Tenodi 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 increased significantly when this medicine was administered to patients with moderate to severe renal impairment. Therefore, in patients with baseline creatinine clearance <50mL/min, the dosing interval for this medicine should be adjusted according to Table 1. These dosing interval adjustment guidelines are based on a model of single-dose pharmacokinetic data from patients with various degrees of renal impairment who were not infected with HIV or HBV, including patients with end-stage renal disease requiring hemodialysis. Since the safety and efficacy of these dosing interval adjustment guidelines have not been clinically evaluated in patients with moderate or severe renal impairment, renal function and clinical response to treatment should be closely monitored in these patients (see Warning 3). No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); calculated creatinine clearance and serum phosphate should be monitored regularly (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. Generally, administer 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 dosing guidelines are available for these patients.

Child dose

Children 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 weighing less than 35kg. There are no data to support dosage recommendations for pediatric patients with renal impairment.

This medication can cause serious liver problems, so special caution is advised for women, individuals with obesity, or those who have been on medication for a long time. If liver dysfunction is suspected, stop taking the medication immediately. Discontinuation of this medication may worsen hepatitis, thus prolonged medical supervision is necessary after cessation. Since this drug is primarily excreted through the kidneys, individuals with renal impairment must undergo kidney function testing before and during treatment. Individuals with significantly impaired kidney function should adjust the dosing interval and should not take it concurrently with other drugs that may affect the kidneys. This medication should not be taken with certain other antivirals, so consult with a physician. Patients co-infected with HIV and hepatitis B should not use this medication alone and should receive appropriate combination therapy. Bone density may decrease, so individuals at risk of fractures or with bone health issues should regularly monitor their bone condition. Body fat distribution may change, so consult a physician if there are changes in body weight or shape. In the early stages of antiviral therapy, there may be excessive immune responses, so inform the physician immediately of any abnormal symptoms. If initial treatment is ineffective, it may be necessary to adjust the treatment method, making regular testing important. Individuals with certain genetic disorders or those with allergies to the ingredients should not take this medication. Care should be taken for those allergic to the coloring agent yellow 5. In pregnancy, it should be used only when absolutely necessary, and breastfeeding mothers should avoid nursing as the medication can be passed to the baby. The safety in children under 12 years has not been established, so caution is required in usage. Elderly patients may have reduced liver or kidney function, thus exercising more caution during use is advisable. In cases of overdose, seek medical attention immediately for appropriate treatment, as some drugs may be removed by hemodialysis. This medication should be kept out of reach of children and stored in its original container.

Hepatomegaly associated with hyperlipidemia and fatty liver disease, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, weakness, nausea, gastrointestinal disorder, dizziness, vomiting, indigestion, lipodystrophy, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety, pneumonia, fever, abdominal pain, low back pain, anorexia, abdominal distension, fatigue, sinusitis, upper respiratory infection, rhinitis, dizziness, nausea, vomiting, abdominal distension, pneumonia, rash response, sweating, weight loss, weight loss, increased alpha-1-fetoprotein, increased alkaline phosphatase in blood, increased blood cholesterol, increased neutrophil count, decreased urine volume, hair loss, erythema multiforme, sweat gland inflammation, nail ingrowth, hives, myofibrillar myopathy, herniated disc, osteoarthritis, limb pain, sensory loss, cerebral infarction, dementia, diabetic neuropathy, metabolic encephalopathy, confusion, seizures, cholelithiasis, gallbladder disease, cirrhosis, cholecystitis, alcoholic sclerosis, hepatic cyst, liver failure, hepatic fibrosis, missed drug dosage, foreign substance, hand fracture, humeral fracture, ligament sprain, sleep disorders, bladder dysfunction, urinary stones, dysuria, renal cyst, ureterolithiasis, anemia, febrile neutropenia, leukopenia, splenomegaly, thrombocytopenia, decreased appetite, eating disorders, cough, rhinitis, upper respiratory cough syndrome, hypertension, deep vein thrombosis, conjunctival hemorrhage, corneal degeneration, ocular movement disorder, ocular congestion, graft-versus-host disease, benign prostatic hyperplasia, pancreatitis, increased amylase, hepatitis, increased liver enzymes, rhabdomyolysis, osteomalacia, muscle weakness, myopathy, acute tubular necrosis, proximal tubular acidosis, interstitial nephritis, renal diabetes insipidus, increased creatinine, proteinuria, polyuria

This medication may be sensitive to air and moisture, thus it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help to maintain the effectiveness of the drug for a longer duration.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle