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:

Physicians Total Care, Inc.

INN (International Name):

ATENOLOL

Composition:

ATENOLOL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atenolol and chlorthalidone tablets are indicated in the treatment of hypertension. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient’s needs, it may be more convenient than the separate components. Atenolol and chlorthalidone tablets are contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (seeWARNINGS ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.

Product summary:

Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg are 10/32”, scored, round, white tablets imprinted DAN 5782 supplied in: bottles of 30     (NDC 54868-2683-1) bottles of 90     (NDC 54868-2683-2) bottles of 100    (NDC 54868-2683-0). Atenolol and Chlorthalidone Tablets USP, 100 mg-25 mg are 12/32”, unscored, round, white tablets imprinted DAN 5783 supplied in: bottles of 30     (NDC 54868-3064-0) bottles of 90     (NDC 54868-3064-1). Dispense in a well-closed, light-resistant container with a child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from heat, light and moisture. Manufactured by: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2009        190808 0609B Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL AND CHLORTHALIDONE - ATENOLOL AND CHLORTHALIDONE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
ATENOLOL AND CHLORTHALIDONE
TABLETS USP
REVISED: JUNE 2009
RX ONLY 190808
DESCRIPTION
Atenolol and chlorthalidone tablets are for the treatment of
hypertension. It combines the
antihypertensive 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:
C
H N O
M.W. 266.34
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:
C
H ClN O S
M.W. 338.77
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.
1
14
22
2
3
14
11
2
4
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 chlort