Label: DILTIAZEM HYDROCHLORIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 29, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 - H)-one, 3 ...
  • CLINICAL PHARMACOLOGY
    The therapeutic benefits achieved with diltiazem hydrochloride are believed to be related to its ability to inhibit the influx of calcium ions during membrane depolarization of cardiac and ...
  • INDICATIONS AND USAGE
    Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
  • CONTRAINDICATIONS
    Diltiazem hydrochloride tablets are contraindicated in: Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker - Patients with second- or third-degree AV ...
  • WARNINGS
    1. Cardiac Conduction:Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This ...
  • PRECAUTIONS
    General - Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal ...
  • ADVERSE REACTIONS
    Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities usually ...
  • OVERDOSAGE
    The oral LD - 50sin mice and rats range from 415 mg/kg to 740 mg/kg and from 560 mg/kg to 810 mg/kg, respectively. The intravenous LD - 50sin these species were 60 mg/kg and 38 mg/kg ...
  • DOSAGE AND ADMINISTRATION
    Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery Spasm:Dosage must be adjusted to each patient’s needs. Starting with 30 ...
  • HOW SUPPLIED
    Diltiazem hydrochloride tablets, USP 30 mg are supplied in bottles of 30 (NDC 50228-481-30), 100 (NDC 50228-481-01), 500 (NDC 50228-481-05), and 1000 (NDC 50228-481-10). Each white to off white ...
  • PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information