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:

Northstar Rx LLC.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 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 tablets are 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 are uncoated tablets. Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg are white to off white, round, biconvex, bevelled tablets, with debossing of '11' above breakline and '67' below breakline on one side and plain on the other side and are supplied as follows: NDC 16714-936-01 in bottle of 100 tablets with child-resistant closure Atenolol and Chlorthalidone Tablets USP, 100 mg/25 mg are white to off white, round, biconvex, beveled tablets, with debossing of '11' over '68' on one side and plain on the other side and are supplied as follows: NDC 16714-937-01 in bottle of 100 tablets with child-resistant closure Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, Northstar Rx LLC at Tel.: [phone].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ATENOLOL AND CHLORTHALIDONE- ATENOLOL AND CHLORTHALIDONE TABLET
NORTHSTAR RX LLC.
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ATENOLOL AND CHLORTHALIDONE TABLETS, USP
RX ONLY
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].
Atenolol, USP is a white or almost white powder and is sparingly
soluble in water; soluble
in absolute alcohol and practically insoluble in ether.
Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene
sulfonamide:
Chlorthalidone, USP is white to yellowish crystalline powder.
Each atenolol and chlorthalidone tablet, USP intended for oral
administration contains
atenolol 50 mg or 100 mg and chlorthalidone 25 mg. In addition, each
uncoated tablet
1
contains the following inactive ingredients: citric acid, colloidal
silicon dioxide,
croscarmellose sodium, magnesium stearate, pregelatinized starch and
silicified
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
ATENOLOL AND CHLORTHALIDONE TABLETS
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
tablets 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) activities.
This preferential effect is not absolute, however, and at higher
doses, atenolol