Medication info

Adefavir Tablet 10 mg (Adefovir Dipivoxil)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Adefovir Dipivoxil›10mg / 1 tablet
Manufacturer / importer
Ildong Pharmaceutical Co., Ltd.
Appearance
White to off-white round tablet
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201003190 · Notified 2010.04.30

This product's status changed to Approval withdrawn on 2025.12.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic hepatitis B virus infection
Who takes it
Adults
Adult dose
1. Adults Administer 10 mg of adefovir dipivoxil orally once daily, regardless of meals. 2. Patients with renal impairment A significant increase in drug exposure was observed when this medication was administered to patients with renal impairment. Therefore, 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 safety and efficacy of these dosing-interval adjustment guidelines have not been clinically evaluated. Since they are based on data from patients who already had renal impairment at the start of treatment, it is not appropriate to apply these guidelines to patients who develop renal impairment during treatment with this medication. Therefore, closely monitor the clinical response and renal function of these patients. <Table> Dosing-interval adjustment guidelines for patients with renal impairment * Creatinine clearance was calculated using the Cockcroft-Gault method with lean body weight or ideal body weight. 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 guidelines are available for these patients.

Ingredients

Manufacturer
Ildong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B virus infection

  • Active viral replication
  • elevated serum aminotransferase levels
  • chronic hepatitis B virus infection
  • target-type liver function
  • non-target-type liver function
View approved original text

This medication is used for the treatment of chronic hepatitis B patients. It is particularly effective in cases where active viral replication has been confirmed, and serum aminotransferase levels have been continuously elevated or when active disease is confirmed by a biopsy. It applies to both HBeAg positive and negative patients, and also includes those with lamivudine resistance. It helps improve liver function and suppress viral activity.

How to take

Adult dose

1. Adults Administer 10 mg of adefovir dipivoxil orally once daily, regardless of meals. 2. Patients with renal impairment A significant increase in drug exposure was observed when this medication was administered to patients with renal impairment. Therefore, 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 safety and efficacy of these dosing-interval adjustment guidelines have not been clinically evaluated. Since they are based on data from patients who already had renal impairment at the start of treatment, it is not appropriate to apply these guidelines to patients who develop renal impairment during treatment with this medication. Therefore, closely monitor the clinical response and renal function of these patients. <Table> Dosing-interval adjustment guidelines for patients with renal impairment * Creatinine clearance was calculated using the Cockcroft-Gault method with lean body weight or ideal body weight. 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 guidelines are available for these patients.

Precautions

This medication should not be taken in excess of the recommended dose. Taking more than the recommended dose can result in serious health risks. After discontinuing treatment, there may be a worsening of hepatitis; thus, liver function should be regularly monitored for a period after stopping medication. If a worsening of hepatitis is detected, treatment can be resumed. Patients with already impaired liver function or advanced cirrhosis require careful monitoring of their liver status at the start of treatment and during treatment. This medication may affect the kidneys, so patients with normal kidney function are advised to undergo kidney function tests before treatment. Patients with poor kidney function or those taking other medications that may affect kidney function need to exercise greater caution. If kidney function deteriorates during treatment, dose adjustments may be necessary, so regular blood tests should be conducted to check kidney status. This medication should only be used after confirming the presence of HIV infection, and it is essential that patients with HIV infection receive HIV treatment first. If a patient requiring HIV treatment takes this medication alone, there is a risk of developing HIV resistance. This medication can rarely cause adverse effects such as lactic acidosis and severe hepatomegaly, so if any unusual symptoms occur, immediate consultation with a physician is necessary. Taking this medication does not reduce the risk of transmitting hepatitis B to others, so appropriate measures for infection prevention must continue. Pregnant women should take this medication only if absolutely necessary and under the guidance of a physician, as the effects on the fetus are not fully known; it is advisable to avoid use during breastfeeding. Safety and efficacy have not been sufficiently confirmed for children and adolescents, so use in this age group should be decided cautiously. Elderly patients may have decreased kidney function, so special caution is needed when taking this medication. Overdose may cause gastrointestinal disturbances, and if needed, the drug can be removed through hemodialysis. This medication should be kept out of reach of children and should not be transferred to other containers for safety. During treatment, symptoms such as headaches, fatigue, dyspepsia, nausea, abdominal pain, and diarrhea may occur, and healthcare professionals should be alerted if symptoms persist. This medication may affect kidney function, so additional caution is necessary when taken with other medications that affect the kidneys or in patients with existing kidney problems. It is important to regularly undergo blood tests and liver function tests during treatment to monitor health status.

Side effects

  • Worsening of hepatitis
  • elevated serum ALT
  • increased serum creatinine
  • decreased serum phosphorus
  • weakness
  • headache
  • fever
  • abdominal pain
  • nausea
  • vomiting
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  • bowel gas retention
  • diarrhea
  • indigestion
  • liver failure
  • hypophosphatemia
  • increased cough
  • pharyngitis
  • sinusitis
  • itching
  • rash
  • kidney failure
  • renal insufficiency
  • hematuria
  • elevated AST
  • increased creatine kinase
  • elevated amylase
  • diabetes
  • osteomalacia
  • myopathy
  • tubular interstitial disease
  • Fanconi syndrome
  • pancreatitis
  • liver neoplasm
  • increased sputum
  • cirrhosis
  • varices
  • fatigue
  • abnormal red blood cells
  • jaundice
  • ascites
  • resistance
  • proteinuria
  • dysuria
  • urethral disease
  • hypernitrogenemia
  • localized skin reaction
  • bone marrow hyperplasia
  • bone marrow suppression
  • splenomegaly

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it should be stored at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White to off-white round tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

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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.