Viread

Viread

Viread Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 HIV-1 Infection

VIREAD® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The following points should be considered when initiating therapy with VIREAD for the treatment of HIV-1 infection:

  • VIREAD should not be used in combination with TRUVADA® or ATRIPLA® [See Warnings and Precautions (5.4)].
1.2 Chronic Hepatitis B

VIREAD is indicated for the treatment of chronic hepatitis B in adults.

The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:

  • This indication is based on data from one year of treatment in primarily nucleoside-treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Efficacy in Patients with Chronic Hepatitis B (14.2)].
  • The numbers of patients in clinical trials who were nucleoside-experienced or who had lamivudine-associated mutations at baseline were too small to reach conclusions of efficacy [See Clinical Efficacy in Patients with Chronic Hepatitis B (14.2)].
  • VIREAD has not been evaluated in patients with decompensated liver disease.

History

There is currently no drug history available for this drug.

Other Information

VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.

The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P • C4H4O4 and a molecular weight of 635.52. It has the following structural formula:

Chemical Structure

Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C.

VIREAD tablets are for oral administration. Each tablet contains 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are coated with Opadry II Y–30–10671–A, which contains FD&C blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.

In this insert, all dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted.

Viread Manufacturers


  • State Of Florida Doh Central Pharmacy
    Viread (Tenofovir Disoproxil Fumarate) Tablet, Coated [State Of Florida Doh Central Pharmacy]
  • Remedyrepack Inc.
    Viread (Tenofovir Disoproxil Fumarate) Tablet, Coated [Remedyrepack Inc. ]
  • Gilead Sciences, Inc.
    Viread (Tenofovir Disoproxil Fumarate) Tablet, Coated Viread (Tenofovir Disoproxil Fumarate) Powder [Gilead Sciences, Inc.]
  • Cardinal Health
    Viread (Tenofovir Disoproxil Fumarate) Tablet, Coated [Cardinal Health]

Login To Your Free Account