Donggu Tenofovir Disoproxil Fumarate Tablet

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, in patients with baseline creatinine clearance <50mL/min, adjust the dosing interval according to Table 1. No dosage 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. Dosage interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50: Recommended 300mg dosage interval, every 24 hours Creatinine clearance (mL/min)a 30-49: Recommended 300mg dosage interval, every 48 hours Creatinine clearance (mL/min)a 10-29: Recommended 300mg dosage interval, every 72-96 hours Patients on hemodialysis: Recommended 300mg dosage interval, 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. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosage 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. Pediatric patients weighing less than 35kg with chronic hepatitis B: Safety and efficacy have not been established. There are no data to support dosage recommendations for pediatric patients with renal impairment.

This medication may cause severe liver problems, so extra caution should be taken, especially for women, obese individuals, and those who have been using similar medications for a long time. If there are any suspected symptoms of liver abnormalities, discontinuation of the medication should be immediate. Stopping treatment abruptly may worsen hepatitis, so liver function should be regularly monitored for several months after stopping the medication. This medication is primarily excreted through the kidneys, so individuals with impaired kidney function should have their kidney function thoroughly checked before and during the use of this drug. If kidney function is severely reduced, the dosing interval should be adjusted, and it is advisable not to use it with other medications that may affect the kidneys. This medication should not be used together with certain combination products or other similar medications, and patients infected with both HIV and hepatitis B must use it under a specialized combination therapy plan. It may reduce bone mineral density, increasing the risk of fractures, so patients with a history of fractures or at risk of reduced bone density should undergo regular bone density tests. While on this medication, changes in body fat distribution may occur, and the immune system may become suddenly activated leading to inflammatory responses or autoimmune diseases. Initial treatment may not fully suppress the virus, so treatment efficacy should be carefully monitored. People who are allergic to this medication or have a genetic disorder related to carbohydrate metabolism should not take it. Those with allergies to specific pigments should also exercise caution. Common side effects that may occur during treatment include headache, diarrhea, nausea, depression, fatigue, and rash. It should only be used during pregnancy when necessary, and nursing mothers should avoid breastfeeding while taking this medication. The safety and efficacy in children under 12 years have not been established. Elderly patients should take care regarding the possibility of decreased liver and kidney function when taking this medication. In case of overdose, immediate consultation with healthcare providers is necessary, and this medication can be partially removed by hemodialysis. Keep this medication out of the reach of children and store it sealed in its original container.

Severe liver enlargement accompanied by fatty liver disease, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, weakness, nausea, dizziness, dyspepsia, vomiting, fatty infiltration, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety disorder, pneumonia, fever, abdominal pain, lower back pain, fatigue, sinusitis, upper respiratory infection, rhinopharyngitis, dizziness, fatigue, itching, abdominal distension, loss of appetite, pneumonia, sweating, weight loss, fracture, osteomalacia, muscle weakness, neuromuscular disease, acute tubular necrosis, hepatic steatosis, hepatitis, increased liver enzymes, rhabdomyolysis, renal failure, interstitial nephritis, nephrogenic diabetes insipidus, proteinuria, polyuria, allergic reactions, hypokalemia, hypophosphatemia, dyspnea, pancreatitis, elevated amylase, cholelithiasis, liver cirrhosis, alcoholic sclerosis, liver dysfunction, hepatic fibrosis, hand fracture, febrile neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, sleep disturbances, bladder dysfunction, urolithiasis, dysuria, renal cyst, ureteral stone disease, anemia, splenomegaly, thrombocytopenia, decreased appetite, eating disturbances, cough, rhinitis, upper respiratory cough syndrome, hypertension, conjunctival hemorrhage, ocular movement disorders, conjunctival hyperemia, benign prostatic hyperplasia, hair loss, erythema multiforme, sialadenitis, onychocryptosis, urticaria, muscle fiber involvement, herniated disc, osteoarthritis, limb pain, dementia, confusion, convulsions, cholecystitis, liver cyst, missed drug dosage, foreign substance, humeral fracture, ligament sprain, sensory loss, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, granuloma, weight loss, increased alpha1-fetoprotein, increased alkaline phosphatase in blood, increased blood cholesterol, increased neutrophil count, decreased urine output, metastatic brain tumor, liver neoplasm, skin papilloma

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it should be stored at room temperature, which is neither too hot nor too cold, ideally between 1°C and 30°C.

Appearance

Pale blue, almond-shaped film-coated tablets

Package unit

30 tablets/bottle