Hepareed 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 was significantly increased when this medicine was administered to patients with moderate to severe renal impairment. Therefore, for patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval according to Table 1. These dosing-interval adjustment recommendations are based on pharmacokinetic modeling data for a single dose in patients with varying degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis, who were not infected with HIV or HBV. Since the safety and efficacy of these dosing-interval adjustment recommendations 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 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 phosphorus (see Warning 3). Table 1. Dosing-interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a Patients on hemodialysis ≥50 30-49 10-29 Recommended dosing interval for 300mg Every 24 hours Every 48 hours Every 72-96 hours Every 7 days or approximately 12 hours after completion of 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 recommendation is 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. Children weighing less than 35kg with chronic hepatitis B: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data on which to base a dose recommendation.

This medication can cause serious liver issues; therefore, female patients at risk of liver disease or those using it long-term should be particularly cautious. If treatment is suddenly discontinued, hepatitis may worsen; therefore, regular assessments of the condition should be performed according to the physician's instructions, even after discontinuation. Since it may affect kidney function, kidney function tests must be conducted prior to and during treatment, and dosing intervals should be adjusted for patients with impaired kidney function. Taking this medication with certain other drugs may increase the risk of side effects; thus, medications that are contraindicated for co-administration should not be taken together. Patients co-infected with HIV and hepatitis B should not use this drug alone, but should receive appropriate combination therapy. Bone density may decrease, so patients at risk of fractures should regularly check their bone health and consider calcium and vitamin D supplementation if necessary. Changes in body fat distribution may occur, so weight and body shape changes should be monitored. During the recovery of the immune system, inflammatory responses or autoimmune diseases may arise; immediate consultation with a physician is advised if any abnormal symptoms occur. During the initial treatment, the virus may not be adequately suppressed; hence, the effectiveness of the treatment should be evaluated periodically, and treatment plans should be adjusted as necessary. Patients with allergies to this medication or its components or those with certain genetic metabolic disorders should not use it. Patients allergic to certain dyes should use it with caution. It should be used only when necessary during pregnancy, and breastfeeding mothers should avoid nursing while taking this medication. Safety and efficacy have not been established for children under 12 years of age, so it is not used in this group. Elderly patients should take it with caution considering the possibility of decreased kidney and liver function. In case of overdose, immediately inform medical personnel and seek treatment such as hemodialysis if necessary. This medication should be kept out of reach of children and stored in its original container.

Hepatomegaly with associated hepatic steatosis, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, asthenia, nausea, gastrointestinal disturbances, dizziness, vomiting, indigestion, arthralgia, myalgia, insomnia, anxiety, pneumonia, fever, abdominal pain, low back pain, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, nausea, abdominal distension, loss of appetite, sweating, weight loss, steatorrhea, peripheral neuropathy, pneumonia, decreased bone density, fractures, osteomalacia, muscle weakness, myopathy, allergic reactions, hypokalemia, hypophosphatemia, shortness of breath, pancreatitis, elevated amylase, hepatic steatosis, increased liver enzymes, rhabdomyolysis, acute tubular necrosis, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, asthenia, indigestion, constipation, gastroesophageal reflux disease, ascites, abdominal distension, urinary tract infection, gastroenteritis, shingles, septic shock, worsening condition, increased ALT, increased AST, hepatocellular carcinoma, metastatic brain tumor, osteoporosis, flank pain, back pain, sensory impairment, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, seizures, cholelithiasis, cirrhosis, alcoholic sclerosis, hepatic insufficiency, hepatic fibrosis, hand fractures, febrile neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, hair loss, erythema multiforme, sialadenitis, onychocryptosis, urticaria, myofascial pain, herniated disc, osteoarthritis, limb pain, trigger finger, dementia, confusion, sleep disorders, bladder dysfunction, urolithiasis, dysuria, renal cysts, ureterolithiasis, anemia, splenomegaly, hypertension, conjunctival hemorrhage, oculomotor disorders, conjunctival congestion, benign prostatic hyperplasia

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance

Pale blue almond-shaped film-coated tablets

Package unit

30 tablets/bottle