Medication info
Hepsevir Tablet 10 mg (Adefovir Dipivoxil)

Hepsevir Tablet 10 mg (Adefovir Dipivoxil)

Prescription medicationTabletOral
Ingredient · strength
Adefovir Dipivoxil›10mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
White to grayish white round tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201508403 · Approved 2015.12.23

Summary

Main use
Treatment of chronic hepatitis B
Who takes it
Adults
Adult dose
Adults: Administer 10 mg of adefovir dipivoxil orally once daily, with or without food. Patients with renal impairment: In patients with a creatinine clearance of less than 50 mL/min, the dosing interval should be adjusted as shown in the table below. The pharmacokinetics of adefovir have not been evaluated in patients with a creatinine clearance of less than 10 mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B

  • Active viral replication
  • serum aminotransferase (ALT or AST) elevation
  • chronic hepatitis B virus infection
  • hepatic failure
  • non-hepatic failure
  • lamivudine resistant hepatitis B
View approved original text

This medication is used for the treatment of patients who are infected with chronic hepatitis B virus and have confirmed active viral replication. It is effective in cases where serum aminotransferase levels are continuously elevated or when active disease is confirmed in liver tissue. It can also treat patients with chronic hepatitis B virus, whether HBeAg positive or negative, as well as patients with lamivudine resistance. This drug treats chronic hepatitis B by improving liver function based on histological, virological, biochemical, and serological responses.

How to take

Adult dose

Adults: Administer 10 mg of adefovir dipivoxil orally once daily, with or without food. Patients with renal impairment: In patients with a creatinine clearance of less than 50 mL/min, the dosing interval should be adjusted as shown in the table below. The pharmacokinetics of adefovir have not been evaluated in patients with a creatinine clearance of less than 10 mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Precautions

This medication must be taken exactly as prescribed and should not exceed the recommended dosage. Abrupt discontinuation of treatment may lead to a serious exacerbation of hepatitis B; therefore, regular liver function tests should be performed for a certain period after discontinuation. Patients with severely impaired liver function or cirrhosis should monitor their liver status more closely at the beginning of treatment. This medication may affect kidney function; therefore, patients with renal disease or those at risk should undergo kidney function testing before use and continue to monitor renal function during treatment. Safety for patients with end-stage renal disease undergoing hemodialysis has not been fully confirmed. This medication should only be used after confirming HIV infection status, and patients infected with HIV should first receive appropriate antiviral treatment. Pregnant women should use this drug carefully, as the effects on the fetus are not fully known, and it should only be used when absolutely necessary. Breastfeeding women are advised to avoid breastfeeding while taking this medication. The safety for children and adolescents has not been fully established. Elderly patients may have reduced kidney and heart function, so caution is required during use. In case of overdose, immediately inform a healthcare professional, and if necessary, the drug can be removed through hemodialysis. This medication may interact with other drugs that affect kidney function; therefore, you must consult with your healthcare provider regarding concomitant medications. The effects on driving or operating machinery are not known, but no specific effects are anticipated. During treatment with this medication, liver function, kidney function, and blood test results should be monitored regularly, and any abnormal symptoms should be reported to a healthcare professional immediately.

Side effects

  • Worsening hepatitis
  • elevated serum ALT
  • increased serum creatinine
  • decreased serum phosphorus
  • weakness
  • headache
  • fever
  • abdominal pain
  • nausea
  • vomiting
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  • gastrointestinal air retention
  • diarrhea
  • liver failure
  • indigestion
  • elevated ALT and AST
  • abnormal liver function
  • hypophosphatemia
  • increased cough
  • pharyngitis
  • sinusitis
  • itching
  • rash
  • renal failure
  • kidney insufficiency
  • hematuria
  • elevated creatine kinase
  • elevated amylase
  • diabetes
  • osteomalacia
  • myopathy
  • tubular disorders
  • Fanconi syndrome
  • pancreatitis
  • liver neoplasm
  • increased sputum
  • fatigue
  • erythrocyte abnormalities
  • jaundice
  • ascites
  • resistance
  • dysuria
  • urethral disease
  • hypernitrogenemia
  • localized skin reactions
  • myelodysplasia
  • bone marrow suppression
  • splenomegaly

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1°C and 30°C at room temperature. This will help preserve the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

White to grayish white round tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.