Label: LOVASTATIN tablet

  • NDC Code(s): 61442-141-01, 61442-141-05, 61442-141-10, 61442-141-60, view more
  • Packager: Carlsbad Technology, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 7, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Lovastatin is a cholesterol lowering agent isolated from a strain of - Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the ...
  • Clinical Pharmacology
    The involvement of low-density lipoprotein cholesterol (LDL-C) in atherogenesis has been well-documented in clinical and pathological studies, as well as in many animal experiments ...
  • Indications and Usage
    Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in ...
  • CONTRAINDICATIONS
    Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases (see - WARNINGS ) ...
  • WARNINGS
    Myopathy/Rhabdomyolysis - Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ...
  • Precautions
    General - Lovastatin may elevate creatine phosphokinase and transaminase levels (see - WARNINGS and ...
  • ADVERSE REACTIONS
    Adverse Reactions - Phase III Clinical Studies - In Phase III controlled clinical studies involving 613 patients treated with lovastatin, the adverse experience profile was similar to that shown ...
  • OVERDOSAGE
    After oral administration of lovastatin to mice, the median lethal dose observed was >15 g/m - 2. Five healthy human volunteers ...
  • Dosage and Administration
    The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin (see NCEP Treatment Guidelines ...
  • HOW SUPPLIED
    Lovastatin Tablets USP (white to off white round, unscored tablets) containing 10mg of lovastatin and engraved with - “CTI 141" Bottle of ...
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bottle Label - NDC 61442-141-01 - Lovastatin Tablets USP 10 mg - Rx Only - Carlsbad Technology, Inc. 100 Tablets
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bottle Label - NDC 61442-142-01 - Lovastatin Tablets USP 20 mg - Rx Only - Carlsbad Technology, Inc. 100 Tablets
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bottle Label - NDC 61442-143-01 - Lovastatin Tablets USP 40 mg - Rx Only - Carlsbad Technology, Inc. 100 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information