Tenofovir Disoproxil Fumarate Tablets

Adult dose

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Patients with renal impairment For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. Creatinine clearance (mL/min)a ≥50: Take 1 tablet every 24 hours Creatinine clearance (mL/min)a 30-49: Take 1 tablet every 48 hours Creatinine clearance (mL/min)a 10-29: Take 1 tablet every 72-96 hours Patients on hemodialysis: Take 1 tablet every 7 days or approximately 12 hours after dialysisb No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); regularly monitor calculated creatinine clearance and serum phosphate (see Warning 3). a. Calculated using ideal (lean body) weight. b. Administer once weekly, assuming hemodialysis sessions of approximately 4 hours each, 3 times per week. This medicine should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Child dose

Pediatric patients 12 years and older (35kg or more): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: No data are available to recommend a dose.

This drug may cause a sudden worsening of hepatitis if treatment is interrupted; therefore, patients who stop treatment should undergo regular check-ups at the hospital for several months. Patients with hypersensitivity to this drug or specific genetic lactose metabolism disorders should not take it. This drug should not be used in conjunction with other tenofovir-containing drugs or adefovir. Patients with impaired kidney function should have kidney function tests before taking this drug and undergo regular testing during treatment. Caution is especially needed when taking other medications that may burden the kidneys. This drug may lower bone density, so patients at risk of osteoporosis should assess their bone health condition. If persistent pain in bones or muscles occurs, consult a healthcare professional immediately. Patients with a history of allergies should be cautious about the pigment ingredients in this drug. Common side effects include headache, diarrhea, nausea, fatigue, and rash; if symptoms are severe, consult a doctor. This drug is reportedly relatively safe during pregnancy; however, pregnant women must consult with a healthcare professional before taking it. Breastfeeding mothers are advised to avoid breastfeeding while taking this drug, as it may pass through breast milk to the baby. Safety and efficacy in children under 12 years of age or weighing less than 35 kg have not been established. Elderly patients may have decreased kidney and liver function, so caution is needed when taking it. In case of overdose, seek medical attention immediately; this drug can be partially removed via hemodialysis. Store this drug at room temperature and keep it out of reach of children. Additionally, during treatment, there may be interactions with other medications, so especially when used with didanosine, HIV protease inhibitors, hepatitis C treatments, and medications affecting the kidneys, it is essential to follow the healthcare professional's instructions.

• Worsening hepatitis
• hypersensitivity
• acute renal failure
• Fanconi syndrome
• hypophosphatemia
• bone pain
• limb pain
• fractures
• muscle pain
• proximal tubular injury

This drug should be stored in a sealed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1°C and 30°C. Therefore, it is important to avoid extremely hot or cold places and maintain proper temperature during storage.

Appearance

Light blue almond-shaped film-coated tablet

Package unit

30 tablets per bottle