Tenofovir DF Tablets (Tenofovir Disoproxil Fumarate)

Adult dose

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300mg) once daily. 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, for patients with baseline creatinine clearance <50mL/min, the dosing interval for this medicine should be adjusted according to Table 1. These dosing-interval adjustment recommendations are based on pharmacokinetic modeling of single-dose data from patients with varying degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis, who were not infected with HIV or HBV. Since the safety and efficacy of these dosing-interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, clinical response to treatment and renal function should be closely monitored in these patients (see ‘3. Patients requiring careful administration: 1) Development or worsening of renal impairment’). No adjustment to the dosing interval of this medicine is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); calculated creatinine clearance estimates, serum phosphate, urine glucose, and urine protein should be monitored regularly (see ‘Patients requiring careful administration: 1) Development or worsening of renal impairment’). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a Patients receiving hemodialysis ≥50 30-49 10-29 Recommended dosing interval for 300mg Every 24 hours Every 48 hours Every 72-96 hours Every 7 days or approximately 12 hours after completion of dialysisb a. Calculated using ideal (lean) body weight. b. Generally, administer once weekly, 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 (300mg) once daily. It may be taken with or without food. The safety and efficacy have not been established in pediatric patients weighing less than 35kg with chronic hepatitis B. There are no data to recommend a dose for pediatric patients with renal impairment.

This medication is used for the treatment of hepatitis B virus infection. Sudden discontinuation of this medication can worsen hepatitis; hence, long-term medical supervision is necessary after stopping treatment. Patients who are allergic to this medication or its components should not take it. Additionally, patients with lactose intolerance or certain genetic disorders should avoid this medication. This medication should not be taken in combination with other drugs with the same or similar components, so caution is required regarding co-administration. Patients with impaired kidney function should have their kidney function tested frequently before and during treatment, as this medication may affect the kidneys. In cases of significantly reduced kidney function, dosage adjustments are necessary, and it is advisable not to take it alongside other medications that stress the kidneys. This medication may also impact bone health; thus, patients at risk for bone pain or fractures should regularly check their bone health status. During pregnancy, this medication should only be used when absolutely necessary, and breastfeeding mothers are advised to avoid breastfeeding to prevent drug transmission to the infant. Safety and efficacy in children under 12 years or weighing less than 35 kg have not been established. Elderly patients may have decreased liver and kidney function, requiring caution when taking this medication. Drug interactions with other medications may occur, so it is essential to inform the doctor or pharmacist of any other medications being taken. In cases of overdose, immediate medical attention is required, and this medication can be partially removed by hemodialysis. This medication should be stored at room temperature and kept out of reach of children. It is safer to keep the medication in its original container and not transfer it to another container.

• Worsening of hepatitis
• hypersensitivity
• acute renal failure
• Fanconi syndrome
• renal impairment
• bone pain
• limb pain
• fractures
• muscle pain
• proximal tubular dysfunction

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1°C and 30°C to preserve its effectiveness.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle