Medication info
Adeptin Tablets 10 mg (Adefovir Dipivoxil)

Adeptin Tablets 10 mg (Adefovir Dipivoxil)

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

MFDS item code 201003199 · Approved 2010.04.30 · Insurance code 645403400

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 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. 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
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B

  • Active viral replication
  • elevated serum aminotransferase levels
  • chronic hepatitis B
View approved original text

This medication is used in patients with chronic hepatitis B virus infection who have confirmed active viral replication, are experiencing continuously elevated serum aminotransferase levels, or show active disease in tissue biopsies. It is especially effective in the treatment of both HBeAg positive and negative chronic hepatitis B patients, as well as those with lamivudine-resistant hepatitis B. This medication helps improve liver function based on histological, virological, biochemical, and serological responses. Thus, it is used to treat liver function decline caused by chronic hepatitis B.

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 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. 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 must be taken strictly according to the recommended dosage, and should not exceed it. After stopping treatment, hepatitis may worsen, so liver function should be regularly checked and treatment should be resumed if necessary. Patients with significantly impaired liver function or cirrhosis must pay extra attention to monitoring their liver condition during and after treatment. This medication can affect the kidneys, so patients with poor renal function or those taking other medications that affect the kidneys should undergo frequent renal function tests. If kidney function declines, dosage adjustment may be necessary, and patients with very poor renal function should consult a doctor before using it. HIV infection status must be verified, and patients infected with HIV should not be treated with this medication alone but should receive appropriate antiviral therapy. During administration, serious side effects such as lactic acidosis or severe liver enlargement accompanied by steatosis may occur, so treatment should be immediately discontinued if these symptoms are suspected. Hepatitis B can still be transmitted to others while taking this medication, so precautions for infection prevention are necessary. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this medication and should use effective contraception methods. During breastfeeding, this medication may be transmitted through breast milk, so it is advisable to avoid breastfeeding. Safety in children and adolescents has not been established, and special caution should be taken in older adults due to the possibility of decreased renal function. In case of overdose, gastrointestinal disturbances may occur, and blood dialysis may be used to remove the drug if necessary. This medication should be stored out of the reach of children and should not be transferred to other containers.

Side effects

  • Worsening hepatitis
  • elevated serum ALT
  • increased serum creatinine
  • decreased serum phosphorus
  • weakness
  • headache
  • fever
  • abdominal pain
  • nausea
  • vomiting
Show 40 more
  • air in gastrointestinal tract
  • diarrhea
  • hepatic failure
  • dyspepsia
  • elevated ALT and AST
  • abnormal liver function
  • hypophosphatemia
  • increased cough
  • pharyngitis
  • sinusitis
  • itching
  • rash
  • renal failure
  • renal dysfunction
  • hematuria
  • elevated creatine kinase
  • elevated amylase
  • diabetes
  • osteomalacia
  • myopathy
  • proximal tubular disease
  • Fanconi syndrome
  • pancreatitis
  • liver neoplasm
  • cirrhosis
  • varices
  • fatigue
  • abnormal red blood cells
  • jaundice
  • ascites
  • resistance
  • increased sputum
  • proteinuria
  • dysuria
  • urethral disease
  • hyperazotemia
  • localized skin reactions
  • myeloproliferative disorder
  • bone marrow suppression
  • splenomegaly

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

Storage

This medication must be stored in a tightly sealed container to prevent air or moisture from entering, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help ensure the medication's efficacy is safely maintained.

Appearance and packaging

Appearance

White to grayish white round tablets

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.