Label: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE- diltiazem hydrochloride capsule, extended release

  • NDC Code(s): 75907-044-01, 75907-045-01, 75907-046-01
  • Packager: Dr. Reddy's Labratories Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 19, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one ...
  • CLINICAL PHARMACOLOGY
    The therapeutic effects of diltiazem hydrochloride are believed to be related to its ability to inhibit the influx of calcium ions during membrane depolarization of cardiac and vascular smooth ...
  • INDICATIONS AND USAGE
    Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive ...
  • CONTRAINDICATIONS
    Diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV ...
  • WARNINGS
    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 have ...
  • OVERDOSAGE
    The oral LD50's in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50's in these species were 60 and 38 mg/kg, respectively. The oral LD50 in ...
  • DOSAGE AND ADMINISTRATION
    Dosages must be adjusted to each patient's needs, starting with 60 to 120 mg twice daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage ...
  • HOW SUPPLIED
    Diltiazem Hydrochloride Extended-Release Capsules, USP (Twice a Day Dosage) are available as follows: StrengthQuantityNDC NumberDescription - 60 mg10075907-044-01The 60 mg capsules are ...
  • SPL UNCLASSIFIED SECTION
    Distributed by: Dr. Reddy’s Laboratories Inc. Princeton, NJ 08540 - Product of Australia - Revised 11/2023 - 63500
  • PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label
    NDC 75907-044-01 - Twice-a-Day Dosage - Diltiazem HCl - Extended-Release - Capsules, USP - 60 mg - Rx Only - 100 Capsules - Dr. Reddy's Laboratories, Inc
  • PRINCIPAL DISPLAY PANEL - 90 mg Capsule Bottle Label
    NDC 75907-045-01 - Twice-a-Day Dosage - Diltiazem HCl - Extended-Release - Capsules, USP - 90 mg - Rx Only - 100 Capsules - Dr. Reddy's Laboratories, Inc
  • PRINCIPAL DISPLAY PANEL - 120 mg Capsule Bottle Label
    NDC 75907-046-01 - Twice-a-Day Dosage - Diltiazem HCl - Extended-Release - Capsules, USP - 120 mg - Rx Only - 100 Capsules - Dr. Reddy's Laboratories, Inc
  • INGREDIENTS AND APPEARANCE
    Product Information