Label: ATENOLOL AND CHLORTHALIDONE tablet

  • NDC Code(s): 0591-5782-01, 0591-5783-01
  • Packager: Actavis Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 29, 2024

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  • DESCRIPTION
    Atenolol and chlorthalidone tablets, USP are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking ...
  • 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 ...
  • INDICATIONS AND USAGE
    Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily ...
  • 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 ...
  • 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 ...
  • PRECAUTIONS
    General - Atenolol and chlorthalidone tablets may aggravate peripheral arterial circulatory disorders. Information for Patients - Hypoglycemia - Inform patients or caregivers that there is a ...
  • 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 ...
  • POTENTIAL ADVERSE EFFECTS
    In addition, a variety of adverse effects not observed in clinical trials with atenolol but reported with other beta-adrenergic blocking agents should be considered potential adverse effects of ...
  • OVERDOSAGE
    No specific information is available with regard to overdosage and atenolol and chlorthalidone in humans. Treatment should be symptomatic and supportive and directed to the removal of any ...
  • 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 ...
  • HOW SUPPLIED
    Atenolol and chlorthalidone tablets USP, 50 mg/25 mg are white, round, scored tablets imprinted with “DAN 5782” on one side and plain on the other side. Supplied in bottles of - 100 (NDC ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5782-01 - Atenolol and Chlorthalidone Tablets, USP - 50 mg/25 mg - Rx only - 100 Tablets
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5783-01 - Atenolol and Chlorthalidone Tablets, USP - 100 mg/25 mg - Rx only - 100 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information