Medication info

Tenofovir Tablets (Tenofovir Disoproxil Fumarate)

Prescription medicationExpired
Ingredient · strength
Tenofovir Disoproxil Hemiedisylate›Strength being verified
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
Light blue almond-shaped film-coated tablets
Packaging
30 tablets per bottle
Approval status
Expired

MFDS item code 201801394 · Approved 2018.03.29

This product's status changed to Expired on 2023.03.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who uses it
Adults · Children
Adult dosage
Adults: For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this medicine by referring 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). Creatinine clearance ≥50mL/min: every 24 hours Creatinine clearance 30-49mL/min: every 48 hours Creatinine clearance 10-29mL/min: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysis. In general, 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 12 years of age or older (35kg or more): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. Pediatric patients with chronic hepatitis B who weigh less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dose recommendations.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B and HIV-1 infection

  • HIV-1 infection
  • chronic hepatitis B
View approved original text

This medication is used for the treatment of HIV-1 infection in adults and children over 12 years, in combination with other antiretroviral medications. However, it should not be taken together with other combination drugs containing tenofovir. It is also used for the treatment of chronic hepatitis B, and general precautions should be considered when initiating treatment. This medication is effectively used for the treatment of HIV-1 infection and chronic hepatitis B.

Dosage and Administration

Adult dosage

Adults: For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this medicine by referring 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). Creatinine clearance ≥50mL/min: every 24 hours Creatinine clearance 30-49mL/min: every 48 hours Creatinine clearance 10-29mL/min: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysis. In general, 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 12 years of age or older (35kg or more): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. Pediatric patients with chronic hepatitis B who weigh less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dose recommendations.

Precautions

This medication can put a significant strain on the liver, therefore, patients with liver disease or liver function problems should use it with particular caution. If symptoms of severe liver issues such as liver dysfunction, lactic acidosis, or steatosis occur, stop taking the medicine immediately. Continuing treatment should be monitored carefully for several months after stopping, as hepatitis may worsen. Since this drug is primarily excreted through the kidneys, patients with impaired kidney function should have regular kidney function tests before and during use. Patients with very low kidney function need to adjust the dosing interval and should avoid using this medication with other drugs that can strain the kidneys. Additionally, this medication should not be taken with certain other antiviral drugs, and patients co-infected with HIV and hepatitis B should only use it under the guidance of a specialist with appropriate combination therapy. Bone density reduction may occur, and patients at risk of fractures or with bone health issues should be tested for bone density and consider calcium and vitamin D supplements if necessary. Changes in body fat distribution or abnormalities in the immune system may occur, so consult with healthcare providers if unusual symptoms arise during treatment. This medication should not be used by patients with hypersensitivity or genetic issues such as lactose intolerance. Common side effects during treatment include headache, diarrhea, nausea, rash, and fatigue. If severe symptoms occur, immediately inform healthcare personnel. This medication should only be used during pregnancy if absolutely necessary, and breastfeeding mothers should avoid breastfeeding while taking this medication. Safety and efficacy in children under 12 years have not been established, so its use in this population is not recommended. Elderly patients should have their dosage adjusted and be monitored closely considering possible declines in kidney and liver function. In case of overdose, immediate medical attention is required, and the drug can be removed through blood dialysis. This medication should be kept out of reach of children and stored in its original container.

Side effects

Severe hepatomegaly accompanied by hyperlipidemia, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, decreased bone density, fractures, osteomalacia, muscle weakness, myopathy, central obesity, nuchal fat expansion, peripheral wasting syndrome, facial wasting syndrome, breast enlargement, Cushing-like syndrome, immune reconstitution syndrome, rash, diarrhea, headache, pain, depression, asthenia, nausea, dizziness, dyspepsia, vomiting, lipodystrophy, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety disorder, pneumonia, fever, abdominal pain, low back pain, chest pain, loss of appetite, abdominal distension, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, nausea, vomiting, abdominal discomfort, constipation, gastroesophageal reflux disease, ascites, urinary tract infection, gastroenteritis, herpes zoster, septic shock, weight loss, sensory loss, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, convulsions, cholelithiasis, cirrhosis, alcoholic sclerosis, hepatic failure, hepatic fibrosis, hand fractures, fever-induced neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, hair loss, erythema multiforme, sialadenitis, onychocryptosis, urticaria, fibromyalgia, herniated disc, osteoarthritis, limb pain, trigger finger, dementia, delirium, sleep disorders, bladder dysfunction, urolithiasis, dysuria, renal cyst, ureteric calculi, anemia, splenomegaly, hypertension, conjunctival hemorrhage, ocular motility disorders, ocular congestion, benign prostatic hyperplasia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Light blue almond-shaped film-coated tablets

Package unit

30 tablets per bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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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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.