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Medication Guide 2040755 200/300 mg Emtricitabine and Tenofovir Disoproxil Fumarate Tablets HIGHLIGHTS OF PRESCRIBING INFORMATION Recommended dose in renally impaired HIV-uninfected individuals: Do not use emtricitabine and tenofovir 7 DRUG INTERACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING Coadministered Dose of Coadministered % Change of Tenofovir Pharmacokinetic These highlights do not include all the information needed to use EMTRICITABINE AND TENOFOVIR DISOPROXIL disoproxil fumarate tablets in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is No drug interaction trials have been conducted using emtricitabine and tenofovir disoproxil fumarate tablets. Drug N Parametersb (90% CI) observed in uninfected individuals while using emtricitabine and tenofovir disoproxil fumarate tablets for PrEP, Drug Drug (mg) The blue, capsule shaped, film coated tablets contain 200 mg of emtricitabine and 300 mg of tenofovir disoproxil FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE AND TENOFOVIR interaction trials have been conducted with emtricitabine and tenofovir disoproxil fumarate, the components of C AUC C fumarate (which is equivalent to 245 mg of tenofovir disoproxil), are debossed with H on one side and with 124 DISOPROXIL FUMARATE TABLETS. evaluate potential causes and re-assess potential risks and benefits of continued use. (2.4) max min emtricitabine and tenofovir disoproxil fumarate tablet. This section describes clinically relevant drug interactions h 14 on the other side, and are available in unit of use bottles [containing a dessicant (silica gel sachet) and closed with a EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use -------------------------------------------------DOSAGE FORMS AND STRENGTHS--------------------------------------------- observed with emtricitabine and tenofovir disoproxil fumarate [See Clinical Pharmacology (12.3)]. Indinavir 800 three times daily x 13 Tablets: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. (3) 7 days (i 3 to h 33) child-resistant closure] of: Initial U.S. Approval: 2004 POM Schedule: S2 NS2 PP 7.1 Didanosine ------------------------------------------------------CONTRAINDICATIONS------------------------------------------------------- e,f 90/400 once daily x h 47 h 35 h 47 30 tablets (NDC 68554-3060-0) WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE Coadministration of emtricitabine and tenofovir disoproxil fumarate and didanosine should be undertaken with caution Ledipasvir/ Sofosbuvir Do not use emtricitabine and tenofovir disoproxil fumarate tablets for pre-exposure prophylaxis in individuals with 10 days 24 (h 37 to h 58) (h 29 to h 42) (h 38 to h 57) EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR unknown or positive HIV-1 status. Emtricitabine and tenofovir disoproxil fumarate tablets should be used in HIV- and patients receiving this combination should be monitored closely for didanosine-associated adverse reactions. Store below 30°C. Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions. DISOPROXIL FUMARATE TABLET FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION infected patients only in combination with other antiretroviral agents. (4) e,g Ledipasvir/ Sofosbuvir h 64 h 50 h 59 Keep container tightly closed -------------------------------------------------WARNINGS AND PRECAUTIONS------------------------------------------------- When tenofovir disoproxil fumarate was administered with didanosine the C and AUC of didanosine increased 23 See full prescribing information for complete boxed warning. max (h 54 to h 74) (h 42 to h 59) (h 49 to h 70) New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess significantly [See Clinical Pharmacology (12.3)]. The mechanism of this interaction is unknown. Higher didanosine Dispense only in original container Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. h 90/400 once daily x estimated creatinine clearance before initiating treatment with emtricitabine and tenofovir disoproxil fumarate. Ledipasvir/ Sofosbuvir h 79 h 98 h 163 Do not use if seal over bottle opening is broken or missing. the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of emtricitabine and In patients at risk for renal dysfunction, assess estimated creatinine clearance, serum phosphorus, urine Suppression of CD4+ cell counts has been observed in patients receiving tenofovir DF with didanosine 400 mg daily. 