Emtricitabine Dosage
This dosage information may not include all the information needed to use Emtricitabine safely and effectively. See additional information for Emtricitabine.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for HIV Infection
Capsules: 200 mg orally once a day
Oral solution: 240 mg (24 mL) orally once a day
Usual Adult Dose for Nonoccupational Exposure
(Not approved by FDA)
Centers for Disease Control and Prevention recommendations:
Capsules: 200 mg orally once a day plus efavirenz plus (tenofovir or zidovudine), or plus lopinavir-ritonavir plus zidovudine
Duration: 28 days
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.
Usual Pediatric Dose for HIV Infection
0 to 3 months:
Oral solution: 3 mg/kg orally once a day
3 months through 17 years:
Oral solution: 6 mg/kg orally once a day
Maximum dose: 240 mg (24 mL)
34 kg or more and able to swallow intact capsules: 200 mg (1 capsule) orally once a day
Renal Dose Adjustments
Adults:
CrCl 30 to 49 mL/min:
Capsules: 200 mg orally every 48 hours
Oral solution: 120 mg orally every 24 hours
CrCl 15 to 29 mL/min:
Capsules: 200 mg orally every 72 hours
Oral solution: 80 mg orally every 24 hours
CrCl less than 15 mL/min:
Capsules: 200 mg orally every 96 hours
Oral solution: 60 mg orally every 24 hours
The safety and efficacy of these dosing guidelines have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Pediatric patients: There are insufficient data to recommend dose adjustments; however, dose reductions or increased intervals should be considered.
Liver Dose Adjustments
No adjustment recommended.
Precautions
Lactic acidosis and severe hepatomegaly with steatosis, including fatalities, have been reported with the use of nucleoside analogs alone or in combination, including emtricitabine and other antiretrovirals. Risk factors for lactic acidosis may include female gender, obesity, and prolonged nucleoside exposure. Caution is recommended in patients with risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
It is recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B virus (HBV) before initiating antiretroviral therapy. Emtricitabine is not approved for the treatment of chronic HBV infection and its safety and efficacy have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 after discontinuation of emtricitabine and were associated with liver failure and liver decompensation in some patients. Close clinical and laboratory monitoring of hepatic function is recommended in patients coinfected with HBV and HIV-1 for at least several months after discontinuation, and antihepatitis B therapy should be initiated if indicated.
Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.
Clinical studies of emtricitabine did not contain sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Emtricitabine should always be used in combination with other antiretroviral agents.
Related drugs not for coadministration with emtricitabine include emtricitabine-tenofovir, efavirenz/emtricitabine/tenofovir, and emtricitabine/rilpivirine/tenofovir, in which emtricitabine is one of the active components. Due to similar resistance profiles and lack of therapeutic benefit, the concomitant use of emtricitabine and lamivudine-containing medications is not recommended.
The potential for HIV-1 cross-resistance among reverse transcriptase inhibitors exists but has not been fully explored. It is unknown what effect therapy will have on the activity of subsequently administered nucleoside reverse transcriptase inhibitors. Selection of antiretroviral agents for a patient's medication regimen should be done carefully.
Dialysis
Hemodialysis:
Capsules: 200 mg orally every 96 hours
Oral Solution: 60 mg orally every 24 hours
Doses should be given after dialysis sessions when administered on dialysis days.
Other Comments
The oral solution should preferably be refrigerated. If not refrigerated, any remainder should be discarded after 3 months.
Emtricitabine may be taken without regard to meals.
