Label: TENORETIC- atenolol and chlorthalidone tablet

  • NDC Code(s): 24979-256-07, 24979-257-07
  • Packager: TWi Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 31, 2024

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  • DESCRIPTION
    TENORETIC® (atenolol and chlorthalidone) is for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking ...
  • CLINICAL PHARMACOLOGY
    Tenoretic - 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 ...
  • INDICATIONS AND USAGE
    TENORETIC 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 strokes and ...
  • CONTRAINDICATIONS
    TENORETIC is contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see WARNINGS); anuria; hypersensitivity to this ...
  • 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 - TENORETIC may aggravate peripheral arterial circulatory disorders. Information for Patients - Inform patients or caregivers that there is a risk of hypoglycemia when TENORETIC is ...
  • ADVERSE REACTIONS
    TENORETIC is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for TENORETIC are essentially the same as those ...
  • OVERDOSAGE
    No specific information is available with regard to overdosage and TENORETIC in humans. Treatment should be symptomatic and supportive and directed to the removal of any unabsorbed drug by ...
  • 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
    TENORETIC 50 Tablets (atenolol 50 mg and chlorthalidone 25 mg), are white, round, biconvex, uncoated tablets with TENORETIC on one side and 115 on the other side, bisected, supplied in bottles of ...
  • SPL UNCLASSIFIED SECTION
    TENORETIC is a trademark of TWi Pharmaceuticals, Inc. Product of USA - Distributed by: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 - Revised: 01/2024 - PKG03121
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 50 mg
    NDC 24979-256-07 - Rx Only - Tenoretic® 50 - (atenolol and chlorthalidone) Each tablet contains: 50 mg atenolol and - 25 mg chlorthalidone - 90 tablets - Almatica®
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg
    NDC 24979-257-07 - Rx Only - Tenoretic® 100 - (atenolol and chlorthalidone) Each tablet contains: 100 mg atenolol and - 25 mg chlorthalidone - 90 tablets - Almatica®
  • INGREDIENTS AND APPEARANCE
    Product Information