ATENOLOL AND CHLORTHALIDONE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

ANI Pharmaceuticals, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Atenolol and Chlorthalidone 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 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 classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. 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 is contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (See WARNINGS ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.

製品概要:

Atenolol and Chlorthalidone Tablets, USP 50 mg/25 mg (atenolol, USP 50 mg and chlorthalidone, USP 25 mg) are white to off-white, round, biconvex, uncoated tablets, bisected on one side and debossed with “N 390” on the other side, supplied in bottles of 100 tablets (NDC 70954-390-10). Atenolol and Chlorthalidone Tablets, USP 100 mg/25 mg (atenolol, USP 100 mg and chlorthalidone, USP 25 mg), are white to off-white, round, biconvex, uncoated tablets, debossed with "N" on one side and "391" on other side, supplied in bottles of 100 tablets (NDC 70954-391-10). Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [see USP]. Dispense in well-closed, light-resistant containers. Trademarks are the property of their respective owners. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 03/2024 LB4403-01

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ATENOLOL AND CHLORTHALIDONE - ATENOLOL AND CHLORTHALIDONE TABLET
ANI PHARMACEUTICALS, INC.
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ATENOLOL AND CHLORTHALIDONE TABLETS, USP
RX ONLY
DESCRIPTION
Atenolol and Chlorthalidone Tablets, USP 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]-.
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:
Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C.
Each Atenolol and Chlorthalidone Tablet, USP 100 mg/25 mg contains:
Atenolol, USP ....................................... 100 mg
Chlorthalidone, USP
........................................................ 25 mg
Each Atenolol and Chlorthalidone Tablet, USP 50 mg/25 mg contains:
1
Atenolol, USP ......................................... 50 mg
Chlorthalidone, USP
….................................................... 25 mg
Inactive ingredients: magnesium stearate, microcrystalline cellulose,
povidone, 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 -sele