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Tablet
Files
Tenofovir DF
Strength: 300mg
Count: 20
NDC
50268-758-12
Class
Rx
Brand Name
Viread
Imprint Code
TDF
Color(s)
WHITE
Shape
ROUND (convex)
Score
no score
Case Count
NA
Inactive Ingredients
croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are coated with Opadry White Y-1-7000, which contains Hypromellose, Titanium dioxide USP & Polyethylene glycol 400 (Macrogol) USP.
Indications and Usage
1.1 HIV-1 Infection Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate for the treatment of HIV-1 infection: Tenofovir disoproxil fumarate should not be used in combination with ATRIPLA®, COMPLERA®, DESCOVY®, GENVOYA®, ODEFSEY®, STRIBILD®, TRUVAD®or VEMLIDY®. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate for the treatment of HBV infection: The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease. Tenofovir disoproxil fumarate was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. The number of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy.
