Tenof Hepa 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 not known. For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this medicine as shown in Table 1. Creatinine clearance (mL/min)a ≥50: every 24 hours Creatinine clearance (mL/min)a 30-49: every 48 hours Creatinine clearance (mL/min)a 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or about 12 hours after dialysisb For patients with mild renal impairment, no adjustment of the dosing interval is needed (creatinine clearance 50-80mL/min); regularly monitor calculated creatinine clearance and serum phosphate (see Warning 3). a. Calculated using ideal (lean) body weight. b. Generally, administer once weekly, assuming three hemodialysis sessions of approximately 4 hours each per week. This medicine should be taken 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 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 who weigh less than 35kg. There are no data to recommend a dose for pediatric patients with renal impairment.

This drug can cause severe liver problems; therefore, caution is advised especially in women, obese patients, and those who have taken similar medications for a long time. If symptoms indicating liver dysfunction appear, the medication should be stopped immediately. Abrupt discontinuation of this medication can worsen hepatitis; hence, close monitoring by a physician is required for several months after discontinuation. It may affect kidney function, so regular kidney function tests should be done before and during treatment. Patients with significantly impaired kidney function need to adjust the dosing interval and should not take it with other drugs that affect the kidneys. This medication should not be combined with other drugs containing similar ingredients. Patients co-infected with HIV and hepatitis B should use this medication only under a specialized treatment plan. Bone density may decrease, so patients at risk for fractures or suspected osteoporosis should have their bone density checked, and calcium and vitamin D supplements may be beneficial. Patients should carefully monitor for abnormal distribution of body fat. In the process of immune system recovery, inflammatory responses or autoimmune diseases may occur; any unusual symptoms should be reported immediately. The efficacy of this medication alone or in specific combination therapies may be decreased, thus regular monitoring of viral loads during treatment is necessary. Patients with allergies to this medication or its components should not take it, and patients with genetic lactose intolerance should also avoid its use. Patients with a history of allergies should take this medication with caution due to its coloring agents. Common side effects during use include diarrhea, headache, nausea, fatigue, and rash; if symptoms are severe, consult a physician. It should only be used during pregnancy when absolutely necessary, and breastfeeding mothers should avoid nursing as the drug may pass to the baby. The safety and efficacy in children under 12 years of age have not been established. Elderly patients should be cautious when taking this medication, considering the possible decline in liver and kidney functions. In case of overdose, seek medical attention immediately for appropriate treatment, and some drugs may be removed by hemodialysis. This medication should be kept out of reach of children and not transferred to other containers.

hepatic enlargement accompanied by fatty liver, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, weakness, nausea, gastrointestinal disorders, dizziness, vomiting, indigestion, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety, pneumonia, fever, abdominal pain, low back pain, decreased appetite, abdominal distension, sweating, weight loss, sinusitis, upper respiratory tract infection, nasopharyngitis, dizziness, fatigue, pruritus, steatosis, fracture, decreased bone density, osteomalacia, muscle weakness, myopathy, allergic reaction, hypokalemia, hypophosphatemia, shortness of breath, pancreatitis, increased amylase, hepatic steatosis, hepatitis, increased liver enzymes, rhabdomyolysis, acute tubular necrosis, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, febrile neutropenia, leukopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, sleep disorders, bladder dysfunction, urolithiasis, dysuria, renal cyst, ureterolithiasis, anemia, splenomegaly, thrombocytopenia, decreased appetite, eating disorders, cough, rhinitis, upper respiratory tract cough syndrome, hypertension, conjunctival hemorrhage, ocular motility disorders, conjunctival hyperemia, benign prostatic hyperplasia, hair loss, erythema multiforme, sialadenitis, onychocryptosis, urticaria, muscle fiber disease, herniated disc, osteoarthritis, limb pain, trigger finger, sensory impairment, cerebral infarction, dementia, diabetic neuropathy, metabolic encephalopathy, confusion, seizures, cholelithiasis, gallbladder disease, cirrhosis, cholecystitis, alcoholic sclerosis, liver cyst, liver failure, liver fibrosis, missed drug dosage, foreign material, hand fracture, humeral fracture, ligament sprain, chest discomfort, worsening condition, feeling strange, feeling hot, granulomatous lesions, weight loss, increased alpha-1-fetoprotein, increased alkaline phosphatase in blood, increased blood cholesterol, increased neutrophil count, decreased urine output, metastatic brain tumor, liver neoplasm, skin papilloma, osteoporosis, arthralgia, flank pain, sensory impairment, cerebral infarction, diabetic neuropathy, seizures, cholelithiasis, gallbladder disease, sleep disorders

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle