Label: FLOLIPID- simvastatin suspension

  • NDC Code(s): 29273-401-04, 29273-402-04
  • Packager: Salerno Pharmaceuticals Co.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 9, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use FLOLIPID safely and effectively. See full prescribing information for FLOLIPID. FLOLIPID (simvastatin) oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosing - The usual dosage range is 5 to 40 mg/day. FLOLIPID should be taken in the evening on an empty stomach - [see ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Oral Suspension: 20 mg/5 mL (4 mg per mL) off-white to pinkish-orange suspension with a strawberry flavor. Oral Suspension: 40 mg/5 mL (8 mg per mL) off-white to pinkish-orange suspension ...
  • 4 CONTRAINDICATIONS
    FLOLIPID is contraindicated in the following conditions: Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myopathy/Rhabdomyolysis - Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN) ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Strong CYP3A4 Inhibitors, Cyclosporine, or Danazol - Strong CYP3A4 inhibitors: Simvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of CYP3A4. Simvastatin is ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Category X [See - Contraindications (4).] FLOLIPID is contraindicated in women who are or may become ...
  • 10 OVERDOSAGE
    Significant lethality was observed in mice after a single oral dose of 9 g/m - 2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m ...
  • 11 DESCRIPTION
    FLOLIPID Oral Suspension is a lipid-lowering agent that is derived synthetically from a fermentation product of - Aspergillus terreus.After oral ingestion, simvastatin ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin is a specific inhibitor of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 72-week carcinogenicity study, mice were administered daily doses of simvastatin of 25, 100, and 400 mg/kg body weight, which ...
  • 14 CLINICAL STUDIES
    14.1 Clinical Studies in Adults - Reductions in Risk of CHD Mortality and Cardiovascular Events - In 4S, the effect of therapy with simvastatin on total mortality was assessed in 4,444 patients ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    FLOLIPID (simvastatin) Oral Suspension 20 mg/5 mL (4 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows: NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel. Patients ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg/5 mL and 40 mg/5 mL
    NDC 29273-401-04 - FloLipid - simvastatin - 20 mg/5 mL - Oral Suspension - IMPORTANT: SHAKE WELL BEFORE USING - For Oral Use Only Discard 30 days after opening - Rx Only - Net Contents ...
  • INGREDIENTS AND APPEARANCE
    Product Information