Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Mylan Institutional Inc.
ALBUTEROL SULFATE
ALBUTEROL 2 mg
ORAL
PRESCRIPTION DRUG
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease. Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.
Albuterol Tablets, USP, contain albuterol sulfate equivalent to 2 mg of albuterol. The tablets containing albuterol sulfate equivalent to 2 mg of albuterol are white, scored, round tablets debossed with M255 on the scored side. They are available as follows: NDC 51079-657-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-6539 R7 6/20
Abbreviated New Drug Application
ALBUTEROL- ALBUTEROL TABLET MYLAN INSTITUTIONAL INC. ---------- DESCRIPTION Albuterol tablets contain 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 structural formula: Albuterol sulfate has a molecular weight of 576.71, and the molecular formula is (C H NO ) •H SO . Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Each albuterol tablet for oral administration contains 2 or 4 mg of albuterol as 2.4 or 4.8 mg of albuterol sulfate, respectively. Each tablet also contains the following inactive ingredients: lactose (hydrous), magnesium stearate, pregelatinized (corn) starch and sodium lauryl sulfate. 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 mediators of immediate hypersensitivity from cells, especially from mast cells. Albuterol has been shown in most controlled Preberite celoten dokument