Medication info
Hepcure Tablet 10 mg (Adefovir Dipivoxil)

Hepcure Tablet 10 mg (Adefovir Dipivoxil)

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

MFDS item code 201003206 · Notified 2010.04.30 · Insurance code 640005780

Summary

Main use
Treatment of chronic hepatitis B
Who takes it
Adults
Adult dose
Adults: The recommended dose of adefovir dipivoxil is 10 mg orally once daily, with or without food. Patients with renal impairment: In patients with a creatinine clearance of less than 50 mL/min, adjust the dosing interval 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
HK inno.N Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B

  • Active viral replication
  • elevated serum amino transferase
  • chronic hepatitis B virus infection
  • targeting liver function
  • non-targeting liver function
  • lamivudine resistant hepatitis B
View approved original text

This medicine is used in patients with chronic hepatitis B virus infection, where active virus replication and persistently elevated serum amino transferase (ALT or AST) levels or active disease confirmed by biopsy are noted. It effectively improves liver function in both HBeAg positive and negative chronic hepatitis B patients and patients with lamivudine resistance. The therapeutic effect is demonstrated based on virological, biochemical, histological, and serological responses. This helps to inhibit liver damage and slow the progression of the disease.

How to take

Adult dose

Adults: The recommended dose of adefovir dipivoxil is 10 mg orally once daily, with or without food. Patients with renal impairment: In patients with a creatinine clearance of less than 50 mL/min, adjust the dosing interval 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 at the recommended dosage and should not be exceeded. After stopping treatment, hepatitis may worsen, so liver function should be regularly monitored for a period after discontinuing the medication. Particularly, patients with compromised liver function or advanced cirrhosis should be carefully monitored for liver condition from the beginning of treatment. This medicine can affect the kidneys, so patients with impaired kidney function or those taking medications that may burden the kidneys should frequently check kidney function. Kidney function should be monitored through blood tests, and dosage adjustments may be necessary if needed. HIV infection status must be confirmed, and patients infected with HIV should use this medication in conjunction with appropriate antiviral therapy, not alone. Rarely, severe side effects such as lactic acidosis or hepatomegaly may occur, necessitating immediate consultation with healthcare professionals if unusual symptoms appear. During the use of this medication, care is needed to prevent the transmission of hepatitis B, and caution should be exercised to avoid infecting others. Women who are pregnant or may become pregnant must consult a specialist before taking this medication and should implement effective contraception if necessary. The safety and efficacy of this medication have not been established in children or adolescents and should be used cautiously in this population. Elderly patients are at higher risk for reduced kidney function, so care should be taken when administering the drug. In case of overdose, immediate medical attention is required, and blood dialysis can remove some of this medication. This medication should be kept out of reach of children and should not be transferred to other containers. Additionally, when taken with other medications that may affect kidney function, close monitoring for side effects is necessary.

Side effects

  • Worsening of hepatitis
  • elevated serum ALT
  • weakness
  • headache
  • fever
  • abdominal pain
  • nausea
  • vomiting
  • pneumatosis intestinalis
  • diarrhea
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  • liver failure
  • dyspepsia
  • elevated ALT and AST
  • abnormal liver function
  • hypophosphatemia
  • increased cough
  • pharyngitis
  • sinusitis
  • itching
  • rash
  • elevated creatinine
  • renal failure
  • impaired renal function
  • hematuria
  • elevated creatine kinase
  • elevated amylase
  • diabetes
  • osteomalacia
  • myopathy
  • proximal tubular disease
  • Fanconi syndrome
  • pancreatitis
  • liver neoplasm
  • increased sputum
  • cirrhosis
  • varices
  • fatigue
  • abnormal erythrocytes
  • jaundice
  • ascites
  • resistance
  • proteinuria
  • dysuria
  • urethral disease
  • hyperazotemia
  • 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 prevent air and moisture from entering. A storage temperature between 1 degree and 30 degrees Celsius at room temperature is recommended to maintain the drug's efficacy and safety for a long time.

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.