These highlights do not include all the information needed to use Adefovir Dipivoxil Tablets safely and effectively. See full prescribing information for Adefovir Dipivoxil Tablets.
Adefovir Dipivoxil Tablets for oral use
Initial U.S. Approval: 2002
|
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS |
|
See full prescribing information for complete boxed warning. |
-
Severe acute exacerbations of hepatitis may occur in patients who discontinue Adefovir Dipivoxil Tablets. Monitor hepatic function closely in these patients. (5.1)
-
Chronic use of Adefovir Dipivoxil Tablets may result in nephrotoxicity in patients at risk of renal dysfunction or having underlying renal dysfunction. Monitor renal function closely in these patients. Dose adjustment may be required. (5.2)
-
HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV infection. (5.3)
-
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.4)
|
RECENT MAJOR CHANGES
Warnings and Precautions
-
Coadministration with other Products(5.5)-11/2012
INDICATIONS AND USAGE
Adefovir Dipivoxil Tablets is a nucleotide analogue indicated for the treatment of chronic hepatitis B in patients 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
-
One tablet containing 10 mg adefovir dipivoxil once daily orally with or without food. (2.1)
-
Dose adjustment in renal impairment for adults (2.2)
|
|
|
|
|
Creatinine Clearance (mL/min)* |
|
|
|
|
Greater than or equal to 50 |
30 to 49 |
10 to 29 |
Hemodialysis Patients |
|
Recommended dose and dosing interval |
10 mg every 24 hours |
10 mg every 48 hours |
10 mg every 72 hours |
10 mg every 7 days following dialysis |
-
No dose recommendations for (2.1):
-
Non-hemodialysis patients with creatinine clearance less than 10 mL per minute.
-
Adolescent patients with renal impairment.
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg (3)
CONTRAINDICATIONS
