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:

Mutual Pharmaceutical Company, Inc.

INN (International Name):

Atenolol

Composition:

Atenolol 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atenolol and chlorthalidone tablets 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 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 pharmac

Product summary:

Atenolol and chlorthalidone tablets, USP are available in two strengths: Atenolol 50 mg and chlorthalidone 25 mg round, white, scored, debossed MP 153 Atenolol 100 mg and chlorthalidone 25 mg round, white, unscored, debossed MP 152 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL AND CHLORTHALIDONE- ATENOLOL AND CHLORTHALIDONE TABLET
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
ATENOLOL AND CHLORTHALIDONE TABLETS USP
RX ONLY
DESCRIPTION
Atenolol and chlorthalidone is 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]-. The molecular and structural formulas
are:
C
H N O
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) benzene
sulfonamide. The molecular
and structural formulas are:
C
H CIN O S
Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C.
Atenolol and chlorthalidone tablets for oral administration are
available as:
1
14
22
2
3
14
11
2
4
Atenolol
50 mg
Chlorthalidone
25 mg
or
Atenolol
100 mg
Chlorthalidone
25 mg
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 vasodilators.
ATENOLOL:
Atenolol is a beta -selective (cardioselective) beta-adrenergic
receptor blocking agent without
membrane stabilizing or intrinsic sympathomimetic (partial agonist)
act