Tenorob 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. Drug exposure was significantly increased when this medication was administered to patients with moderate to severe renal impairment. Therefore, for patients with a baseline creatinine clearance of <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. The safety and efficacy of these dosing interval adjustment guidelines 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). In patients with mild renal impairment, no adjustment of the dosing interval is necessary (creatinine clearance 50-80mL/min); monitor calculated creatinine clearance and serum phosphate regularly (see Warning 3). Creatinine clearance (mL/min) ≥50: Recommended 300mg dosing interval every 24 hours Creatinine clearance (mL/min) 30-49: Recommended 300mg dosing interval every 48 hours Creatinine clearance (mL/min) 10-29: Recommended 300mg dosing interval every 72-96 hours Patients on hemodialysis: Recommended 300mg dosing interval every 7 days or approximately 12 hours after dialysisb a. Calculate using ideal (lean) body weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours. This medication 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

Children 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. Children with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: No data are available to support a dose recommendation.

This drug can cause serious liver problems, so particular caution is needed for women, obese individuals, and those who have used the drug for a long time. If signs of liver dysfunction occur during treatment, the medication must be discontinued immediately. Sudden discontinuation can worsen hepatitis, so regular medical observation for several months after stopping is required. It may affect kidney function, so regular kidney function tests should be conducted before and during treatment. Patients with weak kidney function may need adjusted dosing intervals and should not take it with other nephrotoxic medications. This drug should not be taken with certain other medications, so inform your doctor or pharmacist of any current medications. Patients co-infected with HIV and hepatitis B should not use this drug alone, but only as part of an appropriate combination therapy. Bone mineral density may decrease, increasing fracture risk, so individuals with a history of fractures or at risk should regularly check their bone health. Body fat distribution may change, so monitor for any changes in body. As the immune system recovers, inflammatory responses or autoimmune diseases may occur, so consult medical personnel if any abnormal symptoms appear. While taking this drug, viral suppression may not be optimal, so ensure to monitor treatment efficacy consistently and adjust treatment methods as necessary. Individuals allergic to this drug or with genetic lactose-related issues should not use it. This drug contains certain colorants, so those with allergies should be cautious. During pregnancy, consult with a doctor and take only if necessary, and lactating mothers should avoid breastfeeding. Children under 12 years old should not take it as safety and efficacy have not been established. Elderly patients may experience weakened liver, kidney, or heart function, so caution is necessary during use. In cases of overdose, contact a medical facility immediately, and in necessary cases, the drug can be removed via hemodialysis. The medication should be kept out of reach of children and stored in its original container.

Hepatomegaly associated with hyperlipidemia and dystrophy, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, asthenia, nausea, dizziness, vomiting, dyspepsia, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety, pneumonia, fever, abdominal pain, lower back pain, loss of appetite, abdominal distension, fatigue, sinusitis, upper respiratory tract infection, nasopharyngitis, nausea, vomiting, abdominal distension, pneumonia, weight loss, sweating, fractures, osteomalacia, muscle weakness, myopathy, acute tubular necrosis, hepatic steatosis, hepatitis, increased liver enzymes, rhabdomyolysis, renal failure, interstitial nephritis, nephrogenic diabetes insipidus, proteinuria, polyuria, allergic reactions, hypokalemia, hypophosphatemia, respiratory distress, pancreatitis, increased amylase, rash reaction, asthenia, febrile neutropenia, leukopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, dyspepsia, constipation, gastroesophageal reflux disease, ascites, urinary tract infection, gastroenteritis, herpes zoster, septic shock, deterioration of 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, cirrhosis, alcohol-induced sclerosis, liver failure, hepatic fibrosis, hand fracture, febrile neutropenia, thrombocytopenia, sleep disorders, bladder dysfunction, urolithiasis, dysuria, kidney cyst, ureterolithiasis, anemia, splenomegaly, hypertension, conjunctival hemorrhage, ocular movement disorders, ocular congestion, benign prostatic hyperplasia

This drug must be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature at room temperature between 1 and 30 degrees Celsius. This will help preserve the drug's efficacy over time.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle