Hepateno Tablets (Tenofovir Disoproxil Hemihydrate)

Adult dose

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245mg of tenofovir disoproxil) 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 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 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. Because the safety and efficacy of these recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, closely monitor renal function and clinical response to treatment in these patients (see Warnings 3). No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); regularly monitor calculated creatinine clearance and serum phosphate (see Warnings 3). Table 1. Dosing-interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a Patients on hemodialysis ≥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. Usually administered once weekly, assuming 3 hemodialysis sessions of approximately 4 hours each per week. This medicine should be administered after dialysis is completed. Tenofovir pharmacokinetics have not been evaluated in patients with creatinine clearance less than 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 (at least 35kg): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245mg of tenofovir disoproxil) once daily. It may be taken with or without food. Pediatric patients weighing less than 35kg: Safety and efficacy have not been established in patients with chronic hepatitis B. Pediatric patients with renal impairment: No data are available to support dose recommendations.

This medication may cause a sudden worsening of hepatitis if treatment is stopped, so patients should continue to receive medical check-ups and tests for several months after discontinuation. Patients allergic to this drug or any of its components should not take it. Patients with hereditary lactose intolerance should not take this medication due to the lactose content. This medication should not be taken with other drugs containing tenofovir, especially with drugs containing adefovir. Patients with impaired kidney function must regularly have kidney function tests during and before taking this medication, and those with severely decreased kidney function must adjust the dosing interval. Caution is needed when taking this drug with other medications that may affect the kidneys, and it is advisable that patients who frequently take non-steroidal anti-inflammatory drugs (NSAIDs) do not use this medication. Patients with low bone density or at risk for osteoporosis should monitor their bone health status and consider calcium and vitamin D supplements if necessary. Patients allergic to dye components contained in this drug should use it cautiously. Side effects such as headache, diarrhea, nausea, fatigue, depression, and rash may occur during treatment; if symptoms are severe, consult a doctor. This drug can be taken during pregnancy if necessary, but women planning to become pregnant or nursing should consult a doctor, and breastfeeding should be avoided while on this medication. Safety and efficacy have not been established for pediatric patients under 12 years of age or weighing less than 35 kg. Elderly patients should take this medication cautiously due to differing drug responses caused by decreased kidney function. In case of overdose, consult medical personnel immediately and receive necessary treatment; this drug can be partially removed by hemodialysis. When storing, keep it in a tightly sealed container away from children and in its original packaging.

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

This drug should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to keep the medication in a cool, room temperature environment, specifically between 1 to 30 degrees Celsius.

Appearance

Pale blue almond-shaped film-coated tablets

Package unit

30 tablets/bottle