Tenofecton Tablets (Tenofovir Disoproxil Hemifumarate)

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. In patients with mild renal impairment, no dose interval adjustment is necessary (creatinine clearance 50-80mL/min). Regularly monitor the estimated creatinine clearance and serum phosphate (see Warning 3). Table 1. Dose interval adjustment based on 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 hemodialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours, administer once weekly. This medicine should be administered after hemodialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance <10mL/min who are not receiving hemodialysis; therefore, no dosage 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. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to provide dosage recommendations for pediatric patients with renal impairment.

This medication is used for the treatment of hepatitis B, and discontinuation can lead to severe exacerbation of hepatitis; therefore, the liver condition must be carefully monitored for an extended period even after discontinuation. Patients who have an allergy to this medication or certain hereditary lactose metabolism disorders should not be administered this drug. As this drug is excreted through the kidneys, patients with impaired kidney function should undergo renal function tests before taking the medication and should have their renal status regularly checked during treatment. Special caution is needed when taken with other medications that may affect kidney function, and concomitant use with certain drugs is contraindicated. This medication may affect bone health, so patients with low bone density or a risk of fractures should consider bone density testing, and if symptoms such as bone pain or muscle weakness occur, they should consult a healthcare professional immediately. Additionally, this drug contains the dye Yellow No. 5, and patients with allergies to it should exercise caution. It is known that this medication does not pose a significant risk to the fetus during pregnancy; however, it should be discussed with a healthcare professional if used during pregnancy. Breastfeeding mothers are advised to avoid nursing as the drug may be secreted into breast milk. The safety and efficacy of this drug have not been established in children under 12 years of age or weighing less than 35 kg. Elderly patients should take caution during use due to the potential for reduced kidney and other organ functions. In case of overdose, contact a medical institution immediately to receive appropriate treatment, as some medications can be removed through blood dialysis. When storing, it should be kept at room temperature and kept out of reach of children, ensuring it is tightly closed in its original container. There may be interactions with certain medications, so if taking other drugs, it is essential to inform the healthcare provider.

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

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius. This will help keep the drug effective for a longer period.

Appearance

Light blue almond-shaped film-coated tablets

Package unit

30 tablets/bottle