Tenofovir 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. 2. Patients with renal impairment Drug exposure was significantly increased when this medicine was administered to patients with moderate to severe renal impairment. Therefore, for patients with baseline creatinine clearance <50mL/min, adjust the dosing interval according to Table 1. These dosing-interval adjustment recommendations are based on a model using pharmacokinetic data for single doses in patients with various 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, closely monitor renal function and clinical response to treatment in these patients (see Warning 3). No dosing-interval adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); regularly monitor calculated creatinine clearance and serum phosphate (see Warning 3). Table 1 Dosing-interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50 30-49 10-29 Recommended interval for 300mg doses Every 24 hours Every 48 hours Every 72-96 hours 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 below 10mL/min who are not receiving hemodialysis; therefore, no dosing 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 (300mg) once daily. 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 recommend a dose for pediatric patients with renal impairment. Patients receiving hemodialysis Every 7 days or approximately 12 hours after dialysisb

This drug may pose a risk of severe liver problems, especially for women or individuals who are obese, so liver health should be monitored closely. If any abnormal liver symptoms are suspected, stop taking this drug immediately. Sudden discontinuation of treatment may exacerbate hepatitis, so regular liver condition checks should continue even after cessation. This drug is predominantly eliminated through the kidneys; therefore, patients with impaired kidney function should regularly check their renal function and adjust the dosage if necessary. The risk of side effects may increase when taken with certain other medications, so concurrent use must be discussed with healthcare professionals. This drug should be used alongside specialized antiretroviral therapy for patients who are simultaneously infected with HIV and hepatitis B, and an HIV test is recommended before starting treatment. Bone density may decrease, increasing the risk of fractures, so patients with a history of fractures or at risk should undergo bone density testing. There may be changes in body fat distribution, so weight and body shape changes should be monitored closely. In the process of immune recovery, inflammatory responses or autoimmune diseases may occur, so symptoms should be carefully monitored during the early stages of treatment. Patients with allergies to this drug or lactose intolerance should not take it, and caution is advised for those with allergies to certain dyes. During pregnancy, this drug should only be used when absolutely necessary, and breastfeeding mothers are advised to avoid nursing. Its safety and efficacy for children under 12 have not been established, and elderly patients may require closer monitoring due to possible reduced liver and kidney function. In cases of overdose, professional treatment is necessary, and hemodialysis may help remove the drug. This drug should be kept out of the reach of children and stored in its original container.

Severe hepatomegaly accompanied by fatty liver and metabolic disorders, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, weakness, nausea, dizziness, vomiting, dyspepsia, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety disorder, pneumonia, fever, abdominal pain, lumbar pain, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, loss of appetite, abdominal distension, sweating, weight loss, pruritus, fracture, osteomalacia, muscle weakness, myopathy, acute tubular necrosis, hepatitis, increased liver enzymes, rhabdomyolysis, renal failure, interstitial nephritis, nephrogenic diabetes insipidus, proteinuria, polyuria, allergic reaction, hypokalemia, hypophosphatemia, dyspnea, pancreatitis, increased amylase, hepatic steatosis, rash reaction, weakness, dyspepsia, constipation, gastroesophageal reflux disease, ascites, urinary tract infection, gastroenteritis, herpes zoster, septic shock, worsening condition, increased ALT, increased AST, hepatocellular carcinoma, metastatic brain tumor, osteoporosis, flank pain, spinal pain, sensory impairment, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, seizures, cholelithiasis, liver cirrhosis, alcoholic sclerosis, liver failure, liver fibrosis, hand fracture, febrile neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, hair loss, erythema multiforme, sialadenitis, ingrown toenails, urticaria, fibromyalgia, herniated disc, osteoarthritis, limb pain, trigger finger, dementia, confusion, cholecystitis, hepatic cyst, gallbladder disease, missed drug dosage, foreign body, humeral fracture, ligament sprain, sleep disorders, bladder dysfunction, urinary stones, dysuria, renal cyst, ureterolithiasis, anemia, splenomegaly, decreased appetite, eating disorders, cough, rhinitis, upper respiratory cough syndrome, hypertension, conjunctival hemorrhage, ocular motility disorder, conjunctival hyperemia, benign prostatic hyperplasia

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness over time.

Appearance

Light blue almond-shaped film-coated tablet

Package unit

For domestic use - 30 tablets/bottle