Teddyard Tablet (Tenofovir Disoproxil Fumarate)
Tenofovir Disoproxil Fumarate 300mg
Tablet · Prescription medication
Iyeon Pharmaceutical Co., Ltd.
MFDS item code 201903751 · Approved 2019.06.05
This product's status changed to Expired on 2024.06.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of chronic hepatitis B and HIV-1 infection
This medication is used alongside other antiretrovirals for the treatment of HIV-1 infection in adults and children aged 12 years and older. However, caution must be exercised to avoid co-administration with fixed-dose combinations containing tenofovir disoproxil fumarate. It is also used in the treatment of chronic hepatitis B in adults and children aged 12 years and older, and general precautions should be followed at the start of treatment. In summary, this drug is effectively used for the treatment of HIV-1 infection and chronic hepatitis B.
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, in patients with baseline creatinine clearance <50mL/min, adjust the dosing interval for this medicine according to Table 1. These dosing-interval adjustment guidelines are based on models of single-dose pharmacokinetic data 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 guidelines 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 phosphate (see Warning 3). Table 1 Dosing-interval adjustment 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 Recommended 300mg dosing interval a. Calculated using ideal (lean body) weight. b. Administer once weekly, generally 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 on hemodialysis; therefore, no dosing recommendations are available for these patients.
Children 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. Safety and efficacy have not been established in pediatric patients with chronic hepatitis B weighing less than 35kg. There are no data to recommend a dose for pediatric patients with renal impairment.
This medication may cause serious liver problems; therefore, patients at risk for liver disease should be particularly cautious. If treatment is discontinued, hepatitis may suddenly worsen, so regular monitoring as per physician's instructions is required even after stopping. It may affect kidney function; thus, kidney function tests should be conducted before and during treatment. The risk of side effects may increase when taken with other specific medications, so it is essential to inform your doctor of any other medications you are taking. Bone density may decrease, necessitating attention to bone health, and consult a physician if there is a risk of fractures. Changes in body fat distribution may occur; report any bodily changes to healthcare professionals. The immune system may react suddenly, leading to inflammation or autoimmune diseases, so inform your doctor immediately of any abnormal symptoms. Before using this drug, check for allergies or specific genetic diseases; if they exist, use should be avoided. Pregnant or breastfeeding women should only use this drug after consulting a doctor, especially during breastfeeding because the medication may be transferred to the baby. It is not used in children under 12 years, as safety has not been established. Elderly patients should be cautious when using this medication, as effects may change due to decreased kidney function. In case of overdose, seek medical attention immediately for appropriate treatment, and this drug can be partially removed through hemodialysis. Store out of reach of children, and keep in the original container for safety.
Severe hepatomegaly accompanied by fatty liver and lipomatosis, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, malaise, nausea, dizziness, dyspepsia, vomiting, lipodystrophy, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety disorder, pneumonia, fever, abdominal pain, low back pain, anorexia, abdominal distension, fatigue, sinusitis, upper respiratory tract infection, nasopharyngitis, dizziness, sweating, weight loss, pneumonia, allergic reaction, hypokalemia, hypophosphatemia, dyspnea, pancreatitis, increased amylase, hepatic steatosis, hepatitis, elevated liver enzymes, rhabdomyolysis, osteomalacia, muscle weakness, myopathy, acute tubular necrosis, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, malaise, fractures, decreased bone density, central obesity, posterior neck fat expansion, peripheral wasting, facial wasting, breast enlargement, Cushingoid features, immune reconstitution syndrome, autoimmune disease, early virological failure, rash reaction, nausea, vomiting, abdominal distension, insomnia, pruritus, fatigue, low back pain, skin rash, nausea, vomiting, abdominal distension, insomnia, pruritus, fever, rash, hair loss, erythema multiforme, sialadenitis, onychocryptosis, urticaria, myofibrillar myopathy, herniated disc, osteoarthritis, limb pain, trigger finger, sensory loss, cerebral infarction, dementia, diabetic neuropathy, metabolic encephalopathy, confusion, seizures, choledocholithiasis, gallbladder disease, cirrhosis, cholecystitis, alcoholic sclerosis, liver cysts, hepatic dysfunction, liver fibrosis, underdosing, foreign body, hand fractures, humeral fractures, ligament sprains, sleep disorders, bladder dysfunction, urinary stones, dysuria, renal cysts, ureteral calculi, anemia, febrile neutropenia, leukopenia, splenomegaly, thrombocytopenia, loss of appetite, eating disorders, cough, rhinitis, upper respiratory tract cough syndrome, hypertension, deep vein thrombosis, conjunctival hemorrhage, corneal degeneration, ocular movement disorders, conjunctival injection, graft-versus-host disease, benign prostatic hyperplasia
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to keep the efficacy and safety of the drug for a long time.
Light blue almond-shaped film-coated tablets
For domestic use - 30 tablets/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.