Tenovir Tablets (Tenofovir Disoproxil Fumarate)

Adult dosage

For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245 mg of tenofovir disoproxil) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. In patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. No adjustment of the dosing interval 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. Adjustment of dosing interval 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. 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 recommendations are available for these patients.

Children's dosage

Children aged 12 years and older (35kg or more): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245 mg of tenofovir disoproxil) 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: There are no data to support a dose recommendation.

This drug should be used cautiously in patients with liver dysfunction. Serious liver diseases may occur while taking this drug due to inflammation or fat accumulation in the liver, so the liver health condition should be checked regularly. Stopping treatment suddenly may increase the risk of hepatitis worsening, so it is essential to follow the physician's instructions when stopping. Since it may affect kidney function, regular kidney function tests before and during treatment are important. Patients with poor kidney function may require dose adjustments and should not take it with other drugs that may cause renal toxicity. This drug should not be combined with certain combinations or other antiviral agents, and patients co-infected with HIV and hepatitis B should use it under a specialized treatment plan. Bone mineral density reduction may occur, so patients at risk of fractures or with bone health issues should regularly check their bone health status and may take supplements if necessary. Changes in body fat distribution may occur, so careful monitoring of weight and body shape changes is recommended. In the process of immune recovery, inflammatory responses or autoimmune diseases may occur, so if any abnormal symptoms arise, immediate consultation with a physician is necessary. This drug should not be administered to patients with specific genetic metabolic disorders, and caution is needed in case of allergic reactions. During pregnancy, it should only be used if necessary and after consulting a physician, and breastfeeding mothers should avoid breastfeeding. Safety for children under 12 years has not been established, and it is advisable not to use it. For the elderly, careful management of dosages and conditions is essential considering the possibility of impaired liver and kidney function. Drug interactions may occur; therefore, if you are taking other medications, be sure to inform your physician or pharmacist. In the case of overdose, immediately contact a medical institution for appropriate treatment, and hemodialysis may be helpful. This drug should be kept out of reach of children and stored in its original container to maintain quality.

Severe hepatomegaly accompanied by lipidosis and fatty liver, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, kidney impairment, decreased bone density, fractures, osteomalacia, central obesity, nuchal fat expansion, peripheral wasting syndrome, facial wasting syndrome, breast enlargement, Cushing-like syndrome, immune reconstitution syndrome, autoimmune disease, early virological failure, rash, diarrhea, headache, pain, depression, asthenia, nausea, abdominal pain, low back pain, dyspepsia, vomiting, lipodystrophy, arthralgia, myalgia, insomnia, dizziness, peripheral neuropathy, anxiety disorder, pneumonia, fever, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, vertigo, decreased appetite, abdominal distension, sweating, weight loss, pneumonia, pancreatitis, increased amylase, hepatic steatosis, hepatitis, increased liver enzymes, rhabdomyolysis, muscle weakness, myopathy, acute tubular necrosis, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, deterioration of condition, dyspepsia, constipation, gastroesophageal reflux disease, ascites, urinary tract infection, gastroenteritis, herpes zoster, septic shock, hepatitis erythema, insomnia, pruritus, sensory loss, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, convulsions, cholelithiasis, hepatic cirrhosis, alcoholic sclerosis, hepatic insufficiency, hepatic fibrosis, bone fracture, fever-induced neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, sleep disorders, bladder dysfunction, urinary stones, dysuria, renal cysts, ureteral calculi, anemia, splenomegaly, decreased appetite, eating disorder, cough, rhinitis, upper respiratory cough syndrome, hypertension, conjunctival hemorrhage, ocular movement disorders, ocular congestion, benign prostatic hyperplasia

This drug may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1°C and 30°C. This ensures that the effectiveness and safety of the drug are maintained for a long time.

Appearance

Pale blue, almond-shaped film-coated tablet

Package unit

30 tablets/bottle