Label: LABETALOL HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated January 21, 2025

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  • DESCRIPTION
    Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha - 1-adrenergic and non-selective - beta-adrenergic receptor blocking actions in a ...
  • CLINICAL PHARMACOLOGY
    Labetalol HCl combines both selective, competitive alpha - 1-adrenergic blocking and nonselective, competitive beta-adrenergic blocking activity in a single substance. In man, the ratios of ...
  • INDICATIONS AND USAGE
    Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop ...
  • CONTRAINDICATIONS
    Labetalol HCl tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with ...
  • WARNINGS
    Hepatic Injury - Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis ...
  • PRECAUTIONS
    General - Impaired Hepatic Function - Labetalol HCl tablets should be used with caution in patients with impaired hepatic function since metabolism of the drug may be diminished. Intraoperative ...
  • ADVERSE REACTIONS
    Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months' duration, discontinuation of labetalol HCl tablets due to ...
  • OVERDOSAGE
    Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to ...
  • DOSAGE AND ADMINISTRATION
    DOSAGE MUST BE INDIVIDUALIZED. The recommended - initialdosage is 100 mg - twicedaily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an ...
  • HOW SUPPLIED
    Labetalol Hydrochloride Tablets, USP 200 mg are available as white to off-white, round biconvex tablets, debossed “AC 371” on one side and bisected on other side, packaged in - NDC ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Labetalol Hydrochloride - GENERIC: Labetalol Hydrochloride - DOSAGE: TABLET, FILM COATED - ADMINSTRATION: ORAL - NDC: 70518-3993-0 - NDC: 70518-3993-1 - NDC: 70518-3993-2 - COLOR: white - SHAPE: ROUND - SCORE ...
  • INGREDIENTS AND APPEARANCE
    Product Information