ATENOLOL AND CHLORTHALIDONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI), CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q)

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

ATENOLOL

Composition:

ATENOLOL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg are 10/32”, scored, round, white tablets imprinted “DAN 5782” supplied in bottles Bottles of 30 NDC 68071-3065-3 Bottles of 60 NDC 68071-3065-6 Bottles of 90 NDC 68071-3065-9 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well- closed, light-resistan container with a child-resistant closure. Protect from heat, light and moisture. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: February 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL AND CHLORTHALIDONE- ATENOLOL AND CHLORTHALIDONE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
ATENOLOL AND
CHLORTHALIDONE
TABLETS, USP
REVISED: FEBRUARY 2015
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:
1
Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral
administration contains: atenolol USP, 50
mg and chlorthalidone USP, 25 mg.
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 a