Bivoclonadefovir Tablets 10 mg (Adefovir Dipivoxil)

Adult dose

Adults: Administer adefovir dipivoxil orally at a dose of 10 mg once daily, with or without food. Patients with renal impairment: Adjust the dosing interval in patients with a creatinine clearance of less than 50 mL/min. Creatinine clearance 50 or higher (mL/min)*: Dose 10 (mg), every 24 hours Creatinine clearance 30 ～ 49 (mL/min)*: Dose 10 (mg), every 48 hours Creatinine clearance 10 ～ 29 (mL/min)*: Dose 10 (mg), every 72 hours Patients on hemodialysis: Dose 10 (mg), every 7 days after dialysis * Creatinine clearance is 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 recommendations are available for these patients.

This medication must be taken at the recommended dosage and should not be taken in excess. Stopping treatment may lead to exacerbation of hepatitis, so liver function should be regularly checked for a period after discontinuation. Patients with significantly damaged liver function or cirrhosis should be closely monitored from the start of treatment, as exacerbation of hepatitis may occur. This medication may affect the kidneys, so patients with reduced kidney function or those taking medications that may burden the kidneys should carefully monitor kidney function. It is important to regularly check creatinine levels to evaluate kidney function through blood tests, and dosage adjustments may be necessary if kidney function declines. This medication must be prescribed only after confirming HIV infection status, and should be used in HIV-infected patients who are under appropriate antiviral therapy. Women who are pregnant or may become pregnant should use this medication cautiously considering its potential risks and should employ effective contraceptive methods simultaneously. Breastfeeding should be avoided while taking this medication. The safety and efficacy for children and adolescents have not been sufficiently established, and caution is required for use. Elderly patients may have a higher likelihood of reduced kidney function, requiring more careful monitoring during administration. In cases of overdose, symptoms should be closely monitored and appropriate treatment such as hemodialysis should be implemented if necessary. This medication does not appear to significantly affect the ability to drive or operate machinery, but caution is advised as individual differences may exist. When taking this medication alongside others that may affect kidney function, the possibility of interactions should be managed carefully. This medication should not be administered to patients with allergies or specific genetic issues such as lactose intolerance. This medication must be kept out of the reach of children and should not be transferred to other containers.

• Worsening hepatitis
• elevated serum ALT
• increased serum creatinine
• nephrotoxicity
• hypophosphatemia
• weakness
• headache
• fever
• abdominal pain
• nausea

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

Appearance

White to off-white round tablets

Package unit

30 tablets/bottle