Tenofovir Tablets (Tenofovir Disoproxil)

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. 2. Patients with renal impairment Drug exposure increased significantly when this medicine was administered to patients with moderate to severe renal impairment. Therefore, in patients with baseline creatinine clearance <50mL/min, adjust the dosing interval according to Table 1. These dosing interval adjustment recommendations are based on a model of single-dose pharmacokinetic data from patients with various degrees of renal impairment who were not infected with HIV or HBV, including patients with end-stage renal disease requiring hemodialysis. The safety and efficacy of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore, renal function and clinical response to treatment should be closely monitored in these patients (see Warning 3). No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); routinely monitor calculated creatinine clearance and serum phosphate (see Warning 3). Table 1. Dosing interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean body) weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each 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 aged 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 support dose recommendations.

This drug is used for the treatment of hepatitis B virus. If treatment is stopped, hepatitis may worsen, so health status must be carefully monitored for several months after discontinuation. It should not be used if there is an allergy to this medication or if there are certain genetic diseases such as lactose intolerance. Furthermore, it should not be taken with certain other medications, so it is crucial to inform healthcare providers about all medications being taken. It must be used with caution in patients with impaired kidney function, and regular kidney function tests should be conducted. Extra care is required when taking other medications that may affect the kidneys. It can also affect bone health, so patients with bone pain or fracture risks should consider a bone density test. It can be used during pregnancy if necessary, but consultation with a doctor is essential during pregnancy. Breastfeeding mothers are advised to avoid breastfeeding while taking this medication. Caution is needed when used in children and the elderly, especially in children under 12 years of age or children weighing less than 35kg, as safety and efficacy have not been established. In case of overdose, immediate medical attention should be sought, and this medication can be partially removed through hemodialysis. While taking this medication, the specified storage methods should be followed, and it must be kept out of reach of children. Additionally, changes in weight, blood sugar, blood lipids, etc., should be monitored during treatment, and if abnormal symptoms occur, immediate consultation with medical personnel is necessary.

• Hepatitis exacerbation
• acute renal failure
• Fanconi syndrome
• hypophosphatemia
• renal tubular damage
• bone pain
• limb pain
• fractures
• muscle pain
• proximal tubulopathy

This medication must be stored in a tightly sealed container to protect it from air or humidity. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle