Bukwang Adefovir Tablets 10 mg (Adefovir Dipivoxil)

Adult dose

Administer 10 mg of adefovir dipivoxil orally once daily, regardless of meals. 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. 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.

This medication must be taken at the recommended dosage, and exceeding the dosage can be dangerous. Upon discontinuation of treatment, hepatitis may worsen; therefore, regular monitoring of liver function is necessary to carefully observe the condition. Patients with severe liver disease or cirrhosis require more careful management during and after treatment. This drug may affect kidney function, so patients with impaired kidney function or those taking other medications that may affect the kidneys must undergo frequent kidney function tests. The safety of this drug in patients with end-stage renal disease undergoing hemodialysis has not been thoroughly studied and caution is warranted. This medication should only be used after confirming HIV infection status, and patients with HIV infection require separate antiviral treatment. Severe hepatomegaly accompanied by lactic acidosis or steatosis may occur, so if related symptoms are suspected, immediate consultation with healthcare professionals is recommended. There is no evidence that this drug reduces the risk of hepatitis B transmission, therefore, additional preventive measures should be taken. Caution is necessary in patients with carnitine deficiency, and consultation with a professional is required when taking medications that may interact with this drug. Women who are pregnant or breastfeeding should be cautious when using this medication, and it is particularly advisable to avoid use during breastfeeding. The safety and efficacy in pediatric and adolescent populations have not been adequately established, so caution is advised when using this drug. Elderly patients should be evaluated for the potential for decreased kidney function before administration and monitored carefully. In the event of overdose, seek immediate medical attention for appropriate treatment, and dialysis may be used to remove this drug. This medication must be kept out of reach of children and should not be transferred to another container. During treatment, side effects such as headache, weakness, dyspepsia, abdominal pain, nausea, and others may occur; should symptoms be severe, notify healthcare professionals. Serious side effects such as nephrotoxicity, abnormal liver function, osteomalacia, musculoskeletal disorders may occur, necessitating regular monitoring. When coadministering with other nephrotoxic medications, careful monitoring for potential interactions is required. Regular blood tests and liver and kidney function tests should be conducted during the administration of this drug, and immediate consultation with healthcare professionals is required if any abnormalities are observed.

• Worsening hepatitis
• elevated ALT
• weakness
• headache
• fever
• abdominal pain
• nausea
• vomiting
• air in the gastrointestinal tract
• diarrhea

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Maintaining the storage temperature between 1 and 30 degrees Celsius is recommended to preserve the drug's efficacy for a longer duration.

Appearance

White or grayish-white round tablets

Package unit

30 tablets/bottle