Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI), CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q)
Aidarex Pharmaceuticals LLC
ATENOLOL
ATENOLOL 50 mg
ORAL
PRESCRIPTION DRUG
Atenolol and chlorthalidone is 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 and chlorthalidone. 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 cl
Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg are 10/32”, scored, round, white tablets imprinted DAN 5782 supplied in bottles of 30, 60 and 90. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature.] Dispense in a well-closed, light-resistant container with a child-resistant closure. Protect from heat, light and moisture. Protect from heat, light and moisture. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Parsippany, NJ 07054 USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: December 2012
Abbreviated New Drug Application
ATENOLOL AND CHLORTHALIDONE- ATENOLOL AND CHLORTHALIDONE TABLET AIDAREX PHARMACEUTICALS LLC ---------- ATENOLOL AND CHLORTHALIDONE TABLETS USP REVISED: DECEMBER 2012 RX ONLY DESCRIPTION Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihy- pertensive activity of two agents: a beta -selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2- hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula: Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula: Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. 1 Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. CLINICAL PHARMACOLOGY ATENOLOL AND CHLORTHALIDONE Atenolol and chlorthalidone have been used singly and concomitantly for the treatment of hypertension. The antihypertensive effects of these agents are additive, and studies have shown that there is no interference with bioavailability when these agents are given together in the single combination tablet. Therefore, this combination provides a convenient formulation for the concomitant administration of these two entities. In patients with more severe hypertension, atenolol and chlorthalidone may be administered with other antihypertensives such as Read the complete document