Initenofovir 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. Patients with renal impairment In patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. In patients with mild renal impairment, no adjustment of the dosing interval is necessary (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: 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 recommendations are available for these patients.

Child dose

Pediatric patients 12 years of age 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 have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to support dosage recommendations for pediatric patients with renal impairment.

This medication may cause serious problems with the liver, so special caution is needed for women, obese individuals, and those using it for extended periods. If there are signs of liver dysfunction or suspicion, the medication should be stopped immediately. Abrupt discontinuation of this medication may worsen hepatitis, so continuous monitoring of the condition as per a doctor's guidance is required even after stopping. It may put strain on the kidneys, so patients with reduced kidney function should undergo kidney function tests before and during use. It is safe to avoid taking this medication with other drugs affecting the kidneys. This medication should not be taken with certain combination products or similar ingredients. Patients co-infected with HIV and hepatitis B should not use this medication alone but should receive appropriate combination therapy. As bone density may decrease, patients with fracture risks or suspected osteopenia should undergo regular assessments of bone health. Changes in body fat distribution or immune reactions may occur, so consulting a doctor if abnormal symptoms are present is advised. It should only be used during pregnancy if necessary, and nursing mothers should avoid breastfeeding. The safety and efficacy in children under 12 years have not been established. Elderly patients over 65 years or those with severely reduced kidney function require special caution during use. During treatment with this medication, side effects such as headache, diarrhea, nausea, rash, etc., may occur, and they should inform a doctor if symptoms are severe or persist. There may also be potential interactions with other medications when taking this medication, so it is crucial to disclose any current medications. In the event of overdose, immediate hospital visit for appropriate treatment is recommended, and this medication can be partially removed through hemodialysis. Finally, this medication should be kept out of the reach of children and stored in the original container to maintain its quality.

Severe hepatomegaly accompanied by steatosis and hypertension, aggravated hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, weakness, nausea, mild to moderate gastrointestinal disturbances, dizziness, abdominal pain, lumbago, dyspepsia, vomiting, lipodystrophy, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety, pneumonia, fever, fatigue, sinusitis, upper respiratory tract infection, nasopharyngitis, vertigo, fatigue, sweating, weight loss, anorexia, abdominal distension, pneumonia, sensory impairment, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, seizures, cholelithiasis, liver cirrhosis, alcoholic sclerosis, hepatic insufficiency, hepatic fibrosis, hand fractures, febrile neutropenia, leukopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, pancreatitis, increased amylase, fatty liver disease, hepatitis, increased hepatic enzymes, rhabdomyolysis, osteomalacia, muscle weakness, myopathy, acute tubular necrosis, proximal tubular dysfunction, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, weakness, dyspepsia, constipation, gastroesophageal reflux disease, ascites, urinary tract infection, gastroenteritis, shingles, septic shock, chest discomfort, worsening condition, feeling strange, feeling hot, granulomatous lesions, increased alpha-1-fetoprotein, increased alkaline phosphatase in blood, increased blood cholesterol, increased neutrophil count, decreased urine output, metastatic brain tumors, hepatic neoplasms, skin papillomas, hair loss, erythema multiforme, sialadenitis, nail ingrowth, urticaria, myofibrosis, herniated disc, osteoarthritis, limb pain, trigger finger, dementia, confusion, cholecystitis, liver cysts, sleep disorders, bladder dysfunction, urinary stones, dysuria, renal cysts, ureteral calculi, anemia, splenomegaly, thrombocytopenia, decreased appetite, eating disorders, cough, rhinitis, upper respiratory cough syndrome, hypertension, conjunctival hemorrhage, ocular movement disorders, eye congestion, benign prostatic hyperplasia

This medication may be sensitive to air or moisture, so it should be kept in a sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. Proper storage can help preserve the medication's effectiveness for a long time.

Appearance

Light blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle