Drugplain

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate 600 mg/1

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate · TABLET, FILM COATED · Teva Pharmaceuticals USA, Inc.

No Recall History
Plain English

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate is a tablet, film coated containing efavirenz, emtricitabine and tenofovir disoproxil fumarate at 600 mg/1, taken oral. Manufactured by Teva Pharmaceuticals USA, Inc..

Key Facts

Brand Name
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Generic Name
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
NDC Code (Product)
0093-5234
Manufacturer
Teva Pharmaceuticals USA, Inc.
Strength
600 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA091215
Drug Class
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Marketing Start
10/01/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

anaemia7 reports
maternal exposure during pregnancy6 reports
neutropenia6 reports
kaposi^s sarcoma4 reports
renal failure3 reports
vomiting3 reports
abnormal dreams2 reports
abortion spontaneous2 reports
acute kidney injury2 reports
bacterial sepsis2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Testing: Consult Full Prescribing Information for important testing recommendations prior to initiation and during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. (2.1) Recommended dosage in adults and pediatric patients weighing at least 40 kg: One tablet once daily taken orally on an empty stomach, preferably at bedtime. (2.2) Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL/min. (2.3) Hepatic impairment: Not recommended in patients with moderate to severe hepatic impairment. (2.4) Dosage adjustment with rifampin coadministration: An additional 200 mg/day of efavirenz is recommended for patients weighing 50 kg or more. (2.5) 2.1 Testing Prior to Initiation and During Treatment with Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Prior to or when initiating efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1) ]. Prior to initiation and during use of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess …

Contraindications

4 CONTRAINDICATIONS Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see Warnings and Precautions (5.2) ] . Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ]. Previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. (4) Coadministration with voriconazole. (4) Coadministration with elbasvir/grazoprevir. (4)

Drug Interactions

7 DRUG INTERACTIONS Consult Full Prescribing Information prior to and during treatment for important potential drug interactions. (4 , 5.4 , 7 ) HIV-1 protease inhibitors: Coadministration of efavirenz, emtricitabine and tenofovir disoproxil fumarate with either lopinavir/ritonavir or darunavir and ritonavir increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. Coadministration of efavirenz, emtricitabine and tenofovir disoproxil fumarate with either atazanavir or atazanavir and ritonavir is not recommended. (7.3) 7.1 Efavirenz Efavirenz has been shown in vivo to induce CYP3A and CYP2B6. Other compounds that are substrates of CYP3A or CYP2B6 may have decreased plasma concentrations when coadministered with EFV. Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of EFV, resulting in lowered plasma concentrations [see Dosage and Administration (2.2) ]. There is limited information available on the potential for a pharmacodynamic interaction between EFV and drugs that prolong the QTc interval. QTc prolongation has been observed with the use of EFV [see Clinical Pharmacology (12.2) ]. Conside…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ] . Rash [see Warnings and Precautions (5.2) ]. Hepatotoxicity [see Warnings and Precautions (5.3) ]. Psychiatric Symptoms [see Warnings and Precautions (5.5) ]. Nervous System Symptoms [see Warnings and Precautions (5.6) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.7) ]. Embryo-Fetal Toxicity [see Warnings and Precautions (5.8) ]. Bone Loss and Mineralization Defects [see Warnings and Precautions (5.9) ]. Convulsions [see Warnings and Precautions (5.10) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.11) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.12) ]. Fat Redistribution [see Warnings and Precautions (5.13) ]. Most common adverse reactions (incidence greater than or equal to 10%) observed in an active-controlled clinical trial of EFV, FTC, and TDF are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. (6.1) To report SUSPECTE…

Frequently Asked Questions

What is Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate used for?

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate contains Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate a controlled substance?

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate is not classified as a controlled substance by the DEA.

What is the generic name for Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate?

The generic name for Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate is Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate. There are 4 other brand versions of Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate.

What is the NDC code for Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate 600 mg/1?

The NDC (National Drug Code) for Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate 600 mg/1 is 0093-5234, listed by Teva Pharmaceuticals USA, Inc..

Product NDC

0093-5234

Package NDC

0093-5234-56

Other Efavirenz, Brands

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

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