Label: DILTIAZEM HYDROCHLORIDE tablet
- NDC Code(s): 67046-1492-3
- Packager: Coupler LLC
- This is a repackaged label.
- Source NDC Code(s): 50228-481
- 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 SECTIONRx only
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DESCRIPTIONDiltiazem 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 ...
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CLINICAL PHARMACOLOGYThe 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 ...
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INDICATIONS AND USAGEDiltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
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CONTRAINDICATIONSDiltiazem 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 ...
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WARNINGS1. Cardiac Conduction:Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This ...
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PRECAUTIONSGeneral - 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 ...
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ADVERSE REACTIONSSerious 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 ...
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OVERDOSAGEThe 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 ...
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DOSAGE AND ADMINISTRATIONExertional 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 ...
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HOW SUPPLIEDDiltiazem 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 ...
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