and 30°C (36° and 86°F). Dispense in a tight, light-resistant container. Manufactured by: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 740:03 4/09
Abbreviated New Drug Application
ALBUTEROL SULFATE - ALBUTEROL SULFATE SYRUP DISPENSING SOLUTIONS, INC. ---------- ALBUTEROL SULFATE SYRUP 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-a,a'-diol sulfate (2:1) (salt), and the following chemical structure: Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C H NO ) o H SO . 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. Each 5 mL (teaspoonful), for oral administration contains 2.4 mg of albuterol sulfate equivalent to 2 mg of albuterol. Albuterol Sulfate Syrup also contains the inactive ingredients citric acid anhydrous, FD & C Yellow No. 6, hydroxypropyl methylcellulose, orange flavor, purified water, saccharin, sodium benzoate, and sodium citrate. The pH of the syrup is 3.5 to 4.5. 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 Διαβάστε το πλήρες έγγραφο