Label: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 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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  • INDICATIONS & USAGE
    1.1 Treatment of HIV-1 Infection - Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults ...
  • DOSAGE & ADMINISTRATION
    2.1 Testing Prior to Initiation of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for Treatment of HIV-1 Infection or for HIV-1 PrEP - Prior to or when initiating emtricitabine and tenofovir ...
  • DOSAGE FORMS & STRENGTHS
    Emtricitabine and tenofovir disoproxil fumarate tablets are available in one dose strength. 200 mg/300 mg Tablets: 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) ...
  • CONTRAINDICATIONS
    Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)].
  • WARNINGS AND PRECAUTIONS
    5.1 Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection - All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating ...
  • ADVERSE REACTIONS
    The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1)] ...
  • DRUG INTERACTIONS
    7.1 Drugs Affecting Renal Function - FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion [see Clinical Pharmacology (12.3)] ...
  • USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects - Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil ...
  • DESCRIPTION
    Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside ...
  • HOW SUPPLIED
    Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 and 100 tablets with child-resistant closure as follows: 200 mg of FTC and 300 mg of TDF (equivalent ...
  • 88436-1 - Section Title Not Found In Database
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Important Information for Uninfected Individuals Taking Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for ...
  • MEDICATION GUIDE
    Medication Guide - Emtricitabine and Tenofovir Disoproxil Fumarate - (EM-trye-SYE-ta-been and ten-OF-oh-vir DYE-soe-PROX-il FUE-ma-rate) Tablets - Read this Medication Guide before you start taking ...
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  • INGREDIENTS AND APPEARANCE
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