Details About Generic Salt ::  Adefovir

Main Medicine Class::    

(Ah-DEF-fah-vihr die-pihv-VOX-ill)
Hepsera
Tablets
10 mg
Class: Antiviral Agent

 

Drugs Class ::

 Action Inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA.

Absorption: Bioavailability of adefovir is approximately 59%. Cmax is approximately 18.4 ng/mL and Tmax is approximately 1.75 hr.

Distribution: Up to 4% is protein bound. Vd is approximately 352 to 392 mL/kg (IV doses at steady state).

Metabolism: Adefovir dipivoxil (prodrug) is rapidly converted to adefovir (active).

Elimination: The t1/2 is approximately 7.48 hr; 45% of dose is recovered as adefovir in the urine over 24 hr.

Renal function impairment: The Cmax , AUC, and t1/2 increased in those with moderate or severe renal impairment or with end-stage renal disease. Dosing interval modification is recommended.

Indications for Drugs ::

 Indications Treatment of chronic hepatitis B in adults with evidence of active viral replication and evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Drug Dose ::

 Route/Dosage

Adults: PO 10 mg qd.

Renal impairment Adults: PO For Ccr 50 mL/min or less, administer 10 mg q 24 hr; for Ccr 20 to 49 mL/min, administer 10 mg q 48 hr; for Ccr 10 to 19 mL/min, administer 10 mg q 72 hr; hemodialysis patients, administer 10 mg q 7 days following dialysis.

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity. Exacerbation of hepatitis: Severe acute exacerbation has been reported after discontinuation of treatment. Lactic acidosis/Severe hepatomegaly with steatosis: Have been reported (sometimes fatal) with use of nucleoside analogs or in combination with antiviral agents. Underlying renal dysfunction: Chronic administration of adefovir dipivoxil may result in nephrotoxicity.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

Treatment-related adverse events reported in pre- and postliver transplantation patients include the following:

CNS: Headache. DERMATOLOGIC: Pruritus; rash. EENT: Pharyngitis. GI: Nausea; vomiting; diarrhea; flatulence. GU: Increases in creatinine; renal failure; renal insufficiency. HEPATIC: Hepatic failure; increases in ALT and AST; abnormal liver function. RESPIRATORY: Increased cough; sinusitis. OTHER: Asthenia; abdominal pain; fever.

Drug Mode of Action ::  

 Action Inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA.

Absorption: Bioavailability of adefovir is approximately 59%. Cmax is approximately 18.4 ng/mL and Tmax is approximately 1.75 hr.

Distribution: Up to 4% is protein bound. Vd is approximately 352 to 392 mL/kg (IV doses at steady state).

Metabolism: Adefovir dipivoxil (prodrug) is rapidly converted to adefovir (active).

Elimination: The t1/2 is approximately 7.48 hr; 45% of dose is recovered as adefovir in the urine over 24 hr.

Renal function impairment: The Cmax , AUC, and t1/2 increased in those with moderate or severe renal impairment or with end-stage renal disease. Dosing interval modification is recommended.

Drug Interactions ::

 Interactions

Ibuprofen, drugs that reduce renal function: May increase plasma concentrations of adefovir.

Drug Assesment ::

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note renal impairment, HIV infection, and concurrent use of potentially nephrotoxic medications (eg, NSAIDs).
  • Ensure that HIV testing is done prior to starting therapy in patients whose HIV status is unknown.
  • Monitor renal function and liver enzymes periodically during therapy. Be prepared to adjust dosing interval should evidence of renal impairment be noted.
  • Monitor patient for evidence of lactic acidosis (eg, extreme fatigue, unexplained muscle pain, dyspnea, dizziness, lightheadedness, abdominal pain with nausea and vomiting, chills, tachycardia, irregular heartbeat) and hepatitis (eg, jaundice, right upper quadrant pain, dark urine, light stools). If noted, discontinue therapy and notify health care provider immediately.
  • Monitor patient for evidence of CNS, GI, and general body side effects. If noted and significant, inform health care provider.
OVERDOSAGE: SIGNS & SYMPTOMS
  GI side effects

Drug Storage/Management ::

 Administration/Storage

  • Administer with or without food. Administer with food if GI upset occurs.
  • Give prescribed dose once daily to patient with normal renal function.
  • Follow manufacturer’s guidelines for dosing intervals in patients with renal impairment.
  • Store tablets at controlled room temperature (59° to 86°F).

Drug Notes ::

 Patient/Family Education

  • Advise patient to review the Patient Information pamphlet carefully before starting therapy and to read and check for new information each time the medication is refilled.
  • Explain name, dose, action, and potential side effects of therapy.
  • Review dosing schedule with patient.
  • Advise patient that tablets can be taken without regard to food but can be taken with food if GI upset occurs.
  • Advise patient that if a dose is missed to take it as soon as remembered on that day. Caution patient to not take more than 1 dose of adefovir dipivoxil in a day nor to take 2 doses at the same time.
  • Caution patient to not change the dose or stop taking unless advised to do so by their health care provider. Stopping therapy may result in severe exacerbation of the hepatitis.
  • Advise patient to get an HIV test before starting therapy and any time after that when there is a chance of exposure to HIV.
  • Advise patient that medication will not cure hepatitis B infection nor any other viral infection (eg, HIV) and to continue to take other antiviral medications as prescribed.
  • Advise patient that this therapy will not prevent transmission of hepatitis B to others nor is it know if it can prevent cirrhosis, liver failure, or liver cancer that may develop as a result of hepatitis B infection.
  • Advise patient to immediately report any of the following to their health care provider: difficulty breathing, unusual muscle pain, generalized body discomfort, unexplained drowsiness, dizziness, light-headedness, fast or irregular heart beat, stomach pain with nausea and vomiting, cold feeling, especially in arms and legs, yellowing of the skin or eyes, appetite loss, bowel movements turn light in color, or urine turns very dark in color.
  • Instruct women to notify health care provider if planning on becoming pregnant or breastfeeding.
  • Instruct patient to not take any prescription or OTC medications or dietary supplements unless advised by health care provider.
  • Advise patient that laboratory tests and follow-up visits will be required to monitor therapy and to keep appointments.

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