Drugplain

Viread 300 mg/1

TENOFOVIR DISOPROXIL FUMARATE · TABLET, COATED · Gilead Sciences, Inc.

No Recall History
Plain English

Viread is a tablet, coated containing tenofovir disoproxil fumarate at 300 mg/1, taken oral. Manufactured by Gilead Sciences, Inc..

Key Facts

Brand Name
Viread
Generic Name
TENOFOVIR DISOPROXIL FUMARATE
NDC Code (Product)
61958-0401
Manufacturer
Gilead Sciences, Inc.
Strength
300 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
NDA021356
Marketing Start
10/26/2001

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

bone density decreased10,655 reports
renal injury9,278 reports
skeletal injury8,329 reports
chronic kidney disease7,278 reports
osteonecrosis7,261 reports
bone loss7,071 reports
multiple fractures6,826 reports
renal failure6,678 reports
osteoporosis5,384 reports
tooth loss4,514 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and 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 weighing at least 10 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. ( 1.2 ) 1.1 HIV-1 Infection VIREAD is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.2 Chronic Hepatitis B VIREAD is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 kg .

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Testing: Prior to or when initiating VIREAD test for hepatitis B virus infection and HIV-1 infection. Prior to initiation and during use of VIREAD, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorous. ( 2.1 ) Recommended tablet dosage in adults and pediatric patients weighing at least 35 kg: One VIREAD 300 mg tablet once daily taken orally without regard to food. ( 2.2 ) Recommended dosage in pediatric patients at least 2 years of age and adults: Tablets: For patients weighing at least 17 kg who can swallow an intact tablet, one VIREAD tablet (150 mg, 200 mg, 250 mg, or 300 mg based on body weight) once daily taken orally without regard to food. ( 2.2 ) Oral powder: For patients weighing at least 10 kg and unable to swallow a tablet, 8 mg per kg VIREAD oral powder (up to a maximum of 300 mg) taken once daily with food. ( 2.3 ) Recommended dosage in renally impaired adult patients: Creatinine clearance (CrCl) 30–49 mL/min: 300 mg every 48 hours. ( 2.4 ) CrCl 10–29 mL/min: 300 mg every 72 to 96 …

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. ( 7.2 ) Coadministration decreases atazanavir concentrations. When coadministered with VIREAD, use atazanavir given with ritonavir. ( 7.2 ) Coadministration of VIREAD with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. ( 7.2 ) Consult Full Prescribing Information prior to and during treatment for important drug interactions. ( 7.2 ) 7.1 Drugs Affecting Renal Function Tenofovir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3) ]. Coadministration of VIREAD with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the coadministered drug. Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.2) ]. Drugs that decrease renal function may increase concentrations of tenofovir. In the treatment of chronic h…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1) ] . New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.2) ] . Immune Reconstitution Syndrome [see Warnings and Precautions (5.4) ] . Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5) ] . Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6) ] . In HIV-infected adult subjects: Most common adverse reactions (incidence greater than or equal to 10%, Grades 2–4) were rash, diarrhea, nausea, headache, pain, depression, and asthenia. ( 6.1 ) In HBV-infected subjects with compensated liver disease: Most common adverse reaction (all grades) was nausea (9%). ( 6.1 ) In HBV-infected subjects with decompensated liver disease: Most common adverse reactions (incidence greater than or equal to 10%, all grades) were abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia. ( 6.1 ) In pediatric subjects: Adverse reactions in pediatric subjects were consistent with those observed in adults. ( 6.1 )…

Frequently Asked Questions

What is Viread used for?

Viread contains TENOFOVIR DISOPROXIL FUMARATE. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Viread a controlled substance?

Viread is not classified as a controlled substance by the DEA.

What is the generic name for Viread?

The generic name for Viread is TENOFOVIR DISOPROXIL FUMARATE. There are 8 other brand versions of TENOFOVIR DISOPROXIL FUMARATE.

What is the NDC code for Viread 300 mg/1?

The NDC (National Drug Code) for Viread 300 mg/1 is 61958-0401, listed by Gilead Sciences, Inc..

Product NDC

61958-0401

Package NDC

61958-0401-1

Other Tenofovir Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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