Adefovir Dipivoxil (Hepsera) – Drug Information

Generic Name : Adefovir Dipivoxil

Therapeutic Classification : Antivirals

Overview :

Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon and Hepsera. This medication is a reverse transcriptase inhibitor (ntRTI), used to treat a chronic viral infection of the liver (hepatitis B) in people 12 years of age and older. It slows the growth of HBV by blocking reverse transcriptase, an enzyme that is helpful for viral reproduction.  It slows the growth of HBV by blocking reverse transcriptase, an enzyme that is helpful for viral reproduction.

Mechanism of Action :

Adefovir is an acyclic nucleotide analog of adenosine monophosphate which is phosphorylated to the active metabolite adefovir diphosphate by cellular kinases. Adefovir diphosphate is inhibits HBV DNA polymerase by competing with the natural substrate deoxyadenosine triphosphate and thus resulting reduces the viral DNA synthesis.

Pharmacokinetics :

Absorption :

Bioavailability: 59%

Peak plasma time: 0.58-4 hour

Distribution :

Volume of distribution: 317-467 mL/kg

Elimination :

Half-life: 7.48±1.65 hour

Excretion: Urine; renal glomerular filtration, active tubular secretion

Contraindication for Adafovir dipivoxil :

Contraindicated in patients who are taking tenofovir, hypersensitivity to any of the components of the product & liver enlargement.

Pregnancy Category :

Category C

Animal studies have shown adverse effects on the fetus and there are no appropriate studies in pregnant women, but potential benefits may allow the use of the drug in pregnant women despite the potential for risks.

Dosage for Adefovir dipivoxil :

  • It comes as a tablet to take by mouth, with or without food.
  • Adult recommended dose 10mg/day.
  • This medication is not recommended for use in children less than 12 years of age.

Adverse Reactions and Side Effects :

  • Most Common : Weakness, headache, abdominal pain, diarrhea, nausea, indigestion, flatulence, increased creatinine, and decrease in blood phosphate level.
  • Miscellaneous : Kidney failure, fanconi syndrome , muscle pain, softening of bones & Inflammation of pancreas.

Warnings and Precautions :

  • Caution should be strictly followed in patients with history of kidney, liver diseases, abnormal liver function tests, liver transplant, HIV infection, obesity, any allergy, who are taking other medications, elderly, during pregnancy and breastfeeding.
  • Monitor kidney and liver functions regularly while taking this medication.
  • This medication should not be used concurrently with tenofovir disoproxil fumarate or tenofovir disoproxil fumarate-containing products.

Storage Condition for Adefovir dipivoxil :

Store it in room temperature (25°C), and in an airtight container.

Trade Name / Brand Name :

India :

Adesera (10mg) | Adfovir | Adesera | Adheb

International :

Hepsera

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