Emtricitabine/tenofovir disoproxil fumarate

Consult the complete prescribing information for each agent prior to administration of emtricitabine/tenofovir disoproxil fumarate combination tablets. [Pg.1880]

Emtricitabine/tenofovir disoproxil fumarate is not indicated for the treatment of chronic hepatitis B virus (HBV) infection safety and efficacy have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine or tenofovir disoproxil fumarate. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who discontinue emtricitabine/tenofovir disoproxil fumarate and are coinfected with HIV and HBV. If appropriate, initiation of antihepatitis B therapy may be warranted (see Warnings). [Pg.1880]

In treatment-naive patients, consider emtricitabine/tenofovir disoproxil fumarate as an alternative to the combination of tenofovir disoproxil fumarate plus lamivudine (3TC) for those patients who might benefit from a once-daily regimen. In treatment-experienced patients, guide the use of emtricitabine/tenofovir disoproxil fumarate by laboratory testing and treatment history. [Pg.1880]

The dose of emtricitabine/tenofovir disoproxil fumarate is 1 tablet taken orally once daily with or without food. [Pg.1880]

Pharmacokinetics One emtricitabine/tenofovir disoproxil fumarate tablet was bioequivalent to 1 emthcitabine capsule (200 mg) plus 1 tenofovir disoproxil fumarate tablet (300 mg) following single-dose administration to fasting healthy subjects. [Pg.1881]

Avoid emtricitabine/tenofovir disoproxil fumarate with concurrent or recent use of a nephrotoxic agent. Carefully monitor patients at risk for or with a history of renal dysfunction and those receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus. [Pg.1883]

Frampton JE, Croom KF (2006) Efavirenz/emtricitabine/tenofovir disoproxil fumarate triple combination tablet. Drugs 66 1501-1512... [Pg.154]

Decks E, Perry C (2010) Efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen (Atripla ) a review of its use in the management of HIV infection. Drugs 70 2315-2338... [Pg.366]

OUn JL, Spooner LM, Klibanov OM. Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single tablet for HlV-1 infection treatment. Ann Pharmacother 2012 46(12) 1671-7. [Pg.436]

Manzardo C, Gatell JM. Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate) a new Paradigm for HlV-1 treatment. AIDS Rev 2014 16(1) 35. ... [Pg.436]

Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, Dejesus E, Antunes F, et al. Cobidstat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients week 48 results. J Infect Dis... [Pg.436]

Zolopa A, Sax PE, Dejesus E, Mills A, Cohen C, Wohl D, et al. A randomized double-blind comparison of coformulated elvitegravir/cobi-cistat/emtricitabine/tenofovir disoproxil fumarate versus efevirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection analysis of week 96 results. J Acquir Immune Defic S)fndr 2013 63(1) 96-100. [Pg.436]

Quayyum S, Dong H, Kovacic D, Sohail S, Waters B, Thornton C, et al. Combination therapy efavirenz/emtricitabine/tenofovir disoproxil fumarate associated with hepatic failure. Curr Drug Saf 2012 7(5) 391-3. [Pg.438]

Tenofovir in its prodrug form tenofovir, disoproxil fumarate (TDF), is indicated in the treatment of HIV infections (AIDS). It is administered as a single oral dose of 300 mg per day. When combined with emtricitabine and efavirenz, TDF has proven to be more efhcacious than the standard combination therapy of combivir (azidothymidine plus lamivudine) and efavirenz (Gallant et al. 2006) and less prone to cause adverse side effects (Pozniak et al. 2006 De Clercq 2007b). [Pg.69]

Tablets 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate (equivalent to 245 mg tenofovir disoproxil) (Rx)...

Renal function impairment Significantly increased drug exposures occurred when emtricitabine or tenofovir disoproxil fumarate were administered to patients with moderate to severe renal impairment. Because the safety and efficacy of the dosing... [Pg.1880]

Fixed dose combination This combination contains fixed doses of 2 nucleoside analogs emtricitabine and tenofovir disoproxil fumarate. Do not administer concomitantly with emtricitabine or tenofovir disoproxil fumarate. [Pg.1882]

Renal function impairment Emtricitabine and tenofovir disoproxil fumarate are principally eliminated by the kidney. Dosing interval adjustment is recommended in all patients with Ccr 30 to 49 mL/min do not administer the combination to patients with Ccr less than 30 mL/min or patients requiring hemodialysis. [Pg.1882]

In 2001, tenofovir disoproxil fumarate 61, a prodrug of tenofovir was approved for treatment of HIV, subsequently being preregistered in the USA for treatment of hepatitis B. Emtricitabine 62, a reverse transcriptase inhibitor, was approved in 2003 for HIV. What is of import is that these compounds are now part of fixed dose combination therapies for treatment of HIV, either two drug (tenofovir disoproxil fumarate/emtricitabine) or three drug Atripla (tenofovir disoproxil fumarate/emtricitabine/efavirenz) formulations. Thus, even 50 + years after Bergmann s discovery of bioactive arabinose nucleosides, small molecules synthesised as result of his discoveries are still in clinical use and others are in clinical trials for treatment of viral diseases. [Pg.21]

ABBREVIATIONS EFV, efavirenz 3TC, lamivudine AZT, zidovudine TDF, tenofovir disoproxil fumarate d4T, stavudine LPV/r, lopinavir/ritonavir coformulation FTC, emtricitabine NVP, nevirapine ddl, didanosine ATV, atazanavir fosAPV, fosamprenavir RTV, ritonavir IDV, indinavir NFV, nelfinavir SQV, saquinavir. [Pg.840]

There was no pharmacokinetic interaction between tenofovir disoproxil fumarate 300 mg daily and emtricitabine 200 mg daily in a study in healthy subjects. UK and US guidelines (2006) for treatment of HIV in-... [Pg.807]

Fisher M, Moyle GJ, Shahmanesh M, Orkin C, Kingston M, Wilkins E, Ewan J, Liu H, Ebrahimi R, Reilly G. SWEET (Simplification With Easier Emtricitabine Tenofovir) group UK. A randomized comparative trial of continued zidovudine/ lamivudine or replacement with tenofovir disoproxil fumarate/erntridtabine in efa-virenz-treated HIV-l-infected individuals. J Acquir Immune Defic Syndr 2009 51 (5) 562-8. [Pg.609]

Owino F, Mandala J, Ambia J, Agot K, Van Damme L. Neurological syndrome in an HIV-prevention trial participant randomized to daily tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) in Bondo, Kenya. Int Med Case Rep J 2013 29(6) 91-3. [Pg.438]

Tenofovir is a derivative of adenosine 5 -monophosphate lacking a complete ribose ring and is the only nucleotide analog currently marketed for the treatment of HIV infection. Because the parent compound had very poor oral bioavailability, tenofovir is available only as the disoproxil fumarate prodrug, which has improved oral absorption and cellular penetration substantially. Like lamivudine and emtricitabine, tenofovir is active against HIV-1, HIV-2,... [Pg.675]

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