14 days 15 (h 56 to h 104) (h 77 to h 123) (h 132 to h 197) tenofovir disoproxil fumarate tablet. (5.1) glucose and urine protein before initiating treatment with emtricitabine and tenofovir disoproxil fumarate and 17 PATIENT COUNSELING INFORMATION In patients weighing greater than 60 kg, the didanosine dose should be reduced to 250 mg when it is coadministered i 90/400 once daily x h 40 Emtricitabine and tenofovir disoproxil fumarate is not approved for the treatment of chronic hepatitis B periodically during treatment. Avoid administering emtricitabine and tenofovir disoproxil fumarate with concurrent with emtricitabine and tenofovir disoproxil fumarate. Data are not available to recommend a dose adjustment of Ledipasvir/ Sofosbuvir h 32 h 91 or recent use of nephrotoxic drugs. (5.3) 10 days 14 (h 25 to h 39) (h 31 to h 50) (h 74 to h 110) As a part of patient counseling, healthcare providers must review the emtricitabine and tenofovir disoproxil virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected didanosine for adult or pediatric patients weighing less than 60 kg. When coadministered, emtricitabine and tenofovir fumarate Medication Guide with every uninfected individual taking emtricitabine and tenofovir disoproxil fumarate Coadministration with Other Products: Do not use with drugs containing emtricitabine, tenofovir alafenamide disoproxil fumarate and Videx EC may be taken under fasted conditions or with a light meal (less than 400 kcal, 20% with HIV-1 and HBV who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. 400/100 twice daily x h 32 h 51 to reduce the risk of acquiring HIV. Therefore, hepatic function should be monitored closely in HBV-infected patients who discontinue or tenofovir disoproxil fumarate including ATRIPLA, COMPLERA, emtricitabine, GENVOYA, ODEFSEY, STRIBILD, fat). Lopinavir/ Ritonavir 14 days 24 (h 25 to h 38) (h 37 to h 66) tenofovir disoproxil fumarate.; or with drugs containing lamivudine. Do not administer in combination with emtricitabine and tenofovir disoproxil fumarate tablets. If appropriate, initiation of anti-hepatitis B therapy 7.2 HIV-1 Protease Inhibitors Saquinavir/ Ritonavir 1000/100 twice daily x 35 h 23 Important Information for All Patients and Uninfected Individuals may be warranted. (5.2) HEPSERA. (5.4) Decreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathologic Tenofovir decreases the AUC and Cmin of atazanavir [See Clinical Pharmacology (12.3)]. When coadministered with 14 days (h 16 to h 30) Advise patients and uninfected individuals that: Emtricitabine and tenofovir disoproxil fumarate tablets used for a PrEP indication must only be prescribed emtricitabine and tenofovir disoproxil fumarate, it is recommended that atazanavir 300 mg is given with ritonavir 100 j h 25 fracture or other risk factors for osteoporosis or bone loss. (5.5) Sofosbuvir 400 mg single dose 16 The long term effects of emtricitabine and tenofovir disoproxil fumarate are unknown. to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use. Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy. (5.6) mg. Emtricitabine and tenofovir disoproxil fumarate should not be coadministered with atazanavir without ritonavir. (h 8 to h 45) Drug-resistant HIV-1 variants have been identified with the use of emtricitabine and tenofovir disoproxil Immune reconstitution syndrome: May necessitate further evaluation and treatment. (5.7) Lopinavir/ritonavir, atazanavir coadministered with ritonavir, and darunavir coadministered with ritonavir have been Emtricitabine and Tenofovir disoproxil fumarate Tablets are for oral ingestion only. fumarate tablets for a PrEP indication following undetected acute HIV-1 infection. Do not initiate emtricitabine shown to increase tenofovir concentrations [See Clinical Pharmacology (12.3)]. Tenofovir disoproxil fumarate is a Tacrolimus 0.05 mg/kg twice daily x 21 h 13 Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients. Monitor Patients and uninfected individuals should not discontinue emtricitabine and tenofovir disoproxil fumarate and tenofovir disoproxil fumarate tablets for a PrEP indication if signs or symptoms of acute HIV infection carefully and consider treatment modification. (5.8) substrate of P-glycoprotein (Pgp) and breast cancer resistance protein (BCRP) transporters. When tenofovir disoproxil 7 days (h 1 to h 27) are present unless negative infection status is confirmed. (5.9) without first informing their physicians. Comprehensive management to reduce the risk of acquiring HIV-1: Use as part
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