Tenofovir Disoproxil Fumarate Tablets

Adult dosage

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. 2. Patients with renal impairment Drug exposure was significantly increased when this product was administered to patients with moderate to severe renal impairment. Therefore, for patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this product with reference to Table 1. These dosing interval adjustment recommendations are based on models of single-dose pharmacokinetic data from patients with various 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 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 Warnings 3). No dosing interval adjustment is necessary for 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 ≥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 dialysisb a. Calculated using ideal (lean) body weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each per week. Administer this product 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, there are no dosing recommendations for these patients.

Children's dosage

Pediatric patients aged 12 years and older (35kg or more): 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 with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data on which to base dosing recommendations.

This drug may cause serious liver problems, so patients at risk of liver disease should exercise caution. Stopping this medication suddenly can increase the risk of hepatitis worsening, so close monitoring is required when stopping treatment under medical guidance. This drug is primarily excreted through the kidneys, so patients with impaired kidney function should regularly monitor their kidney function and adjust the dosing interval. Taking this medication with certain other specific drugs may increase the risk of side effects, so consultation with a doctor or pharmacist is essential. This medication should be used under a special treatment plan for patients who are co-infected with HIV and hepatitis B. Bone density may decrease, so patients with a risk of fractures should periodically check their bone health and take calcium and vitamin D supplements if necessary. Changes in body fat distribution may occur, so if there are noticeable changes in body shape, inform the healthcare provider. Immune reconstitution syndrome, where the immune system overly reacts, may occur, so immediate consultation with the medical staff should be sought if abnormal symptoms appear. This medication should not be administered to patients with specific genetic disorders, and caution is required in patients with a history of allergies. It should only be used during pregnancy if absolutely necessary, and breastfeeding mothers should avoid breastfeeding while taking this medication for safety. The safety and efficacy in children under 12 years of age have not been established, and it is generally advised not to use it in this age group. Elderly patients may have reduced liver and kidney function, so care should be taken when prescribing. In case of overdose, seek immediate medical attention for appropriate treatment; some of the drug may be removed through dialysis. This medication should be stored out of reach of children and kept in its original container to maintain its quality.

Severe hepatic steatosis accompanied by lipidosis, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, decreased bone density, fractures, osteomalacia, muscle weakness, neuromuscular disease, central obesity, posterior neck fat accumulation, peripheral wasting syndrome, facial wasting syndrome, breast enlargement, Cushingoid, immune reconstitution syndrome, autoimmune diseases, early virological failure, rash, diarrhea, headache, pain, depression, fatigue, nausea, dizziness, dyspepsia, vomiting, arthralgia, myalgia, insomnia, anxiety, pneumonia, fever, abdominal pain, low back pain, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, dizziness, fatigue, rash reaction, sweating, weight loss, loss of appetite, abdominal distension, decreased appetite, constipation, gastroesophageal reflux disease, ascites, gastric ulcer, gastritis, abdominal discomfort, chronic gastritis, epigastric discomfort, dry mouth, duodenal ulcer, hemorrhoids, intestinal metaplasia, portal hypertensive gastropathy, upper respiratory infection, gastroenteritis, Helicobacter infection, localized infection, periodontitis, dental pulpitis, septic shock, chest discomfort, worsening condition, feeling strange, feeling hot, granulomatous lesions, elevated alpha-1-fetoprotein, increased serum alkaline phosphatase, increased serum cholesterol, increased neutrophil count, decreased urine output, hair loss, erythema multiforme, salivary gland inflammation, ingrown toenails, urticaria, muscle fiber distribution, disc herniation, osteoarthritis, limb pain, trigger finger, sensory loss, cerebral infarction, dementia, diabetic neuropathy, metabolic encephalopathy, confusion, convulsions, cholelithiasis, gallbladder disease, liver cirrhosis, cholecystitis, alcoholic sclerosis, liver cysts, liver failure, liver fibrosis, missed drug dosage, foreign substance, hand fracture, humeral fracture, ligament sprain, sleep disorders, bladder dysfunction, urolithiasis, dysuria, renal cysts, ureteral calculi, anemia, febrile neutropenia, leukopenia, splenomegaly, thrombocytopenia, hypertension, deep vein thrombosis, conjunctival hemorrhage, corneal degeneration, ocular motility disorders, ocular congestion, graft-versus-host disease, benign prostatic hyperplasia

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain room temperature between 1 and 30 degrees Celsius. This will help to maintain the drug's efficacy and safety for an extended period.

Appearance

Light blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle