Medication info
Adefovir Dipivoxil Tablet 10 mg

Adefovir Dipivoxil Tablet 10 mg

Prescription medicationTabletOral
Ingredient · strength
Adefovir Dipivoxil›10mg / 1 tablet
Manufacturer / importer
Green Cross Corporation
Appearance
White to off-white round tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201003189 · Approved 2010.04.30 · Insurance code 643604550

Summary

Main use
Treatment of chronic hepatitis B
Who takes it
Adults
Adult dose
Adults: Administer 10 mg of adefovir dipivoxil orally once daily, regardless of meals. 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 guidelines are available for these patients.

Ingredients

Manufacturer
Green Cross Corporation

Efficacy & effects

Treatment of chronic hepatitis B

  • Active viral replication
  • elevated serum aminotransferases
  • chronic hepatitis B
  • target liver function
  • non-target liver function
  • lamivudine-resistant hepatitis B
View approved original text

This medication is used in patients with chronic hepatitis B virus infection confirmed by active viral replication and persistently elevated serum aminotransferase (ALT or AST) levels. It is also effective in cases where active disease is confirmed by histological examination. This drug is applicable for both HBeAg positive and negative chronic hepatitis B patients, and can be used in both target and non-target patients depending on the degree of liver function impairment. It is particularly suitable for treatment of chronic hepatitis B patients who have developed resistance to lamivudine. Therefore, it is used to treat chronic hepatitis B by improving liver function and viral activity based on comprehensive testing.

How to take

Adult dose

Adults: Administer 10 mg of adefovir dipivoxil orally once daily, regardless of meals. 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 guidelines are available for these patients.

Precautions

This medication must be taken at the recommended dosage, as exceeding the dosage may be dangerous. Stopping treatment may cause sudden worsening of hepatitis, so liver function should be regularly monitored for a certain period even after discontinuation. Patients with poor liver function or cirrhosis require careful observation from the start of treatment. This drug may affect the kidneys, hence patients with poor kidney function or those taking other medications that may affect the kidneys should use it with caution. It is important to routinely conduct kidney function tests before and during treatment. Patients who are infected with HIV should check their HIV status before using this medication, and if HIV treatment is necessary, proper treatment should be received first. Caution is advised when administering this drug to pregnant women, and women of childbearing potential should use effective contraception. It is advisable to avoid breastfeeding while taking this medication. The safety and effectiveness of this drug have not been adequately established in children, adolescents, and the elderly, thus caution is required. In case of overdose, consult medical personnel immediately, and take necessary measures such as blood dialysis if needed. This medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken. Furthermore, this medication does not completely eliminate the risk of hepatitis B transmission, so appropriate measures to prevent infection should continue. Keep out of reach of children, and avoid transferring to other containers.

Side effects

  • Worsening hepatitis
  • elevated ALT
  • increased serum creatinine
  • weakness
  • headache
  • fever
  • abdominal pain
  • nausea
  • vomiting
  • intestinal pneumatosis
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  • diarrhea
  • liver failure
  • dyspepsia
  • hypophosphatemia
  • increased cough
  • pharyngitis
  • sinusitis
  • itching
  • rash
  • renal failure
  • inadequate renal function
  • osteomalacia
  • bone pain
  • fractures
  • myopathy
  • proximal tubular disease
  • Fanconi syndrome
  • pancreatitis
  • cirrhosis
  • varices
  • fatigue
  • increased sputum
  • erythrocyte abnormalities
  • jaundice
  • ascites
  • resistance
  • proteinuria
  • dysuria
  • urethral disorder
  • hypernitrogenemia
  • localized skin reactions
  • myeloproliferation
  • 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 closed container to protect it from air and moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the drug and prevent deterioration.

Appearance and packaging

Appearance

White to off-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.