Medication info
Tenofovir Tablets (Tenofovir Disoproxil Fumarate)

Tenofovir Tablets (Tenofovir Disoproxil Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Tenofovir Disoproxil Fumarate›300mg / 1 tablet
Manufacturer / importer
Korea Union Pharm Co., Ltd.
Appearance
Light blue almond-shaped film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201706821 · Approved 2017.08.25 · Insurance code 665507040

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who takes it
Adults · Children
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 For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine according to Table 1. No adjustment to the dosing interval is needed in patients with mild renal impairment (creatinine clearance 50-80mL/min). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a: ≥50 — Recommended interval for 300mg dose: every 24 hours Creatinine clearance (mL/min)a: 30-49 — Recommended interval for 300mg dose: every 48 hours Creatinine clearance (mL/min)a: 10-29 — Recommended interval for 300mg dose: every 72-96 hours Patients on hemodialysis — Recommended interval for 300mg dose: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions of approximately 4 hours each per week, administer once weekly. This medicine should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance less than 10mL/min who are not receiving hemodialysis; therefore, no dosing guidelines are 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. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: No data are available to support dose recommendations.

Ingredients

Manufacturer
Korea Union Pharm 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 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and above. However, it must not be taken with other combination products containing tenofovir disoproxil fumarate. Additionally, this medication is effective for the treatment of chronic hepatitis B and is particularly used in adults and children over 12 years of age. General precautions for its use must always be considered when treating chronic hepatitis B. This medication is used to treat HIV-1 infection and chronic hepatitis B.

How to take

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 For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine according to Table 1. No adjustment to the dosing interval is needed in patients with mild renal impairment (creatinine clearance 50-80mL/min). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a: ≥50 — Recommended interval for 300mg dose: every 24 hours Creatinine clearance (mL/min)a: 30-49 — Recommended interval for 300mg dose: every 48 hours Creatinine clearance (mL/min)a: 10-29 — Recommended interval for 300mg dose: every 72-96 hours Patients on hemodialysis — Recommended interval for 300mg dose: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions of approximately 4 hours each per week, administer once weekly. This medicine should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance less than 10mL/min who are not receiving hemodialysis; therefore, no dosing guidelines are 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. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: No data are available to support dose recommendations.

Precautions

This medication is used for the treatment of hepatitis B virus infection. Sudden discontinuation of this medication during treatment can lead to a rapid worsening of hepatitis; therefore, long-term medical observation is necessary even after discontinuation. Individuals who are allergic to any ingredient in this medication or have specific genetic metabolic disorders like lactose intolerance should not take this medication. Moreover, this medication must not be used in conjunction with other drugs that contain the same active ingredient or with certain specific medications, so it is essential to consult with healthcare providers. Patients with reduced kidney function may experience additional burden on their kidneys from this medication; thus, regular kidney function tests should be performed prior to and during treatment, and the dosing interval should be adjusted as needed. This medication can cause bone-related side effects, such as decreased bone density or osteomalacia in some patients, so those with bone health issues or risk factors should consider bone density testing. While taking this medication, side effects such as headache, diarrhea, nausea, fatigue, rash, and others may occur; if these symptoms are severe or persistent, medical advice should be sought. Pregnant women may use this medication as there is sufficient safety data regarding the fetus, but it should always be used according to a doctor’s instructions. Breastfeeding mothers are advised to avoid this medication as it may be excreted in breast milk and affect the baby. This medication should generally not be used in children under 12 years of age or weighing less than 35 kg due to insufficient evidence of safety and efficacy. Special attention should be given when administering this medication to elderly patients with reduced kidney function, and it's essential to inform healthcare providers about any concurrent medications due to potential interactions. In case of overdose, appropriate treatment should be initiated, and the patient's condition should be closely monitored, as the medication can be removed by hemodialysis. This medication must be stored at room temperature and kept out of reach of children, ideally in its original container.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • kidney dysfunction
  • bone pain
  • limb pain
  • fractures
  • muscle pain
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  • proximal tubular nephropathy
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • weakness
  • nausea
  • dizziness
  • abdominal pain
  • low back pain
  • dyspepsia
  • vomiting
  • lipodystrophy
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • rash reaction
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • nasopharyngitis
  • dizziness
  • nausea
  • vomiting
  • abdominal distension
  • loss of appetite
  • sweating
  • weight loss
  • pneumonia
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • muscle disease
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • elevated liver enzymes
  • weakness
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • urinary tract infection
  • gastroenteritis
  • shingles
  • septic shock
  • exacerbation
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • flank pain
  • spinal pain
  • sensory impairment
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic failure
  • hepatic fibrosis
  • hand fracture
  • febrile neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal dystrophy
  • graft-versus-host disease
  • hair loss
  • polycyclic erythema
  • hidradenitis
  • nail ingrowth
  • urticaria
  • fibromyalgia
  • herniated disc
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • gallbladder disease
  • cholecystitis
  • hepatic cyst
  • missed medication dosage
  • foreign body
  • humeral fracture
  • ligament sprain
  • sleep disorders
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureteral stones
  • anemia
  • splenomegaly
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • ocular motility disorders
  • conjunctival hyperemia
  • 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 prevent exposure to air, and it is best kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness.

Appearance and packaging

Appearance

Light blue almond-shaped film-coated tablets

Package unit

30 tablets/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.

Questions about this medicine

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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.