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恩曲他滨胶囊EMTRIVA CAP(二)
2013-06-12 15:04:31 来源: 作者: 【 】 浏览:14687次 评论:0
ery 24 hours
(8 mL) 60 mg every 24 hours
(6 mL)
Although there are insufficient data to recommend a specific dose adjustment of Emtriva in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval similar to adjustments for adults should be considered.

Dosage Forms and Strengths
Emtriva is available as capsules and oral solution.

Emtriva capsules, containing 200 mg of emtricitabine, are size 1 hard gelatin capsules with a blue cap and white body, printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body.

Emtriva oral solution is a clear, orange to dark orange liquid containing 10 mg of emtricitabine per mL.

Contraindications
Emtriva is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products.

Warnings and Precautions
Lactic Acidosis/Severe Hepatomegaly with Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination, including emtricitabine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogs to any patient with known risk factors for liver diseases; however, cases have also been reported in patients with no known risk factors. Treatment with Emtriva should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Patients Coinfected with HIV-1 and HBV
It is recommended that all patients with HIV-1 be tested for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy. Emtriva is not approved for the treatment of chronic HBV infection and the safety and efficacy of Emtriva have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of Hepatitis B have been reported in patients after the discontinuation of Emtriva. In some patients infected with HBV and treated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Emtriva. If appropriate, initiation of anti-Hepatitis B therapy may be warranted.

Coadministration with Related Products
​Emtriva is a component of ATRIPLA (a fixed-dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate), COMPLERA (a fixed-dose combination of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate), STRIBILD (a fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate), and TRUVADA (a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate). Emtriva should not be coadministered with ATRIPLA, COMPLERA, STRIBILD, or TRUVADA. Due to similarities between emtricitabine and lamivudine, Emtriva should not be coadministered with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (

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