国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI)
Aphena Pharma Solutions - Tennessee, LLC
ATENOLOL
ATENOLOL 50 mg
ORAL
PRESCRIPTION DRUG
Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with diffe
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Atenolol tablets USP, 25 mg (White to off-white marble finish, round, flat beveled edge tablets. Debossed with "TEVA" on one side and with "787" on the other side.) are supplied in bottles of 100 and 1000. Atenolol tablets USP, 50 mg (White to off-white marble finish, round, flat beveled edge tablets. Scored and debossed with "93" above the score and "752" below the score on one side, debossed with "TEVA" on the other side.) are supplied in bottles of 100 and 1000. Atenolol tablets USP, 100 mg (White to off-white marble finish, round, flat beveled edge tablets. Debossed with "TEVA" on one side and with "753" on the other side.) are supplied in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. AB 11/2012
Abbreviated New Drug Application
ATENOLOL- ATENOLOL TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- ATENOLOL TABLETS USP 0787 0752 0753 DESCRIPTION Atenolol, USP, a synthetic, beta -selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are: C H N O M.W. (free base) 266.34 It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. CLINICAL PHARMACOLOGY Atenolol is a beta -selective (cardioselective) beta-adrenergic receptor blocking agent without membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities. This preferential effect is not absolute, however, and at higher doses, atenolol inhibits beta -adrenoreceptors, chiefly located in the bronchial and vascular musculature. PHARMACOKINETICS AND METABOLISM In man, absorption of an oral dose is rapid and consistent but incomplete. Approximately 50% of an oral dose is absorbed from the gastrointestinal tract, the remainder being excreted unchanged in the feces. Peak blood levels are reached between two (2) and four (4) hours after ingestion. Unlike propranolol or metoprolol, but like nadolol, atenolol undergoes little or no metabolism by the liver, and the absorbed portion is eliminated primarily by renal excretion. Over 85% of an intravenous dose is excreted in urine within 24 hours compared with approximately 50% for an oral dose. Atenolol also differs from 1 14 22 2 3 1 2 propranolol in that only a small amount (6% to 16%) is bound to proteins in the plasma. This kinetic profile results in rela 阅读完整的文件