Compacteno 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. Patients with renal impairment For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this product as shown in Table 1. For patients with mild renal impairment, no adjustment to the dosing interval is necessary (creatinine clearance 50-80mL/min); regularly monitor the calculated estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein. Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a: ≥50 — Recommended interval for 300mg dose: every 24 hours Creatinine clearance (mL/min)a: 30-49 — Recommended interval for 300mg dose: every 48 hours Creatinine clearance (mL/min)a: 10-29 — Recommended interval for 300mg dose: every 72-96 hours Patients receiving hemodialysis — Recommended interval for 300mg dose: every 7 days or approximately 12 hours after dialysisb 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 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 of this product have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to support dose recommendations for pediatric patients with renal impairment.

This medication is used to treat hepatitis B virus. Abrupt discontinuation of this medication may cause a severe exacerbation of hepatitis, therefore, regular monitoring of liver status under a doctor's guidance must be done for several months after stopping treatment. Individuals with known allergies to this medication or certain genetic conditions such as lactose intolerance should not take it. Additionally, this medication should not be used in conjunction with certain other antiviral agents; therefore, concomitant use should be avoided. Patients with impaired kidney function should undergo kidney function testing before taking this medication, and should regularly monitor their kidney function during treatment. Due to the risk of nephrotoxicity, it should not be taken with medications that may burden the kidneys. This medication may also affect bone health, and if bone pain or muscle weakness occurs, immediate consultation with a doctor is necessary, and patients with low bone density should consider undergoing bone density testing. Patients allergic to Yellow No. 5 should exercise caution when taking this medication. Common side effects may include headache, diarrhea, nausea, fatigue, rash, etc., and if severe symptoms occur, immediate consultation with healthcare professionals is required. Pregnant or nursing women should consult with a doctor before taking this medication, especially while breastfeeding, it is advisable to avoid breastfeeding due to the risk of exposing the baby through breast milk. Children under 12 years of age or weighing less than 35 kg have not established safety and efficacy for this medication, and therefore should not use it. Elderly patients may have decreased liver and kidney function, so caution is required when taking this medication. In case of overdose, immediate medical attention should be sought for appropriate treatment, and this medication can be partially removed via hemodialysis. This drug should be stored at room temperature, away from the reach of children, and kept in its original container.

• Worsening of hepatitis
• acute renal failure
• Fanconi syndrome
• hypophosphatemia
• renal impairment
• bone pain
• limb pain
• fractures
• muscle pain
• muscle weakness

This medication should be stored in a sealed container to protect it from air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way helps ensure the drug's effectiveness is maintained safely.

Appearance

Light blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle