Medication info
Tenofovir Tablets (Tenofovir Disoproxil Fumarate)

Tenofovir Tablets (Tenofovir Disoproxil Fumarate)

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

MFDS item code 202003605 · Approved 2020.05.18 · Insurance code 646005040

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 <50mL/min, adjust the dosing interval of this medicine by referring to Table 1. No adjustment to the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min) Table 1 Adjustment of dosing interval according to creatinine clearance ≥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 the total dialysis sessionb The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosage 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. Pediatric patients under 35kg with chronic hepatitis B: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dosage recommendations.

Ingredients

Manufacturer
Medika Korea 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 to treat HIV-1 infection in adults and children over 12 years of age, in combination with other antiretroviral medications. However, it is important not to take it with other combination products containing tenofovir. Additionally, this medication is also safely used for patients with chronic hepatitis B and is effective in treating chronic hepatitis B infection. It is essential to be familiar with the general precautions prior to starting treatment. Therefore, this medication is used for the treatment of 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 <50mL/min, adjust the dosing interval of this medicine by referring to Table 1. No adjustment to the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min) Table 1 Adjustment of dosing interval according to creatinine clearance ≥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 the total dialysis sessionb The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosage 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. Pediatric patients under 35kg with chronic hepatitis B: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dosage recommendations.

Precautions

This medication is used to treat hepatitis B virus infections. Hepatitis may worsen upon discontinuation, so it is necessary to carefully monitor liver status for several months after discontinuation. Do not take if you have an allergy to this medication or have certain genetic disorders. Caution is needed as it should not be taken in combination with certain other medications. Patients with impaired kidney function or at risk of kidney impairment should undergo regular kidney function tests while taking this medication. Particularly, the risk may increase if taken with medications that are nephrotoxic. It may also affect bone health, so patients at risk of osteoporosis or fractures may consider bone density testing and intake of calcium and vitamin D. This medication contains certain dyes, so patients allergic to these should take it cautiously. It is generally safe to use during pregnancy, but a doctor should be consulted during pregnancy. Nursing mothers should avoid breastfeeding as this medication may pass into breast milk. The safety and efficacy of this medication in children under 12 years of age or weighing less than 35 kg have not been established. Elderly patients over 65 years of age may have reduced kidney and liver function, so they should consult a doctor before use. In case of an overdose, seek medical attention immediately for necessary treatment, and this medication can be removed by blood dialysis. Store this medication at room temperature and keep it out of the reach of children, storing it in its original container for safety.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • renal impairment
  • bone pain
  • limb pain
  • fracture
  • muscle pain
Show 124 more
  • muscle weakness
  • decreased bone density
  • osteomalacia
  • arthralgia
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • fever
  • abdominal pain
  • lower back pain
  • dyspepsia
  • vomiting
  • steatosis
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • nasopharyngitis
  • loss of appetite
  • abdominal distension
  • sweating
  • weight loss
  • chest pain
  • pneumonia
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • rhabdomyolysis
  • acute renal failure
  • acute tubular necrosis
  • proximal tubular dysfunction
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • asthenia
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • rash
  • osteomalacia
  • muscle weakness
  • myopathy
  • acute renal failure
  • renal failure
  • elevated serum creatinine
  • progression of liver disease
  • hepatic erythema
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • abdominal distension
  • urinary tract infection
  • gastroenteritis
  • shingles
  • septic shock
  • asthenia
  • worsening condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • flank pain
  • sensory loss
  • cerebral infarction
  • diabetic neuropathy
  • metabolic brain disease
  • convulsions
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic insufficiency
  • hepatic fibrosis
  • hand fracture
  • febrile neutropenia
  • leukopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • nail ingrowth
  • urticaria
  • muscle fiber disease
  • herniated disc
  • osteoarthritis
  • limb pain
  • trigger finger
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureteral stone disease
  • anemia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • ocular motility disorder
  • eye 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 sealed container to prevent air and moisture exposure, and it is safe to store it at room temperature between 1 to 30 degrees Celsius. Therefore, it is important to avoid direct sunlight and not to store it in excessively hot or cold places to maintain the medication's efficacy.

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.