Terabil Tablet (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. Patients with renal impairment Drug exposure was significantly increased when this drug 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 guidelines are based on a model using single-dose pharmacokinetic 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 guidelines have not been clinically evaluated in patients with moderate or severe renal impairment, closely monitor clinical response to treatment and renal function in these patients (see “3. Patients requiring careful administration, 1) Onset or worsening of renal impairment”). In patients with mild renal impairment, the dosing interval for this drug does not need to be adjusted (creatinine clearance 50-80mL/min); estimated creatinine clearance, serum phosphate, urine glucose, and urine protein should be monitored regularly (see “Patients requiring careful administration, 1) Onset or worsening of renal impairment”). 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 total dialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions of approximately 4 hours each per week, administer once weekly. This drug 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 of age 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. Pediatric patients under 35kg with chronic hepatitis B: Safety and efficacy have not been established. There are no data to support dose recommendations for pediatric patients with renal impairment.

This medication is an antiviral agent used in the treatment of hepatitis B virus infection. Discontinuing treatment can lead to a rapid worsening of hepatitis, so periodic testing is necessary for several months after stopping medication. This medication should not be taken by patients allergic to it or those with specific genetic lactose issues. Taking it in conjunction with other specific antivirals is prohibited, so it is necessary to consult with a physician. It may affect kidney function, and patients with kidney disease or at risk should have regular kidney function tests before and during treatment. Avoid using it with drugs that can cause nephrotoxicity, and immediately inform healthcare professionals if any kidney-related symptoms occur. This medication may also affect bone health, so patients at risk for osteoporosis or fractures should consider bone density tests, and consult a physician if experiencing bone or muscle pain. Common side effects reported in clinical trials include headache, diarrhea, nausea, fatigue, and rash, and severe adverse reactions should be promptly reported to healthcare professionals. It can be relatively safely used during pregnancy, but administration must be discussed with a physician, and breastfeeding should be avoided if nursing. The safety and efficacy of this medication have not been established in children under 12 years or weighing less than 35 kg. Elderly patients may respond differently to the medication due to impaired liver or kidney function, so caution is necessary. In case of overdose, immediate medical attention is required, and some removal is possible through hemodialysis. This medication should be stored at room temperature, kept away from children's reach, and stored in its original container to prevent degradation in quality.

• Hepatitis exacerbation
• hypersensitivity
• acute renal failure
• Fanconi syndrome
• hypophosphatemia
• renal impairment
• bone pain
• limb pain
• fractures
• muscle pain

This medication may be sensitive to air or humidity, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance

Light blue, almond-shaped film-coated tablets

Package unit

30 tablets/bottle