Tenofovir Bel Tablets (Tenofovir Disoproxil Aspartate)

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 medication was administered to patients with moderate to severe renal impairment. Therefore, for patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this medication according to Table 1. These dosing-interval adjustment recommendations are based on models using single-dose pharmacokinetic data from patients with varying 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, monitor renal function and clinical response to treatment closely in these patients (see Warning 3). No adjustment to the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); monitor calculated creatinine clearance and serum phosphate regularly (see Warning 3). Table 1. Dosing interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a Hemodialysis patients ≥50 30-49 10-29 Recommended interval for taking 1 tablet Every 24 hours Every 48 hours Every 72-96 hours Every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean) body weight. b. The dose is administered once weekly, generally assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours. This medication 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

Children 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. Children with chronic hepatitis B who weigh less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dose recommendations.

This medication is used for the treatment of hepatitis B, and stopping treatment may exacerbate hepatitis; therefore, regular monitoring of liver condition per physician's guidance is necessary even after cessation. Patients with allergies to this medication or its ingredients should not take it, nor should patients with certain genetic disorders such as lactose intolerance. Additionally, this medication should not be taken with certain other medications, so if you are taking any medicines, it is essential to inform your doctor or pharmacist. Patients with impaired kidney function should undergo kidney function tests before taking this medication and periodically monitor their kidney status during treatment, ensuring not to take it with drugs that may put additional strain on the kidneys. This medication may affect bone health, so patients with weak bones or a high risk of fractures should consider undergoing a bone density test, and if symptoms such as bone pain or muscle weakness occur, they should immediately consult a healthcare professional. Common side effects that may occur include headache, diarrhea, nausea, fatigue, and rash; severe abnormal symptoms should be reported to a doctor immediately. It is relatively safe for use during pregnancy, but pregnant or nursing mothers should always consult their doctor before taking it, particularly nursing mothers are advised to avoid breastfeeding while taking this medication. For children, safety and efficacy have only been established for those aged 12 and older and weighing more than 35 kg; therefore, children below these criteria should not take it. Elderly patients may have reduced kidney and liver function; special caution is necessary for them, and individuals with significantly low kidney function should adjust the dosing interval. In the case of overdose, it is crucial to visit a medical institution immediately for appropriate treatment, and this medication can be partially removed via hemodialysis. Finally, this medication should be stored at room temperature away from air and moisture, out of reach of children, and it is safest to keep it in its original container.

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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Doing so will help preserve the medication's effectiveness and safety.

Appearance

Pale blue almond-shaped film-coated tablets

Package unit

30 tablets/bottle