Applies to the following strength(s): 10 mg
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Hepatitis B
10 mg orally once a day, without regard to food
Usual Pediatric Dose for Chronic Hepatitis B
Less than 12 years: Not recommended.
12 years or older: 10 mg orally once a day, without regard to food
Renal Dose Adjustments
CrCl 30 to 49 mL/min: 10 mg orally every 48 hours
CrCl 10 to 29 mL/min: 10 mg orally every 72 hours
CrCl less than 10 mL/min, non-hemodialysis: Data not available
Liver Dose Adjustments
No adjustment recommended.
Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients who have discontinued antihepatitis B therapy, including therapy with adefovir dipivoxil. Patients who discontinue adefovir dipivoxil should have close monitoring of hepatic function at repeated intervals with both clinical and laboratory follow-up for at least several months. If appropriate, resumption of antihepatitis B therapy may be warranted.
Exacerbation of hepatitis B may result from resistance to adefovir dipivoxil and may lead to liver decompensation and possible fatal outcome. To reduce the risk of resistance, adefovir dipivoxil should be administered with lamivudine and should not be used as monotherapy in patients with lamivudine-resistant hepatitis B. To reduce the risk of resistance, treatment modification should be considered in patients using adefovir dipivoxil monotherapy if serum hepatitis B DNA remains over 1000 copies/mL with continued therapy.
The use of adefovir dipivoxil in patients at risk of or having underlying renal dysfunction, and patients taking other nephrotoxic agents may result in nephrotoxicity. Creatinine clearance should be calculated prior to initiating adefovir therapy. Close clinical and laboratory monitoring of all patients' renal function is recommended and appropriate dosage adjustments should be made if indicated. The risks and benefits of treatment should be carefully evaluated before discontinuing adefovir due to treatment-emergent nephrotoxicity.
HIV resistance may occur in patients treated with antihepatitis B therapies, including adefovir dipivoxil, that have activity against HIV in a chronic hepatitis B patient with unrecognized or untreated HIV infection. HIV antibody testing should be offered to all patients prior to the start of adefovir dipivoxil therapy.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with antiretrovirals. Risk factors 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 hepatomegaly.
Adefovir dipivoxil should not be administered concomitantly with tenofovir or tenofovir-containing products including emtricitabine-tenofovir, efavirenz/emtricitabine/tenofovir, cobicistat/elvitegravir/emtricitabine/tenofovir, and emtricitabine/rilpivirine/tenofovir.
Adefovir dipivoxil use is not recommended in pediatric patients less than 12 years of age.
Hemodialysis: 10 mg orally every 7 days following a dialysis session
Peritoneal dialysis: Data not available
Adolescents: Data not available
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- Drug class: nucleoside reverse transcriptase inhibitors (NRTIs)
Other brands: Hepsera