Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Mylan Pharmaceuticals 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 are available containing albuterol sulfate, USP 2.4 mg equivalent to albuterol 2 mg or albuterol sulfate, USP 4.8 mg equivalent to albuterol 4 mg. The 2 mg tablets are white, uncoated, round, flat-faced, scored tablets debossed with M above the score and 255 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0255-01 bottles of 100 tablets The 4 mg tablets are white, uncoated, round, flat-faced, scored tablets debossed with M above the score and 572 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0572-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Revised: 7/2020 ALB:R16
Abbreviated New Drug Application
ALBUTEROL- ALBUTEROL SULFATE TABLET MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Albuterol tablets contain albuterol sulfate 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, USP 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 monohydrate, magnesium stearate, pregelatinized starch (corn) 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 tablets, 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 tablets have b Baca dokumen lengkap