Drugplain

Atenolol and Chlorthalidone 100 mg/1

Atenolol and Chlorthalidone · TABLET · Actavis Pharma, Inc.

No Recall History
Plain English

Atenolol and Chlorthalidone is a tablet containing atenolol and chlorthalidone at 100 mg/1, taken oral. Manufactured by Actavis Pharma, Inc..

Key Facts

Brand Name
Atenolol and Chlorthalidone
Generic Name
Atenolol and Chlorthalidone
NDC Code (Product)
0591-5783
Manufacturer
Actavis Pharma, Inc.
Strength
100 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA073665
Drug Class
beta-Adrenergic Blocker [EPC]; Thiazide-like Diuretic [EPC]
Marketing Start
08/01/1992

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective123 reports
nausea100 reports
rash77 reports
hypertension75 reports
headache74 reports
dyspnoea72 reports
arthralgia71 reports
diarrhoea71 reports
drug intolerance71 reports
malaise68 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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, …

Dosage & Administration

DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED (See INDICATIONS AND USAGE ). Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one atenolol and chlorthalidone 50mg/25mg tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one atenolol and chlorthalidone 100mg/25mg tablet given once a day. When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure. Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m 2 (normal range is 100 mL/min/1.73m 2 to 150 mL/min/1.73m 2 ); therefore, the following maximum dosages are recommended for patients with renal impairment. Creatinine Clearance (mL/min/1.73m 2 ) Atenolol Elimination Half-Life (hrs.) Maximum Dosage 15 to 35 16 to 27 50 mg daily < 15 > 27 50 mg every other day

Warnings

WARNINGS Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. IN PATIENTS WITHOUT A HISTORY OF CARDIAC FAILURE, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, atenolol and chlorthalidone tablets should be withdrawn (See DOSAGE AND ADMINISTRATION ). Renal and Hepatic Disease and Electrolyte Disturbances Since atenolol is excreted via the kidneys, atenolol and chlorthalidone tablets should be used with caution in patients with impaired renal function. In patients with renal disease, thiazides may precipitate azotemia. Since cumulative effects may develop in the presence of impaired renal function, if progressive renal impairment becomes evident, atenolol and chlorthalidone…

Contraindications

CONTRAINDICATIONS 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.

Drug Interactions

Drug Interactions Atenolol and chlorthalidone tablets may potentiate the action of other antihypertensive agents used concomitantly. Patients treated with atenolol and chlorthalidone tablets plus a catecholamine depletor (e.g., reserpine) should be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope or postural hypotension. Calcium channel blockers may also have an additive effect when given with atenolol and chlorthalidone tablets (See WARNINGS ). Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta-blockers. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers. Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude the therapeutic effectiveness of norepinephrine. Thiazides may increase the responsiveness to tubocurarine. Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects …

Adverse Reactions

ADVERSE REACTIONS Atenolol and chlorthalidone tablets are usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for atenolol and chlorthalidone tablets are essentially the same as those seen with the individual components. Atenolol The frequency estimates in the following table were derived from controlled studies in which adverse reactions were either volunteered by the patient (US studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects for atenolol and placebo is similar, causal relationship to atenolol is uncertain. Volunteered (US Studies) Total-Volunteered and Elicited (Foreign + US Studies) Atenolol (n = 164) % Placebo (n = 206) % Atenolol (n = 399) % Placebo (n = 407) % CARDIOVASCULAR Bradycardia 3 0 3 0 Cold Extremities 0 0.5 12 5 Postural Hypotension 2 1 4 5 Leg Pain 0 0.5 3 1 CENTRAL NERVOUS SYSTEM / NEUROMUSCULAR Dizziness 4 1 13 6 Vertigo 2 0.5 2 0.2 Light-Headedness 1 0 3 0.7 Tiredness 0.6 0.5 26 13 Fa…

Frequently Asked Questions

What is Atenolol and Chlorthalidone used for?

Atenolol and Chlorthalidone contains Atenolol and Chlorthalidone. It is a tablet taken oral. Consult your doctor for specific uses.

Is Atenolol and Chlorthalidone a controlled substance?

Atenolol and Chlorthalidone is not classified as a controlled substance by the DEA.

What is the generic name for Atenolol and Chlorthalidone?

The generic name for Atenolol and Chlorthalidone is Atenolol and Chlorthalidone. There are 2 other brand versions of Atenolol and Chlorthalidone.

What is the NDC code for Atenolol and Chlorthalidone 100 mg/1?

The NDC (National Drug Code) for Atenolol and Chlorthalidone 100 mg/1 is 0591-5783, listed by Actavis Pharma, Inc..

Product NDC

0591-5783

Package NDC

0591-5783-01

Other Atenolol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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