Donggwang Tenofovir 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. 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 guidelines are based on a model of single-dose pharmacokinetic data in patients with various degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis, who were not infected with HIV or HBV. As the safety and efficacy of these dosing interval adjustment guidelines have not been clinically evaluated in patients with moderate or severe renal impairment, 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 phosphorus (see Warning 3). Table 1 Dosing interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50: Recommended 300mg dosing interval every 24 hours Creatinine clearance (mL/min)a 30-49: Recommended 300mg dosing interval every 48 hours Creatinine clearance (mL/min)a 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. Calculated using ideal (lean body) weight. b. Administer once weekly, generally 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 dosing recommendations are available for these patients.

Child dose

Children aged 12 years or 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 dose recommendations.

This drug carries a risk of severe liver problems, so patients with any issues or risk factors related to liver health should exercise particular caution. If this medicine is suddenly discontinued, hepatitis may worsen, so liver condition should be closely monitored for an extended period after discontinuation. It may affect kidney function, thus regular kidney function tests should be conducted before and during treatment, and the interval of administration should be adjusted for patients with poor kidney function. This medication should not be taken with certain other medications, and if taken in combination, it is essential to consult healthcare professionals. Patients with both HIV and hepatitis B should not use this drug alone but should utilize it in conjunction with appropriate antiretroviral therapy. Bone density may decrease, so patients at risk of fractures or concerned about osteoporosis should receive a bone density test and consider taking calcium and vitamin D supplements if needed. Body fat distribution may change, and inflammatory reactions may occur during the recovery of the immune system, so any unusual symptoms should be reported to healthcare professionals immediately. This medication should not be administered to patients with specific genetic metabolic disorders, nor should it be used if there is an allergy to the ingredients. During pregnancy, it should only be used when absolutely necessary, and nursing mothers should avoid breastfeeding when taking this medication. The safety and efficacy in children under 12 years of age have not been established, so use is not recommended. Elderly patients may have different drug reactions due to impaired kidney function, so caution is advised. In case of overdose, it is crucial to visit a medical facility immediately for appropriate treatment, as this medication can be partially removed through hemodialysis. It is important to have regular blood tests and kidney and liver function assessments during the course of this medication to detect any abnormalities. When storing the medication, keep it out of reach of children and store it in its original container; transferring it to another container increases the risk of misuse or degradation in quality.

Severe hepatomegaly accompanied by cholestasis and steatosis, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, weakness, nausea, dizziness, dyspepsia, vomiting, lipodystrophy, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety, pneumonia, fever, abdominal pain, back pain, anorexia, abdominal distension, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, nausea, vomiting, abdominal distension, pneumonia, sweating, weight loss, dyspepsia, constipation, gastroesophageal reflux disease, ascites, urinary tract infection, gastroenteritis, herpes zoster, septic shock, hepatic steatosis, hepatitis, increased liver enzymes, rhabdomyolysis, osteomalacia, muscle weakness, myopathy, acute renal failure, acute tubular necrosis, proximal tubular dysfunction, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, allergic reactions, hypokalemia, hypophosphatemia, dyspnea, pancreatitis, increased amylase, hepatitis erythema, fracture, osteoporosis, flank pain, spinal pain, sensory loss, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, seizures, cholelithiasis, liver cirrhosis, alcoholic sclerosis, hepatic insufficiency, liver fibrosis, hand fractures, febrile neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, sleep disorders, bladder dysfunction, urolithiasis, dysuria, renal cysts, ureteral calculi, anemia, splenomegaly, thrombocytopenia, decreased appetite, eating disorders, cough, rhinitis, upper airway cough syndrome, hypertension, conjunctival hemorrhage, ocular motility disorders, conjunctival hyperemia, graft-versus-host disease

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is recommended to maintain room temperature between 1 degree and 30 degrees Celsius. This will help safely preserve the drug's efficacy.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle