ATENOLOL AND CHLORTHALIDONE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Unichem Pharmaceuticals (USA), Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Atenolol and chlorthalidone tablets, USP  50 mg/25 mg, are light pink colored, round shaped, biconvex, uncoated tablet debossed with '2' ' break line', '7' on one side and 'U' on other side, supplied in bottles of 100 tablets (NDC 29300-400-01) and in bottles of 500 tablets (NDC 29300-400- 05) Atenolol and chlorthalidone tablets, USP  100 mg/25 mg, are light yellow colored, round shaped, biconvex, uncoated tablet debossed with '26' on one side and 'U' on the other side, supplied in bottles of 100 tablets (NDC 29300-401-01) and in bottles of 500 tablets (NDC 29300-401- 05 ) Store at 20° C to 25°C (68° F to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers. To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured by UNICHEM LABORATORIES LTD. Ind. Area, Meerut Road, Ghaziabad – 201 003, India. Manufactured for: East Brunswick, NJ 08816 03-R-01/2024 13015256

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ATENOLOL AND CHLORTHALIDONE- ATENOLOL AND CHLORTHALIDONE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
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ATENOLOL AND CHLORTHALIDONE TABLETS, USP
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, USP is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl)
amino] propoxy]-.
Atenolol, USP (free base) is a relatively polar hydrophilic compound
with a water solubility
of 10.0376 mg/mL at 37° C. It is freely soluble in 1N HCl (100.810
mg/mL at 25°C) and
slightly soluble in chloroform (1.0438 mg/mL at 25°C).
Chlorthalidone, USP is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)
benzene sulfonamide:
Chlorthalidone, USP is insoluble in water at 20°C.
Each atenolol and chlorthalidone tablets, USP 50 mg/25 mg contains:
Atenolol, USP…………………………….. 50 mg
Chlorthalidone, USP……………………… 25 mg
Each atenolol and chlorthalidone tablets, USP 100 mg/25 mg contains:
Atenolol, USP……………………………100 mg
1
Chlorthalidone, USP ……………………..25 mg
Inactive ingredients: magnesium stearate, microcrystalline cellulose,
povidone, sodium
starch glycolate (potato), ferric oxide red (for 50 mg/25 mg) and
ferric oxide yellow (for
100 mg/25 mg)
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 vasodilator